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Manuscript Accepted Early View Article Early View Article: Online published version of an accepted article before publication in the final form. Journal Name: Edorium Journal of Disability and Rehabilitation Type of Article: Review Article Title: Scoping review of the development of artificial eyes throughout the years Authors: Holly Chinnery, Simon B N Thompson, Siamak Noroozi, Bryce Dyer doi: To be assigned Early view version published: September 24, 2016 How to cite the article: Chinnery H, Thompson SBN, Noroozi S, Dyer B. Scoping review of the development of artificial eyes throughout the years. Edorium Journal of Disability and Rehabilitation. Forthcoming 2016. Disclaimer: This manuscript has been accepted for publication. This is a pdf file of the Early View Article. The Early View Article is an online published version of an accepted article before publication in the final form. 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Manuscript Accepted 1 Early View Article TYPE OF ARTICLE: Review Article 2 3 TITLE: Scoping review of the development of artificial eyes throughout the years 4 5 AUTHORS: 6 Holly Chinnery1, Simon B N Thompson2, Siamak Noroozi3, Bryce Dyer4 7 8 9 AFFILIATIONS: 1 (BSc (Hons), MSc, PG Cert), Post-graduate Researcher, Psychology Research 10 Centre, Faculty of Science & Technology, Bournemouth University, Poole, UK, 11 [email protected] 12 2 (BA (Hons), MPhil, PhD, PhD, PGDIS, PGCLTHE, PGCRDS, PFMBNS, MARB, 13 MNYAS, FRSA, SFHEA), Associate Professor of Clinical Psychology and 14 Neuropsychology, Psychology Research Centre, Faculty of Science & Technology, 15 Bournemouth University, Poole, UK, [email protected] 16 3 (MEng, PhD), Director of Design simulation Research Centre, Faculty of Science 17 and Technology, Department of Design and Engineering, , Bournemouth University, 18 Poole, UK, [email protected] 19 4 (BA (Hons, MSc, PhD), Head of Research & Professional Practice and Principal 20 Academic, Faculty of Science and Technology, Department of Design and 21 Engineering, , Bournemouth University, Poole, UK, [email protected] 22 23 CORRESPONDING AUTHOR DETAILS 24 Holly Chinnery 25 P104, Poole House, Psychology Research Centre, Faculty of Science & Technology 26 Talbot Campus, Fern Barrow, Poole Dorset UK BH12 5BB 27 Email: [email protected] 28 29 30 Short Running Title: Development of artificial eyes Manuscript Accepted Early View Article 31 Guarantor of Submission: The corresponding author is the guarantor of 32 submission. 33 34 35 36 37 38 39 40 41 42 43 44 45 46 47 48 49 50 51 52 53 54 55 56 57 58 59 60 61 Manuscript Accepted Early View Article 62 SUMMARY 63 Research into the development of prosthetics still focuses on factors that either 64 facilitate or impede the physical adjustment of the prosthetic. Little consideration has 65 been given to the continual progression of their design and the psychosocial impact 66 that wearing a prosthetic has on the patient. 67 enhance the outcome not only for the patient, but for practitioners as well. 68 With the design, manufacturing and fitting process of artificial eyes remaining the 69 same since the 1960’s, an understanding of its development in order to improve its 70 current form is needed. A better designed artificial eye will not only have physical 71 benefits for the wearer, but also psychological benefits where the way the wearer 72 thinks about themselves and their artificial eye, as well as their perceptions of what 73 others think about them, will lead to better adjustment and improved wellbeing. 74 In order to assess how artificial eyes can be improved, a scoping review of the 75 development of artificial eyes was undertaken. It is envisioned that this review will 76 help identify future research and development in order to create better outcomes for 77 practitioners and artificial eye wearers alike. 78 Thirty-eight articles were included in the review, 73% of which were qualitative in 79 nature. 80 The scoping review found good documentation of the history and current 81 manufacturing process of artificial eyes. However, research into the psychological 82 impact of artificial eye wearers is sparse. Changes to the current manufacturing 83 process have largely been ocularist led with various impression techniques being 84 developed. Patients with artificial eyes and/or facial disfigurement have higher levels 85 of anxiety and depression than the general population leading to maladaptive coping 86 mechanisms and reduced emotional wellbeing. 87 Explanations for the lack of development in this field include: the small population 88 which can affect funding grants; technology not yet able to produce the required 89 results; availability of resources and research being focused on the disease rather 90 than the secondary effects. 91 92 Understanding such factors will Manuscript Accepted 93 Early View Article TITLE: Scoping review of the development of artificial eyes throughout the years. 94 95 ABSTRACT 96 Losing an eye following trauma can lead to profound psychosocial difficulties making 97 it imperative for the wearer to be fitted with an aesthetically pleasing custom-made 98 artificial eye. Despite recent technological advancements, current design and 99 manufacturing processes have remained unchanged in over 55 years. With the aim 100 of portraying current knowledge regarding the development of artificial eyes in order 101 to aid future development, a scooping review was conducted. Six online search 102 engines were used: Scopus, PubMed, MedLine Complete, Web of Science, Science 103 Direct and Google Scholar. 104 underwent numerical and thematic analysis with three thematic themes emerging. 105 History and the current process of artificial eyes has been well documented; 106 however, the impact of wearing artificial eyes is sparse. On-going research and 107 development into the design and manufacturing processes of artificial eyes and the 108 psychosocial impact of wearing an artificial eye is needed. Thirty-eight articles met the inclusion criteria and 109 110 Keywords: artificial eyes, eye loss, prosthetic eyes, psychosocial impact of 111 prosthetics, historical and technological development of artificial eyes 112 113 114 115 116 117 118 119 120 121 122 123 Manuscript Accepted 124 Early View Article TITLE: Scoping review of the development of artificial eyes throughout the years. 125 126 INTRODUCTION 127 Human understanding of expressions and what they mean emerges very early on in 128 life. Confronted with and revealing a whole host of emotions when we look into one 129 another’s eyes gives credence to the saying ‘our eyes are the windows to our soul’. 130 Our eyes act as our navigational tools: we adjust and modify our behaviour and act 131 in accordance to our interpretations, whether that’s related to our physical 132 surrounding, social interactions or emotional contact. With many aspects of human 133 functioning relying on our eyes, a loss of one or both can have a significant impact 134 on a person. 135 The loss of an eye(s) can be caused by a congenital defect or be acquired. 136 Examples include malignancies, intraocular and extraocular infections, trauma, 137 orbital tumours and painful blind eyes [1]. Following the loss of an eye, patients are 138 fitted with an artificial eye. Today’s artificial eyes are a thin hard acrylic shell that 139 covers the surface of the eye, fitting over an orbital implant and under the eyelids [1]. 140 Research into the impact that the loss of an eye has, highlights medical, 141 psychological, social, emotional and physical difficulties [1-7]. 142 perspective the loss of one eye results in a change from binocular vision to 143 monocular vision leading to initial feelings of disorientation and clumsiness [4]. 144 Although adjustments by turning the head can overcome the defects in depth 145 perception and field of vision some activities of daily living such as playing sports, 146 driving and work requiring prolonged visual vigilance will continually be impacted. 147 Psychological adjustment to the loss of an eye comes with emotional acceptance in 148 all areas of one’ life including personal, professional and societal. In circumstances 149 where a person has not adjusted to the loss, difficulties such as depression, anxiety, 150 low self-esteem, low self-image and feelings of hopelessness may arise. This can 151 lead to maladaptive coping mechanisms impacting social functioning and 152 independence. Thus, in order to provide the best overall care, understanding and 153 sensitivity to the loss is required [2]. From a medical Manuscript Accepted Early View Article 154 Whilst research has documented the factors associated with the loss of an eye [3-6], 155 knowledge surrounding the impact wearing artificial eyes is still in its infancy. 156 Furthermore, despite its progression in related fields, such as prosthetic limbs, 157 technological development regarding artificial eye design and manufacturing has 158 stagnated. These two key facets are essential in identifying future research and 159 development in order to create better outcomes for practitioners and artificial eye 160 wearers alike. 161 In order to achieve this, a strong knowledge base needs to be created. Therefore, 162 the objective of the scoping review is to portray current knowledge regarding the 163 development of artificial eyes in order to aid future development. 164 165 METHOD 166 This review followed the five framework stages outlined by Arksey & O’Malley’s 167 (2005). 168 169 Stage 1: Identification of the research question 170 Based on two facets: development of artificial eyes remaining the same since the 171 1960s, and, peoples’ needs evolving over time, led to the research question: ‘What is 172 known from the existing literature about the development of artificial eyes throughout 173 the years?’ It is envisioned that this review will be an aid in creating an 174 understanding of where and if technology can provide the tools required by artificial 175 eye wearers. To gain a rounded understanding of artificial eyes, a search strategy 176 involving the historical and development of artificial eyes and what influences the 177 development was deemed necessary. 178 179 Stage 2: Identifying relevant studies 180 In order to locate a wide variety of research relating to artificial eye development, no 181 time span or language constraints were applied. A threefold search strategy was 182 adopted: electronic databases, internet search and reference list search. The search 183 was performed between August 6th and August 31st 2016 using six databases: 184 PubMed; MedLine Complete; Web of Science; Science Direct and Google Scholar. Manuscript Accepted Early View Article 185 The search strategy used terms to denote ‘artificial eyes’ (prosthetic eyes, ocular 186 prosthesis) combined with a range of terms denoting its development (history, 187 technology, impact, emotional wellbeing). The final stage of the search strategy was 188 reference checking. 189 190 Stage 3: Study selection 191 A total of 280 references were identified from the search strategy. An inclusion and 192 exclusion criteria was developed and applied to all studies that represented a best fit 193 with the research question. Articles relating to the historical and technological 194 development of artificial eyes; needs of and the impact upon those wearing artificial 195 eyes and participants who had undergone enucleation, exenteration and evisceration 196 as a result of genetics, trauma, injury, infection and disease were included in the 197 review. Furthermore, due to the scarcity of publications about the psychological 198 impact of wearing artificial eyes, references were sought for those associated with 199 facial disfigurement only (see table 2) 200 Articles regarding stock eyes, eye shells, implants and orbital prosthesis; those that 201 assess the condition of and aftercare of artificial eyes and clinical/case reports were 202 excluded. Reflecting time and budget constraints, the time span of articles was 203 amended. With the change of material in the construction of artificial eyes occurring 204 following the end of World War II, it was decided that all articles pre-dating 1950 205 would be removed from the search, enabling the remaining articles to reflect current 206 methods utilised in its design. 207 The inclusion and exclusion criteria were applied to all 280 references using 208 abstracts or the full articles where available. Of these, 121 were considered to meet 209 the inclusion criteria. Full reports were obtained for 38 articles. The remaining 54 210 articles consisted of those that predated the exclusion criteria (17) and those 211 unavailable through library sources (66). A full list of these articles can be found in 212 the appendix. 213 214 215 Manuscript Accepted Early View Article 216 Stage 4: Charting the data 217 A data charting form was created using the database programme Excel. All 38 218 articles were entered into the form that contained the following information: author(s), 219 year of publication, study location; intervention type, duration of the intervention; 220 study population; aim(s) of the study; methodology and key findings/results. These 221 data formed the basis of the analysis. 222 223 Stage 5: Collating, summarizing and reporting the results 224 A scoping review aims to ‘map’ or identify literature in the field. This was done in two 225 stages: firstly, basic numerical analysis and secondly, thematic analysis. 226 227 RESULTS 228 229 Numerical analysis 230 Geographical distribution of articles reviewing the development of artificial eyes 231 Figure 1 shows the number and proportion of research reports that looked at the 232 development of artificial eyes. The majority of the articles were carried out in the 233 USA (54%). In comparison a far smaller proportion of articles were derived from the 234 UK (18%). New Zealand accounted for 7% of the articles and Australia accounted 235 for 4% of the articles. Articles from the rest of Europe and the world accounted for 236 the rest 237 238 Categorizing the articles 239 The articles were related to the historical development, current process and the 240 impact upon patients with artificial eyes and facial disfigurement. In order to reflect 241 this heterogeneity, studies were grouped together. 242 Figure 2 shows the classification scheme used and the number of studies according 243 to each intervention category. The majority of articles were narrative inquiries (39%) 244 followed by historical reviews (26%) and questionnaires (22%). Literature reviews, 245 interviews and interview and questionnaires made up the remaining typologies. 246 Types of research methods used to understand the development of artificial eyes Manuscript Accepted Early View Article 247 Table 3 reflects the number and proportion of studies according to type of research. 248 The majority of studies (90%) used qualitative methods. Of these narrative inquiries 249 compromised 39% of articles and historical reviews compromised 26% of articles. 250 The remaining 35% of articles were a combination of quantitative and mixed 251 methods research. 252 Geographical distribution of articles of artificial eye development according to 253 research method 254 Table 4 shows the number and proportion of studies by country for each of the four 255 typologies used. 256 conducted in the USA (54%). In comparison, research in the UK has been more 257 evenly spread: Narrative inquiry (60%); historical review (20%) and questionnaires 258 (20%). The majority of studies were narrative inquiries which were 259 260 Summary of the characteristics of articles 261 The 38 studies of the development of artificial eyes were included in this review. The 262 data shows that: 263 264 265 266 o The majority of articles were conducted in the USA and were qualitative in nature. o Narrative Inquiries were most commonly studied, followed by historical reviews and then questionnaires. 267 o UK studies encompassed both qualitative and quantitative articles reviewing 268 the historical development, current methods and the impact of artificial eyes 269 and facial disfigurement. 270 271 272 273 274 275 276 277 o Articles related to specific techniques were mainly of single rather than multiple approaches. o Few studies assessed the needs of the artificial eye wearer. Manuscript Accepted 278 Early View Article Thematic Analysis 279 280 History of artificial eyes 281 Anecdotal reports and relics from ancient civilizations point to the first artificial eyes 282 being made by the Egyptians in the 4th Dynasty (2613 – 2392 BC) and the ancient 283 cultures of Babylon and Jericho [7-14]. 284 The Egyptians, Greeks and Romans embellished important statues, mummies and 285 animals with artificial eyes [10, 14, 15]. They were known as ‘art eyes’ and were 286 made from precious stones such as earthenware, enamelled bronze, copper and 287 gold. The orbit was filled with wax or plaster on top of which the precious stone was 288 inserted to represent the iris of an eye [5, 9, 10, 11, 14, 16]. It is thought that these 289 ‘art eyes’ were used for cosmetic purposes as a symbol of light and life in their 290 religious beliefs [8-9]. 291 From the 26th Dynasty through the Dark/Middle Ages (500 – 1500 AD), the making 292 of artificial eyes was largely abandoned [10, 12]. 293 period (1400 – 1700 AD) that artificial eyes saw a resurgence [14]. 294 The 16th century saw artificial eyes being fitted in the socket and experimentation 295 with materials. Ambroise Paré, a French surgeon, described two types of artificial 296 eyes: the ‘Hypoblephara’, which fitted underneath the eyelid, and the ‘Ekblephara’ 297 which fitted externally: both of which were expensive, heavy, painful to wear and 298 lacked the moist quality of a normal eye [7, 11]. 299 Paré was also credited with evolving the making of artificial eyes from gold and silver 300 to glass [5, 8-10, 12]. Glass eyes were made of lead or soda both of which were 301 durable but caused severe tissue reactions and erosion limiting their lifespan to 9-24 302 months [5]. Despite these shortcomings, glass was better tolerated by the orbital 303 tissue [17]. and was seen as being able to eliminate the problems associated with 304 metal artificial eyes (gold and silver) such as its weight and expense [11]. The use of 305 glass saw their shape change from sphere to a shell form reducing irritation to the 306 socket but putting patients at risk of bruising the conjunctival bed due to not being 307 able to adequately replace lost orbital volume [12, 16, 18]. It was not until the Renaissance Manuscript Accepted Early View Article 308 In the 18th Century, the importance of a custom-fit eye to the socket to overcome the 309 above problems was being realized [12]. Experimenting with new materials and 310 methods for making human glass eyes, Ludwig Müller-Uri, a German glassblower 311 who produced dolls eyes that had good human-like qualities, developed cryolite 312 glass which was hard and light and did not irritate the conjunctiva [3-10]. By 313 providing support at the anterior of the socket, creating lightness of weight, replacing 314 sharp edges with rounded edges and displacing soft tissues of the orbit around the 315 prosthesis to fill volume thus eliminating a sunken appearance, the shape of the 316 artificial eye changed to what is now known as the Snellen Reform Eye [11-12, 19]. 317 Despite the Snellen Reform Eye’s vast improvements over the shell eye, they were 318 uncomfortable in terms of pressure points causing irritation and discharge from large 319 quantities of trapped tears and mucus partially due to being unable to achieve best fit 320 due to the abstract nature of the Snellen Reform Eye and without the help of an 321 impression [19]. 322 Fragility, surface erosion, imperfect fit, superficial staining and spontaneous 323 breakage of glass eyes led to investigation into other materials such as vulcanite and 324 celluloid in the 19th Century [10, 17, 20]. 325 With the turn of the 20th century artificial eye services were becoming more 326 regulated. 327 standard sizes and colours that could not be altered [21]. 328 secretions and rapid deterioration saw the fabrication of glass eyes using sand with a 329 low oxide content being exclusively used until World War II (WWII) where it became 330 unobtainable in Germany resulting in the United States temporarily relying on stock 331 eyes to meet the need of the military and civilian population [8, 14, 16, 22]. In 1946 332 the Veterans Administration based in America, initiated the ‘Plastic Artificial Eye 333 Program’ to train ocularist to make artificial eyes for a large number of disfigured and 334 disabled veterans [4]. 335 A polymerised form of methyl-methacrylate, acrylic resin is lightweight, easy to 336 mould, fit and adjust, has good colour permanence, is resistant to rough handling, 337 easily fabricated, durable and provides an aesthetic appearance, thus making it the 338 most suitable material that is still used today[6-8, 12]. The few disadvantages During this time artificial eyes were made of glass and supplied in Vulnerability to socket Manuscript Accepted Early View Article 339 associated with plastic artificial eyes include not being fully scratch resistant, not 340 capturing iris depth and colour fading, are all related to poor restoration. With the 341 right equipment and materials, these obstacles can be overcome [17]. Further 342 developments in the design of artificial eyes came with the development of orbital 343 implants in the 1980s. 344 345 Current design and manufacturing process of artificial eyes 346 Initially based on the shell and reform form used for glass eyes[16] acrylic artificial 347 eyes also caused soreness due to ill fit, lack of mobility and lid distortion due to 348 incorrect shape[9]. 349 Medical Schools, identified that due to the individuality of each enucleated socket, 350 artificial eyes need to be custom-made[8, 12, 14, 16, 21, 22, 23]. 351 Although custom-made artificial eyes necessitates the work of a skilled artist making 352 it a time consuming and costly process, they permit accurate colouring of the iris, 353 veining and tinting of the sclera making it more cosmetically satisfactory to the 354 patient [4]. 355 facial contours and increasing the degree of motility are achieved in custom made 356 artificial eyes[4, 19, 23,], allowing even distribution of volume and weight in the 357 socket reducing long-term discomfort and producing better cosmetic outcomes[9, 358 14]. Furthermore, by providing close contact with the soft tissue, the artificial eye 359 allows normal tear secretion, volume replacement, adequate orbital fat and absence 360 of socket inflammation[7, 19, 24]. These advantages result in the artificial eye 361 moving like a natural eye following almost simultaneously with the patient’s natural 362 eye[9]. 363 In order to approximate the natural eye, accurate records of the posterior wall and its 364 relation to the palpebral and the extent of the superior and inferior fornices of the 365 palpebral is required in order to provide sufficient support[23]. 366 support, the eyebrow can fall nasal-wards, the eyelid muscles can become weaker 367 leading to entropion and the edge of the eyelids can become inverted[9]. Currently, 368 this is achieved by a method known as the impression technique. The fabrication of 369 an artificial eye using the impression method establishes the defect contour and the Research conducted by the United States Naval Dental and Accurate fitting of the socket, minimising tissue distortion, improved Without sufficient Manuscript Accepted Early View Article 370 iris and sclera can be individually characterised offering better aesthetic and more 371 precise outcomes [1, 6, 8, 19]. 372 The initial impression technique in the mid-1940s reported partial success in fitting 373 artificial eyes [19]. However, by pressing the paste (which was often heavy) into the 374 socket to fill all spaces and smoothing out the conjunctiva folds and wrinkles often 375 led to overfilling [19]. 376 for a short period of time, thus not giving enough time for the orbicularis muscle to 377 reflex from the foreign object, a good fit was not always achieved[19, 25]. These 378 techniques often caused discomfort and ignited fear in the patient as a result of the 379 process, materials and equipment used [25]. 380 Advancements in this method include the direct/external impression technique and 381 the modified impression technique [6, 8, 25]. Whereas the former involves injecting 382 low viscosity alginate or reversible hydrocolloid material directly into the socket, the 383 latter places a stemmed tray into the eye socket for the material to be inserted into. 384 Variations to the modified impression technique include attaching a solid suction rod 385 to an existing prosthesis and investing it in an irreversible hydrocolloid mould before 386 replacing it with clear acrylic resin (custom ocular tray impression); applying 387 ophthalmic alginate to a suitable stock eye which is inserted into the socket for a 388 definitive impression (stock ocular tray modified technique); trimming/polishing a 389 stock eye or using alginate or soft wax which is invested and processed (ocular 390 prosthesis modification technique); and adapting baseplate was around half an 391 appropriately sized steel ball to create a wax blank which is tested in a socket and 392 adjusted as required (wax scleral blank technique) [1, 3-5, 7, 19, 21-22, 24]. 393 Despite these advancements, all impression techniques are unable to design the 394 front of an artificial eye, thus is unable to manipulate the eyelids to their proper 395 opening and shape [25]. 396 Following an impression of the socket, a plaster mould is created using molten wax 397 to produce a replica [5, 7]. Whilst the wax is being cured, the iris is produced. The 398 iris disc is sized based on the observations of the natural eye and measuring the 399 distance from the facial midline and pupillary light reflex allowing a guide for a 400 centrally placed iris ensuring correct alignment [5]. Several methods such as paints, Furthermore, by only testing the wax mould of the impression Manuscript Accepted Early View Article 401 pigments and papers have been used: paper discs, ethyl-cellulose discs or directly 402 on the acrylic resin sclera using watercolours or oil paints [3-4, 6]. Relying upon the 403 artistic skills of the skilled technician led to the development of creating an iris using 404 digital imaging. 405 Digital imaging involves taking a digital photograph of a patient’s natural iris which is 406 then compared to the natural iris. Adjustments are made to the colour, brightness, 407 contrast or hue using graphics software, if required [8]. Once aesthetically pleasing, 408 the image is covered with 3 light coats of water resistant spray before attaching it to 409 the ocular disc and then the wax pattern [8]. 410 Digital imaging provides aesthetic quality as it closely replicates the natural iris with 411 minimal colour adjustment and modifications needed. Furthermore, this method is 412 simple and practical as well as being less time consuming than the traditional 413 method [6, 8]. However, special digital photography equipment and computer 414 software is needed [8, 26] and the light instability of photographic dyes results in the 415 coloured iris fading quickly [4]. 416 Following insertion of the iris into the wax pattern, it is cast in clear acrylic resin and 417 cured under compression [5]. 418 sclera using liquid monomer and polymer clear powder [3-4, 6]. The artificial eye is 419 then coated with a layer of clear acrylic resin before being cured under heat and 420 pressure, cooled and polished [3, 5-6, 21]. 421 The current methods used in the fabrication of artificial eyes are labour intensive and 422 time consuming with the end result being heavily dependent on the experience of the 423 ocularist. 424 fabrication of artificial eyes a challenging task in prosthetics. Once cooled, red cotton thread is adhered to the The need for both functional and aesthetic consideration makes the 425 426 Impact of artificial eyes and facial disfigurement 427 Due to the search of the impact of artificial eyes producing few results, the review 428 was widened to include facial disfigurements. 429 430 431 Manuscript Accepted Early View Article 432 Artificial eyes 433 The search strategy produced eleven articles related to the impact of artificial eyes 434 that met the inclusion criteria. Of these, four full articles were obtained. 435 436 With literature primarily focusing on the before and after the loss of an eye, the long- 437 term psychological impact of living with artificial eyes has received little attention[2,- 438 28]. 439 McBain et al., (2014) reported that 40% of artificial eye wearers take an average of 2 440 years to adjust to their prosthetic with clinical levels of anxiety, depression and 441 appearance related distress being experienced[27-28]. Research has shown that this 442 is related to older age, having children and the belief that the prosthesis influences 443 social and interpersonal relationships rather than the clinical aspects such as 444 duration of prosthetic wear, age of acquisition, gender, current age or type of 445 prosthesis [2, 27, 29]. Satisfaction with the shape, colour, motility, comfort and 446 fixation are often expressed by patients [27]. Primary concerns largely remain the 447 same over time, with health of the remaining eye, ability to judge distance, receiving 448 good advice and changes to appearance being at the forefront [28]. 449 Identification of the factors linked to artificial eye wearers wellbeing are starting to be 450 investigated. Hill et al., (2011) found the visibility of the condition rather than the 451 extent, type and severity of the disfigurement increases levels of distress. 452 Incorporating the emotional, psychosocial and economic impact on the artificial eye 453 wearer, ensures better care for the patient decreasing levels of distress and 454 increasing their confidence in the care received [23-27]. 455 456 Facial disfigurement 457 Twenty-nine articles regarding the psychological impact of facial disfigurements were 458 found during the search strategy. Of these, twenty-four met the inclusion criteria; 459 eight of which full articles were obtained for. 460 The psychological care of patients with facial disfigurement is also overlooked 461 despite patients having lower levels of quality of life compared to controls [30-33]. 462 High levels of anxiety and depression, maladaptive behaviours and reduced Manuscript Accepted Early View Article 463 emotional wellbeing have been found in this population group [33] suggesting that 464 psychological adjustment to the facial disfigurement is a key indicator of overall 465 recovery[33]. Psychological adjustment has been shown to be worse for patients 466 with acquired facial disfigurement than congenital facial disfigurement with females 467 having significantly higher levels of anxiety compared with males [30, 33]. Reactions 468 of other people to the disfigurement, location and maintenance of the prosthesis, 469 impact of treatment and self-perception of their illness can affect patient’s levels of 470 adjustment leading to high levels of distress [30, 32-33]. 471 Patients with facial disfigurement report difficulties in social settings when meeting 472 someone for the first time and in forming friendships leading to high levels of anxiety, 473 low self-esteem and creating expectations about life chances [32, 34]. Reasons for 474 this include focusing on information that supports their internal views. Providing 475 social support that matches the patient’s needs and challenging beliefs about the 476 disfigurement can lead to successful outcomes such as acceptance [34-35]. Self- 477 acceptance comes from finding meaning of the distress whereby the patient looks 478 beyond their physical disability. In turn, this makes them feel more accepted by 479 others and increases their level of confidence and independence, reducing social 480 distress, depression and anxiety [35-36]. 481 Measuring patient’s quality of life can provide useful information regarding the health 482 needs of these patients when planning prosthetic rehabilitation [30]. By 483 understanding a patient’s distress, the stigma they face and type of social support 484 required, psychological growth can occur whereby the patient redefines themselves 485 with positive support of others [37-38]. 486 487 DISCUSSION 488 The scoping review has ‘mapped’ literature documenting the development of artificial 489 eyes throughout the years. Three themes were identified in the review with the 490 current design and manufacturing process being the most referenced. 491 From their innovation in ancient Egypt, artificial eyes have undergone noteworthy 492 advancement [11]. The 16th Century saw a resurgence in the manufacturing and 493 design process where artificial eyes were being fitted in the socket and Manuscript Accepted Early View Article 494 experimentation with materials lead to the use of cryolite glass; changing the shape 495 from a sphere to a shell form then later to the Snellen Reform Eye[6, 9]. Despite 496 investigation with other materials, it was not until WWII that methyl-methacrylate 497 replaced glass as the main material [4, 10]. Its advantages included being 498 lightweight, easy to mould, fit and adjust, durability and having good colour 499 permanence [6, 17]. The few disadvantages associated with this material are largely 500 related to poor restoration as a result of inadequate equipment and materials20]. 501 The advent of WWII also highlighted the importance of obtaining an accurate 502 impression of the socket for optimal fit. With custom-made eyes came research into 503 effective ways to fabricate an artificial eye [3, 6, 18]. Being created from dental 504 material, the process of manufacturing methyl-methacrylate artificial eyes has largely 505 followed the same procedures employed in manufacturing dentures [11]. Whilst 506 adaptions have been made, this has largely been through trial and error by ocularist 507 throughout the years [4, 13, 15]. 508 509 Whilst the impression technique has gone through minimal changes, development of 510 the artificial eye has occurred through digital photography of the iris. Although this 511 method can be cost and time efficient, simple and practical [6, 21], special 512 equipment is required which is not always able to provide fine details of structures. 513 Research into the psychological impact of artificial eyes and facial disfigurement has 514 highlighted above average levels of clinical anxiety and depression, maladaptive 515 behaviours and reduced emotional wellbeing. Patients internal views about their 516 disfigurement and prosthesis affects their psychological adjustment [2], resulting in 517 reduced self-acceptance which increases distress and perceived stigma. By 518 understanding how the prosthesis affects the patient’s quality of life, adequate 519 support can be provided resulting in the patient’s psychological growth [27]. 520 521 522 523 524 Manuscript Accepted 525 Early View Article Strengths and limitations 526 527 Methodological issues 528 ‘Mapping’ the literature produces a vast amount of research, thus creates difficulty in 529 deciding breadth over depth. However, the framework of a scoping review allows 530 prioritisation of certain aspects of the literature that is the best fit of the research 531 question. The development and application of the inclusion and exclusion criteria 532 after the search strategy allows for the most relevant articles to be included based on 533 familiarity with the literature. 534 Due to the nature of the scoping review, 74% of the articles were qualitative in 535 nature, providing detailed background information and processes involved that 536 quantitative studies would not be able to achieve. Most of the studies were narrative 537 inquiries or historical reviews. Whilst the majority of articles were related to the 538 current design and manufacturing of artificial eyes, there has been minimal changes 539 in the technological development of artificial eyes. Variations of the impression 540 technique have been developed through trial and error by the ocularists, rather than 541 specific research. As this specialty area grows, quantitative studies should be 542 undertaken that would further enhance our knowledge and lead us closer to 543 incorporating technological advancements into the design and manufacturing 544 process. 545 The remaining 26% of articles used mixed methods or quantitative methods, all of 546 which addressed the psychological impact of artificial eyes and facial disfigurement. 547 Articles addressed quality of life, levels of distress and stigma in both population 548 groups. Commonly used measures included the Hospital Anxiety and Depression 549 Scale, Quality of life Core Questionnaire, Perceived Stigmatization Questionnaire 550 and the Social Distress Scale; focusing more on a patient’s ability to cope rather than 551 satisfaction with their situation. As a quantitative measure, questionnaires are not 552 able to provide the whys and how of a patient’s response. Only two articles 553 administered interviews, one of which was combined with a questionnaire. 554 Whereas articles regarding the psychological impact of facial disfigurements had an 555 adequate sample size, articles related to artificial eye impact had a small sample Manuscript Accepted Early View Article 556 size. A possible reason for this is the small population of patients requiring artificial 557 eyes. 558 largely focused on specific techniques developed by ocularists. Thus, the results are 559 subjective in nature, have a lack or rigour, are unable to be generalised and difficult 560 to replicate. 561 By not being discriminative in the location of publication, saw various techniques 562 employed in the manufacturing and fitting process; some of which may not be 563 applicable or used in other countries or services where different levels of standards 564 exist. 565 produced to create a standard of care for all wearers within and between countries. Articles related to the current design and manufacturing of artificial eyes Through continuous research, recommendations and guidelines may be 566 567 Future research 568 This review has identified both positive and negative outcomes of the current form of 569 artificial eyes and the impact it has on the patient, yet there is a lack of clear 570 evidence to support any future technological development. Although the scoping 571 review suffers from some methodological weaknesses, employing a systematic 572 review would not rid it of them all, thus would not offer any more conclusive 573 evidence. 574 The overwhelming advantages associated with acrylic resin may be reason for a lack 575 of research into other materials that can be more beneficial, particularly 576 biocompatible materials. The use of biocompatible materials has been used for the 577 heart, ear, dental implants, prosthetic joints, ocular lenses, and maxillofacial 578 reconstruction. Its use in artificial eyes is yet to be investigated. 579 biomaterial; 580 polyurethanes, collagen, elastin and silk; is worthy of extensive research. 581 Future research suggestions have been made for the psychological impact artificial 582 eyes has on the wearer. By understanding the predictors, therapeutic treatment can 583 be incorporated into the rehabilitation process improving the patient’s psychological 584 adjustment. Knowledge of these predictors will come from methodologies that get to 585 the crux of the patient’s experience. Therefore, future research needs to employ 586 qualitative methods such as interviews, specifically those that are experience led. artificial and natural polymers including poly One type of (vinyl chloride), Manuscript Accepted Early View Article 587 Not only can this help with the patients psychological wellbeing, it may also create 588 suggestions for the advancement of artificial eyes. 589 590 Key messages and recommendations 591 The overall aim of the scoping review is to understand the development of artificial 592 eyes and its impact on the wearers in order to improve the current process. The list 593 below sets out key messages and recommendations identified in the review. 594 595 596 Areas and questions for research • Qualitative studies need to be undertaken in the psychological impact of 597 artificial eye wearers, in particular, living with an artificial eye(s) and the fitting 598 of an artificial eye(s). 599 • With the current process being ocularist experience led, a quantitative study 600 of the current design and manufacturing process is needed. 601 contribute to developing uniformity between artificial eye services. 602 • This may There is a need to know more about the effectiveness of support networks of 603 artificial eye wearers, such as family, friends, work collogues, peers and 604 acquaintances. 605 • Research needs undertaking into the relationship between different 606 techniques in the design and manufacturing of artificial eyes and patient 607 satisfaction/outcomes. 608 • Interventions need to be developed based on the psychological needs of artificial eye wearers. 609 610 611 612 Research design • depth and breadth of data collected. 613 614 • 617 Longitudinal studies to examine changes of need of artificial eye wearers in the short and long term. 615 616 A wider range of research methods needs to be employed to increase the • Innovative approaches to the design and manufacturing of artificial eyes drawing on ocularists, patients and their families experience and expertise. Manuscript Accepted 618 CONFLICT OF INTEREST 619 The authors declare no conflict of interests. Early View Article 620 621 AUTHOR’S CONTRIBUTIONS 622 623 Holly Chinnery 624 Group 1 – Substantial contribution to the conception and design, Acquisition of data, 625 Analysis and interpretation of data 626 Group 2 - Drafting the article, revising it critically for important intellectual content. 627 Group 3 - Final approval of the version to be published 628 629 Simon B N Thompson 630 Group1 - Conception and design 631 Group 2 - Critical revision of the article 632 Group 3 - Final approval of the version to be published 633 634 Siamak Noroozi 635 Group1 - Conception and design 636 Group 2 - Critical revision of the article 637 Group 3 - Final approval of the version to be published 638 639 Bryce Dyer 640 Group1 - Conception and design 641 Group 2 - Critical revision of the article 642 Group 3 - Final approval of the version to be published 643 644 ACKNOWLEDGEMENTS 645 Author 1 is funded by the Vice Chancellor’s Open Scholarship for Postgraduate 646 Research at Bournemouth University. 647 648 Manuscript Accepted 649 REFERENCES 650 1. 2. 3. 4. 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Manuscript Accepted 919 Early View Article TABLES 920 921 Table 1: Number of studies of the development of artificial eyes found within different 922 sources 923 924 925 926 927 928 929 930 931 932 933 934 935 936 937 938 939 940 941 942 943 944 945 Bibliographic Source N % Electronic databases 229 82 Reference checking 30 11 Internet search 21 7 Manuscript Accepted Early View Article 946 Table 2: Publications regarding the psychological impact of wearing artificial eyes 947 and facia disfigurement 948 Eye loss Facial disfigurement % N % N Included 3 27 8 73 Excluded 7 24 22 76 Manuscript Accepted 949 Early View Article Table 3: Number and proportion of studies according to type of research (N = 38) 950 N % o Narrative Inquiry 15 39 o Historical Review 10 26 o Literature Review 2 5 o Interviews 1 3 9 22 Qualitative methods Quantitative o Questionnaires Mixed methods o Interview & 1 5 Questionnaire 951 952 953 954 955 956 957 958 959 960 961 962 963 964 965 966 967 968 Page 34 of 37 Manuscript Accepted 969 Early View Article Table 4: Geographical distribution of studies according to methodology (N = 38) 970 Narrativ Historica Literatur Questionnair e Inquiry l Review e Review e Intervie Interview & w questionnair e No % No % USA 8 53 7 70 UK 3 20 1 10 1 10 1 10 Australi No % No % No % No % 1 1 4 1 a New 1 Zealand Rest Of 1* 1**** Europe* Rest of 3** 4*** World** 971 972 * Portugal (1) 973 ** Brazil (1); India (2) 974 *** Nigeria (1) Turkey (1) Japan (1) Brazil (1) 975 **** Germany (1) 976 977 978 979 980 981 982 983 984 985 986 Page 35 of 37 Manuscript Accepted 987 Early View Article FIGURE LEGENDS 988 989 Figure 1: Distribution of articles reviewing the development of artificial eyes, by 990 country (N = 38) 991 992 Figure 2: Number and proportion of studies according to typology (N = 38) 993 994 FIGURES 995 996 997 998 999 1000 1001 1002 1003 1004 1005 1006 1007 Note. * Portugal (1); Germany (1); ** Brazil (3); Nigeria (1); India (1); Turkey (1); 1008 Japan (1) 1009 1010 Figure 1: Distribution of articles reviewing the development of artificial eyes, by 1011 country (N = 38) 1012 1013 1014 1015 1016 1017 1018 Page 36 of 37 Manuscript Accepted Early View Article 1019 1020 1021 1022 1023 1024 1025 1026 1027 1028 1029 1030 1031 Figure 2: Number and proportion of studies according to typology (N = 38) Page 37 of 37