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Transcript
Clinical evaluations of the quantitative locator for conjunctiva resection used as
an instrument for the treatment of conjunctivochalasis
Keywords: conjunctivochalasis, conjunctiva resection, treatment
ZHANG Xing-ru, LI Qing-song, XIANG Min-hong, ZHENG Yi-ren, ZHOU
Huan-ming, ZHANG Zhen-yong , ZHANG Long
Department of Ophthalmology, Putuo Hospital, Shanghai Chinese Traditional
Medicine University, Shanghai 200062, China (Zhang XR, Li QS, Xiang MH, Zhou
HM, Zhang ZY, Zhang L)
Department of Ophthalmology, Shanghai No.10 Hospital, Tongji University, Shanghai
200072, China (Zheng YR)
Correspondence to Dr. LI Qing-song, Department of Ophthalmology, Putuo Hospital,
Shanghai Chinese Traditional Medicine University, Shanghai 200062, China. (E-mail:
[email protected])
This study was supported by Innovative Project of Science &Technology Committee,
Putuo District, Shanghai (2008-B-88,2010PTKW07)
Purpose To evaluate the quantitative locator for conjunctiva resection when used as
an instrument for the treatment of conjunctivochalasis (CCh).
Methods
Poly β-hydroxyethyl methacrylate resin / HEMA (water gel) was used as
the material to make the quantitative locator which is designed to suit the specific
patient. 46 patients with bilateral symptomatic CCh were included in this prospective
study. Of the patients, while the right eye underwent the popularly used
crescent-shaped conjunctiva resection (Group І), the left eye was treated with
conjunctiva resection assisted by the quantitative locator (Group П). International
Ocular Surface Disease Index (OSDI), scores of remnant conjunctiva fold,
complications and conjunctival cut healing, height of tear meniscus, tear break-up
time (BUT), and time of surgery were evaluated. Tasting chloromycetin test (TCT)
was used to evaluate how the lacrimal duct worked.
Results OSDI was significantly lower in Group П (8.82±2.36) than that in Group І
(14.67.3±2.21)(t = 12.22, p <0.01). Conjunctiva fold remained in Group II was less
than that in Group I. Scores of remnant conjunctiva fold in Group I were significantly
1
higher than that in Group II(t=31.8, p<0.01).While evaluation scores of conjunctival
cut healing in Group I were lower than that in Group II, scores of complication in
group I were significantly higher than that in Group II at 8 weeks after surgery (t =
89.60, p <0.01). There was no significant difference in eyes with normal BUT(Х2=
0.031, p=0.985)between the two groups, as it was in eyes with positive TCT(Х2 =
0.14, p = 0.93) and in eyes with normal height of tear meniscus(Х2= 0.48, p=0.78).
Mean surgery time was significantly shorter in Group II (17.11±2.08 minutes) than
that in Group I (25.22±4.78 minutes) (t=13.84, p<0.01).
Conclusion Quantitative locator can be used as an effective, safe, and less
time-consuming instrument to facilitate conjunctival excision for symptomatic CCh
treatment.
Conjunctivochalasis (CCh), defined as a redundant, loose, nonedematous inferior
bulbar conjunctiva interposed between the globe and the lower eyelid, tends to be
bilateral and is more prevalent in older populations.1,2Patients vary in the degree of
their symptomology ranging from asymptomatic to experiencing ocular irritation, pain,
subconjunctival hemorrhage, epiphora, dry eye, and/or ulceration.
3-5
Treatment of
conjuntivochalasis varies depending on the severity of symptoms. Asymptomatic eyes
can be left untreated and followed up periodically for signs of progression. If
symptoms continue despite topical treatment, surgery may be needed to remove the
segments of redundant conjunctiva. In view of surgical procedures, crescent-shaped
conjunctiva resection, first introduced by Hughes,
5
successfully treats CCh by
removing crescent-shaped conjunctiva under the lower eyelid and closing the
conjunctival incision with a continuous silk suture. This approach has been widely
used and demonstrated to be successful. 4,6 However, it is difficult to design how
much conjunctival tissue should be excised before operation as well as in the
operation phase. This is usually more complicated with attendant subconjunctival
hemorrhage. So if a tool could be applied to facilitate the excision of conjunctiva, it
may optimize this procedure.
Herein we introduce a quantitative locator for conjunctiva resection and
performed it on 46 patients with bilateral symptomatic CCh.
2
METHODS
Design of locator
The quantitative locator used in this study is made of β-hydroxyethyl methacrylate /
HEMA. It consists of a circle at the centre with a diameter in 12 mm and two arcs 5
mm posterior from the circle. A slit between the two arcs was made as an access of
loose conjunctiva to the surface of the locator. Five holes each with a diameter in 1
mm at the 2, 4, 6, 8, 10-o’clock positions of the outer arc are made for the
micro-forceps to pull out the conjunctiva beneath the inner face of the locator after it
is placed on the eyeball.(Figures 1 and 2)
Patients
46 patients (twenty males, twenty-six females; mean age, 70.77 ± 9.42 years) with
bilateral symptomatic CCh but without other ocular surface diseases were included in
this study. All Parents provided informed consent according to the Tenets of the
Declaration of Helsinki. Of the patients, while the right eye underwent the popularly
used crescent-shaped conjunctiva resection (Group І), the left eye was treated with
conjunctiva resection assisted by the quantitative locator (Group П).This study was
approved by the Ethnic Committee of Putuo Hospital, Shanghai Chinese Traditional
Medicine University.
Surgical procedures
Conjunctiva excision assisted by quantitative locator
0.5% Alcaine eye drops were administered to anesthetize the conjunctiva before
surgery. After the eye was exposed with a speculum, the locator (Figure 3) was placed
on the eyeball with its centre coincident with the centre of cornea. A forceps was used
to pull out the loose conjunctiva from the little holes located at the edge of the outer
arc and next from the slit between the two arcs. In this way, loose conjunctiva can be
laid on the surface of the locator without sliding, and therefore can be easily excised.
After excision of the conjunctiva, the locator was lifted and the cut was sutured with a
10-0 silk suture. 0.5% gentamicin and artificial tear eye drops were administered 4
times per day for two weeks.
3
Crescent-shaped conjunctiva resection procedure
After topically anesthetized with 0.5% Alcaine eye drops, the eye was exposed with a
speculum and loose conjunctiva was pushed downward and the folded conjunctiva
was kept 5 mm posterior from the limbus. Redundant conjunctiva was gathered
together with no influencing on the eye movement and the gathered conjunctiva was
excised like a crescent. The cut was approximated with a 10-0 nylon silk suture. The
duration of keeping sutures should be 10~14 days during which 0.5% gentamicin and
artificial eye drops were administered 4 times per day.
Clinical evaluations
Ocular surface symptoms evaluations
OSDI was used to evaluate the ocular symptoms7as it was described by Li, et al.2
Loose conjunctiva excision evaluation
At 2, 4, 8 weeks after surgery, patients were examined under the slit lamp microscope.
Score was recorded as 0 with no loose conjunctiva, whereas it was recorded as 1 score
with grade I conjunctival fold and recorded as 2, 3, 4 scores as such.
Conjunctival wound healing evaluation
Conjunctival wound healing was evaluated by healing scores. Grade A healing was
recorded as 3 scores when the conjunctiva demonstrated to be fine with healing line
and no scar formation; Grade B healing was recorded as 2 scores with little
conjunctival scar or swelling but with no infection; and Grade C healing was recorded
as 1 score with infection of conjunctiva. This classification and healing scores
respectively were documented at 2, 4, 8 weeks after surgery.
Complications evaluation
Below are the main complications after CCh surgery: conjunctival fold remaining,
roughness of conjunctival cut, scar, restriction of eye movement, shallow conjunctival
sac, cut break, and infection. If one complication occurred, 1 score was recorded; two
4
complications occurred, 2 scores was recorded as such. No complication was recorded
as 0 score.
Tear meniscus and BUT evaluation
Height of tear meniscus was measured by micro-scale in the slit lamp and defined
abnormal when it was lower than 0.3 mm or the tear meniscus was irregular, dry or
broken. BUT was measured and evaluated as described in ophthalmic textbook.
Lacrimal duct function evaluation
Tasting chloromycetin test (TCT), described by Zhang, et al in their early report,
8
was used to evaluate how the lacrimal duct worked.
Statistical analysis
All statistical analyses were performed with a statistics program SAS 6.0.
Statistical significance was evaluated usingX2 and t-test. P <0.05 was considered
significant.
RESULTS
Ocular surface symptoms evaluations
OSDI scores were significantly lower in Group II than that in Group I at all time
points. There was a decrease in OSDI scores from a mean value of 30.28 at baseline
before surgery to 8.82 at 8 weeks after surgery in Group II, as it was from 30.43 to
14.67 in Group I (Table 1).
Table 1 OSDI in two groups before and after surgery at all time points
Surgical procedures
Locator-assisted conjunctiva
excision
Crescent-shaped conjunctiva
resection
eyes
OSDI
Pre-op
2 weeks
4 weeks
8 weeks
46
30.28±5.68
22.08±3.13
16.95±2.77
8.82±2.36
46
30.43± 5.04
24.56±3.30
21.71±2.88
14.67 ±2.51
t=5.04,p<0.01,
t=10.80 ,
p<0.01
t=12.22 ,
p<0.01
Loose conjunctiva excision evaluation
Conjunctiva fold remained in Group II was less than that in Group I. Scores of
remnant conjunctiva fold in Group I were significantly higher than that in Group II
(t=31.8, p<0.01)At 8 weeks after surgery, 2 eyes with Grade I CCh were observed
5
in Group II whereas 5 eyes with Grade I and 2 eyes with Grade II CCh appeared in
Group I (Table 2). A normal conjunctival surface with no folded conjunctiva was
observed at 8 weeks after locator-assisted conjunctiva excision (Figure 4).
Table 2 . Scores of remnant conjunctiva evaluation after surgery at all time points
Surgical
procedures
Locator-assis
ted
conjunctiva
excision
Crescent-sha
ped
conjunctiva
resection
eyes
2 weeks after
surgery
4 weeks after
surgery
0、 I 、II 、III scores
8 weeks after
surgery
0、 I 、II 、 scores 0、 I 、II 、III scores
III
46
42、4、0、0
4
43、3、0、0
3
44、2、0、0
2
46
37、6、3、0
12
39、5、2、0
9
39、5、2、0
9
t=40.75,
p<0.01
t=30.57,
p<0.01
t=31.85,
p<0.01
Evaluation of conjunctival wound healing
There was no significant difference in scores of conjunctival wound healing
evaluation between the two groups at 2 weeks after surgery (t = 1.43, p = 0.159), but
not at 4 weeks (t = 3.760, p <0.01) and 8 weeks (t = 5.62, p <0.01) (Table 3) . A
smooth conjunctiva surface with no evident cut line was observed at 8 weeks after
locator-assisted conjunctival excision (Figure 4).
Table 3. Scores of conjunctival wound healing evaluation
Surgical procedures
eyes
Scores
2 weeks
4 weeks
8 weeks
Locator-assisted conjunctiva excision 46
84
103
126
Crescent-shaped conjunctiva resection 46
82
92
103
t=1.43, p=0.159 t = 3.76,p<0.01
t= 5.62,p<0.01
Evaluation of the height of tear meniscus and BUT
There was no significant difference in BUT(Х2= 0.031,p=0.985)between the two
groups, as it was in the height of tear meniscus(Х2= 0.48, p=0.78). While there was a
normal height of tear meniscus in 40 eyes (86.9%) and a normal BUT (≥10 s) in 33 eyes
(71.7%)in Group II at 8 weeks after surgery, the height of tear meniscus and BUT were
respectively normal in 32 eyes(69.5%)and 30 eyes(65.5%)in Group I at this time point.(Table
4,5)
6
Table 4 Evalution of the height of tear meniscus
Surgical procedures
Eyes with normal height of tear meniscus (% )
Eyes
pre-op
Locator-assisted
excision
Crescent-shaped
resection
conjunctiva
conjunctiva
2 weeks
4 weeks
8 weeks
46
0(0.0%)
30(65.2%)
38(82.6%) 40(86.9%)
46
0(0.0%)
29(63.0%)
29(63.0%) 32(69.5%)
Table 5 BUT before and after surgery at all time points
Surgical procedures
Locator-assisted
excision
Crescent-shaped
resection
Eyes with BUT≥10s(%)
Eyes
conjunctiva
conjunctiva
pre-op
2 weeks
4 weeks
8 weeks
46
8(17.3%) 30(65.2%) 32(69.5%) 33(71.7%)
46
9(19.5%) 28(60.8%) 28(60.8%) 30(65.5%)
Evaluation of complications
Scores of complications in group I were significantly higher than that in Group II (t =
89.60, p <0.01). Fewer complications occurred in locator-assisted conjunctiva
excision. (Table 6)
Table 6 Scores of complications evaluation
Surgical procedures
Eyes
Locator-assisted conjunctiva excision
Crescent-shaped conjunctiva resection
46
46
Scores
2 weeks
4 weeks
8 weeks
21
51
12
33
9
30
t=55.56,p<0.01 t=57.90,p<0.01 t=89.60,p<0.01
Evaluation of lacrimal duct function
There was no significant difference in TCT between the groups(Х2=0.14, p=0.93)
(Table 7). Larimal duct function respectively resumed in 23 eyes(50.0%) in Group
II and 20 eyes (43.4%)in Group I at 8 weeks after surgery.
Table 7
Evaluation of lacrimal duct function
Surgical procedures
Locator-assisted
conjunctiva
excision
Crescent-shaped conjunctiva
resection
Eyes with positive TCT(%)
Eyes
pre-op
2 weeks
4 weeks
8 weeks
46
0(0.0%) 8(17.3%) 21(45.6%) 23(50.0%)
46
0(0.0%) 8(17.3%) 18(39.1%) 20(43.4%)
Х2=0.14, p=0.93
7
Surgical time
Mean surgery time was significantly shorter in Group II (17.11±2.08 minutes) than
that in Group I (25.22±4.78 minutes)((t=13.84, p<0.01).
DISCUSSION
The crescent excision of the inferior bulbar conjunctiva has been advised as a
surgical procedure in the management of conjunctivochalasis refractory to medical
treatments. 9,10 In this procedure, it is of vital to design delicately how much bulbar
conjunctiva should be excised. As Liu4 has cautioned, overzealous resection of the
conjunctival tissue may result in a compromised lower fornix, which may restrict
motility or cause incision broken and corneal problems whereas underestimated
resection would cause loose conjunctiva remain.
This study highlighted an instrument termed as quantitative locator for
conjunctiva resection. This locator is made of β-hydroxyethyl methacrylate acetate /
HEMA (water gel) with chemical stability, bringing no stimulations. As it becomes
soft in water, it is easy to be implanted into conjunctival sac without scratching. By
using the locator, the operator can accurately design how much conjunctiva tissue
should be excised. Since excessive or insufficient conjunctiva excision could possibly
be avoided, this procedure is superior to currently used crescent-shaped conjunctiva
resection as evidenced by an array of clinical evaluations in this report. OSDI is
widely accepted and used as a method for the study concerned with ocular surface
disease. Scores of OSDI is lower in locator-assisted conjunctiva excision than that in
crescent-shaped resection. This might be attributable to the improvement in relatively
accurate loose conjunctiva excision as shown by evaluations of remnant conjunctiva
fold and wound healing in this study. As for the insignificant differences in
evaluations of the height of tear meniscus, BUT, and TCT between the two surgical
procedures, it may lie in the similar resolving of mechanical problems caused by the
interposed conjunctiva fold between the globe and the lower eyelid. Among the
advantages of locator-assisted conjunctiva excision, its fewer complications may
encourage a most liberal use. However, this procedure is limited by its inevitable
suturing of conjunctiva cut which may carry risks of suture-related disadvantages and
complications such as postoperative discomfort, abscesses, granuloma formation, and
8
giant papillary conjunctivitis. In this regard, suture-related complications could be
reduced by amniotic membrane transplantation after conjunctiva is approximated by
suture.11 Also, fibrin glue may offer a novel way of repairing conjunctival defects and
has been shown to avoid suture-related complications, decrease surgical time, and
decrease ocular inflammation and discomfort postoperatively. 12,13The use of fibrin
glue has been proven to be rather safe, but the potential for side effects cannot be
ruled out given that many of the constituents are derived from human blood plasma. 14
Both these two approaches may achieve a good therapeutic result for CCh when used
as adjunctive methods for conjuntiva excision to better reconstruct the conjunctival
surface. Further studies are warranted to investigate if the locator-assisted conjunctiva
excision would be more effective in treating CCh under the help of amniotic
membrane transplantation or fibrin glue.
In conclusion, quantitative locator can be used as an effective, safe, and less
time-consuming instrument to facilitate conjunctival excision for symptomatic CCh
treatment.
9
Right Eye
Left Eye
Figure 1. A schematic diagram illustrating the design of the locator. It consists of a
circle at the centre with a diameter in 12 mm and two arcs 5 mm posterior from the
limbus. A slit between the two arcs was made as an access of loose conjunctiva to the
surface of the locator (arrows). Five holes with a diameter in 1 mm at the 2, 4, 6, 8,
10-o’clock positions of the outer arc are made for the micro-forceps to pull out the
conjunctiva beneath the inner face of the locator after it is placed on the eyeball.
Figure 2. The locator made of β-hydroxyethyl methacrylate / HEMA
Figure 3. The locator is placed on eyeball and the loose conjunctiva is pulled out
from the little holes located at the edge of the outer arc and from the slit between
the two arcs.
10
Figure 4. A 76-year-old male patient with CCh. A) before surgery; B) 8 weeks
after locator-assisted conjunctiva excision.
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