Download Conflict of Interest Statement

4/8/2016
Conflict of Interest Statement
Laser Corneal Surgery using an Apple I‐Pad instead of an operating microscope*
JOHNS HOPKINS CURRENT CONCEPTS
VAIL, MARCH 2016
James J. Salz, MD
Harry G. Glen, MD
Leonard Teye‐Botchway, MD
Stephen D. Klyce, PhD
James J. Salz, MD has received travel & research support from NTK Enterprises
Harry G. Glen, MD is a paid consultant to NTK Enterprises
Leonard Teye‐Botchway, MD has no financial interest
Stephen D. Klyce, PhD Is a paid consultant to NTK Enterprises
*This investigational device is not yet FDA approved for use in the USA
NTK Optimal Keratoplasty (Opti-K®) –
For Presbyopia & Low Hyperopia
Opti-K® is a laser procedure of cornea reshaping for
temporary reduction of symptoms of presbyopia and
low hyperopia while maintaining or improving
distance visual acuity and minimizing epithelial
damage and discomfort.
Opti‐K Laser and Apple I‐Pad System
Laser and I‐Pad mounted over the patient in Bermuda setting with surgeon Leonard Teye‐Botchway, MD ready to perform the surgery.
Lighted applanation suction ring with sapphire window on eye with laser probe ready to be placed into cone, centered, and secured with magnets in bottom of cone.
16 paracentral spots of laser energy (cw thulium fiber
laser:1.93 µm Wavelength in a probe) are delivered to
the cornea in 2.5 seconds while the epithelium is
protected from thermal damage with a lighted,
sapphire applanation window suction ring (SAWSR)
mounted in a conical holder. The procedure can be
performed in the office under topical anesthesia with
an Apple I-Pad instead of an operating microscope to
center the laser application over the pupil.
Apple I‐Pad view of suction ring applied and well centered over pupil
View of reticule in suction ring and Laser spots 10 min post-Tx
pupil through the I‐Pad Screen
Pt. RH 52 yo Female
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Pre-op
1 day
1 week
1 month
1 year
2 years
MRSE
+1.75 D
-1.00 D
-0.50 D
+0.25 D
+0.63 D
+0.25 D
UDVA
20/63
20/32
20/20
20/16
20/25
20/25
UNVA
20/100
20/25
20/32
20/40
20/40
20/50
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4/8/2016
Pt RH 38 mos po OptiK x 1
Pt very happy with VA OS
Slit lamp photo
Pt RH 38 mos PO OptiK x 1
UCVA 20/25 J3 Ref= Plano
Spots barely visible
Video of Procedure with pupil centration using the I‐Pad
FDA Study Revised Protocol 2015
• Patients included had normal eyes with a stable refraction, were 40 and older with low hyperopia defined as manifest refractive spherical equivalent (MRSE) between +0.63 to +2.5 D, and distance uncorrected visual acuity (D‐UCVA) between 20/63‐2 and 20/32+2. Bromfenac ophthalmic solution, 0.07%, was used post‐operative (1 drop after treatment
Centration Results of 104 Eyes
Examples: 0.02mm is almost perfectly centered while 0.28mm is slightly decentered
Average decentration was 0.186 mm which is not clinically significant. Only 1 eye was
decentered by more than 0.5 mm (0.51 mm).
Results at 1 Month
The dominant eyes of the first 4 patients with low
hyperopia were treated on Nov. 30, 2015. There
were no complications: patients were comfortable.
MRSE: 1.09±0.19(S.D.)D pre-op, -0.34±0.35D at 1
day, -0.10±0.29D at 1 week, and 0.10±0.31D at 1
month. Distance uncorrected visual acuity of the
treated eyes averaged 20/34 (LogMAR
0.235±0.150) pre-op, 20/20 (LogMAR 0.000±0.099)
at 1 day, 20/17 (logMAR -0.075±0.030) at 1 week,
and 20/14 (logMAR -0.145±0.060 at 1 month.
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4/8/2016
SummaryPatientTKTreatmentsandocularmeasurements
.
Binocular(B)UDVAandUNVAvaluesareshown.*Cycloplegic refractionmeasurements;md:missingdata.
1 month data‐ 4 eyes
After 9th Rx the patient was examined in Miami by Dr. William Trattler
(She later had a 10th treatment in Nassau)
Summary of examination in Miami by Dr. Trattler
Date
4-08
MRSE (D)
+2.50 OU
Add (D)
+1.00 OU
B-UDVA
20/20
B-UNVA
20/50
5-08
Plano
+1.50 OD, +1.75 OS
20/20
20/50
1m Post-1st Tx (4-08)
Comments
Pre-Tx
1-09
+0.75 OU
+1.50 OU
20/20
20/40
7m Post-2nd Tx (5-08)
4-10
+1.75 OU
+1.75 OU
20/32
20/80
22m Post-2nd Tx (5-08)
11-10
+1.38 OD, +1.50 OS
+2.00 OU
20/16
20/50
4m Post-3rd Tx (7-10)
4-11
+1.50 OD, +1.25 OS
+1.75 OU
20/20
20/50
9m Post-3rd Tx (7-10)
6-11
+0.88 OU
+1.75 OU
20/25
20/32
2m Post-4th Tx (4-11)
10-11
+1.13 OD, +0.88 OS
+1.75 OU
20/20
20/40
3m Post-5th Tx (6-11)
5-12
+1.00 OD, +0.88 OS
+2.00 OU
20/25
20/50
5m Post-7th Tx (12-11)
10-12
+0.88 OU
+1.75 OU
20/20
20/50
4m Post-8th Tx (6-12)
1-13
+0.88 OD, +0.63 OS
+1.75 OU
20/20
20/40
3m Post-9th Tx (10-12)
2-13
+0.75 OD, plano OS*
n/a
md
md
4m Post-9th Tx (10-12)
6-13a
+1.13 OU
+1.75 OU
20/25
20/50
8m Post-9th Tx (10-12)
6-13b
md
md
20/20
20/25
Imd Post-10th (6-13)
Pt. TK Nassau SL Photos OU in Miami
showing faint subepithelial opacities
UCVA was 20/30 OU MR OD +0.75 D OS Plano
Endo counts WNL, Slit lamp exam showed multiple faint paracentral opacities best visualized on retro‐illumination
Topography showed symmetrical central steepening
Magellan Topos 4 ½ yrs Post Op
The patient reported no symptoms of glare or halos and was pleased with the results of her treatment Summary
Use of an Apple I‐Pad allows laser corneal surgery to be performed in an office setting. There are millions of pure presbyopic, low hyperopic presbyopes, and near emmetropic, presbyopic
post LASIK, PRK, and lens Implant patients who are potential candidates for this procedure. Many of these patients are risk adverse and might consider a very simple, safe, office based, low cost procedure to improve their vision. Opti‐
K is expected to regress over time and require retreatments, but the concept of paying for re‐
treatments is well accepted with botox and fillers. See e‐poster by Salz, et al reporting a patient who had bilateral Opti‐K treatments 10 times over a 4 ½ year period.
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