12/9/2014. Khaled Sharif, FRCS, FRCOphth Sharif Eye Centers (Amman, Dubai, Doha)

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1 Khaled Sharif, FRCS, FRCOphth Sharif Eye Centers (Amman, Dubai, Doha) 1

2 Same demography and psychology as refractive surgery patients More than 100,000 refractive surgeries over the past 20 years at our centers High demand for coloured contact lenses. 2

3 EYE COLOUR CHANGE AVALABLE OPTIONS (PROS & CONS) 1. COSMETIC CONTACT LENSES 2. IMPLANTABLE COLOURED LENSES LASER THERAPY FOR IRIS COLOUR CHANGE 3

4 Dr. Gregg Homer, Phd Strōma Medical, California THE STRŌMA PROCEDURE 4

5 The Blue Eye In a blue eye, the stroma fibers of the iris scatter incoming white light, creating a translucent, blue-gray appearance. 5

6 In a brown eye, a thin layer of brown pigment covers the anterior iris, preventing light creating an opaque brown iris. The Brown Eye Strōma Laser The Strōma laser is a Q-Switched Nd:YAG, which produces a Highly discriminatory, photo-absorbed frequency. 6

The Brown Eye Strōma Laser The Strōma laser is a Q-Switched

7 Strōma Procedure The Strōma laser fires a series of small, computerguided pulses across the iris to photo-disrupt stromal melanocytes. Because of its photo-absorption properties, the energy passes through the clear cornea and selectively targets the brown melanocytes, leaving the cornea and posterior iris stroma undisturbed. Pigment Elimination Photo-disrupted melanocytes release cytokine protein molecules into the aqueous humor of anterior chamber. The cytokine signal recruits macrophages (Greek for big eaters ), which engulf and digest photodisrupted melanocytes as cellular debris. Complete elimination of melanocytes takes 1-4 weeks. 7

posterior iris stroma undisturbed. Pigment Elimination Photo-disrupted melanocytes release cytokine protein molecules into the aqueous humor of anterior chamber.

8 The Outcome The final outcome is the removal of the brown stromal pigment and the emergence of the underlying natural blue stroma. SAFETY OF THE STRŌMA PROCEDURE 8

9 Iris Pigment Back of Eye Front of Eye This is an OCT image of a brown iris. Notice the thick layer of pigment covering the posterior (back) of the iris, as compared to the relatively thin layer covering the anterior (front) of the iris. Pigmentary Glaucoma In the case of pigmentary glaucoma or PG, the anterior zonular fibers rub against the posterior iris, dislodging pieces of pigment. The aqueous flow then carries these pieces of pigment into the anterior chamber. 9

covering the anterior (front) of the iris.

10 Pigmentary Glaucoma The smaller pieces of pigment pass easily through the TM and out the Schlemm s canal. The larger pieces, however, become lodged in the TM and inhibit the normal outflow of aqueous humor. Pigmentary Glaucoma As a result, intraocular pressure or IOP builds up inside the eye, which, if left untreated for a long enough period of time, can lead to glaucoma. 10

The larger pieces, however, become lodged in the TM and inhibit the normal outflow of aqueous

11 DISTINCTIONS BETWEEN PIGMENTARY GLAUCOMA AND STRŌMA 1. Pigment Density Recall that in PG, the pigment originates from the thicker layer covering the posterior iris, as compared to the far thinner layer covering the anterior iris. The larger pieces dislodged from the posterior iris are thus likely to be far larger than any pieces dislodged from the anterior iris. Back of Eye Front of Eye 11

posterior iris, as compared to the far thinner layer covering the anterior iris.

12 2. Abrasion v. Digestion: PG Recall that in PG, pigment is dislodged by the abrasion of zonular fibers against the posterior iris, resulting in the passage of both larger and smaller pieces of pigment into the anterior chamber. 2. Abrasion v. Digestion: Strōma In the Strōma procedure, however, the photo-disrupted melanocytes release cytokines, which, in turn, recruit macrophages that engulf and digest these melanocytes as common microscopic cellular debris. These microscopic particles pass easily through the TM and out the Schlemm s canal, without creating any increase in IOP. 12

both larger and smaller pieces of pigment into the anterior chamber.

13 3. Dispersion Time PG occurs after many years of untreated pigmentary abrasion, TM occlusion, elevated IOP. The Strōma procedure, however, takes only seconds, and the macrophagic digestion and elimination process occurs over 2 to 4 weeks. Any increase in IOP should be quickly detected and treated in follow-up visits, before any nerve damage occurs. 4. IOP Ranges: PG Normal IOP ranges from 10 mm Hg to 21 mm Hg. Average IOP is about 16 mm Hg. The risk of developing glaucoma does not rise significantly until IOP exceeds 21 mm Hg. The average IOP of patients with PG is about 29 mm Hg.* * Siddiqui, et al., What is the risk of developing pigmentary glaucoma from pigment dispersion syndrome? 135 Am J Ophthalmol (2003). 13

Any increase in IOP should be quickly detected and treated in follow-up visits, before any nerve damage occurs. 4. IOP Ranges: PG Normal IOP ranges from 10 mm Hg to 21 mm Hg.

14 4. IOP Ranges: Strōma In Strōma's human studies to date, all patients remained within the normal IOP range at all times. Post-op IOP never rose above pre-op IOP, and in most cases, IOP actually fell (by as much as 35%). 5. Treatment Options: PG Treatment options for PG include topical IOP-lowering medications (such as latanoprost, which dilates the Schlemm s canal and expands the TM) and laser treatments (such as SLT, which selectively targets and disperses pieces of pigment trapped in the TM). 14

Treatment Options: PG Treatment options for PG include topical IOP-lowering medications (such as latanoprost, which dilates

15 5. Treatment Options: Strōma Even if pigment were to become lodged in the TM of a Strōma patient, it would be quickly detected and treated in follow-up exams. Because Strōma pigment digestion occurs over such a short period of time, short-term treatment with a topical medication should suffice. If a case were resistant to topical medication, a single, non-invasive SLT treatment would be available. Conclusions The causes of PG are entirely different from the effects of the Strōma procedure: The density of the posterior iris pigment dispersed in PG is far higher than the density of the anterior iris pigment dispersed in Strōma. In PG, pigment is abraded from the posterior pigment in large and small pieces; in Strōma, pigment is photo-disrupted and eliminated as micro-particles through the normal macrophagic digestive process and aqueous outflow. In PG, pigment dispersion occurs over the life of the patient; in Strōma, dispersion is completed within 4 weeks. The average IOP range is 10 mm HG to 21 mm Hg, and the average of PG patients is about 29 mm Hg. The IOP range of Strōma patient was 12 mm Hg to 20 mm Hg. In Strōma's human studies, post-op IOP never rose above pre-op IOP, and in most cases, IOP actually fell (by as much as 35%). Even if pigment appeared in the TM of a Strōma patient, it would be quickly detected and easily treated in follow-up exams with short-term topical medication. 15

If a case were resistant to topical medication, a single, non-invasive SLT treatment would be available.

16 FAQ Is the effect permanent? Will the patient s eyes turn blue immediately? Will the treatment of all patients results in blue eyes? Can you change an eye s colour from brown to green or from green to blue? WAIT FOR FDA APPROVAL 16

17 Khaled Sharif, FRCS, FRCOphth Sharif Eye Centers (Amman, Dubai, Doha) 17

EXPANDING YOUR HORIZONS

Glaucoma Therapy EXPANDING YOUR HORIZONS Learn how to control glaucoma with SLT therapy. SLTPATIENT EDUCATION PROGRAM Glaucoma Glaucoma is a degenerative disease that if left untreated can cause permanent