Observational Study of Vision Improvement in Patients With Retinal Disorders

Study Overview
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Brief Summary
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The purpose of this study is to assess the vision improvement achieved by patients with retinal disorders who received corneal treatments by a low vision aid device.

Detailed Description
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The purpose of this study is to assess the vision improvement achieved by patients with retinal disorders, including age-related macular degeneration and diabetic macular edema, who received corneal treatments by a low vision aid device. Patient records will be analyzed to determine measures of vision improvement including best spectacle-corrected distance visual acuity (CDVA). Analyses will include descriptive statistics and correlation between outcomes and baseline characteristics.

Official Title
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Observational Study of Vision Improvement in Patients With Retinal Disorders

Conditions
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Age-related Macular Degeneration, Diabetic Macular Edema

Intervention / Treatment
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* Device: Corneal treatment by a low vision aid device


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: - Female or male - Any race - Patient is at least 50 years old - Patient has diagnosed retinal disorder that causes central vision loss in one or both eyes - Treated eyes, at time of treatment, were pseudophakic or phakic with no significant vision loss due to cataract - Patient had moderate to severe baseline vision impairment with CDVA of 20/63 or worse (decimal = 0.317 or less; logMAR greater than or equal to 0.50) in the treated eye(s) - Patient CDVA records are available at baseline and at 1m or longer post-Tx times Exclusion Criteria: 1 - Corneal disease or disorder in either eye 2 - Increased intraocular pressure (above 20mm Hg), glaucoma or history of glaucoma 3 - Presence or history of any other condition or finding that, in the opinion of the investigator, makes the patient unsuitable for retrospective observational study -

Ages Eligible for Study
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Minimum Age: 50 Years
Maximum Age: 100 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Age-related Macular Degeneration<br> | Device: Corneal treatment by a low vision aid device<br>* Near infrared light is used to irradiate the cornea to change the modulus of small volumes of anterior stroma. The modulus change produces a change in light distribution onto the retina. Light rays are redirected from dysfunctional areas of the retina to functional areas, thereby improving patient vision.<br>|
| Diabetic Macular Edema<br> | Device: Corneal treatment by a low vision aid device<br>* Near infrared light is used to irradiate the cornea to change the modulus of small volumes of anterior stroma. The modulus change produces a change in light distribution onto the retina. Light rays are redirected from dysfunctional areas of the retina to functional areas, thereby improving patient vision.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| CDVA | Best spectacle-corrected distance visual acuity | 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Age-related macular degeneration, Diabetic macular edema