Age-related Macular Degeneration, Diabetic Macular Edema
Conditions
Keywords
Age-related macular degeneration, Diabetic macular edema
Brief summary
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
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.
Interventions
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.
Sponsors
Optimal Acuity Corporation
Study design
Observational model
COHORT
Time perspective
OTHER
Eligibility
Sex/Gender
ALL
Age
50 Years to 100 Years
Healthy volunteers
Yes
Inclusion criteria
1. \- Female or male 2. \- Any race 3. \- Patient is at least 50 years old 4. \- Patient has diagnosed retinal disorder that causes central vision loss in one or both eyes 5. \- Treated eyes, at time of treatment, were pseudophakic or phakic with no significant vision loss due to cataract 6. \- 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) 7. \- 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 \-
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| CDVA | 12 months | Best spectacle-corrected distance visual acuity |
Countries
Canada
Outcome results
None listed