Observational Study of Vision Improvement in Patients With Retinal Disorders

Optimal Acuity

Status: Completed

Conditions: Diabetic Macular Edema; Age-related Macular Degeneration

Treatments: Device: Corneal treatment by a low vision aid device

Study type: Observational

Funder types: Industry

Identifiers

NCT04693702

Retro2

Details and patient eligibility

About

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.

Full 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.

Enrollment: 54 patients

Sex: All

Ages: 50 to 100 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

54 participants in 2 patient groups

Age-related Macular Degeneration

Treatment:

Device: Corneal treatment by a low vision aid device

Diabetic Macular Edema

Treatment:

Device: Corneal treatment by a low vision aid device