Observational Study of Vision Improvement in Late Stage Dry AMD Patients

Completed

• Conditions: Dry Age-related Macular Degeneration

• Registration Number: NCT04349254
• Lead Sponsor: Optimal Acuity Corporation

Brief Summary

The purpose of this study is to assess the vision improvement achieved by patients with late stage dry age-related macular degeneration 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 late stage dry age-related macular degeneration who received corneal treatments by a low vision aid device. Patient records for patients with at least 12 months follow-up will be analyzed to determine measures of vision improvement including best spectacle-corrected distance and near visual acuity. Analyses will include descriptive statistics and correlation between outcomes and baseline characteristics.

Study Timeline

• Study First Submitted: 2020-04-14
• Study First Submitted QC: 2020-04-14
• Study First Posted: 2020-04-16
• Study Start: 2020-08-14
• Primary Completion: 2020-12-31
• Study Completion: 2020-12-31
• Status Verified: 2021-02
• Last Update Submitted: 2021-02-22
• Last Update Posted: 2021-02-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 17

Inclusion Criteria

1. • Male or female
2. • Any race
3. • Patient is at least 50 years old
4. • Patient has diagnosed late stage dry age-related macular degeneration in one or both eyes.
5. • Treated eyes were pseudophakic at the time of treatment.
6. • Patient had moderate to severe baseline vision impairment with best spectacle-corrected distance visual acuity (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 12 month post-treatment.

Exclusion Criteria

1. • Corneal disease or disorder in either eye.
2. • Increased intraocular pressure (above 20 mm 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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
CDVA	12 months	Best spectacle-corrected distance visual acuity (CDVA)

Secondary Outcome Measures

Name	Time	Method
CNVA	12 months	Best spectacle-corrected near visual acuity (CNVA)

Trial Locations

Locations (1)

Bochner Eye Institute; 🇨🇦 Toronto, Ontario, Canada