Comparing Visual Acuity Measurements (How Well You Can See) Using a Standard ETDRS Chart & a Handheld ETDRS Chart

Completed

• Conditions: Diabetic Retinopathy

• Registration Number: NCT01622816
• Lead Sponsor: Julia Haller

Brief Summary

Comparing visual acuity measurements (measurements of how well you can see) using a standard ETDRS (Early Treatment Diabetic Retinopathy Study) chart and a handheld ETDRS chart

Detailed Description

Prospective determination of agreement between standard ETDRS chart and handheld illuminated ETDRS equivalent chart in eyes with retinal pathology

Study Timeline

• Study Start: 2012-03
• Study First Submitted: 2012-04-19
• Study First Submitted QC: 2012-06-14
• Study First Posted: 2012-06-19
• Primary Completion: 2013-12
• Study Completion: 2014-03
• Status Verified: 2016-11
• Last Update Submitted: 2016-11-09
• Last Update Posted: 2016-11-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 70

Inclusion Criteria

1. Ability to provide written informed consent and comply with study assessments for the full duration of the study (one visit per patient).
2. Age greater than 18 years.
3. Clinical diagnosis of retinal disease (including age-related macular degeneration, macular degeneration, retinal vessel occlusion, among others).

Exclusion Criteria

1. Presence of a significant cataract as determined by your doctor.
2. Presence of a significant posterior capsular opacity (haziness in your eyes) as determined by your doctor.
3. Diagnosis of uveitis (inflammation in part of the eye).

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
ETDRS Letter Score	1 Day	To determine the visual acuity measurement using this handheld internally illuminated ETDRS chart, and a standard back illuminated EDTRS chart. This will be done during the visual acuity test.

Secondary Outcome Measures

Name	Time	Method
ETDRS Letter Score Consistency	1 Day	To use the score results to determine whether this new, handheld chart, called the RAM-ETDRS chart, is just as efficient as the standard ETDRS eye chart in measuring your vision. This will be done during your visual acuity exam.

Trial Locations

Locations (1)

Mid Atlantic Retina- Wills Eye Institute; 🇺🇸 Philadelphia, Pennsylvania, United States