Comparing Visual Acuity Measurements (How Well You Can See) Using a Standard ETDRS Chart & a Handheld ETDRS Chart
Prospective Determination of Agreement Between Standard ETDRS (Early Treatment Diabetic Retinopathy Study) Chart and Handheld Illuminated ETDRS Equivalent Chart in Eyes With Retinal Pathology
1 other identifier
observational
70
1 country
1
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for all trials
Started Mar 2012
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 1, 2012
CompletedFirst Submitted
Initial submission to the registry
April 19, 2012
CompletedFirst Posted
Study publicly available on registry
June 19, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2014
CompletedNovember 10, 2016
November 1, 2016
1.8 years
April 19, 2012
November 9, 2016
Conditions
Outcome Measures
Primary Outcomes (1)
ETDRS Letter Score
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.
1 Day
Secondary Outcomes (1)
ETDRS Letter Score Consistency
1 Day
Eligibility Criteria
Patients enrolled in clinical trials for various retinal diseases at the Wills Eye Institute
You may qualify if:
- Ability to provide written informed consent and comply with study assessments for the full duration of the study (one visit per patient).
- Age greater than 18 years.
- Clinical diagnosis of retinal disease (including age-related macular degeneration, macular degeneration, retinal vessel occlusion, among others).
You may not qualify if:
- Presence of a significant cataract as determined by your doctor.
- Presence of a significant posterior capsular opacity (haziness in your eyes) as determined by your doctor.
- Diagnosis of uveitis (inflammation in part of the eye).
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Julia Hallerlead
Study Sites (1)
Mid Atlantic Retina- Wills Eye Institute
Philadelphia, Pennsylvania, 19107, United States
Related Publications (1)
Rahimy E, Reddy S, DeCroos FC, Khan MA, Boyer DS, Gupta OP, Regillo CD, Haller JA. PROSPECTIVE EVALUATION OF VISUAL ACUITY AGREEMENT BETWEEN STANDARD EARLY TREATMENT DIABETIC RETINOPATHY STUDY CHART AND A HANDHELD EQUIVALENT IN EYES WITH RETINAL PATHOLOGY. Retina. 2015 Aug;35(8):1680-7. doi: 10.1097/IAE.0000000000000518.
PMID: 25719987BACKGROUND
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Julia Haller, MD
Wills Eye Institute
Study Design
- Study Type
- observational
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Investigator
Study Record Dates
First Submitted
April 19, 2012
First Posted
June 19, 2012
Study Start
March 1, 2012
Primary Completion
December 1, 2013
Study Completion
March 1, 2014
Last Updated
November 10, 2016
Record last verified: 2016-11
Data Sharing
- IPD Sharing
- Will not share