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

Diabetic Retinopathy Clinical Trial

Official title:

Prospective Determination of Agreement Between Standard ETDRS (Early Treatment Diabetic Retinopathy Study) Chart and Handheld Illuminated ETDRS Equivalent Chart in Eyes With Retinal Pathology

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01622816
• Other study ID #: ETDRS2012
• Status: Completed
• Phase: N/A
• First received: April 19, 2012
• Last updated: November 9, 2016
• Start date: March 2012
• Est. completion date: March 2014

Study information

• Verified date: November 2016
• Source: Wills Eye
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial 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

Description:

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 70
• Est. completion date: March 2014
• Est. primary completion date: December 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Time Perspective: Prospective

Related Conditions & MeSH terms

• Diabetic Retinopathy
• Retinal Diseases

Locations

Country	Name	City	State
United States	Mid Atlantic Retina- Wills Eye Institute	Philadelphia	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
Julia Haller

Country where clinical trial is conducted

United States, 

References & 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	ETDRS Letter Score Consistency	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.	1 Day	No