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CompletedNCT01622816Updated Nov 10, 2016

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

An observational study in Diabetic Retinopathy, sponsored by Julia Haller. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2016-11-10.

Sponsored by Julia Haller · Observational

Study type
Observational
Time perspective
Prospective
Enrollment
70
Ages
18 Years and older
Sex
All
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Study 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

Read the detailed description

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

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Conditions studied

  • Diabetic Retinopathy
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In context

Retinal Diseases

815 studies on the registry are indexed under Retinal Diseases; 105 are open to participants now.

This study's enrollment of 70 is below the median of 180 across 282 observational studies indexed under Retinal Diseases.

Browse Retinal Diseases studies →

Lead sponsor

This is the only study on the registry with Julia Haller as lead sponsor.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Probability sample

Study population

Patients enrolled in clinical trials for various retinal diseases at the Wills Eye Institute

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

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).
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Study design

Time perspective
Prospective
Enrollment
70 participants (actual)
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What researchers measure

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.

    Time frame: 1 Day

Secondary outcomes

  1. 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.

    Time frame: 1 Day

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Study locations

1 site
  • Mid Atlantic Retina- Wills Eye Institute
    Philadelphia, Pennsylvania 19107, United States
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References and documents

Publications

  • 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. PubMed 25719987 ↗

Individual participant data

Plan to share: No

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 10, 2016, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT01622816
Lead sponsor
Julia Haller
Responsible party
Julia Haller (Investigator, Wills Eye) — Sponsor-investigator
First posted
Jun 19, 2012
Start date
Mar 2012
Primary completion
Dec 2013
Completion
Mar 2014
Last update
Nov 10, 2016

Study contacts

Julia Haller, MD
principal investigator · Wills Eye Institute

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Nov 2016. You cannot join it, but the record below documents what was studied.

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Discussion

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