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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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT01622816
Enrollment
70
Registered
2012-06-19
Start date
2012-03-31
Completion date
2014-03-31
Last updated
2016-11-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diabetic Retinopathy

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

Interventions

None listed

Sponsors

Julia Haller
Lead SponsorOTHER

Study design

Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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).

Design outcomes

Primary

MeasureTime frameDescription
ETDRS Letter Score1 DayTo 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

MeasureTime frameDescription
ETDRS Letter Score Consistency1 DayTo 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.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026