Completed

Diabetic Retinopathy and Visual Function Study

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What is being collected

Data Collection

Who is being recruted

Cardiovascular Diseases+16

+ Diabetes Mellitus

+ Diabetic Angiopathies

See all eligibility criteria
How is the trial designed

Observational
Study Start: November 1992
See protocol details

Summary

Principal SponsorNational Eye Institute (NEI)
Last updated: March 4, 2008
Sourced from a government-validated database.Claim as a partner

Study start date: November 1, 1992

Actual date on which the first participant was enrolled.

The purpose of this study is to evaluate possible mechanisms of central visual loss in patients with diabetes mellitus. The visual loss of interest to be investigated is that associated with macular edema (prior to and following laser photocoagulation treatment) and that associated with panretinal photocoagulation. The evaluation will be performed with psychophysical testing, i.e., static perimetry and contrast sensitivity function. Of particular interest, the mechanisms of visual loss associated with macular edema (prior to and following laser photocoagulation) will be further investigated. Photoreceptor-mediated visual loss will be assessed by measurements of the Stiles-Crawford effect. Visual loss mediated by post-receptoral retinal changes will be assessed by measuring the Westheimer spatial desensitization/sensitization effect.

NCT00001346
Principal SponsorNational Eye Institute (NEI)
Last updated: March 4, 2008
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

100 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Cardiovascular DiseasesDiabetes MellitusDiabetic AngiopathiesEndocrine System DiseasesEye DiseasesNervous System DiseasesNeurologic ManifestationsRetinal DegenerationRetinal DiseasesSensation DisordersSigns and SymptomsPathological Conditions, Signs and SymptomsVascular DiseasesVision DisordersDiabetes ComplicationsDiabetic RetinopathyMacular DegenerationMacular EdemaVision, Low

Criteria

Patients with diabetic retinopathy that has not been previously treated are eligible for the study. Patients who have had laser photocoagulation (either focal or scatter) are not eligible.

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

National Eye Institute (NEI)

Bethesda, United StatesOpen National Eye Institute (NEI) in Google Maps
CompletedOne Study Center