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CompletedNCT00001346Updated Mar 4, 2008

Diabetic Retinopathy and Visual Function Study

An observational study in Diabetic Retinopathy, Macular Degeneration and Vision, Subnormal, sponsored by National Eye Institute (NEI). Completed at 1 site in United States. Per ClinicalTrials.gov, last updated 2008-03-04.

Sponsored by National Eye Institute (NEI) · Observational

Study type
Observational
Enrollment
100
Sex
All
01

Study summary

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.

Read the detailed description

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.

02

Conditions studied

  • Diabetic Retinopathy
  • Macular Degeneration
  • Vision, Subnormal

Keywords

  • Diabetic Macular Edema
  • Diabetic Retinopathy
  • Macular Edema
  • Photocoagulation
  • Psychophysical Testing
  • Stiles-Crawford Effect
03

In context

Vision, Low

214 studies on the registry are indexed under Vision, Low; 41 are open to participants now.

This study's enrollment of 100 is below the median of 141 across 51 observational studies indexed under Vision, Low.

Browse Vision, Low studies →

Lead sponsor

National Eye Institute (NEI) is the lead sponsor of 266 studies on the registry; 17 are open to participants now.

Of its 8 completed or terminated interventional studies of FDA-regulated products, 8 (100%) have results posted.

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

04

Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
All
Accepts healthy volunteers
No

Eligibility 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.

05

Study design

Enrollment
100 participants
06

Study locations

1 site
  • National Eye Institute (NEI)
    Bethesda, Maryland 20892, United States
07

References and documents

Publications

  • Higgins KE, Meyers SM, Jaffe MJ, Roy MS, de Monasterio FM. Temporary loss of foveal contrast sensitivity associated with panretinal photocoagulation. Arch Ophthalmol. 1986 Jul;104(7):997-1003. doi: 10.1001/archopht.1986.01050190055039. PubMed 3729795 ↗
  • Klein R, Klein BE, Moss SE, Davis MD, DeMets DL. The Wisconsin epidemiologic study of diabetic retinopathy. II. Prevalence and risk of diabetic retinopathy when age at diagnosis is less than 30 years. Arch Ophthalmol. 1984 Apr;102(4):520-6. doi: 10.1001/archopht.1984.01040030398010. PubMed 6367724 ↗
  • Klein R, Klein BE, Moss SE, Davis MD, DeMets DL. The Wisconsin epidemiologic study of diabetic retinopathy. III. Prevalence and risk of diabetic retinopathy when age at diagnosis is 30 or more years. Arch Ophthalmol. 1984 Apr;102(4):527-32. doi: 10.1001/archopht.1984.01040030405011. PubMed 6367725 ↗
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 4, 2008, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00001346
Lead sponsor
National Eye Institute (NEI)
First posted
Dec 10, 2002
Start date
Nov 1992
Completion
Oct 2000
Last update
Mar 4, 2008
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Feb 2000. You cannot join it, but the record below documents what was studied.

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