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Visual Function, Center Point Thickness and Macular Volume After Photocoagulation

H

Hospital Juarez de Mexico

Status

Completed

Conditions

Macular Edema
Diabetic Retinopathy

Study type

Observational

Funder types

Other

Identifiers

NCT00906659
HJM 1453/08.02.26

Details and patient eligibility

About

The purpose of this study is to correlate changes of visual function three weeks after photocoagulation for macular edema, with changes of center point thickness and macular volume.

Full description

Photocoagulation for clinically significant macular edema is effective to reduce the incidence of moderate visual loss. Selective photocoagulation for focal macular edema statistically reduces macular thickening, measured with optical coherence tomography, as early as two weeks after treatment, without significant changes over center point thickness. Although anatomic improvement has been demonstrated with OCT, clinical improvement takes longer to be evident: the Early Treatment Diabetic Retinopathy Study describe that clinical differences in visual function are after the eight month, and all the treatment strategies for macular edema used in this study were associated with an increased rate of moderate visual loss, during the first six weeks. Differences in research can achieve statistical significance, without clinical significance. A study was conducted to identify changes of visual function three weeks after photocoagulation for focal macular edema, and to correlate them with changes of CPT and macular volume, in order to compare the behavior of anatomical changes with visual changes.

Enrollment

89 patients

Sex

All

Ages

40 to 70 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • type 2 diabetes
  • regardless of diabetes duration and retinopathy severity level
  • one or both eyes with focal clinically significant macular edema
  • treated with selective or focal photocoagulation
  • visual capacity under subjective refraction before and three weeks after treatment
  • adequate quality 6 mm fast macular map both on the day of photocoagulation, and three weeks after it

Exclusion criteria

  • patients with myopia over -6.00 diopters
  • any retinal disease different from diabetic retinopathy at the moment of photocoagulation
  • eyes with a thickened posterior vitreous
  • eyes with vitreoretinal traction at the macula
  • if they had required scatter photocoagulation before the three weeks evaluation

Trial design

89 participants in 1 patient group

diabetic macular edema
Description:
type 2 patients who had been treated with selective photocoagulation for clinically significant macular edema

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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