Visual Function, Center Point Thickness and Macular Volume After Photocoagulation

Completed

• Conditions: Diabetic Retinopathy; Macular Edema

• Registration Number: NCT00906659
• Lead Sponsor: Hospital Juarez de Mexico

Brief Summary

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.

Detailed 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.

Study Timeline

• Study Start: 2006-01
• Primary Completion: 2007-12
• Study Completion: 2008-03
• Status Verified: 2009-05
• Study First Submitted: 2009-05-19
• Study First Submitted QC: 2009-05-20
• Last Update Submitted: 2009-05-20
• Study First Posted: 2009-05-21
• Last Update Posted: 2009-05-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 89

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
visual capacity (under subjective refractive correction was measured in decimal equivalent)	before the treatment and 3 weeks after photocoagulation
center point thickness (measured in µm)	before the treatment and 3 weeks after photocoagulation
macular volume (measured in mm3)	before the treatment and 3 weeks after photocoagulation

Trial Locations

Locations (1)

Hospital Juarez de Mexico; 🇲🇽 Mexico, Distrito Federal, Mexico