Visual Function, Center Point Thickness and Macular Volume After Photocoagulation

NCT ID: NCT00906659

Last Updated: 2009-05-21

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 89 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2006-01-31
• Study Completion Date: 2008-03-31

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.

Conditions

Diabetic Retinopathy; Macular Edema

Study Design

• Observational Model Type: CASE_ONLY
• Study Time Perspective: PROSPECTIVE

Study Groups

diabetic macular edema

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

No interventions assigned to this group

Eligibility Criteria

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

• Minimum Eligible Age: 40 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Hospital Juarez de Mexico

OTHER_GOV

Sponsor Role: lead

Responsible Party

Hospital Juarez de Mexico

Principal Investigators

Dulce M Razo Blanco Hernandez, MD

Role: STUDY_DIRECTOR

Hospital Juarez de Mexico

Virgilio Lima Gomez, MD, MSc

Role: STUDY_CHAIR

Hospital Juarez de Mexico

Aleyda S Cruz Diaz, MD

Role: PRINCIPAL_INVESTIGATOR

Hospital Juarez de Mexico

Locations

Hospital Juarez de Mexico

Mexico City, Mexico City, Mexico

Countries

Mexico

Other Identifiers

HJM 1453/08.02.26

Identifier Type: -

Identifier Source: org_study_id