Visual Function, Center Point Thickness and Macular Volume After Photocoagulation

NCT00906659 | Completed

• 1 other identifier: HJM 1453/08.02.26
• Study Type: observational
• Target: 89
• Locations: 1 country
• Sites: 1

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.

Conditions

Diabetic Retinopathy; Macular Edema

Keywords

center point thickness; diabetic retinopathy; diabetic macular edema; macular volume; visual capacity; visual function

Outcome Measures

Primary Outcomes (3)

• 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

Study Arms (1)

diabetic macular edema

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

Eligibility Criteria

• Age: 40 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Target population were type 2 diabetics from Mexico City and its metropolitan area, accessible population were the patients who attended a General Hospital in Mexico City

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Hospital Juarez de Mexico: lead

Study Sites (1)

Hospital Juarez de Mexico

Mexico City, Mexico City, 07760, Mexico

Location

MeSH Terms

Conditions

Diabetic Retinopathy; Macular Edema

Condition Hierarchy (Ancestors)

Retinal Diseases; Eye Diseases; Diabetic Angiopathies; Vascular Diseases; Cardiovascular Diseases; Diabetes Complications; Diabetes Mellitus; Endocrine System Diseases; Macular Degeneration; Retinal Degeneration

Study Officials

• Dulce M Razo Blanco Hernandez, MD

  Hospital Juarez de Mexico

  STUDY DIRECTOR

• Virgilio Lima Gomez, MD, MSc

  Hospital Juarez de Mexico

  STUDY CHAIR

• Aleyda S Cruz Diaz, MD

  Hospital Juarez de Mexico

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER GOV

Study Record Dates

• First Submitted: May 19, 2009
• First Posted: May 21, 2009
• Study Start: January 1, 2006
• Primary Completion: December 1, 2007
• Study Completion: March 1, 2008
• Last Updated: May 21, 2009

Record last verified: 2009-05

Locations

ME (1)