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Visual Function, Center Point Thickness and Macular Volume After Photocoagulation

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00906659
Recruitment Status : Completed
First Posted : May 21, 2009
Last Update Posted : May 21, 2009
Information provided by:
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.

Condition or disease
Diabetic Retinopathy Macular Edema

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.

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Study Type : Observational
Actual Enrollment : 89 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Correlation of Visual Function, Center Point Thickness and Macular Volume Changes Three Weeks After Focal Photocoagulation for Diabetic Macular Edema
Study Start Date : January 2006
Actual Primary Completion Date : December 2007
Actual Study Completion Date : March 2008

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Edema

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

Primary Outcome Measures :
  1. visual capacity (under subjective refractive correction was measured in decimal equivalent) [ Time Frame: before the treatment and 3 weeks after photocoagulation ]
  2. center point thickness (measured in µm) [ Time Frame: before the treatment and 3 weeks after photocoagulation ]
  3. macular volume (measured in mm3) [ Time Frame: before the treatment and 3 weeks after photocoagulation ]

Information from the National Library of Medicine

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Ages Eligible for Study:   40 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00906659

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Hospital Juarez de Mexico
Mexico, Distrito Federal, Mexico, 07760
Sponsors and Collaborators
Hospital Juarez de Mexico
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Study Director: Dulce M Razo Blanco Hernandez, MD Hospital Juarez de Mexico
Study Chair: Virgilio Lima Gomez, MD, MSc Hospital Juarez de Mexico
Principal Investigator: Aleyda S Cruz Diaz, MD Hospital Juarez de Mexico

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Responsible Party: Virgilio Lima Gomez, Hospital Juarez de Mexico Identifier: NCT00906659    
Other Study ID Numbers: HJM 1453/08.02.26
First Posted: May 21, 2009    Key Record Dates
Last Update Posted: May 21, 2009
Last Verified: May 2009
Keywords provided by Hospital Juarez de Mexico:
center point thickness
diabetic retinopathy
diabetic macular edema
macular volume
visual capacity
visual function
Additional relevant MeSH terms:
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Macular Edema
Retinal Diseases
Diabetic Retinopathy
Signs and Symptoms
Macular Degeneration
Retinal Degeneration
Eye Diseases
Diabetic Angiopathies
Vascular Diseases
Cardiovascular Diseases
Diabetes Complications
Diabetes Mellitus
Endocrine System Diseases