Visual Function, Center Point Thickness and Macular Volume After Photocoagulation
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Purpose
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 |
|---|
|
Diabetic Retinopathy Macular Edema |
| Study Type: | Observational |
| Study Design: | 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 |
- visual capacity (under subjective refractive correction was measured in decimal equivalent) [ Time Frame: before the treatment and 3 weeks after photocoagulation ] [ Designated as safety issue: Yes ]
- center point thickness (measured in µm) [ Time Frame: before the treatment and 3 weeks after photocoagulation ] [ Designated as safety issue: Yes ]
- macular volume (measured in mm3) [ Time Frame: before the treatment and 3 weeks after photocoagulation ] [ Designated as safety issue: Yes ]
| Enrollment: | 89 |
| Study Start Date: | January 2006 |
| Study Completion Date: | March 2008 |
| Primary Completion Date: | December 2007 (Final data collection date for primary outcome measure) |
| Groups/Cohorts |
|---|
|
diabetic macular edema
type 2 patients who had been treated with selective photocoagulation for clinically significant 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.
Eligibility| Ages Eligible for Study: | 40 Years to 70 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
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
Contacts and Locations| Mexico | |
| Hospital Juarez de Mexico | |
| Mexico, Distrito Federal, Mexico, 07760 | |
| 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 |
More Information
No publications provided
| Responsible Party: | Virgilio Lima Gomez, Hospital Juarez de Mexico |
| ClinicalTrials.gov Identifier: | NCT00906659 History of Changes |
| Other Study ID Numbers: | HJM 1453/08.02.26 |
| Study First Received: | May 19, 2009 |
| Last Updated: | May 20, 2009 |
| Health Authority: | Mexico: Federal Commission for Sanitary Risks Protection United States: Federal Government |
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:
|
Diabetic Retinopathy Edema Macular Edema Retinal Diseases Eye Diseases Diabetic Angiopathies Vascular Diseases |
Cardiovascular Diseases Diabetes Complications Diabetes Mellitus Endocrine System Diseases Signs and Symptoms Macular Degeneration Retinal Degeneration |
ClinicalTrials.gov processed this record on May 22, 2013