Visual Function, Center Point Thickness and Macular Volume After Photocoagulation

This study has been completed.
Sponsor:
Information provided by:
Hospital Juarez de Mexico
ClinicalTrials.gov Identifier:
NCT00906659
First received: May 19, 2009
Last updated: May 20, 2009
Last verified: May 2009
  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

Resource links provided by NLM:


Further study details as provided by Hospital Juarez de Mexico:

Primary Outcome Measures:
  • 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
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

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00906659

Locations
Mexico
Hospital Juarez de Mexico
Mexico, Distrito Federal, Mexico, 07760
Sponsors and Collaborators
Hospital Juarez de Mexico
Investigators
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 July 22, 2014