Visual Function, Center Point Thickness and Macular Volume After Photocoagulation

Diabetic Retinopathy Clinical Trial

Official title:

Correlation of Visual Function, Center Point Thickness and Macular Volume Changes Three Weeks After Focal Photocoagulation for Diabetic Macular Edema

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00906659
• Other study ID #: HJM 1453/08.02.26
• Status: Completed
• Phase: N/A
• First received: May 19, 2009
• Last updated: May 20, 2009
• Start date: January 2006
• Est. completion date: March 2008

Study information

• Verified date: May 2009
• Source: Hospital Juarez de Mexico
• Contact: n/a
• Is FDA regulated: No
• Health authority: Mexico: Federal Commission for Sanitary Risks ProtectionUnited States: Federal Government
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 89
• Est. completion date: March 2008
• Est. primary completion date: December 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 40 Years to 70 Years

Eligibility

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

Study Design

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

• Diabetic Retinopathy
• Macular Edema
• Retinal Diseases

Locations

Country	Name	City	State
Mexico	Hospital Juarez de Mexico	Mexico	Distrito Federal

Sponsors (1)

Lead Sponsor	Collaborator
Hospital Juarez de Mexico

Country where clinical trial is conducted

Mexico, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	visual capacity (under subjective refractive correction was measured in decimal equivalent)		before the treatment and 3 weeks after photocoagulation	Yes
Primary	center point thickness (measured in µm)		before the treatment and 3 weeks after photocoagulation	Yes
Primary	macular volume (measured in mm3)		before the treatment and 3 weeks after photocoagulation	Yes