Diabetic Retinopathy Clinical Research Network (DRCRnet) public web site

Protocol: Evaluation of Vitrectomy for Diabetic Macular Edema Study
Status: Closed
Start Date: 08/09/2004
End Date: 02/26/2009
Clinical Trial ID: NCT00709319
Public Dataset:  Download

 

Evaluation of Vitrectomy for Diabetic Macular Edema

 

Protocol Status: Enrollment Completed

 

"Click here to view protocol"

 

A. Study Design

  • Prospective nonrandomized treatment study

 

B. Objectives

1.  To provide information on the following outcomes in eyes with DME that undergo vitrectomy: visual acuity, retinal thickening, resolution of traction (if present), surgical complications.

2.  To identify subgroups in which there appears to be a benefit of vitrectomy and subgroups in which vitrectomy does not appear to be beneficial.

 

C. Major Eligibility Criteria

  • Age >=18 years.
  • At least one eye meeting the following criteria:
    • Vitrectomy being performed as treatment of DME.
    • Diabetic macular edema on clinical exam
    • Best corrected visual acuity 20/800 or better (E-ETDRS visual acuity score >= 3 letters)
        » Acuity in primary analysis cohort 20/63 to 20/400-see below

 

D. Treatment
Vitrectomy will be performed by the investigator’s usual routine.

 

E. Duration of follow-up: One year.

 

F. Main Outcomes

  • Visual acuity
  • Retinal thickening (measured on OCT)
  • Surgical complications (including intraoperative and perioperative medical complications)

The 6-month data will be considered primary for efficacy analyses, since additional treatment beyond that time point may complicate interpretation of the results. Longer term follow-up will be necessary for documentation of complications, such as cataracts.

 

G. Sample Size

Up to 400 patients

  • Approximately 100 patients meeting the following criteria: vitreomacular traction on OCT, visual acuity 20/63 to 20/400, retinal thickness >300 microns in the central subfield on OCT, and cataract extraction not performed in conjunction with vitrectomy.
  • A maximum of 300 additional patients undergoing vitrectomy for DME but not meeting the above criteria.

 

H. Schedule of Study Visits and Examination Procedures

 

 

Study Month

 

0

3

6

12

E-ETDRS visual acuitya

X

X

X

X

Fundus photos

7F

 

7F

7F

OCT

X

X

X

X

IOP

X

X

X

X

Eye Examb

X

X

X

X

Blood Pressure

X

 

 

X

HbA1cc

X

 

 

X

Fluor. Angiod

X

 

 

 

 

Testing is on the study eye only.

a =

includes protocol refraction. E-ETDRS refers to electronic ETDRS testing using the Electronic Visual Acuity Tester that has been validated against 4-meter chart ETDRS testing.

b =

includes lens assessment using standard photos

c =

does not need to be repeated if HbA1c and lab normal values are available from within the prior 3 months (at baseline, can be performed within 3 weeks after enrollment).

d =

does not need to be performed if not part of usual care.

 

 



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