Diabetic Retinopathy Clinical Research Network (DRCRnet) public web site

Protocol: A Pilot Study in Individuals with Center-Involved DME Undergoing Cataract Surgery
Status: Closed
Start Date: 06/01/2009
End Date: 11/12/2010
Clinical Trial ID:  
Public Dataset:  Download

 

A Pilot Study in Individuals with Center-Involved Diabetic Macular Edema Undergoing Cataract Surgery

 

Protocol Status: Completed

"Click here to view protocol"

A. Study Objective

The primary objectives of the study are as follows:

  • Determine feasibility of a randomized trial in eyes with center-involved DME prior to cataract surgery, including:
    • Recruitment potential
    • Logistics of interaction between cataract surgeon's office and DRCR.net sites
      • Clinical site ability to communicate with cataract surgeon's office prior to enrollment
      • Completion of surgery in 1-14 day time frame after enrollment
      • Ability to obtain medical records
    • Trial design
      • Collection of FAs and ability to classify diabetic macular edema (DME) and cystoid macular edema (CME) according to protocol criteria
      • Frequency of ungradeable fundus photographs for level of diabetic retinopathy prior to cataract surgery
      • Evaluation of visual acuity data to obtain a better sample size estimate for a randomized trial
  • Describe all eyes with respect to how cataract surgeons and DRCR.net investigators manage these cases at the time of surgery
  • Evaluate exacerbation of DME and visual acuity at 16 weeks

 

B. Major Eligibility Criteria

  • Age >=18 years
  • Type 1 or type 2 diabetes
  • Only one study eye per subject may be enrolled. The study eye must meet the following:
    •  Presence of cataract for which cataract surgery will be performed within 1-14 days after enrollment
    • Presence of center-involved DME as evidenced by a Zeiss Stratus OCT central subfield thickness >= 250 microns (or spectral domain OCT equivalent)
    • Visual acuity light perception or better

 

C. Cataract Surgery

 The cataract surgery itself is not part of the experimental design. The cataract surgery, including pre-operative and post-operative assessments and management should be by the usual manner of each cataract surgeon.

D. Treatment

All treatment is at the discretion of the cataract surgeon and the investigator. Information will be collected on the treatments received pre-operatively, peri-operatively, and post-operatively for DME or CME (topical drops, laser, corticosteroids, anti-VEGF drugs, oral medications, vitrectomy, or others).

 

E. Follow-up

  • Cataract surgery within 1-14 days following enrollment (performed within 1-7 days if possible)
  • A single follow-up visit will occur at 16 weeks following cataract surgery
  • An additional visit will be completed the first time any post-surgical treatment for DME or CME other than topical drops is to be given, at which OCT will be performed prior to administering treatment
  • Additional visits to occur as needed based on usual care

E. Efficacy Outcome
The primary objective is to determine feasibility of a randomized trial. The secondary outcomes include evaluation of visual acuity and OCT measured central subfield thickness at 16 weeks.

F. Sample Size

A maximum of 500 subjects will be enrolled over an initial six month period with a maximum of 20 subjects per site.

 

G. Schedule of Study Visits and Examination Procedures

 

  Enrollment 0 16w +/- 2 w
Cataract Surgery   X  
E-ETDRS best corrected visual acuitya X   X
OCTb X   X
Fluorescein angiography if performed as part of
routine care
X   X
Eye Examc X   X
Fundus photosd X    

    a = both eyes at each visit; includes protocol refraction in study eye at each follow-up visit and in both eyes at enrollment. E-ETDRS refers to electronic ETDRS testing using the Electronic Visual Acuity Tester that has been validated against 4-meter chart ETDRS testing.
    b=study eye only; also obtained prior to first non-topical DME or CME treatment.
    c = study eye only at baseline and follow-up visits.
    d = study eye only; will assess after first 50 subjects and determine whether to continue collecting.

 

 



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