|
|
|
|
The Course
of Response to Focal Photocoagulation for Diabetic Macular Edema Protocol Status: Completed A. Study Design · Prospective, multi-center single-group intervention
study B. Major Eligibility Criteria · Age >18 years · Type 1 or type 2 diabetes · Diabetic macular edema
involving the center of the macula (OCT central subfield thickness >250
microns) · Investigator
intends to treat the DME with focal photocoagulation C. Treatment Group All study eyes will receive modified ETDRS focal
photocoagulation (see chapter 3) A subject may have only one study eye. D. Sample Size
E. Main Outcomes: OCT-measured retinal thickness and visual
acuity F. Examination
Procedures at Each Visit
Notes: *
follow up continues after 16 weeks only for eyes not receiving additional
treatment (see above) Testing
is only required for the study eye unless otherwise specified below a = protocol refraction
and visual acuity performed on both eyes at baseline, and on study eye only
at all other visits. E-ETDRS refers to electronic ETDRS testing using the
Electronic Visual Acuity Tester that has been validated against 4-meter chart
ETDRS testing. b = does not need to be repeated
if HbA1c available from within the prior 3 months; if not available, can be
performed within 3 weeks after enrollment. |
||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|
|