JCHR

An Observational Study of the

Development of Diabetic Macular Edema

Following Scatter Laser Photocoagulation

Protocol Status: Completed

"Click here to view protocol"

A. Study Design

• Prospective, multi-center nonrandomized treatment study

B. Objectives

1. To determine the incidence and extent of macular edema following scatter laser photocoagulation surgery using optical coherence tomography (OCT) in eyes without macular edema prior to scatter laser photocoagulation.
2. To explore whether the incidence and extent of macular edema varies according to the number of sittings included in the treatement regimen.

C. Major Eligibility Criteria

• Age >=18 years.
• Study eye with (1) OCT central subfield thickness <= 299 microns and (2) early proliferative or severe nonproliferative diabetic retinopathy for which investigator intends to perform full scatter photocoagulation in either 1 sitting or 4 sittings.

D. Treatment
Study eyes will receive scatter photocoagulation given by one of the following two regimens to be selected by the investigator at his/her discretion:

• 1 sitting with a minimum of 1200 to a maximum of 1600 burns, with one burn width separation of burns and scatter extending from the peripheral arcades to beyond the equator.

• 4 sittings, each separated by four weeks (+4 days), with approximately 300 burns in each of the first two sittings and investigator judgment for number of burns for the third and fourth sittings as long as the total for the four sittings is between 1200 and 1600 burns

E. Duration of follow-up: 34 weeks

F. Main Outcomes

Primary

• Retinal thickening (measured with OCT).

Secondary

• Visual acuity (measured with E-ETDRS).

G. Sample Size: 150 eyes

H. Schedule of Study Visits and Examination Procedures