Observational Study of DME Following Scatter Laser Photocoagulation

NCT00687154 | Completed DMC

• 4 other identifiers: NEI-127U10EY018817-03U10EY014229-07U10EY014231-09
• Study Type: interventional
• Target: 155
• Locations: 0 countries
• Sites: N/A

Brief Summary

The development or worsening of macular edema following full scatter photocoagulation is a well recognized occurrence. However, there is limited literature in this regard. The purpose of this study is 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 and to explore whether the incidence and extent of macular edema varies according to the number of sittings included in the treatment regimen. Study eyes will receive one of two types of scatter photocoagulation with results compared through use of OCT and photography images, as well as visual acuity testing.

Conditions

Diabetic Macular Edema

Keywords

DME; Laser; macular edema; retinopathy; scatter photocoagulation

Outcome Measures

Primary Outcomes (1)

• Retinal thickening (measured with OCT)

  34 weeks

Secondary Outcomes (1)

• Visual Acuity (measured with E-ETDRS)

  2 days, 4 weeks, 17, and 34 weeks

Study Arms (2)

1 Sitting

ACTIVE COMPARATOR

Subjects 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 1 sitting

Procedure: Scatter Laser Photocoagulation in 1 Sitting

4 Sittings

ACTIVE COMPARATOR

Subjects 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 4 sittings.

Procedure: Scatter Laser Photocoagulation in 4 Sittings

Interventions

Scatter Laser Photocoagulation in 1 Sitting PROCEDURE

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.

Also known as: PRP

1 Sitting

Scatter Laser Photocoagulation in 4 Sittings PROCEDURE

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.

Also known as: PRP

4 Sittings

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may not qualify if:

• Age \>= 18 years
• Patients \<18 years old are not being included because there would be an insufficient number of patients \<18 years old who would meet eligibility criteria for the study in order to be able to generalize the results to patients \<18 years old or to provide informative data as to the effects of treatment in this age group.
• Diagnosis of diabetes mellitus (type 1 or type 2)
• Any one of the following will be considered to be sufficient evidence that diabetes is present:
• Current regular use of insulin for the treatment of diabetes
• Current regular use of oral anti-hyperglycemia agents for the treatment of diabetes
• Documented diabetes by ADA and/or WHO criteria
• At least one eye meets the study eye criteria listed in section 2.2.2.
• Able and willing to provide informed consent.
• History of chronic renal failure requiring dialysis or kidney transplant.
• History of pancreatic transplant.
• A condition that, in the opinion of the investigator, would preclude participation in the study (e.g., unstable medical status including blood pressure and glycemic control).
• Patients in poor glycemic control who, within the last 4 months, initiated intensive insulin treatment (a pump or multiple daily injections) or plan to do so in the next 4 months should not be enrolled.
• Patient is expecting to move out of the area of the clinical center to an area not covered by another clinical center during the next 8 months.
• A patient can have only one study eye. If both eyes are eligible, the investigator at his/her discretion will select one to be the study eye.

Sponsors & Collaborators

• Jaeb Center for Health Research: lead
• National Eye Institute (NEI): collaborator

Related Publications (1)

• Diabetic Retinopathy Clinical Research Network; Brucker AJ, Qin H, Antoszyk AN, Beck RW, Bressler NM, Browning DJ, Elman MJ, Glassman AR, Gross JG, Kollman C, Wells JA 3rd. Observational study of the development of diabetic macular edema following panretinal (scatter) photocoagulation given in 1 or 4 sittings. Arch Ophthalmol. 2009 Feb;127(2):132-40. doi: 10.1001/archophthalmol.2008.565.

  PMID: 19204228 RESULT

MeSH Terms

Conditions

Macular Edema; Retinal Diseases

Condition Hierarchy (Ancestors)

Macular Degeneration; Retinal Degeneration; Eye Diseases

Study Officials

• Alexander J. Brucker, M.D.

  Scheie Eye Institute

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: May 28, 2008
• First Posted: May 30, 2008
• Study Start: September 1, 2005
• Primary Completion: January 1, 2008
• Study Completion: January 1, 2008
• Last Updated: August 26, 2016

Record last verified: 2016-08