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Sponsored by: |
National Eye Institute (NEI) |
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Information provided by: | National Eye Institute (NEI) |
ClinicalTrials.gov Identifier: | NCT00687154 |
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.
Condition | Intervention |
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Diabetic Macular Edema |
Procedure: Scatter Laser Photocoagulation in 1 Sitting Procedure: Scatter Laser Photocoagulation in 4 Sittings |
Study Type: | Interventional |
Study Design: | Prevention, Non-Randomized, Open Label, Parallel Assignment |
Official Title: | An Observational Study of the Development of Diabetic Macular Edema Following Scatter Laser Photocoagulation |
Enrollment: | 155 |
Study Start Date: | September 2005 |
Study Completion Date: | January 2008 |
Primary Completion Date: | January 2008 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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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
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Procedure: Scatter Laser Photocoagulation in 1 Sitting
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.
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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.
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Procedure: Scatter Laser Photocoagulation in 4 Sittings
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.
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Study eyes will receive scatter photocoagulation given by one of the following two regimens. To reduce selection bias, investigators will be required, prior to study initiation, to indicate which treatment (1 PRP sitting or 4 PRP sittings) they will administer. Only the selected treatment will be performed by a given investigator on study eyes.
Both of these regimens conform with usual clinical practice.
The study aims to enroll 150 eyes. At least 40 eyes will be enrolled with prior focal laser photocoagulation and at least 40 eyes without prior focal laser treatment. After enrollment of 80 eyes (40 with prior treatment and 40 without prior treatment), an interim analysis will be conducted so that focused enrollment strategies can be implemented if the analysis suggests that more subjects in a subgroup should be entered. Approximately half of the eyes will receive each scatter treatment regimen.
The following procedures will be done on the study eye at baseline and at each scheduled visit (except 8 and 12 weeks at which exam data are not collected) unless otherwise specified:
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria: To be eligible, the following inclusion (1-4) and exclusion criteria (5-8) must be met:
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:
Able and willing to provide informed consent.
Exclusion Criteria: A patient is not eligible if any of the following exclusion criteria (5-8) are present:
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.
The patient must have at least one eye meeting all of the inclusion criteria (a-d) and none of the exclusion criteria (e-k) listed below.
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.
The eligibility criteria for a study eye are as follows:
Inclusion
Media clarity, pupillary dilation, and patient cooperation sufficient to administer full scatter photocoagulation and obtain adequate fundus photographs and OCT.
Exclusion
Responsible Party: | Jaeb Center for Health Research ( Roy W. Beck, M.D., Ph.D., Director ) |
Study ID Numbers: | NEI-127 |
Study First Received: | May 28, 2008 |
Last Updated: | May 28, 2008 |
ClinicalTrials.gov Identifier: | NCT00687154 |
Health Authority: | United States: Federal Government; United States: Institutional Review Board |
DME Laser macular edema retinopathy scatter photocoagulation |
Signs and Symptoms Macular Edema Eye Diseases Retinal Degeneration |
Macular Degeneration Edema Retinal Diseases Retinal degeneration |