Abstract

It is hypothesized that light reduction to the eyes of extremely preterm, infants may be effective in preventing Retinopathy of Prematurity (ROP). Previous reports on the use of light reduction to the eyes of preterm infants for prevention of ROP have produced conflicting results. In this study, infants weighing less than 1251 grams at birth will be prospectively randomized within 24 hours of birth to wear goggles containing 97% neutral density filters until 31 weeks of gestational age (GA) or 4 weeks post- natal age (whichever is longer), or to have no extraordinary means of light reduction (control group). Eyes will be examined on a prescribed schedule until any ROP or full vascularization of the retina is achieved. The primary objective of this study will be to determine whether or not light reduction will decrease the incidence of ROP. The complete description of the experimental design and scientific goals of the LIGHT=ROP Study appear in the attached Manual of Procedures. Because this is a feasibility study we will only be able to evaluate statistical trends, not answer the question definitively. In addition to presenting the LIGHT-ROP Study in general, this application is for funding of the study headquarters, study centers (Buffalo and Dallas) and the coordinating center (Houston).

  Funding Agency

Agency
National Institute of Health (NIH)
Institute
National Eye Institute (NEI)
Type
Cooperative Clinical Research--Cooperative Agreements (U10)
Project #
1U10EY009953-01A2
Application #
2163671
Study Section
Vision Research and Training Committee (VSN)
Project Start
1995-04-01
Project End
1997-03-31
Budget Start
1995-04-01
Budget End
1996-03-31
Support Year
1
Fiscal Year
1995
Total Cost
Indirect Cost

  Institution

Name
State University of New York at Buffalo
Department
Ophthalmology
Type
Schools of Medicine
DUNS #
038633251
City
Buffalo
State
NY
Country
United States
Zip Code
14260