The Effects of Light Reduction on Retinopathy of Prematurity (Light-ROP)

June 2, 2006 updated by: National Eye Institute (NEI)
To evaluate the effect of ambient light reduction on the incidence of retinopathy of prematurity (ROP).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Despite progress during the past decade in treatment of ROP, this disease still poses a significant (approximately 2.1 percent) risk of blindness to extremely low birth-weight (<1,251 grams) preterm infants. Current estimates indicate that about 27,000 infants of extremely low birth weight are born annually, of which 74 percent will survive. As techniques of managing smaller and less mature preterm infants continue to improve, it is expected that the number of infants at risk for blindness will continue to increase.

For infants weighing less than 1,251 grams at birth, the Cryotherapy for Retinopathy of Prematurity (CRYO-ROP) Study has shown that the risk of developing severe, acute (threshold) ROP is 6 percent. Although cryotherapy, when applied at the time of threshold ROP, reduces the rate of unfavorable visual outcome, 35 percent of eyes that develop this level of severe, acute disease are blind 1 year after treatment. Moreover, cryotherapy is destructive. Even when cryotherapy prevents progression to retinal detachment, it is associated with peripheral retinal destruction and may, in some cases, be associated with subnormal central vision due to high myopia and/or macular scarring. Corrective surgical treatments for retinal detachment caused by ROP have proven to be of little visual benefit. A preventive treatment for ROP that is safe, efficacious, easily applied, and inexpensive is desirable.

The investigators hypothesize that reducing the amount of light that reaches the eyes of preterm infants may be effective in preventing ROP. Although previous reports on the use of light reduction to the eyes of preterm infants in the nursery have produced conflicting results, there are sufficient reasons to believe that this strategy may be effective in reducing the incidence and severity of ROP. These reasons center on the role of light in the production of destructive free radicals. Supplemental oxygen produces the same free radicals, and the two mechanisms may be additive.

In this masked, controlled study, infants weighing less than 1,251 grams at birth were prospectively randomized within 24 hours of birth to wear goggles or not to wear goggles. Goggles contain 97 percent near neutral density filters and were worn until the infant reached either 31 weeks gestational age or 4 weeks postnatal age, whichever was longer. The goggled and nongoggled infants were exposed to the same ambient light conditions within any given Study Center. Eyes of all infants were examined on a prescribed schedule by certified examiners to determine the incidence of any confirmed ROP.

The primary objective of this study is to answer the following question: Does light reduction to the eyes of extremely low birth-weight infants decrease the incidence of any confirmed ROP (at least 3 contiguous clock hours, any stage, any zone)? The primary end points are therefore ROP or full vascularization.

The secondary objective of this study is to evaluate the following question: Does light reduction to the eyes of extremely low birth-weight infants decrease the incidence of more severe ROP (prethreshold ROP -- the secondary end point)?

The study has recruited approximately 400 infants, equally divided into goggle-wearing and control group. Since randomization must occur within 24 hours of birth, the investigators anticipate a mortality rate of between 10 percent and 20 percent of enrollees prior to outcome. The study is in the followup phase with regular ophthalmologic exams until either ROP regression or normal full retinal vascularization is established. A final exam occurs at adjusted age 6 months.

Study Type

Interventional

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • New York
      • Buffalo, New York, United States
        • The Children's Hospital of Buffalo
    • Texas
      • Dallas, Texas, United States
        • The University of Texas, Southwestern Medical Center at Dallas
      • San Antonio, Texas, United States
        • University of Texas, Health Science Center, San Antonio

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

No older than 1 day (Child)

Accepts Healthy Volunteers

N/A

Genders Eligible for Study

All

Description

Premature infants weighing less than 1,251 grams at birth and having a gestational age of less than 31 weeks were eligible for randomization. Consent must have been obtained within 24 hours of birth. Patients with major congenital anomalies are excluded.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Masking: Double

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

National Eye Institute (NEI)

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 1995

Study Registration Dates

First Submitted

September 23, 1999

First Submitted That Met QC Criteria

September 23, 1999

First Posted (Estimate)

September 24, 1999

Study Record Updates

Last Update Posted (Estimate)

June 5, 2006

Last Update Submitted That Met QC Criteria

June 2, 2006

Last Verified

October 1, 2003

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NEI-58

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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