Completed

Light Reduction for Retinopathy of Prematurity Prevention in Low Birth-Weight Infants

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What is being tested

Data Collection

Who is being recruted

Eye Diseases+3

+ Infant, Newborn, Diseases

+ Infant, Premature, Diseases

See all eligibility criteria
How is the trial designed

Treatment Study

Phase 3
Interventional
Study Start: July 1995
See protocol details

Summary

Principal SponsorNational Eye Institute (NEI)
Last updated: January 27, 2026
Sourced from a government-validated database.Claim as a partner

Study start date: July 1, 1995

Actual date on which the first participant was enrolled.

Retinopathy of Prematurity (ROP) is a condition that can lead to blindness in about 2.1% of extremely low birth-weight infants (those weighing less than 1,251 grams). Current treatments, like cryotherapy, are not always effective and can sometimes cause other vision problems. As medical care improves and more premature infants survive, the number of infants at risk for blindness from ROP is expected to increase. This study aims to find a safe, effective, easy-to-use, and affordable preventive treatment for ROP. The researchers believe that reducing the amount of light that reaches the eyes of premature infants might help prevent ROP, as light can produce harmful substances called free radicals that can damage the eyes. In this study, infants weighing less than 1,251 grams at birth are randomly assigned within 24 hours of birth to either wear goggles or not. These goggles block 97% of light and are worn until the infant reaches either 31 weeks gestational age or 4 weeks postnatal age, whichever is longer. All infants, whether they wear goggles or not, are exposed to the same amount of ambient light. The eyes of all infants are examined on a regular schedule to check for ROP. The main goal of this study is to determine if light reduction decreases the occurrence of any confirmed ROP. The study involves around 400 infants, equally divided into goggle-wearing and control groups, and is currently in the follow-up phase with regular eye exams until either ROP regression or normal full retinal vascularization is established.

Official TitleThe Effects of Light Reduction on Retinopathy of Prematurity (Light-ROP)
Principal SponsorNational Eye Institute (NEI)
Last updated: January 27, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

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

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

Range of ages for which participants are eligible to join.

Conditions

Pathology

Eye DiseasesInfant, Newborn, DiseasesInfant, Premature, DiseasesCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesRetinal DiseasesRetinopathy of Prematurity

Criteria

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 Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 3 locations

Suspended

The Children's Hospital of Buffalo

Buffalo, United StatesOpen The Children's Hospital of Buffalo in Google Maps
Suspended

The University of Texas, Southwestern Medical Center at Dallas

Dallas, United States
Suspended

University of Texas, Health Science Center, San Antonio

San Antonio, United States
Completed3 Study Centers