Clinical Trials Logo

Clinical Trial Summary

The purpose of this study is to compare the dilating effect of 0, 1, 2 or 3 drops of mydriatic (pupil dilating) in premature infants undergoing routine retinal (eye) screening exams for Retinopathy of Prematurity (ROP).


Clinical Trial Description

Premature infants need to have eye exams starting at about 4 weeks of age and continuing until their retinas (membrane at the back of the eye which collects and transfers light) is fully grown. These exams are done to see if they have developed ROP, a disease which can lead to blindness if not treated.

The ophthalmologist (eye doctor) looks through the enlarged pupil (opening at the front of the eye) to see the retina. The drug that is used to dilate the pupil, Cyclomydril, has been shown to have side effects in premature infants. No literature has shown what the optimal dose is for premature babies. Nursery policy is to give 3 drops of Cyclomydril in each eye, at 5 minute intervals, 45-60 minutes before a scheduled eye exam. We sought to reduce the dose without delaying the exam for an under-sized pupil.

In the study, each infant is randomized at the time of the exam to receive either 0, 1 or 2 drops of Cyclomydril in the left eye and 3 drops in the right eye to serve as their own control. The zero-drop group was created to test the contralateral (opposite eye) effect of 3 drops in the right eye. Pupil dilation size is measured using the Colvard pupillometer by a Pediatric Ophthalmologist examiner (G.V.V.) who was not masked to study group assignment.

Measures of pupil size are done at baseline (before any drops given), 45, 90 and 120 minutes after the first drop was given. ROP screening exam is done at the first opportunity to visualize the posterior and peripheral retina.

Additional drops are given at 120 minutes if the observer is unable to complete the exam prior to that point. ;


Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Factorial Assignment, Masking: Open Label, Primary Purpose: Screening


Related Conditions & MeSH terms


NCT number NCT01054027
Study type Interventional
Source Georgetown University
Contact
Status Completed
Phase N/A
Start date March 2007
Completion date March 2008

See also
  Status Clinical Trial Phase
Terminated NCT04506619 - Safety and Efficacy Outcomes Following Previously Administered Short-Term Treatment With SHP607 in Extremely Premature Infants
Completed NCT04004208 - Aflibercept for Retinopathy of Prematurity - Intravitreal Injection Versus Laser Therapy Phase 3
Recruiting NCT03253263 - A Clinical Efficacy and Safety Study of OHB-607 in Preventing Bronchopulmonary Dysplasia in Extremely Premature Infants Phase 2
Completed NCT02386839 - Long-term Safety and Efficacy Outcome Study Comparing Children Previously Enrolled in Study ROPP-2008-01 for the Prevention of Retinopathy of Prematurity (ROP) Phase 2
Withdrawn NCT01470430 - VEGF In Systemic Circulation Of ROP-infants N/A
Active, not recruiting NCT04015180 - Extension Study to Evaluate the Long-term Outcomes of Subjects in Study 20090 Phase 3
Completed NCT01096784 - IGF-1/IGFBP3 Prevention of Retinopathy of Prematurity Phase 2
Completed NCT02640664 - Rainbow Extension Study Phase 3
Completed NCT02134457 - Comparing Alternative Ranibizumab Dosages for Safety and Efficacy in Retinopathy of Prematurity Phase 2
Terminated NCT01954082 - Inositol to Reduce Retinopathy of Prematurity Phase 3