Study on Effective Mydriasis in Premature Infants

Retinopathy of Prematurity (ROP) Clinical Trial

Official title:

A Randomized Controlled Trial to Determine the Lowest Effective Dose for Adequate Mydriasis in Premature Infants

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01054027
• Other study ID #: 2007-109
• Status: Completed
• Phase: N/A
• First received: January 21, 2010
• Last updated: January 21, 2010
• Start date: March 2007
• Est. completion date: March 2008

Study information

• Verified date: January 2010
• Source: Georgetown University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 15
• Est. completion date: March 2008
• Est. primary completion date: November 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• Premature infants undergoing clinically indicated retinal exams

Exclusion Criteria:

• Ocular congenital anomalies

• Pre-threshold ROP

Study Design

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

Related Conditions & MeSH terms

• Premature Birth
• Retinal Diseases
• Retinopathy of Prematurity
• Retinopathy of Prematurity (ROP)

Intervention

Drug:
• 1% phenylephrine and 0.2% cyclopentolate
given as drops, prior to eye exam

Locations

Country	Name	City	State
United States	Georgetown University Hospital	Washington	District of Columbia

Sponsors (1)

Lead Sponsor	Collaborator
Georgetown University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	dilation of the pupil in millimeters		at baseline (no drops yet instilled), 45, 90 and 120 minutes after drops instilled	No