Study on Effective Mydriasis in Premature Infants

January 21, 2010 updated by: Georgetown University

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

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).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed 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 Type

Interventional

Enrollment (Actual)

15

Phase

  • Not Applicable

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
    • District of Columbia
      • Washington, District of Columbia, United States, 20007
        • Georgetown University Hospital

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

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Premature infants undergoing clinically indicated retinal exams

Exclusion Criteria:

  • Ocular congenital anomalies
  • Pre-threshold ROP

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: Screening
  • Allocation: Randomized
  • Interventional Model: Factorial Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 0 Drop
Left eye dose
Drug: 1% phenylephrine and 0.2% cyclopentolate
given as drops, prior to eye exam
Other Names:
  • Cyclomydril
Experimental: 1 Drop
Left eye dose
Drug: 1% phenylephrine and 0.2% cyclopentolate
given as drops, prior to eye exam
Other Names:
  • Cyclomydril
Experimental: 2 drop
Left eye dose
Drug: 1% phenylephrine and 0.2% cyclopentolate
given as drops, prior to eye exam
Other Names:
  • Cyclomydril
Active Comparator: 3 drops
Right eye dose for all groups
Drug: 1% phenylephrine and 0.2% cyclopentolate
given as drops, prior to eye exam
Other Names:
  • Cyclomydril

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
dilation of the pupil in millimeters
Time Frame: at baseline (no drops yet instilled), 45, 90 and 120 minutes after drops instilled
at baseline (no drops yet instilled), 45, 90 and 120 minutes after drops instilled

Collaborators and Investigators

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

Sponsor

Georgetown University

Investigators

  • Principal Investigator: Monisha Bahri, MD, Georgetown University Hospital

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

March 1, 2007

Primary Completion (Actual)

November 1, 2007

Study Completion (Actual)

March 1, 2008

Study Registration Dates

First Submitted

January 21, 2010

First Submitted That Met QC Criteria

January 21, 2010

First Posted (Estimate)

January 22, 2010

Study Record Updates

Last Update Posted (Estimate)

January 22, 2010

Last Update Submitted That Met QC Criteria

January 21, 2010

Last Verified

January 1, 2010

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2007-109

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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