Study on Effective Mydriasis in Premature Infants

This study has been completed.
Sponsor:
Information provided by:
Georgetown University
ClinicalTrials.gov Identifier:
NCT01054027
First received: January 21, 2010
Last updated: NA
Last verified: January 2010
History: No changes posted

January 21, 2010
January 21, 2010
March 2007
November 2007   (final data collection date for primary outcome measure)
dilation of the pupil in millimeters [ Time Frame: at baseline (no drops yet instilled), 45, 90 and 120 minutes after drops instilled ] [ Designated as safety issue: No ]
Same as current
No Changes Posted
Not Provided
Not Provided
Not Provided
Not Provided
 
Study on Effective Mydriasis in Premature Infants
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).

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.

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Factorial Assignment
Masking: Open Label
Primary Purpose: Screening
Retinopathy of Prematurity (ROP)
Drug: 1% phenylephrine and 0.2% cyclopentolate
given as drops, prior to eye exam
Other Name: Cyclomydril
  • Experimental: 0 Drop
    Left eye dose
    Intervention: Drug: 1% phenylephrine and 0.2% cyclopentolate
  • Experimental: 1 Drop
    Left eye dose
    Intervention: Drug: 1% phenylephrine and 0.2% cyclopentolate
  • Experimental: 2 drop
    Left eye dose
    Intervention: Drug: 1% phenylephrine and 0.2% cyclopentolate
  • Active Comparator: 3 drops
    Right eye dose for all groups
    Intervention: Drug: 1% phenylephrine and 0.2% cyclopentolate
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
15
March 2008
November 2007   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Premature infants undergoing clinically indicated retinal exams

Exclusion Criteria:

  • Ocular congenital anomalies
  • Pre-threshold ROP
Both
Not Provided
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01054027
2007-109
No
Monisha Bahri, Georgetown University Medical Center
Georgetown University
Not Provided
Principal Investigator: Monisha Bahri, MD Georgetown University Hospital
Georgetown University
January 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP