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
  Purpose

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).


Condition Intervention
Retinopathy of Prematurity (ROP)
Drug: 1% phenylephrine and 0.2% cyclopentolate

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Factorial Assignment
Masking: Open Label
Primary Purpose: Screening
Official Title: A Randomized Controlled Trial to Determine the Lowest Effective Dose for Adequate Mydriasis in Premature Infants

Resource links provided by NLM:


Further study details as provided by Georgetown University:

Primary Outcome Measures:
  • 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 ]

Enrollment: 15
Study Start Date: March 2007
Study Completion Date: March 2008
Primary Completion Date: November 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 0 Drop
Left eye dose
Drug: 1% phenylephrine and 0.2% cyclopentolate
given as drops, prior to eye exam
Other Name: Cyclomydril
Experimental: 1 Drop
Left eye dose
Drug: 1% phenylephrine and 0.2% cyclopentolate
given as drops, prior to eye exam
Other Name: Cyclomydril
Experimental: 2 drop
Left eye dose
Drug: 1% phenylephrine and 0.2% cyclopentolate
given as drops, prior to eye exam
Other Name: 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 Name: Cyclomydril

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.

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Premature infants undergoing clinically indicated retinal exams

Exclusion Criteria:

  • Ocular congenital anomalies
  • Pre-threshold ROP
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01054027

Locations
United States, District of Columbia
Georgetown University Hospital
Washington, District of Columbia, United States, 20007
Sponsors and Collaborators
Georgetown University
Investigators
Principal Investigator: Monisha Bahri, MD Georgetown University Hospital
  More Information

No publications provided

Responsible Party: Monisha Bahri, Georgetown University Medical Center
ClinicalTrials.gov Identifier: NCT01054027     History of Changes
Other Study ID Numbers: 2007-109
Study First Received: January 21, 2010
Last Updated: January 21, 2010
Health Authority: United States: Institutional Review Board

Keywords provided by Georgetown University:
Retinopathy of Prematurity (ROP)
Eye exams
Premature infants
cyclomydril

Additional relevant MeSH terms:
Mydriasis
Retinal Diseases
Retinopathy of Prematurity
Pupil Disorders
Eye Diseases
Infant, Premature, Diseases
Infant, Newborn, Diseases
Cyclopentolate
Phenylephrine
Oxymetazoline
Mydriatics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Parasympatholytics
Muscarinic Antagonists
Cholinergic Antagonists
Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Cardiotonic Agents
Cardiovascular Agents
Therapeutic Uses
Sympathomimetics
Vasoconstrictor Agents
Nasal Decongestants
Respiratory System Agents
Adrenergic alpha-1 Receptor Agonists
Adrenergic alpha-Agonists

ClinicalTrials.gov processed this record on August 25, 2014