Study on Effective Mydriasis in Premature Infants
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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 |
- 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 |
Inclusion Criteria:
- Premature infants undergoing clinically indicated retinal exams
Exclusion Criteria:
- Ocular congenital anomalies
- Pre-threshold ROP
Contacts and Locations| United States, District of Columbia | |
| Georgetown University Hospital | |
| Washington, District of Columbia, United States, 20007 | |
| 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 Adrenergic alpha-1 Receptor Agonists Adrenergic alpha-Agonists Adrenergic Agonists Adrenergic Agents Cardiotonic Agents Cardiovascular Agents Therapeutic Uses Sympathomimetics Vasoconstrictor Agents |
ClinicalTrials.gov processed this record on June 18, 2013