An interventional study of 1% phenylephrine and 0.2% cyclopentolate in Retinopathy of Prematurity (ROP), sponsored by Georgetown University. Completed at 1 site in United States. Per ClinicalTrials.gov, last updated 2010-01-22.
Sponsored by Georgetown University · Not applicable, Interventional, and Screening
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Among 51 studies in Retinopathy of Prematurity with a site in United States — 6 open to participants now, 10 under way, none of them phase 3. Retinopathy of Prematurity · United States.
Among the 51 studies in Retinopathy of Prematurity with a site in United States, this one is the 28th largest by enrollment of the 32 interventional ones that give a count, is one of 2 that started in 2007, is one of 10 with no phase, and was the 17th registered.
169 studies on the registry are indexed under Retinopathy of Prematurity; 27 are open to participants now.
Browse Retinopathy of Prematurity studies →6 of the 51 studies in Retinopathy of Prematurity with a site in United States are open now. Recruiting first, the newest first:
Duke University · Sites in United States
Ages 0 days–9 mo
FELIQS INC. · Sites in United States
Ages 4 days–5 days
Vanderbilt University Medical Center · Sites in United States
Ages 24 wk–34 wk
Duke University · Sites in United States
Ages up to 2 mo
Duke University · Sites in United States
Healthy volunteers
A study can be open while its sites in United States have not opened yet or have stopped. Only those recruiting at a site in United States →
Of the 19 Retinopathy of Prematurity studies recruiting now, 7 (37%) set no upper age limit and 12 (63%) stop at 75 or younger; 19 take children under 18; 4 take healthy volunteers.
This study: all sexes · no healthy volunteers.
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51 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 3 · Phase 2 13 · Phase 3 11 · Phase 4 1
First in 1986; this study’s year is marked. 2 started in 2007.
By drug class, each counting the studies that test any of its medicines:
This study's enrollment of 15 is below the median of 82 across 102 interventional studies indexed under Retinopathy of Prematurity.
Median enrollment 114 across the 32 interventional studies, 102 across the 15 observational. Of the 35 that completed or were terminated, 14 (40%) have results posted.
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12 of 51 have an industry lead sponsor. The 10 most frequent:
Georgetown University is the lead sponsor of 292 studies on the registry; 40 are open to participants now.
Of its 28 completed or terminated interventional studies of FDA-regulated products, 20 (71%) have results posted.
Georgetown University has 1 study filed under Retinopathy of Prematurity — fewer than ten, so there is no comparison to draw.
3 of the studies in Retinopathy of Prematurity with a site in United States that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT07093255FELIQS INC.Safety, PK and PD of FLQ-101 in Premature Neonates | 2026-12-31 |
| NCT04995341Duke UniversityRetinal Microanatomy in Retinopathy of Prematurity (BabySTEPS2) | 2027-03-31 |
| NCT05558059Duke UniversityImaging Retinal Vasculature in Infant Eyes | 2027-08-31 |
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Among the 51 studies in Retinopathy of Prematurity with a site in United States, from their registry updates:
Nothing recorded among them since 2026-09-25.
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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.
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Exclusion Criteria:
Left eye dose
Drug: 1% phenylephrine and 0.2% cyclopentolate
Left eye dose
Drug: 1% phenylephrine and 0.2% cyclopentolate
Left eye dose
Drug: 1% phenylephrine and 0.2% cyclopentolate
Right eye dose for all groups
Drug: 1% phenylephrine and 0.2% cyclopentolate
Drug pages: Phenylephrine · Cyclopentolate
given as drops, prior to eye exam
Also known as: Cyclomydril
dilation of the pupil in millimeters
Time frame: at baseline (no drops yet instilled), 45, 90 and 120 minutes after drops instilled
The record gives a start of Mar 2007, a primary completion of Nov 2007 and a completion of Mar 2008. It does not say whether these dates are actual or estimated.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Jan 2010. You cannot join it, but the record below documents what was studied.
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Studies of the drugs tested here: Phenylephrine · Cyclopentolate