NCT01054027

Brief Summary

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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
15

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Mar 2007

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2007

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2007

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2008

Completed
1.9 years until next milestone

First Submitted

Initial submission to the registry

January 21, 2010

Completed
1 day until next milestone

First Posted

Study publicly available on registry

January 22, 2010

Completed
Last Updated

January 22, 2010

Status Verified

January 1, 2010

Enrollment Period

8 months

First QC Date

January 21, 2010

Last Update Submit

January 21, 2010

Conditions

Retinopathy of Prematurity (ROP)

Keywords

Retinopathy of Prematurity (ROP)Eye examsPremature infantscyclomydril

Outcome Measures

Primary Outcomes (1)

  • dilation of the pupil in millimeters

    at baseline (no drops yet instilled), 45, 90 and 120 minutes after drops instilled

Study Arms (4)

0 Drop

EXPERIMENTAL

Left eye dose

Drug: 1% phenylephrine and 0.2% cyclopentolate

1 Drop

EXPERIMENTAL

Left eye dose

Drug: 1% phenylephrine and 0.2% cyclopentolate

2 drop

EXPERIMENTAL

Left eye dose

Drug: 1% phenylephrine and 0.2% cyclopentolate

3 drops

ACTIVE COMPARATOR

Right eye dose for all groups

Drug: 1% phenylephrine and 0.2% cyclopentolate

Interventions

1% phenylephrine and 0.2% cyclopentolateDRUG

given as drops, prior to eye exam

Also known as: Cyclomydril
0 Drop1 Drop2 drop3 drops

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Premature infants undergoing clinically indicated retinal exams

You may not qualify if:

  • Ocular congenital anomalies
  • Pre-threshold ROP

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Georgetown University Hospital

Washington D.C., District of Columbia, 20007, United States

Location

MeSH Terms

Conditions

Retinopathy of PrematurityPremature Birth

Interventions

PhenylephrineCyclopentolate

Condition Hierarchy (Ancestors)

Retinal DiseasesEye DiseasesInfant, Premature, DiseasesInfant, Newborn, DiseasesCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesObstetric Labor, PrematureObstetric Labor ComplicationsPregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital Diseases

Intervention Hierarchy (Ancestors)

EthanolaminesAmino AlcoholsAlcoholsOrganic ChemicalsAminesPhenylacetatesAcids, CarbocyclicCarboxylic Acids

Study Officials

  • Monisha Bahri, MD

    Georgetown University Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SCREENING
Intervention Model
FACTORIAL
Sponsor Type
OTHER

Study Record Dates

First Submitted

January 21, 2010

First Posted

January 22, 2010

Study Start

March 1, 2007

Primary Completion

November 1, 2007

Study Completion

March 1, 2008

Last Updated

January 22, 2010

Record last verified: 2010-01

Locations

US(1)