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Sympathomimetic Agent and Anticholinergic Agent

0 Drop for Retinopathy of Prematurity

N/A
Waitlist Available
Led By Monisha Bahri, MD
Research Sponsored by Georgetown University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Premature infants undergoing clinically indicated retinal exams
Timeline
Screening 3 weeks
Treatment Varies
Follow Up at baseline (no drops yet instilled), 45, 90 and 120 minutes after drops instilled
Awards & highlights

Study 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).

Eligible Conditions
  • Retinopathy of Prematurity

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~at baseline (no drops yet instilled), 45, 90 and 120 minutes after drops instilled
This trial's timeline: 3 weeks for screening, Varies for treatment, and at baseline (no drops yet instilled), 45, 90 and 120 minutes after drops instilled for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
dilation of the pupil in millimeters

Trial Design

4Treatment groups
Experimental Treatment
Active Control
Group I: 2 dropExperimental Treatment1 Intervention
Left eye dose
Group II: 1 DropExperimental Treatment1 Intervention
Left eye dose
Group III: 0 DropExperimental Treatment1 Intervention
Left eye dose
Group IV: 3 dropsActive Control1 Intervention
Right eye dose for all groups
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Cyclopentolate
FDA approved

Find a Location

Who is running the clinical trial?

Georgetown UniversityLead Sponsor
345 Previous Clinical Trials
137,351 Total Patients Enrolled
Monisha Bahri, MDPrincipal InvestigatorGeorgetown University Hospital
~1 spots leftby Jun 2025
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