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Adjusted Study Protocol: Within-Subject Paired-Eye Design Comparing Pilocarpine 0.1%, Phentolamine 0.75%, and Combination Therapy for Cyclopentolate Reversal in Children

NCT07012512 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2025-06-10

No results posted yet for this study

Summary

The study aims at reversing pupillary dilatation. and cycloplegia in children undergoing cycloplegic refraction for eyeglasses prescription and ocular examination. This will be achieved using pilocarpine , phentolamine or a combination. This may help decrease the glare and improve near vision early to decrease unwanted effects of cycloplegic drops.

Conditions

  • Pupillary Constriction
  • Accomodation

Interventions

DRUG

Use of phentolamine eye drops to reverse cycloplegia

Use of phentolamine 0.75% eye drops to reverse cycloplegia

DRUG

Pilocarpine 0.1%

Use of pilocarpine 0.1% to reverse cycloplegia

DRUG

Combination of pilocarpine 0.1% and phentolamine 0.75%

Combination of pilocarpine 0.1% and phentolamine 0.75%

Sponsors & Collaborators

  • Mansoura University

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
5 Years
Max Age
12 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-06-01
Primary Completion
2025-12-01
Completion
2025-12-30

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07012512 on ClinicalTrials.gov