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

NCT07012512 | Not Yet Recruiting

• 1 other identifier: Mansoura university Ophthalmic
• Study Type: interventional
• Target: 60
• Locations: 0 countries
• Sites: N/A

Brief 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

Outcome Measures

Primary Outcomes (1)

• Reversal of pupillary dilatation

  Hourly for four hours after administration of the drug

Secondary Outcomes (1)

• Recovery of accommodation after instillation of the drop

  Hourly for four hours after administration of the drug

Study Arms (3)

Pilocarpine group

EXPERIMENTAL

Children will receive pilocarpine drops in one eye and placebo in the other

Drug: Pilocarpine 0.1%

Phentolamine group

ACTIVE COMPARATOR

Children will receive phentolamine eye drop in one eye and placebo in the other

Drug: Use of phentolamine eye drops to reverse cycloplegia

Combined

EXPERIMENTAL

Children will receive a combination of pilocarpine and placebo in one eye and placebo in the other

Drug: Combination of pilocarpine 0.1% and phentolamine 0.75%

Interventions

Use of phentolamine eye drops to reverse cycloplegia DRUG

Use of phentolamine 0.75% eye drops to reverse cycloplegia

Phentolamine group

Pilocarpine 0.1% DRUG

Use of pilocarpine 0.1% to reverse cycloplegia

Pilocarpine group

Combination of pilocarpine 0.1% and phentolamine 0.75% DRUG

Combination of pilocarpine 0.1% and phentolamine 0.75%

Combined

Eligibility Criteria

• Age: 5 Years - 12 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Children between 5 and 12 years undergoing cycloplegia

You may not qualify if:

• Patient refusal

Sponsors & Collaborators

• Mansoura University: lead

MeSH Terms

Conditions

Miosis

Condition Hierarchy (Ancestors)

Pupil Disorders; Neurologic Manifestations; Nervous System Diseases; Eye Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Ahmed AlNagdy

CONTACT

+201096710982; imanatta@mans.edu.eg

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 30, 2025
• First Posted: June 10, 2025
• Study Start: June 1, 2025
• Primary Completion: December 1, 2025
• Study Completion: December 30, 2025
• Last Updated: June 10, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share