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

Not Applicable

Not yet recruiting

• Conditions: Pupillary Constriction; Accomodation
• Interventions: Drug: Pilocarpine 0.1%; Drug: Use of phentolamine eye drops to reverse cycloplegia; Drug: Combination of pilocarpine 0.1% and phentolamine 0.75%

• Registration Number: NCT07012512
• Lead Sponsor: Mansoura University

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.

Detailed Description

To compare the efficacy of pilocarpine 0.1%, phentolamine 0.75%, and combined therapy in reversing cyclopentolate-induced cycloplegia/mydriasis in pediatric patients using a within-subject paired-eye design (treated vs. untreated eye).

Interventions

Cycloplegia Induction:

Both eyes receive cyclopentolate 1% (2 drops, 5 minutes apart). Then cycloplegic effect confirmed at 30 minutes (accommodation ≤2 D, pupil ≥6 mm).

Reversal Agents (administered at 30 minutes post-cyclopentolate):

Pilocarpine group: Pilocarpine 0.1% (1 drop) in the study eye; placebo in the control eye.

Phentolamine group: Phentolamine 0.75% (1 drop) in the study eye; placebo in the control eye.

Combination: Pilocarpine 0.1% + phentolamine 0.75% (1 drop each) in the study eye; placebo in the control eye.

Study Timeline

• Status Verified: 2025-05
• Study First Submitted: 2025-05-30
• Study First Submitted QC: 2025-05-31
• Last Update Submitted: 2025-05-31
• Study Start: 2025-06-01
• Study First Posted: 2025-06-10
• Last Update Posted: 2025-06-10
• Primary Completion: 2025-12-01
• Study Completion: 2025-12-30

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

• Children between 5 and 12 years undergoing cycloplegia

Exclusion Criteria

• Patient refusal

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Pilocarpine group	Pilocarpine 0.1%	Children will receive pilocarpine drops in one eye and placebo in the other
Phentolamine group	Use of phentolamine eye drops to reverse cycloplegia	Children will receive phentolamine eye drop in one eye and placebo in the other
Combined	Combination of pilocarpine 0.1% and phentolamine 0.75%	Children will receive a combination of pilocarpine and placebo in one eye and placebo in the other

Primary Outcome Measures

Name	Time	Method
Reversal of pupillary dilatation	Hourly for four hours after administration of the drug

Secondary Outcome Measures

Name	Time	Method
Recovery of accommodation after instillation of the drop	Hourly for four hours after administration of the drug