NCT07012512

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

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 60 (estimated)
• Sponsor: Mansoura University · Academic / Other
• Sex: All
• Age: 5 Years – 12 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Pupillary Constriction
• Accomodation

Interventions

Type	Name	Description
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%

Timeline

• Start date: 2025-06-01
• Primary completion: 2025-12-01
• Completion: 2025-12-30
• First posted: 2025-06-10
• Last updated: 2025-06-10