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NCT Number: NCT07012512

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

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.

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Key information

Conditions

Pupillary Constriction Accomodation Eye Diseases Miosis Nervous System Diseases Neurologic Manifestations Pathological Conditions, Signs and Symptoms Pupil Disorders Signs and Symptoms

Age range

5 year–12 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Children between 5 and 12 years undergoing cycloplegia

Exclusion criteria

  • Patient refusal

Treatment and study plan

Use of phentolamine eye drops to reverse cycloplegia

Drug

Use of phentolamine 0.75% eye drops to reverse cycloplegia

Pilocarpine 0.1%

Drug

Use of pilocarpine 0.1% to reverse cycloplegia

Combination of pilocarpine 0.1% and phentolamine 0.75%

Drug

Combination of pilocarpine 0.1% and phentolamine 0.75%

Primary outcomes

  1. Reversal of pupillary dilatation

    Time frame: Hourly for four hours after administration of the drug

Secondary outcomes

  1. Recovery of accommodation after instillation of the drop

    Time frame: Hourly for four hours after administration of the drug

Study contacts

Contact information is provided by the study sponsor or research team.

Ahmed AlNagdy

CONTACT

[email protected]

+201096710982

Sponsors and collaborators

Lead sponsor

Mansoura University

Other

Registry information

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Jun 10, 2025
Registry last updated
Jun 10, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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