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

Mansoura University

Status: Not yet enrolling

Conditions: Accomodation; Pupillary Constriction

Treatments: Drug: Combination of pilocarpine 0.1% and phentolamine 0.75%; Drug: Use of phentolamine eye drops to reverse cycloplegia; Drug: Pilocarpine 0.1%

Study type: Interventional

Funder types: Other

Identifiers

NCT07012512

Mansoura university Ophthalmic

Details and patient eligibility

About

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.

Full 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.

Enrollment: 60 estimated patients

Sex: All

Ages: 5 to 12 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Children between 5 and 12 years undergoing cycloplegia

Exclusion criteria

• Patient refusal

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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60 participants in 3 patient groups

Pilocarpine group

Experimental group

Description:

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

Treatment:

Drug: Pilocarpine 0.1%

Phentolamine group

Active Comparator group

Description:

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

Treatment:

Drug: Use of phentolamine eye drops to reverse cycloplegia

Combined

Experimental group

Description:

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

Treatment:

Drug: Combination of pilocarpine 0.1% and phentolamine 0.75%