Adjusted Study Protocol: Within-Subject Paired-Eye Design Comparing Pilocarpine 0.1%, Phentolamine 0.75%, and Combination Therapy for Cyclopentolate Reversal in Children
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Use of phentolamine eye drops to reverse cycloplegia, Pilocarpine 0.1%, Combination of pilocarpine 0.1% and phentolamine 0.75%.
- Who it may be relevant to
- Registry conditions: Pupillary Constriction, Accomodation. Basic parameters: 5 years — 12 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Center list to be confirmed — check the primary protocol.
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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.
Interventions
- 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%
Primary outcome measures
- Reversal of pupillary dilatation [Time frame: Hourly for four hours after administration of the drug]
Secondary outcome measures (1)
- Recovery of accommodation after instillation of the drop [Time frame: Hourly for four hours after administration of the drug]
Eligibility criteria
Inclusion criteria
- Children between 5 and 12 years undergoing cycloplegia
Exclusion criteria
- Patient refusal
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Double blind
- Primary purpose
- Other
Study locations
Center list to be confirmed — check the primary protocol.
Identifiers
NCT: NCT07012512 · Mansoura university Ophthalmic