Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-26 @ 11:12 PM
Ignite Modification Date:
2025-12-26 @ 11:12 PM
NCT ID:
NCT07012512
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:
NCT07012512
Study Brief:
Protocol Section:
NCT07012512