Adjusted Study Protocol: Within-Subject Paired-Eye Design Comparing Pilocarpine 0.1%, Phentolamine 0.75%, and Combination Therapy for Cyclopentolate Reversal in Children
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 60
- 主要终点
- Reversal of pupillary dilatation
研究概览
简要总结
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.
详细描述
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):
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 5 Years 至 12 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Children between 5 and 12 years undergoing cycloplegia
排除标准
- •Patient refusal
研究组 & 干预措施
Pilocarpine group
Children will receive pilocarpine drops in one eye and placebo in the other
干预措施: Pilocarpine 0.1% (Drug)
Phentolamine group
Children will receive phentolamine eye drop in one eye and placebo in the other
干预措施: Use of phentolamine eye drops to reverse cycloplegia (Drug)
Combined
Children will receive a combination of pilocarpine and placebo in one eye and placebo in the other
干预措施: Combination of pilocarpine 0.1% and phentolamine 0.75% (Drug)
结局指标
主要结局
Reversal of pupillary dilatation
时间窗: Hourly for four hours after administration of the drug
次要结局
- Recovery of accommodation after instillation of the drop(Hourly for four hours after administration of the drug)