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临床试验/NCT05442801
NCT05442801已完成4 期

Tropicamide Versus Cyclopentolate Objective Refraction in Pediatric Population

Islamic Hospital, Jordan1 个研究点 分布在 1 个国家目标入组 55 人开始时间: 2022年3月1日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
4 期
状态
已完成
发起方
入组人数
55
试验地点
1
主要终点
Spherical equivalent (SE) mean difference between cyclopentolate and tropicamide

研究概览

简要总结

The primary outcome of this study is to compare cyclopentolate 1% and tropicamide 1% for cycloplegic refractions in pediatric populations. This will be a prospective double-blinded randomized clinical trial (RCT), multi center, with randomized sequencing of cycloplegic agent; each patient received one agent at one visit, and the other agent in the next visit (2 different visits ≥ 1 week apart) within 3 months.

详细描述

Refractive errors assessment especially in pediatric populations is usually affected by the accommodative spasm and possibly a myopic shift in the results. Spasm of accommodation become evident as pesudomyopia or latent hyperopia. Therefore, cycloplegic refraction using cycloplegic drugs is an effective way to reduce fluctuation in accommodation or spasm of ciliary muscle. The drug of choice should have a rapid onset, appropriate cyclopegic effect and minimum side effects. Cyclopentolate and Tropicamide are well known drugs used for accommodation relaxation. Cyclopentolate is widely accepted drug of first choice for patients of all ages. Its cycloplegic effects begins at 25-75 min after administration of the drop and recovery appears through 6-24 h later.6 Ocular side effects may include irritation, lacrimation, allergic blepharoconjunctivitis, conjunctival hyperemia, and increase in intraocular pressure. Some of its systemic side effects are drowsiness, ataxia, disorientation, incoherent speech, restlessness, and visual hallucinations. Tropicamide, as an alternative, is a synthetic analog of tropic acid and is known as a safe agent for cycloplegic refraction. It characterized by a rapid onset and the cycloplegia effect appears 20-30 min after administration. Its recovery appears 6 h later with safer profile compared to cyclopentolate. Several studies have been conducted to compare the cycloplegic effect of these two agents and different results have been reported. Because of inconsistencies in the previous reported results, this randomized clinical trial was conducted to compare the cycloplegic effect between cyclopentolate and tropicamide among pediatric populations (aged between 3 and 16).

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
主要目的
Treatment
盲法
Triple (Participant, Care Provider, Investigator)

入排标准

年龄范围
3 Years 至 16 Years(Child)
性别
All
接受健康志愿者

入选标准

  • Age: 3-16 years
  • Brown irides; grade 4 and 5 using iris color classification system developed by Seddon et al (16)
  • Duration: 2 different visits ≥ 1 weeks apart within 3 months

排除标准

  • Abnormal red reflex (e.g., media opacity)
  • History of heart or neurological diseases
  • History of developmental delay
  • History of a previous allergy to cycloplegic agents
  • Presence of syndromes (e.g., Down's syndrome)
  • History of intraocular surgery

研究组 & 干预措施

Cyclopentolate arm

Active Comparator

To study the effect of cyclopentolate 1% for cycloplegic refractions in pediatric populations:

Firstly, we instilled an anesthetic drop into patients' eyes. Secondly, 2 drops of cyclopentolate 1% (cyclogel) 5 minutes apart were instilled.

Autorefraction was taken at 60 minutes after first drop instillation. Primary outcome: spherical equivalent (SE) of cycloplegic refraction at 60 minutes.

干预措施: Cyclopentolate (Drug)

Tropicamide arm

Active Comparator

To study the effect of tropicamide 1% for cycloplegic refractions in pediatric populations:

Firstly, we instilled an anesthetic drop into patients' eyes. Secondly, 2 drops of tropicamide 1% (mydriacil) 5 minutes apart were instilled. Autorefraction was taken at 30 minutes after first drop instillation. Primary outcome: spherical equivalent (SE) of cycloplegic refraction at 30 minutes.

干预措施: Tropicamide (Drug)

结局指标

主要结局

Spherical equivalent (SE) mean difference between cyclopentolate and tropicamide

时间窗: 3 months

To study the SE of each drug and compare the mean difference between cyclopentolate and tropicamide

次要结局

  • Amplitude of accommodation(3 months)

研究者

发起方
Islamic Hospital, Jordan
申办方类型
Other
责任方
Principal Investigator
主要研究者

Hashem Abu Serhan

Principal Investigator

Islamic Hospital, Jordan

研究点 (1)

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