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Completed

NCT Number: NCT05442801

Cycloplegic Refraction Among Children

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.

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Key information

Age range

3 year–16 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Islamic Hospital

Amman, Jordan

About this study

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).

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Treatment and study plan

Cyclopentolate

Drug

Well known eye drop used for cycloplegic refraction among children.

Other names: Cyclogel

Tropicamide

Drug

Well known eye drop used for cycloplegic refraction among children.

Other names: Mydriacil

Primary outcomes

  1. Spherical equivalent (SE) mean difference between cyclopentolate and tropicamide

    Time frame: 3 months

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

Secondary outcomes

  1. Amplitude of accommodation

    Time frame: 3 months

    To measure the depth of cycloplegia mean difference between cyclopentolate and tropicamide

Sponsors and collaborators

Lead sponsor

Islamic Hospital, Jordan

Other

Registry information

Official study title

Tropicamide Versus Cyclopentolate Objective Refraction in Pediatric Population

Important dates

Study start
2022
Primary completion
2022
Study completion
2022
First posted
Jul 5, 2022
Registry last updated
Jul 5, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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