Cycloplegic Refraction Among Children

NCT ID: NCT05442801

Last Updated: 2022-07-05

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 55 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-03-01
• Study Completion Date: 2022-06-20

Brief Summary

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.

Detailed Description

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).

Conditions

Cycloplegia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

Cyclopentolate arm

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.

Group Type: ACTIVE_COMPARATOR

Cyclopentolate

Intervention Type: DRUG

Well known eye drop used for cycloplegic refraction among children.

Tropicamide arm

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.

Group Type: ACTIVE_COMPARATOR

Tropicamide

Intervention Type: DRUG

Well known eye drop used for cycloplegic refraction among children.

Interventions

Cyclopentolate

Well known eye drop used for cycloplegic refraction among children.

Intervention Type: DRUG

Tropicamide

Well known eye drop used for cycloplegic refraction among children.

Intervention Type: DRUG

Other Intervention Names

Cyclogel; Mydriacil

Eligibility Criteria

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

• Minimum Eligible Age: 3 Years
• Maximum Eligible Age: 16 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Islamic Hospital, Jordan

OTHER

Sponsor Role: lead

Responsible Party

Hashem Abu Serhan

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Wejdan Al-Thawabieh, MD

Role: STUDY_DIRECTOR

Ophthalmology Department, Islamic Hospital, Amman, Jordan

Rami Al-Omari, MD

Role: STUDY_DIRECTOR

Faculty of Medicine, Ophthalmology, Yarmouk University, Irbid

Locations

Islamic Hospital

Amman, , Jordan

Countries

Jordan

Other Identifiers

Cycloplegic Refraction

Identifier Type: -

Identifier Source: org_study_id