Cycloplegic Refraction Among Children

Sponsor

Islamic Hospital, Jordan (Other)

Overall Status

Completed

CT.gov ID

NCT05442801

Collaborator

(none)

Enrollment

Location

Arms

3.6

Actual Duration (Months)

15.1

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Cycloplegia	Drug: Cyclopentolate Drug: Tropicamide	Phase 4

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).

Study Design

Study Type:

Interventional

Actual Enrollment :

55 participants

Allocation:

Randomized

Intervention Model:

Crossover Assignment

Masking:

Triple (Participant, Care Provider, Investigator)

Primary Purpose:

Treatment

Official Title:

Tropicamide Versus Cyclopentolate Objective Refraction in Pediatric Population

Actual Study Start Date :

Mar 1, 2022

Actual Primary Completion Date :

Jun 1, 2022

Actual Study Completion Date :

Jun 20, 2022

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: 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.	Drug: Cyclopentolate Well known eye drop used for cycloplegic refraction among children. Other Names: Cyclogel
Active Comparator: 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.	Drug: Tropicamide Well known eye drop used for cycloplegic refraction among children. Other Names: Mydriacil

Arm

Intervention/Treatment

Active Comparator: 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.

Drug: Cyclopentolate

Well known eye drop used for cycloplegic refraction among children.

Other Names:

Cyclogel

Active Comparator: 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.

Drug: Tropicamide

Well known eye drop used for cycloplegic refraction among children.

Other Names:

Mydriacil

Outcome Measures

Primary Outcome Measures

Spherical equivalent (SE) mean difference between cyclopentolate and tropicamide [3 months]
To study the SE of each drug and compare the mean difference between cyclopentolate and tropicamide

Secondary Outcome Measures

Amplitude of accommodation [3 months]
To measure the depth of cycloplegia mean difference between cyclopentolate and tropicamide

Eligibility Criteria

Criteria

Ages Eligible for Study:

3 Years to 16 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Islamic Hospital	Amman		Jordan

Sponsors and Collaborators

Islamic Hospital, Jordan

Investigators

Study Director: Wejdan Al-Thawabieh, MD, Ophthalmology Department, Islamic Hospital, Amman, Jordan
Study Director: Rami Al-Omari, MD, Faculty of Medicine, Ophthalmology, Yarmouk University, Irbid