Cycloplegic Refraction Among Children

Tropicamide Versus Cyclopentolate Objective Refraction in Pediatric Population

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.

Study Overview

• Status: Completed
• Conditions: Cycloplegia
• Intervention / Treatment: Drug: Cyclopentolate; Drug: Tropicamide

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 Type: Interventional
• Enrollment (Actual): 55
• Phase: Phase 4

Contacts and Locations

Study Locations

• Jordan
  • Amman, Jordan
    • Islamic Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 year to 14 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Spherical equivalent (SE) mean difference between cyclopentolate and tropicamide	To study the SE of each drug and compare the mean difference between cyclopentolate and tropicamide	3 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Amplitude of accommodation	To measure the depth of cycloplegia mean difference between cyclopentolate and tropicamide	3 months

Collaborators and Investigators

• Sponsor: 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

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2022
• Primary Completion (Actual): June 1, 2022
• Study Completion (Actual): June 20, 2022

Study Registration Dates

• First Submitted: June 22, 2022
• First Submitted That Met QC Criteria: June 28, 2022
• First Posted (Actual): July 5, 2022

Study Record Updates

• Last Update Posted (Actual): July 5, 2022
• Last Update Submitted That Met QC Criteria: June 28, 2022
• Last Verified: June 1, 2022

More Information

Terms related to this study

• Keywords: cycloplegia; cyclopentolate; vision; cycloplegic refraction; cyclogyl; tropicamide; mydriacil; refractive errors; latent hyperopia
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Parasympatholytics; Autonomic Agents; Peripheral Nervous System Agents; Muscarinic Antagonists; Cholinergic Antagonists; Cholinergic Agents; Mydriatics; Cyclopentolate; Tropicamide
• Other Study ID Numbers: Cycloplegic Refraction

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No