Cycloplegic Refraction Among Children

NCT05442801 | Completed Phase 4 DMC

• 1 other identifier: Cycloplegic Refraction
• Study Type: interventional
• Target: 55
• Locations: 1 country
• Sites: 1

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.

Conditions

Cycloplegia

Keywords

vision; cycloplegia; cycloplegic refraction; cyclopentolate; cyclogyl; tropicamide; mydriacil; refractive errors; latent hyperopia

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Amplitude of accommodation

  3 months

Study Arms (2)

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.

Drug: Cyclopentolate

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.

Drug: Tropicamide

Interventions

Cyclopentolate DRUG

Well known eye drop used for cycloplegic refraction among children.

Also known as: Cyclogel

Cyclopentolate arm

Tropicamide DRUG

Well known eye drop used for cycloplegic refraction among children.

Also known as: Mydriacil

Tropicamide arm

Eligibility Criteria

• Age: 3 Years - 16 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Islamic Hospital, Jordan: lead

Study Sites (1)

Islamic Hospital

Amman, Jordan

Location

MeSH Terms

Conditions

Refractive Errors

Interventions

Cyclopentolate; Tropicamide

Condition Hierarchy (Ancestors)

Eye Diseases

Intervention Hierarchy (Ancestors)

Phenylacetates; Acids, Carbocyclic; Carboxylic Acids; Organic Chemicals; Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Wejdan Al-Thawabieh, MD

  Ophthalmology Department, Islamic Hospital, Amman, Jordan

  STUDY DIRECTOR

• Rami Al-Omari, MD

  Faculty of Medicine, Ophthalmology, Yarmouk University, Irbid

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: June 22, 2022
• First Posted: July 5, 2022
• Study Start: March 1, 2022
• Primary Completion: June 1, 2022
• Study Completion: June 20, 2022
• Last Updated: July 5, 2022

Record last verified: 2022-06

Data Sharing

• IPD Sharing: Will not share

Locations

JO (1)