Cycloplegic Refraction in Pediatric Patients With Esotropia

NCT06077682 | Unknown Phase 4 DMC

• 1 other identifier: Cycloplegic Refraction & ET
• Study Type: interventional
• Target: 100
• Locations: 2 countries
• Sites: 2

Brief Summary

The primary outcome of this study is to compare cyclopentolate 1% and tropicamide 1% for cycloplegic refractions in pediatric populations with esotropia. 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; Refractive Errors; Esotropia; Vision Disorders

Keywords

Vision; refractive error; cycloplegic agent; cycloplegia; esotropia; tropicamide; cyclopentolate

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

• Alignment: subjects with esotropia Age: 3-16 years Brown irides; grade 4 and 5 using iris color classification system developed by Seddon et al Duration: 2 different visits ≥ 1 week 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
• Jordan University of Science and Technology: collaborator
• Yarmouk University: collaborator

Study Sites (2)

Yarmouk University

Irbid, Jordan

RECRUITING

Hamad Medical Corporation

Doha, 3050, Qatar

NOT YET RECRUITING

MeSH Terms

Conditions

Refractive Errors; Esotropia; Vision Disorders

Interventions

Cyclopentolate; Tropicamide

Condition Hierarchy (Ancestors)

Eye Diseases; Strabismus; Ocular Motility Disorders; Cranial Nerve Diseases; Nervous System Diseases; Sensation Disorders; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

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

Central Study Contacts

Hashem Abu Serhan, MBBS

CONTACT

+974-77912335; hashemabusarhan@yahoo.com

Wejdan Al-Thawabieh, MD

CONTACT

wejdan.al-thawabieh@hotmail.com

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: Dr. Hashem Abu Serhan

Study Record Dates

• First Submitted: October 5, 2023
• First Posted: October 11, 2023
• Study Start: September 1, 2023
• Primary Completion: September 1, 2024
• Study Completion: December 1, 2024
• Last Updated: October 11, 2023

Record last verified: 2023-10

Data Sharing

• IPD Sharing: Will not share

Locations

QA (1); JO (1)