Tropicamide Versus Cyclopentolate for Cycloplegic Refraction in Pediatric Patients With Esotropia: A Randomized Clinical Trial
Status: Recruiting
Location: See all (2) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 4
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.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 3
Maximum Age: 16
Healthy Volunteers: t
View:
• 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
Locations
Other Locations
Jordan
Yarmouk University
RECRUITING
Irbid
Qatar
Hamad Medical Corporation
NOT_YET_RECRUITING
Doha
Contact Information
Primary
Hashem Abu Serhan, MBBS
hashemabusarhan@yahoo.com
+974-77912335
Backup
Wejdan Al-Thawabieh, MD
wejdan.al-thawabieh@hotmail.com
Time Frame
Start Date: 2023-09-01
Estimated Completion Date: 2024-12-01
Participants
Target number of participants: 100
Treatments
Active_comparator: Cyclopentolate arm
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.
Active_comparator: Tropicamide arm
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.
Related Therapeutic Areas
Sponsors
Collaborators: Yarmouk University, Jordan University of Science and Technology
Leads: Islamic Hospital, Jordan