Comparing two eye drops for measuring vision in children with esotropia
Tropicamide Versus Cyclopentolate for Cycloplegic Refraction in Pediatric Patients With Esotropia: A Randomized Clinical Trial
This study is testing which of two eye drops helps doctors get better vision measurements in children with crossed eyes.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Enrollment | 100 (estimated) |
| Ages | 3 Years to 16 Years |
| Sex | All |
| Sponsor | Islamic Hospital, Jordan Academic / other |
| Locations | 2 sites (Irbid and 1 other locations) |
| Trial ID | NCT06077682 on ClinicalTrials.gov |
What this trial studies
This clinical trial aims to compare the effectiveness of two cycloplegic agents, cyclopentolate 1% and tropicamide 1%, in performing cycloplegic refractions in pediatric patients diagnosed with esotropia. The study will be conducted as a prospective double-blinded randomized clinical trial across multiple centers, where each participant will receive one of the agents during one visit and the other agent during a subsequent visit, spaced at least one week apart. The goal is to determine which agent provides more accurate measurements of refractive errors in this population, addressing the confusion surrounding cycloplegic examinations in children.
Who should consider this trial
Good fit: Ideal candidates for this study are children aged 3 to 16 years with a diagnosis of esotropia.
Not a fit: Patients with a history of heart or neurological diseases, developmental delays, or previous allergies to cycloplegic agents may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved accuracy in diagnosing and treating refractive errors in children with esotropia.
How similar studies have performed: Previous studies have shown varying results regarding the effectiveness of different cycloplegic agents, making this approach both relevant and necessary for further exploration.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 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 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
Where this trial is running
Irbid and 1 other locations
- Yarmouk University — Irbid, Jordan (Recruiting)
- Hamad Medical Corporation — Doha, Qatar (Not_yet_recruiting)
Study contacts
- Study coordinator: Hashem Abu Serhan, MBBS
- Email: hashemabusarhan@yahoo.com
- Phone: +974-77912335
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.