Cycloplegic Refraction Among Children

• Status: Completed
• Trial end date: 2022-06-20
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Islamic Hospital, Jordan
• Treatments: Cyclopentolate; Tropicamide

Criteria

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