CompletedPhase 4

Cycloplegic Refraction Among Children

Jordan55 participantsStarted 2022-03-01

Plain-language 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.

Who can participate

Age range3 Years – 16 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

What they're measuring

Spherical equivalent (SE) mean difference between cyclopentolate and tropicamide

Timeframe: 3 months

Trial details

NCT IDNCT05442801

SponsorIslamic Hospital, Jordan

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2022-06-01

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