Active — Not RecruitingNot Applicable

Assessing Patient Comfort, Anxiety, and Satisfaction During CR Comparing Conventional Drops With ROC

Pakistan74 participantsStarted 2025-03-20

Plain-language summary

This study aims to compare the efficacy of conventional cycloplegic agents, such as cyclopentolate, with rapid-onset cycloplegics, like a combination of tropicamide and phenylephrine, in reducing patient anxiety and discomfort during cycloplegic refraction. Cycloplegic refraction is an essential procedure for diagnosing refractive errors, particularly in children, by temporarily paralyzing the ciliary muscle to inhibit accommodation. While cyclopentolate has a relatively quick onset, tropicamide is preferred due to its faster onset and shorter duration. Despite its advantages, concerns about patient discomfort and anxiety during the procedure remain, especially in pediatric populations.

Who can participate

Age range10 Years – 20 Years

SexALL

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

Inclusion Criteria: * Patients aged 10-20years. * Both Male and Female * Healthy participants with no abnormalities detected in anterior segment structures or fundus examination using slit-lamp biomicroscopy and a 90-diopter lens. * No significant refractive error (within the range of ±1 diopter in spherical equivalent). Exclusion Criteria: * History of severe allergic reactions or adverse effects to cycloplegic agents * Severe anxiety, panic disorders, or other psychological conditions that may interfere with reporting the experience accurately. * Uncontrolled systemic diseases (e.g., uncontrolled diabetes or cardiovascular conditions) that may impact the response to cycloplegic agents. * Recent ocular surgery (e.g., LASIK, cataract surgery) or eye trauma affecting refraction accuracy or comfort. * Presence or history of any intraocular diseases, including glaucoma, uveitis, and retinal disorders. * Systemic disorders such as hypertension, cardiovascular disease, or respiratory disease.

What they're measuring

Visual Analog Scale (VAS)

Timeframe: 12 Months

State-Trait Anxiety Inventory (STAI)

Timeframe: 12 Months

Trial details

NCT IDNCT06914063

SponsorSuperior University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2025-06-20