NCT06914063

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

Assessing Patient Comfort, Anxiety, and Satisfaction During Cycloplegic Refraction: Comparing Conventional Drops With Rapid-Onset Cycloplegics

• Status: Active Not Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 74 (actual)
• Sponsor: Superior University · Academic / Other
• Sex: All
• Age: 10 Years – 20 Years
• Healthy volunteers: Not accepted

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.

Detailed description

The study will involve participants aged 3-16 years, with no significant refractive error or ocular pathologies. Patients will be randomly assigned to receive either cyclopentolate or tropicamide with phenylephrine. The primary outcomes include patient comfort, anxiety levels, satisfaction, and procedure time. Discomfort and anxiety will be measured using questionnaires such as the Visual Analog Scale for Comfort and the State-Trait Anxiety Inventory. The study will help determine if rapid-onset cycloplegic provide a better patient experience by reducing discomfort and anxiety. By evaluating these factors, the research seeks to improve clinical practices in optometry and ophthalmology, particularly in pediatric eye examinations.

Conditions

• Cycloplegic Paralysis of Accommodation

Interventions

Type	Name	Description
COMBINATION_PRODUCT	Rapid-Onset Cycloplegic Drops	Rapid-Onset Cycloplegic Drops (e.g., tropicamide with phenylephrine) to assess patient comfort, anxiety, and satisfaction with quicker onset and shorter duration.
DIAGNOSTIC_TEST	Conventional Cycloplegic Drops	Conventional Cycloplegic Drops (e.g., cyclopentolate) to provide a baseline for comparison with the rapid-onset treatment.

Timeline

• Start date: 2025-03-20
• Primary completion: 2025-06-20
• Completion: 2026-02-20
• First posted: 2025-04-06
• Last updated: 2025-04-06

Locations

1 site across 1 country: Pakistan