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

Not Applicable

Active, not recruiting

• Conditions: Cycloplegic Paralysis of Accommodation

• Registration Number: NCT06914063
• Lead Sponsor: Superior University

Brief 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.

Study Timeline

• Status Verified: 2025-03
• Study Start: 2025-03-20
• Study First Submitted: 2025-03-29
• Study First Submitted QC: 2025-03-29
• Last Update Submitted: 2025-03-29
• Study First Posted: 2025-04-06
• Last Update Posted: 2025-04-06
• Primary Completion: 2025-06-20
• Study Completion: 2026-02-20

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 74

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Visual Analog Scale (VAS)	12 Months	The Visual Analogue Scale (VAS) score is a pain measurement tool where patients mark a point on a 10 cm line representing their pain intensity, with the distance from "no pain" measured in millimeters (0-100), indicating pain intensity
State-Trait Anxiety Inventory (STAI)	12 Months	The State-Trait Anxiety Inventory (STAI) is a 40-item self-report questionnaire measuring anxiety, divided into 20 items for state anxiety (how one feels now) and 20 for trait anxiety (how one generally feels). Each item is scored on a 4-point Likert scale, with higher scores indicating greater anxiety

Trial Locations

Locations (1)

Al Shifa trust eye Hospital; 🇵🇰 Sukkur, Sindh, Pakistan