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

NCT ID: NCT06914063

Last Updated: 2025-04-06

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 74 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-03-20
• Study Completion Date: 2026-02-20

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.

Conditions

Cycloplegic Paralysis of Accommodation

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: HEALTH_SERVICES_RESEARCH
• Blinding Strategy: NONE

Study Groups

Rapid-Onset Cycloplegic Drops

Group Type: EXPERIMENTAL

Rapid-Onset Cycloplegic Drops

Intervention Type: COMBINATION_PRODUCT

Rapid-Onset Cycloplegic Drops (e.g., tropicamide with phenylephrine) to assess patient comfort, anxiety, and satisfaction with quicker onset and shorter duration.

Conventional Cycloplegic Drops

Group Type: ACTIVE_COMPARATOR

Conventional Cycloplegic Drops

Intervention Type: DIAGNOSTIC_TEST

Conventional Cycloplegic Drops (e.g., cyclopentolate) to provide a baseline for comparison with the rapid-onset treatment.

Interventions

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.

Intervention Type: COMBINATION_PRODUCT

Conventional Cycloplegic Drops

Conventional Cycloplegic Drops (e.g., cyclopentolate) to provide a baseline for comparison with the rapid-onset treatment.

Intervention Type: DIAGNOSTIC_TEST

Eligibility Criteria

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.

• Minimum Eligible Age: 10 Years
• Maximum Eligible Age: 20 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Superior University

OTHER

Sponsor Role: lead

Responsible Party

Muhammad Naveed Babur

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Al Shifa trust eye Hospital

Sukkur, Sindh, Pakistan

Countries

Pakistan

Other Identifiers

MSRSW/Batch-Fall23/813

Identifier Type: -

Identifier Source: org_study_id