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

Superior University

Status

Active, not recruiting

Conditions

Cycloplegic Paralysis of Accommodation

Treatments

Combination Product: Rapid-Onset Cycloplegic Drops

Diagnostic Test: Conventional Cycloplegic Drops

Study type

Interventional

Funder types

Other

Identifiers

NCT06914063

MSRSW/Batch-Fall23/813

Details and patient eligibility

About

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.

Full 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.

Enrollment

74 patients

Sex

All

Ages

10 to 20 years old

Volunteers

No Healthy Volunteers

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.