Clinical trial NCT06914063: Assessing Patient Comfort, Anxiety, and Satisfaction During CR Comparing Conventional Drops With ROC
Official title: Assessing Patient Comfort, Anxiety, and Satisfaction During Cycloplegic Refraction: Comparing Conventional Drops With Rapid-Onset Cycloplegics
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Cycloplegic Paralysis of Accommodation
Lead sponsor: Superior University
Sponsor class: OTHER
First posted: 2025-04-06
Enrollment: 74
Sex: ALL
Minimum age (years): 10
Maximum age (years): 20
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

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.

Primary outcomes:
measure: Visual Analog Scale (VAS)
timeFrame: 12 Months
measure: State-Trait Anxiety Inventory (STAI)
timeFrame: 12 Months
Secondary outcomes:
Other outcomes:
Locations:
city: Sukkur
country: Pakistan
facility: Al Shifa trust eye Hospital
state: Sindh
Study officials:
References: