Cycloplegic Paralysis of AccommodationNCT06914063
Assessing Patient Comfort, Anxiety, and Satisfaction During CR Comparing Conventional Drops With ROC
A study testing Rapid-Onset Cycloplegic Drops and Conventional Cycloplegic Drops in people with Cycloplegic Paralysis of Accommodation, run by Superior University at 1 site in Pakistan.
Trial 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. Read more about this study
- Who is it for?
- Ages 10 to 20 years
- Conditions the study is for
- Cycloplegic Paralysis of Accommodation
- What is being tested?
- Rapid-Onset Cycloplegic Drops and Conventional Cycloplegic Drops
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 74 participants
- Where
- 1 sitePakistan
- Study dates
- 20 Mar 2025to 20 Feb 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 10 to 20 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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).
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Assessing Patient Comfort, Anxiety, and Satisfaction During Cycloplegic Refraction: Comparing Conventional Drops With Rapid-Onset Cycloplegics
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.
Read the 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
- Being tested
- Rapid-Onset Cycloplegic Drops, Conventional Cycloplegic Drops
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Rapid-Onset Cycloplegic DropsCombination 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 DropsDiagnostic test
Conventional Cycloplegic Drops (e.g., cyclopentolate) to provide a baseline for comparison with the rapid-onset treatment.
| Study group | Role | What they receive |
|---|---|---|
| Rapid-Onset Cycloplegic Drops | Experimental | Not described Receives: Combination Product: Rapid-Onset Cycloplegic Drops |
| Conventional Cycloplegic Drops | Active comparator | Not described Receives: Diagnostic Test: Conventional Cycloplegic Drops |
What is being measured
The primary outcome is the main question the study is designed to answer.
Visual Analog Scale (VAS)
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
Measured: 12 Months
State-Trait Anxiety Inventory (STAI)
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
Measured: 12 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Apr 2025
- Study start20 Mar 2025
- Primary completion20 Jun 2025 (estimated)
- Study completion20 Feb 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cycloplegic Paralysis of AccommodationStudies of the same condition, open and under way.
- More trials run by Superior UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 74 participants (actual)
Sponsor and investigators
- Lead sponsor
- Superior University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Muhammad Naveed Babur, Superior University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06914063
- Sponsor's protocol ID
- MSRSW/Batch-Fall23/813
- Status last verified
- Mar 2025
- First submitted
- 29 Mar 2025
- Last updated
- 6 Apr 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessing Patient Comfort, Anxiety, and Satisfaction During Cycloplegic Refraction: Comparing Conventional Drops With Rapid-Onset Cycloplegics
- ClinicalTrials.gov ID
- NCT06914063
- Acronym / sponsor ID
- MSRSW/Batch-Fall23/813
- Conditions
- Cycloplegic Paralysis of Accommodation
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 74 participants (actual)
- Lead sponsor
- Superior UniversityUniversity, hospital or other
- Study start
- 20 Mar 2025 (actual)
- Primary completion
- 20 Jun 2025 (estimated)
- Study completion
- 20 Feb 2026 (estimated)
- First posted
- 6 Apr 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Rapid-Onset Cycloplegic Drops | Experimental | Combination Product: Rapid-Onset Cycloplegic Drops |
| Conventional Cycloplegic Drops | Active comparator | Diagnostic Test: Conventional Cycloplegic Drops |
Who may qualify
- Ages
- 10 to 20 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- 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).
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Rapid-Onset Cycloplegic DropsRapid-Onset Cycloplegic Drops (e.g., tropicamide with phenylephrine) to assess patient comfort, anxiety, and satisfaction with quicker onset and shorter duration. | Combination product | Rapid-Onset Cycloplegic Drops |
| Conventional Cycloplegic DropsConventional Cycloplegic Drops (e.g., cyclopentolate) to provide a baseline for comparison with the rapid-onset treatment. | Diagnostic test | Conventional Cycloplegic Drops |
Primary outcome
Visual Analog Scale (VAS)
Time frame: 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)
Time frame: 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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Apr 2025.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Rapid-Onset Cycloplegic Drops and Conventional Cycloplegic Drops in people with Cycloplegic Paralysis of Accommodation, run by Superior University at 1 site in Pakistan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 6 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Pakistan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Visual Analog Scale (VAS) (time frame: 12 Months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Apr 2025.