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CycloplegiaPhase 4NCT06077682

Cycloplegic Refraction in Pediatric Patients With Esotropia

A Phase 4 study testing Cyclopentolate and Tropicamide in people with Cycloplegia and Refractive Errors, run by Islamic Hospital, Jordan at 2 sites in 2 countries.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

The primary outcome of this study is to compare cyclopentolate 1% and tropicamide 1% for cycloplegic refractions in pediatric populations with esotropia. This will be a prospective double-blinded randomized clinical trial (RCT), multi-center, with randomized sequencing of cycloplegic agent; each patient received one… Read more about this study

Who is it for?
Ages 3 to 16 yearsHealthy volunteers can take part
Conditions the study is for
Cycloplegia, Refractive Errors, Esotropia
What is being tested?
Cyclopentolate and Tropicamide
Could I receive a placebo?
No, everyone receives an active treatment
How many people
100 participants
Where
2 sitesin 2 countries
Study dates
1 Sep 2023to 1 Dec 2024
Phase
Phase 4
Are there results?
None posted in the registry

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 3 to 16 years
  • All sexes
  • Healthy volunteers accepted
  • Child

Who may be able to join

  • Alignment: subjects with esotropia Age: 3-16 years Brown irides; grade 4 and 5 using iris color classification system developed by Seddon et al Duration: 2 different visits ≥ 1 week apart within 3 months

Who cannot join

  • Abnormal red reflex (e.g., media opacity) History of heart or neurological diseases History of developmental delay History of a previous allergy to cycloplegic agents Presence of syndromes (e.g., Down's syndrome) History of intraocular surgery

Trial locations and contacts

2 sites in 2 countries.

Hashem Abu Serhan, MBBS contact

+974-77912335

hashemabusarhan@yahoo.com

Wejdan Al-Thawabieh, MD contact

wejdan.al-thawabieh@hotmail.com

2 sites in 2 countries

Jordan1 site, 1 recruiting
  • Yarmouk University

    Irbid

    Rami Al-Omari

    Recruiting

Other trials in Jordan

Qatar1 site, 1 recruiting
  • Hamad Medical Corporation

    Doha, 3050

    Hashem Abu Serhan

    Not yet recruiting

Other trials in Qatar

About this study

Official title: Tropicamide Versus Cyclopentolate for Cycloplegic Refraction in Pediatric Patients With Esotropia: A Randomized Clinical Trial

The primary outcome of this study is to compare cyclopentolate 1% and tropicamide 1% for cycloplegic refractions in pediatric populations with esotropia. This will be a prospective double-blinded randomized clinical trial (RCT), multi-center, with randomized sequencing of cycloplegic agent; each patient received one agent at one visit, and the other agent in the next visit (2 different visits ≥ 1 week apart) within 3 months.

Read the detailed description

Many studies have been conducted over the last few decades to assess the need for cycloplegia in assessing refractive errors. Plenty of research on pediatric populations has demonstrated that a lack of cycloplegia may contribute to an overestimation of myopia prevalence or substantial mistakes in estimating the prevalence of emmetropia and hyperopia. (1,2) The amount of refractive error varies by individual, as well as the type of cycloplegic refractive error. (3) As a result, there is no reliable method for adjusting non-cycloplegic refractions to approximate cycloplegic refractions. Consideration should be given to the type of cycloplegic agent to be used, preferred dosing, optimal methods of instillation, indications for use, and potential side effects. Despite the fact that the benefits of a cycloplegic examination are undeniable, there is still some confusion and various practice methods when it comes to cycloplegic exams. (4) Although atropine is the most potent cycloplegic agent currently available in clinical practice, its long duration of action (up to 12 days) and well-known side effects have shifted clinical practice toward cyclopentolate use. Cyclopentolate has been shown to provide effective cycloplegia, even in patients with moderate to severe hyperopia, with a relatively short duration of action (up to 24 hours) and fewer side effects. Thus, since its introduction in 1951, cyclopentolate has largely replaced atropine as the standard of care for pediatric cycloplegic examination. (4,5,6) Nevertheless, numerous adverse effects of cyclopentolate for children have been observed, including dry mouth and skin, tachycardia, fever, hallucinations, delirium, restlessness, seizures, ataxia, acute midbrain hemorrhage, and even death. (7,8,9) Many studies compared cyclopentolate to tropicamide for cycloplegia. (10, 11, 12) Tropicamide, unlike cyclopentolate, is a cycloplegic with a rapid onset and a short duration of action lasting up to 6 hours. In addition, fewer side effects have been reported when compared to cyclopentolate. (3,11) According to the literature, cyclopentolate may cause +0.175 to +0.39 D more hyperopia than tropicamide, which is clinically insignificant. (10,11,13) Furthermore, it has been discovered that there is a strong correlation between the time spent waiting to complete the exam and patient satisfaction levels, so reducing the waiting time clearly increases satisfaction levels. (14, 15) Esotropia is a convergent misalignment of the visual axes. Esotropia can be categorized in a variety of ways, usually based on age of onset or underlying causes: Infantile esotropia or acquired esotropia or accommodative esotropia, either normal accommodative convergence/accommodation (AC/A) ratio or high AC/A ratio or partially accommodative esotropia or Nonaccommodative esotropia, and Sensory esotropia. (16) Prevalence estimates of strabismus range from 0.8% to 6.8% in different populations. In the United States, esotropia and exotropia have similar prevalence rates, whereas in Ireland esotropia has been reported five times more frequently than exotropia, and in Australia esotropia has been reported to be twice as frequent as exotropia. (17) The prevalence of esotropia in children increases with age (e.g., higher prevalence at 4 to 6 years compared with 6 to 11 months), moderate anisometropia, and moderate amounts of hyperopia. (18) The potential benefits of treatment for esotropia include promoting binocular vision and improving visual function in each eye. (19) If binocularity is achieved, the number of surgical procedures over a lifetime and overall cost to society may be reduced. (20) Fusion and stereopsis are necessary for some careers and may be useful in sports such as baseball and activities such as needlepoint and watching 3D movies. (21) The appearance of crossed eyes may reduce employment opportunities because of stigma and bias. (22) In addition, binocular alignment is important for the development of a positive self-image and enhances social interactions by normalizing appearance as well as eye contact. (23) In one study, children aged 5 years and older expressed a negative feeling about dolls that had been altered to be esotropic or exotropic. (24) In another study, elementary school teachers rated personal characteristics of children with esotropia and exotropia more negatively than orthotropic children. (25) In a sample of children enrolled in the Multi-ethnic Pediatric Eye Disease Study, strabismus was associated with a decreased general health-related quality of life in preschool children, based on the parents' proxy reporting. (26) Adequate cycloplegia is necessary for accurate retinoscopy in children because of their increased accommodative tone compared with adults. The aim of this randomized clinical trial (RCT) is to explore the cycloplegic effect of tropicamide versus cyclopentolate in refracting pediatric subjects with esotropia.

Being tested
Cyclopentolate, Tropicamide
Keywords
Vision, refractive error, cycloplegic agent, cycloplegia, esotropia, tropicamide, cyclopentolate
Medical subject headings
Refractive Errors, Esotropia, Vision Disorders

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • CyclopentolateDrug

    Also called Cyclogel

    Well-known eye drop used for cycloplegic refraction among children.

  • TropicamideDrug

    Also called Mydriacil

    Well-known eye drop used for cycloplegic refraction among children.

Study groups in NCT06077682
Study groupRoleWhat they receive
Cyclopentolate armActive comparatorTo study the effect of cyclopentolate 1% for cycloplegic refractions in pediatric populations with ET: Firstly, we instilled an anesthetic drop into patients' eyes. Secondly, 2 drops of cyclopentolate 1% (cyclogel) 5 minutes apart were instilled. Autorefraction was taken at 60 minutes after first drop instillation. Primary outcome: spherical equivalent (SE) of cycloplegic refraction at 60 minutes.
Receives: Drug: Cyclopentolate
Tropicamide armActive comparatorTo study the effect of tropicamide 1% for cycloplegic refractions in pediatric populations with ET: Firstly, we instilled an anesthetic drop into patients' eyes. Secondly, 2 drops of tropicamide 1% (mydriacil) 5 minutes apart were instilled. Autorefraction was taken at 30 minutes after first drop instillation. Primary outcome: spherical equivalent (SE) of cycloplegic refraction at 30 minutes.
Receives: Drug: Tropicamide

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Spherical equivalent (SE) mean difference between cyclopentolate and tropicamide

    To study the SE of each drug and compare the mean difference between cyclopentolate and tropicamide To study the SE of each drug and compare the mean difference between cyclopentolate and tropicamide To study the SE of each drug and compare the mean difference between cyclopentolate and tropicamide To study the SE of each drug and compare the mean difference between cyclopentolate and tropicamide To study the SE mean difference between cyclopentolate and tropicamide

    Measured: 3 months

Secondary outcomes (1)
  1. Amplitude of accommodation

    To measure the depth of cycloplegia mean difference between cyclopentolate and tropicamide

    Measured: 3 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted11 Oct 2023
  2. Study start1 Sep 2023
  3. Primary completion1 Sep 2024 (estimated)
  4. Study completion1 Dec 2024 (estimated)

Resources

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 4
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Crossover
Masking
Triple blind
Who is masked
Participant, Care provider, Investigator
Enrolment
100 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06077682
Sponsor's protocol ID
Cycloplegic Refraction & ET
Status last verified
Oct 2023
First submitted
5 Oct 2023
Last updated
11 Oct 2023
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: The results will be shared with the researchers, and the data will be available upon request from the corresponding author.

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Cyclopentolate and Tropicamide in people with Cycloplegia and Refractive Errors, run by Islamic Hospital, Jordan at 2 sites in 2 countries.

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 1 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 11 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in Jordan, Qatar. 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.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Hashem Abu Serhan, MBBS (+974-77912335, hashemabusarhan@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Spherical equivalent (SE) mean difference between cyclopentolate and tropicamide (time frame: 3 months). 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 11 Oct 2023.

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