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Cycloplegic Refraction in Pediatric Patients With Esotropia

Primary Purpose

Cycloplegia, Refractive Errors, Esotropia

Status
Recruiting
Phase
Phase 4
Locations
International
Study Type
Interventional
Intervention
Cyclopentolate
Tropicamide
Sponsored by
Islamic Hospital, Jordan
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cycloplegia focused on measuring Vision, refractive error, cycloplegic agent, cycloplegia, esotropia, tropicamide, cyclopentolate

Eligibility Criteria

3 Years - 16 Years (Child)All SexesAccepts Healthy Volunteers

Inclusion Criteria: 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 Exclusion Criteria: 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

Sites / Locations

  • Yarmouk UniversityRecruiting
  • Hamad Medical Corporation

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Cyclopentolate arm

Tropicamide arm

Arm Description

To 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.

To 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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Full Information

First Posted
October 5, 2023
Last Updated
October 5, 2023
Sponsor
Islamic Hospital, Jordan
Collaborators
Jordan University of Science and Technology, Yarmouk University
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1. Study Identification

Unique Protocol Identification Number
NCT06077682
Brief Title
Cycloplegic Refraction in Pediatric Patients With Esotropia
Official Title
Tropicamide Versus Cyclopentolate for Cycloplegic Refraction in Pediatric Patients With Esotropia: A Randomized Clinical Trial
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
September 1, 2023 (Actual)
Primary Completion Date
September 1, 2024 (Anticipated)
Study Completion Date
December 1, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Islamic Hospital, Jordan
Collaborators
Jordan University of Science and Technology, Yarmouk University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief 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 agent at one visit, and the other agent in the next visit (2 different visits ≥ 1 week apart) within 3 months.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cycloplegia, Refractive Errors, Esotropia, Vision Disorders
Keywords
Vision, refractive error, cycloplegic agent, cycloplegia, esotropia, tropicamide, cyclopentolate

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Crossover Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Cyclopentolate arm
Arm Type
Active Comparator
Arm Description
To 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.
Arm Title
Tropicamide arm
Arm Type
Active Comparator
Arm Description
To 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.
Intervention Type
Drug
Intervention Name(s)
Cyclopentolate
Other Intervention Name(s)
Cyclogel
Intervention Description
Well-known eye drop used for cycloplegic refraction among children.
Intervention Type
Drug
Intervention Name(s)
Tropicamide
Other Intervention Name(s)
Mydriacil
Intervention Description
Well-known eye drop used for cycloplegic refraction among children.
Primary Outcome Measure Information:
Title
Spherical equivalent (SE) mean difference between cyclopentolate and tropicamide
Description
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
Time Frame
3 months
Secondary Outcome Measure Information:
Title
Amplitude of accommodation
Description
To measure the depth of cycloplegia mean difference between cyclopentolate and tropicamide
Time Frame
3 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
3 Years
Maximum Age & Unit of Time
16 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Hashem Abu Serhan, MBBS
Phone
+974-77912335
Email
hashemabusarhan@yahoo.com
First Name & Middle Initial & Last Name or Official Title & Degree
Wejdan Al-Thawabieh, MD
Email
wejdan.al-thawabieh@hotmail.com
Facility Information:
Facility Name
Yarmouk University
City
Irbid
Country
Jordan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Rami Al-Omari
Facility Name
Hamad Medical Corporation
City
Doha
ZIP/Postal Code
3050
Country
Qatar
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Hashem Abu Serhan

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
The results will be shared with the researchers, and the data will be available upon request from the corresponding author.

Learn more about this trial

Cycloplegic Refraction in Pediatric Patients With Esotropia

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