CycloplegiaPhase 4NCT05442801
Cycloplegic Refraction Among Children
A Phase 4 study testing Cyclopentolate and Tropicamide in people with Cycloplegia, run by Islamic Hospital, Jordan at 1 site in Jordan.
Trial summary
The primary outcome of this study is to compare cyclopentolate 1% and tropicamide 1% for cycloplegic refractions in pediatric populations. 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… Read more about this study
- Who is it for?
- Ages 3 to 16 yearsHealthy volunteers can take part
- Conditions the study is for
- Cycloplegia
- What is being tested?
- Cyclopentolate and Tropicamide
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 55 participants
- Where
- 1 siteJordan
- Study dates
- 1 Mar 2022to 20 Jun 2022
- 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
- Age: 3-16 years
- Brown irides; grade 4 and 5 using iris color classification system developed by Seddon et al (16)
- Duration: 2 different visits ≥ 1 weeks 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
1 site in 1 country.
About this study
Official title: Tropicamide Versus Cyclopentolate Objective Refraction in Pediatric Population
The primary outcome of this study is to compare cyclopentolate 1% and tropicamide 1% for cycloplegic refractions in pediatric populations. 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
Refractive errors assessment especially in pediatric populations is usually affected by the accommodative spasm and possibly a myopic shift in the results. Spasm of accommodation become evident as pesudomyopia or latent hyperopia. Therefore, cycloplegic refraction using cycloplegic drugs is an effective way to reduce fluctuation in accommodation or spasm of ciliary muscle. The drug of choice should have a rapid onset, appropriate cyclopegic effect and minimum side effects. Cyclopentolate and Tropicamide are well known drugs used for accommodation relaxation. Cyclopentolate is widely accepted drug of first choice for patients of all ages. Its cycloplegic effects begins at 25-75 min after administration of the drop and recovery appears through 6-24 h later.6 Ocular side effects may include irritation, lacrimation, allergic blepharoconjunctivitis, conjunctival hyperemia, and increase in intraocular pressure. Some of its systemic side effects are drowsiness, ataxia, disorientation, incoherent speech, restlessness, and visual hallucinations. Tropicamide, as an alternative, is a synthetic analog of tropic acid and is known as a safe agent for cycloplegic refraction. It characterized by a rapid onset and the cycloplegia effect appears 20-30 min after administration. Its recovery appears 6 h later with safer profile compared to cyclopentolate. Several studies have been conducted to compare the cycloplegic effect of these two agents and different results have been reported. Because of inconsistencies in the previous reported results, this randomized clinical trial was conducted to compare the cycloplegic effect between cyclopentolate and tropicamide among pediatric populations (aged between 3 and 16).
- Conditions
- Cycloplegia
- Being tested
- Cyclopentolate, Tropicamide
- Keywords
- vision, cycloplegia, cycloplegic refraction, cyclopentolate, cyclogyl, tropicamide, mydriacil, refractive errors, latent hyperopia
- Medical subject headings
- Refractive Errors
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 group | Role | What they receive |
|---|---|---|
| Cyclopentolate arm | Active comparator | To study the effect of cyclopentolate 1% for cycloplegic refractions in pediatric populations:
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 arm | Active comparator | To study the effect of tropicamide 1% for cycloplegic refractions in pediatric populations:
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.
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
Measured: 3 months
Secondary outcomes (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.
- First posted5 Jul 2022
- Study start1 Mar 2022
- Primary completion1 Jun 2022
- Study completion20 Jun 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CycloplegiaStudies of the same condition, open and under way.
- 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 55 participants (actual)
Sponsor and investigators
- Lead sponsor
- Islamic Hospital, Jordan
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hashem Abu Serhan, Islamic Hospital, Jordan
- Investigators
- Wejdan Al-Thawabieh, MD, Study director, Ophthalmology Department, Islamic Hospital, Amman, JordanRami Al-Omari, MD, Study director, Faculty of Medicine, Ophthalmology, Yarmouk University, Irbid
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05442801
- Sponsor's protocol ID
- Cycloplegic Refraction
- Status last verified
- Jun 2022
- First submitted
- 22 Jun 2022
- Last updated
- 5 Jul 2022
- 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 5 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Tropicamide Versus Cyclopentolate Objective Refraction in Pediatric Population
- ClinicalTrials.gov ID
- NCT05442801
- Acronym / sponsor ID
- Cycloplegic Refraction
- Conditions
- Cycloplegia
- Keywords
- vision, cycloplegia, cycloplegic refraction, cyclopentolate, cyclogyl, tropicamide, mydriacil, refractive errors
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 55 participants (actual)
- Lead sponsor
- Islamic Hospital, JordanUniversity, hospital or other
- Study start
- 1 Mar 2022 (actual)
- Primary completion
- 1 Jun 2022 (actual)
- Study completion
- 20 Jun 2022 (actual)
- First posted
- 5 Jul 2022 (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.
The primary outcome of this study is to compare cyclopentolate 1% and tropicamide 1% for cycloplegic refractions in pediatric populations. 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
Refractive errors assessment especially in pediatric populations is usually affected by the accommodative spasm and possibly a myopic shift in the results. Spasm of accommodation become evident as pesudomyopia or latent hyperopia. Therefore, cycloplegic refraction using cycloplegic drugs is an effective way to reduce fluctuation in accommodation or spasm of ciliary muscle. The drug of choice should have a rapid onset, appropriate cyclopegic effect and minimum side effects. Cyclopentolate and Tropicamide are well known drugs used for accommodation relaxation. Cyclopentolate is widely accepted drug of first choice for patients of all ages. Its cycloplegic effects begins at 25-75 min after administration of the drop and recovery appears through 6-24 h later.6 Ocular side effects may include irritation, lacrimation, allergic blepharoconjunctivitis, conjunctival hyperemia, and increase in intraocular pressure. Some of its systemic side effects are drowsiness, ataxia, disorientation, incoherent speech, restlessness, and visual hallucinations. Tropicamide, as an alternative, is a synthetic analog of tropic acid and is known as a safe agent for cycloplegic refraction. It characterized by a rapid onset and the cycloplegia effect appears 20-30 min after administration. Its recovery appears 6 h later with safer profile compared to cyclopentolate. Several studies have been conducted to compare the cycloplegic effect of these two agents and different results have been reported. Because of inconsistencies in the previous reported results, this randomized clinical trial was conducted to compare the cycloplegic effect between cyclopentolate and tropicamide among pediatric populations (aged between 3 and 16).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cyclopentolate arm | Active comparator | Drug: CyclopentolateTo study the effect of cyclopentolate 1% for cycloplegic refractions in pediatric populations: 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. |
| Tropicamide arm | Active comparator | Drug: TropicamideTo study the effect of tropicamide 1% for cycloplegic refractions in pediatric populations: 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. |
Who may qualify
- Ages
- 3 to 16 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Age: 3-16 years
- Brown irides; grade 4 and 5 using iris color classification system developed by Seddon et al (16)
- Duration: 2 different visits ≥ 1 weeks apart within 3 months
Key exclusion criteria (6 listed)
- 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)
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 |
|---|---|---|
| CyclopentolateAlso: CyclogelWell known eye drop used for cycloplegic refraction among children. | Drug | Cyclopentolate arm |
| TropicamideAlso: MydriacilWell known eye drop used for cycloplegic refraction among children. | Drug | Tropicamide arm |
Primary outcome
Spherical equivalent (SE) mean difference between cyclopentolate and tropicamide
Time frame: 3 months
To study the SE of each drug and compare the mean difference between cyclopentolate and tropicamide
1 secondary outcome
Amplitude of accommodation
Time frame: 3 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jul 2022.
- Individual participant dataSharing planned: No
Related trials for Cycloplegia
Recruiting
The Objective of This Study is to Evaluate the Perfomance of a Photorefraction Device for Screening Ametropia in Children. Eligible Participants Will Undergo Multiple Refractive Error Measurements, Visual Acuity and Strabismus Assessments During a Single Evaluation Visit.
Ametropia, Myopia; Refractive Error
Active, not recruiting
Assessing Patient Comfort, Anxiety, and Satisfaction During CR Comparing Conventional Drops With ROC
Cycloplegic Paralysis of Accommodation
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.
Wejdan Al-Thawabieh, MD study director
Ophthalmology Department, Islamic Hospital, Amman, Jordan
Rami Al-Omari, MD study director
Faculty of Medicine, Ophthalmology, Yarmouk University, Irbid
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Cyclopentolate and Tropicamide in people with Cycloplegia, run by Islamic Hospital, Jordan at 1 site in Jordan.
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 3 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: finished, as of the sponsor's last update on 5 Jul 2022. 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 Jordan. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
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 5 Jul 2022.