AmblyopiaNCT05325021
Correction of Anisometropic Amblyopia in Children.
An observational study of Amblyopia and Anisometropic Amblyopia, run by Benha University at 1 site in Egypt.
Trial summary
Anisometropic amblyopia among children in school age may affects quality of life and educational progress of children. Read more about this study
- Who is it for?
- Ages 4 to 12 years
- Conditions the study is for
- Amblyopia, Anisometropic Amblyopia, Anisometropia and Aniseikonia
- What is being tested?
- Axial length measurement in millimeter (mm) by optical biometry device and Autorefractometer to measure the refractive error in both eyes.
- How many people
- 200 participants
- Where
- 1 siteEgypt
- Study dates
- 2 Apr 2022to 30 Sep 2022
- Phase
- Observational
- 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 4 to 12 years
- All sexes
- No healthy volunteers
- Child
Study population: Residents of a Banha city that were diagnosed as anisometropic amblyopia and are seeking refractive error corrections.
Who may be able to join
- Anisometropic amblyopia.
- Children at school age ranged from 4 to 12 years old.
Who cannot join
- Emmetropia children.
- Children had undergone any intraocular surgeries.
- Other types of amblyopia.
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Ahmed Abdelshafy Tabl
Banhā, Benha, 13511
Ahmed A Tabl, 01222328766, ahmad4lg@gmail.com
Marwa Abdelshafy, MD
About this study
Official title: Correction of Anisometropic Amblyopia in Children at School Age.
Anisometropic amblyopia among children in school age may affects quality of life and educational progress of children.
Read the detailed description
Correction of anisometropic amblyopia depends on type of refractive error and axial length of the eye.
In this study, we will asses the types of anisometropia found in children at school age and investigate possible ways for correction of this type of amblyopia.
- Being tested
- Axial length measurement in millimeter (mm) by optical biometry device, Autorefractometer to measure the refractive error in both eyes.
- Keywords
- amblyopia, axial refractive error, anisometropia
- Medical subject headings
- Amblyopia, Anisometropia, Aniseikonia, Refractive Errors
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Axial length measurement in millimeter (mm) by optical biometry deviceDiagnostic test
Axial length measurement of the anisometropic eye and the fellow one in millimeter (mm) by optical biometry device.
Autorefractometer to measure the refractive error in both eyes.Diagnostic test
Measurement of the refractive state of both eyes for each subject to asses the refractive error in diopter (D).
| Study group | Role | What they receive |
|---|---|---|
| Axial myopia | children have anisometropia due to axial myopia, axial length will be measured by optical biometry device in millimeter (mm). Receives: Diagnostic Test: Axial length measurement in millimeter (mm) by optical biometry device; Diagnostic Test: Autorefractometer to measure the refractive error in both eyes. | |
| Refractive myopia | children have anisometropia due to refractive myopia, axial length will be measured by optical biometry device in mm. Receives: Diagnostic Test: Axial length measurement in millimeter (mm) by optical biometry device; Diagnostic Test: Autorefractometer to measure the refractive error in both eyes. | |
| Axial hyperopia | children have anisometropia due to axial hyperopia, axial length will be measured by optical biometry device in mm. Receives: Diagnostic Test: Axial length measurement in millimeter (mm) by optical biometry device; Diagnostic Test: Autorefractometer to measure the refractive error in both eyes. | |
| Refractive hyperopia | children have anisometropia due to refractive hyperopia, axial length will be measured by optical biometry device in mm. Receives: Diagnostic Test: Axial length measurement in millimeter (mm) by optical biometry device; Diagnostic Test: Autorefractometer to measure the refractive error in both eyes. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Axial length of both eyes.
Measurement of axial length of both eyes in millimeter (mm).
Measured: Immediately after optical biometry test for each eye.
Secondary outcomes (1)
Incidence of refractive errors in anisometropic amblyopia
Type of refractive error found in anisometropia measured by autorefractometer in diopter (D).
Measured: Immediately after autorefractometer test for each eye.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Apr 2022
- Study start2 Apr 2022
- Primary completion30 Sep 2022 (estimated)
- Study completion30 Sep 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AmblyopiaStudies of the same condition, open and under way.
- More trials run by Benha 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
- Observational
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Benha University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ahmed Abdelshafy, Benha University
- Investigators
- Ahmed A Tabl, MD, Principal investigator, Benha University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05325021
- Sponsor's protocol ID
- RC 7-22
- Status last verified
- Apr 2022
- First submitted
- 5 Apr 2022
- Last updated
- 13 Apr 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 13 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Correction of Anisometropic Amblyopia in Children at School Age.
- ClinicalTrials.gov ID
- NCT05325021
- Acronym / sponsor ID
- RC 7-22
- Keywords
- amblyopia, axial refractive error, anisometropia
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Benha UniversityUniversity, hospital or other
- Study start
- 2 Apr 2022 (actual)
- Primary completion
- 30 Sep 2022 (estimated)
- Study completion
- 30 Sep 2022 (estimated)
- First posted
- 13 Apr 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.
Anisometropic amblyopia among children in school age may affects quality of life and educational progress of children.
Detailed description
Correction of anisometropic amblyopia depends on type of refractive error and axial length of the eye.
In this study, we will asses the types of anisometropia found in children at school age and investigate possible ways for correction of this type of amblyopia.
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Axial myopia | – | Diagnostic Test: Axial length measurement in millimeter (mm) by optical biometry device, Diagnostic Test: Autorefractometer to measure the refractive error in both eyes.children have anisometropia due to axial myopia, axial length will be measured by optical biometry device in millimeter (mm). |
| Refractive myopia | – | Diagnostic Test: Axial length measurement in millimeter (mm) by optical biometry device, Diagnostic Test: Autorefractometer to measure the refractive error in both eyes.children have anisometropia due to refractive myopia, axial length will be measured by optical biometry device in mm. |
| Axial hyperopia | – | Diagnostic Test: Axial length measurement in millimeter (mm) by optical biometry device, Diagnostic Test: Autorefractometer to measure the refractive error in both eyes.children have anisometropia due to axial hyperopia, axial length will be measured by optical biometry device in mm. |
| Refractive hyperopia | – | Diagnostic Test: Axial length measurement in millimeter (mm) by optical biometry device, Diagnostic Test: Autorefractometer to measure the refractive error in both eyes.children have anisometropia due to refractive hyperopia, axial length will be measured by optical biometry device in mm. |
Who may qualify
- Ages
- 4 to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Residents of a Banha city that were diagnosed as anisometropic amblyopia and are seeking refractive error corrections.
Key inclusion criteria (2 listed)
- Anisometropic amblyopia.
- Children at school age ranged from 4 to 12 years old.
Key exclusion criteria (3 listed)
- Emmetropia children.
- Children had undergone any intraocular surgeries.
- Other types of amblyopia.
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 |
|---|---|---|
| Axial length measurement in millimeter (mm) by optical biometry deviceAxial length measurement of the anisometropic eye and the fellow one in millimeter (mm) by optical biometry device. | Diagnostic test | Axial hyperopia, Axial myopia, Refractive hyperopia, Refractive myopia |
| Autorefractometer to measure the refractive error in both eyes.Measurement of the refractive state of both eyes for each subject to asses the refractive error in diopter (D). | Diagnostic test | Axial hyperopia, Axial myopia, Refractive hyperopia, Refractive myopia |
Primary outcome
Axial length of both eyes.
Time frame: Immediately after optical biometry test for each eye.
Measurement of axial length of both eyes in millimeter (mm).
1 secondary outcome
Incidence of refractive errors in anisometropic amblyopia
Time frame: Immediately after autorefractometer test for each eye.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Apr 2022.
- Individual participant dataSharing planned: Undecided
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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.
Ahmed A Tabl, MD principal investigator
Benha University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Amblyopia and Anisometropic Amblyopia, run by Benha University at 1 site in Egypt.
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 2 inclusion and 3 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 13 Apr 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 Egypt. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ahmed A Tabl, MD (01222328766, ahmad4lg@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Axial length of both eyes. (time frame: Immediately after optical biometry test for each eye.). 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 13 Apr 2022.