AmblyopiaNCT05223153
OCT-A and Amblyopia
An observational study of Amblyopia, run by Minia University at 1 site in Egypt.
Trial summary
Detect changes in retinal vessel density in the superficial and deep capillary plexuses using OCTA in children with anisometropic amblyopia Read more about this study
- Who is it for?
- Ages 6 to 12 years
- Conditions the study is for
- Amblyopia
- What is being tested?
- Optical Coherence tomography angiography
- How many people
- 32 participants
- Where
- 1 siteEgypt
- Study dates
- 15 Sep 2021to 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 6 to 12 years
- All sexes
- No healthy volunteers
- Child
Study population: Children with unilateral anisometropic amblyopia without previous treatment with glasses or patches
Who may be able to join
- Unilateral anisometropia.
- Refractive error less than -6.00 D and +4.00 D.
- Age less than 12 years.
- No previous amblyopia treatments
Who cannot join
- 1. High refractive error. 2. Bilateral amblyopia. 3. Age more than 12 years.
- -
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Assessment of Macular Microvascular Changes Following Amblyopia Treatment in Children With Anisometropic Amblyopia Using Optical Coherence Tomography Angiography
Detect changes in retinal vessel density in the superficial and deep capillary plexuses using OCTA in children with anisometropic amblyopia
- Conditions
- Amblyopia
- Being tested
- Optical Coherence tomography angiography
- Medical subject headings
- Amblyopia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Optical Coherence tomography angiographyDiagnostic test
Measurement retinal vessel density in the superficial and deep capillary plexuses using OCTA in children with anisometropic amblyopia
| Study group | Role | What they receive |
|---|---|---|
| Amblyopic eye group | Not described Receives: Diagnostic Test: Optical Coherence tomography angiography | |
| Sound eye group | Not described Receives: Diagnostic Test: Optical Coherence tomography angiography |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in retinal vessel density
Detect changes in retinal vessel density in the superficial and deep capillary plexuses using OCTA in children with anisometropic amblyopia and effect of treatment on the retinal vessel density
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 posted3 Feb 2022
- Study start15 Sep 2021
- Primary completion1 Aug 2022
- Study completion30 Sep 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for AmblyopiaStudies 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
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- Minia University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sahar T A Abdelaziz, Minia University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05223153
- Sponsor's protocol ID
- Ophthalomlogy department
- Status last verified
- Oct 2022
- First submitted
- 24 Jan 2022
- Last updated
- 2 Nov 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
AttaAllah HR, Abdelaziz STA, Mohamed AAM, Ibrahiem MFK. Assessment of macular microvascular changes in children following treatment of anisometropic myopic amblyopia using optical coherence tomography angiography. Graefes Arch Clin Exp Ophthalmol. 2023 Sep;261(9):2689-2699. doi: 10.1007/s00417-023-06055-8. Epub 2023 Apr 13.
PubMed 37052667
Study at a glance
From the registry record, last updated by the sponsor on 2 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Macular Microvascular Changes Following Amblyopia Treatment in Children With Anisometropic Amblyopia Using Optical Coherence Tomography Angiography
- ClinicalTrials.gov ID
- NCT05223153
- Acronym / sponsor ID
- Ophthalomlogy department
- Conditions
- Amblyopia
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- Minia UniversityUniversity, hospital or other
- Study start
- 15 Sep 2021 (actual)
- Primary completion
- 1 Aug 2022 (actual)
- Study completion
- 30 Sep 2022 (actual)
- First posted
- 3 Feb 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.
Detect changes in retinal vessel density in the superficial and deep capillary plexuses using OCTA in children with anisometropic amblyopia
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Amblyopic eye group | – | Diagnostic Test: Optical Coherence tomography angiography |
| Sound eye group | – | Diagnostic Test: Optical Coherence tomography angiography |
Who may qualify
- Ages
- 6 to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Children with unilateral anisometropic amblyopia without previous treatment with glasses or patches
Key inclusion criteria (4 listed)
- Unilateral anisometropia.
- Refractive error less than -6.00 D and +4.00 D.
- Age less than 12 years.
- No previous amblyopia treatments
Key exclusion criteria (2 listed)
- 1. High refractive error. 2. Bilateral amblyopia. 3. Age more than 12 years.
- -
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 |
|---|---|---|
| Optical Coherence tomography angiographyMeasurement retinal vessel density in the superficial and deep capillary plexuses using OCTA in children with anisometropic amblyopia | Diagnostic test | Amblyopic eye group, Sound eye group |
Primary outcome
Change in retinal vessel density
Time frame: 3 months
Detect changes in retinal vessel density in the superficial and deep capillary plexuses using OCTA in children with anisometropic amblyopia and effect of treatment on the retinal vessel density
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 2 Nov 2022.
- Derived from this study: PubMed 37052667AttaAllah HR, Abdelaziz STA, Mohamed AAM, Ibrahiem MFK. Assessment of macular microvascular changes in children following treatment of anisometropic myopic amblyopia using optical coherence tomography angiography. Graefes Arch Clin Exp Ophthalmol. 2023 Sep;261(9):2689-2699. doi: 10.1007/s00417-023-06055-8. Epub 2023 Apr 13.
- Individual participant dataSharing planned: No
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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.
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?
An observational study of Amblyopia, run by Minia 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 4 inclusion and 2 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 2 Nov 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?
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?
Change in retinal vessel density (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05223153, which also lists 1 linked publication.
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 2 Nov 2022.