Deprivation AmblyopiaNCT04217772
OCTA Analysis In Children After Lensectomy
A study testing Optical Coherence Tomography Angiography in people with Deprivation Amblyopia, run by Wenzhou Medical University at 2 sites in China.
Trial summary
The aim of this study is to quantify and compare the foveal avascular zone (FAZ), the parafoveal and foveal vessel density of superficial (SCP) and deep capillary plexus (DCP) and retinal thickness in deprivation amblyopic eyes, fellow non-amblyopic eyes, and age-matched normal eyes, using optical coherence tomography… Read more about this study
- Who is it for?
- Ages 3 to 18 yearsHealthy volunteers can take part
- Conditions the study is for
- Deprivation Amblyopia
- What is being tested?
- Optical Coherence Tomography Angiography
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 2 sitesChina
- Study dates
- 1 Dec 2017to 1 Dec 2021
- Phase
- Interventional
- 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 18 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- children after cataract surgery and healthy volunteers
Who cannot join
- presence of corneal opacity preventing detailed imaging
- nystagmus
- retinal disease,
- persistent fetal vasculature
- intraocular inflammation,
- glaucoma
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- vitreoretinal surgery
- premature birth
- neurologic disease
- systemic disease that could alter microvasculature (including diabetes, hypertension, cardiovascular disease and renal disease)
Trial locations and contacts
2 sites in 1 country.
China2 sites, 2 recruiting
- Recruiting
Eye Hospital of WMU
Hangzhou, Zhejiang, 325027
Yune Zhao, +8613968832833, zyehzeye@126.com
- Recruiting
The affiliated Eye Hospital of Wenzhou Medical College
Wenzhou, Zhejiang, 325027
About this study
Official title: Optical Coherence Tomography Angiography Analysis After Childhood Lensectomy
The aim of this study is to quantify and compare the foveal avascular zone (FAZ), the parafoveal and foveal vessel density of superficial (SCP) and deep capillary plexus (DCP) and retinal thickness in deprivation amblyopic eyes, fellow non-amblyopic eyes, and age-matched normal eyes, using optical coherence tomography angiography (OCTA). The FAZ, parafoveal and foveal SCP and DCP, and retinal thickness were measured in normal controls and at least 3 months postoperatively in children with unilateral cataract and compared between groups after adjusting for axial length and spherical equivalents.
- Conditions
- Deprivation Amblyopia
- Being tested
- Optical Coherence Tomography Angiography
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Optical Coherence Tomography AngiographyDevice
A device testing the vascular density in the retina
| Study group | Role | What they receive |
|---|---|---|
| Eyes post-lensectomy | Experimental | Eyes of children after cataract surgery Receives: Device: Optical Coherence Tomography Angiography |
| Healthy Eyes | No intervention | Eyes of healthy volunteers |
What is being measured
The primary outcome is the main question the study is designed to answer.
Foveal retinal thickness
Foveal retinal thickness in microns
Measured: up to 36 months
Area of foveal avascular zone
Area of foveal avascular zone in square microns
Measured: up to 36 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jan 2020
- Study start1 Dec 2017
- Primary completion1 Dec 2020 (estimated)
- Study completion1 Dec 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Deprivation 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Wenzhou Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yune Zhao, Wenzhou Medical University
- Investigators
- Yune Zhao, MD, Principal investigator, Eye Hospital of WMU
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04217772
- Sponsor's protocol ID
- OCTA-LZL
- Status last verified
- Jan 2020
- First submitted
- 29 Dec 2019
- Last updated
- 3 Jan 2020
- Results posted
- No
- Data monitoring committee
- No
- 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 3 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Optical Coherence Tomography Angiography Analysis After Childhood Lensectomy
- ClinicalTrials.gov ID
- NCT04217772
- Acronym / sponsor ID
- OCTA-LZL
- Conditions
- Deprivation Amblyopia
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Wenzhou Medical UniversityUniversity, hospital or other
- Study start
- 1 Dec 2017 (actual)
- Primary completion
- 1 Dec 2020 (estimated)
- Study completion
- 1 Dec 2021 (estimated)
- First posted
- 3 Jan 2020 (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 aim of this study is to quantify and compare the foveal avascular zone (FAZ), the parafoveal and foveal vessel density of superficial (SCP) and deep capillary plexus (DCP) and retinal thickness in deprivation amblyopic eyes, fellow non-amblyopic eyes, and age-matched normal eyes, using optical coherence tomography angiography (OCTA). The FAZ, parafoveal and foveal SCP and DCP, and retinal thickness were measured in normal controls and at least 3 months postoperatively in children with unilateral cataract and compared between groups after adjusting for axial length and spherical equivalents.
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Eyes post-lensectomy | Experimental | Device: Optical Coherence Tomography AngiographyEyes of children after cataract surgery |
| Healthy Eyes | No intervention | –Eyes of healthy volunteers |
Who may qualify
- Ages
- 3 to 18 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (1 listed)
- children after cataract surgery and healthy volunteers
Key exclusion criteria (10 listed)
- presence of corneal opacity preventing detailed imaging
- nystagmus
- retinal disease,
- persistent fetal vasculature
- intraocular inflammation,
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 AngiographyA device testing the vascular density in the retina | Device | Eyes post-lensectomy |
Primary outcome
Foveal retinal thickness
Time frame: up to 36 months
Foveal retinal thickness in microns
Area of foveal avascular zone
Time frame: up to 36 months
Area of foveal avascular zone in square microns
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jan 2020.
- Individual participant dataSharing planned: No
Related trials for Deprivation Amblyopia
Not yet recruiting
Augmented Reality Training for Amblyopia After Congenital Cataract Surgery
Deprivation Amblyopia, Congenital Cataract
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.
Yune Zhao, MD principal investigator
Eye Hospital of WMU
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Optical Coherence Tomography Angiography in people with Deprivation Amblyopia, run by Wenzhou Medical University at 2 sites in China.
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 10 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 3 Jan 2020. 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 China. 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 Zhangliang Li, MD (+8613968832833, lizhangliang0328@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Foveal retinal thickness (time frame: up to 36 months). The study lists 2 primary outcomes in all. 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 3 Jan 2020.