Schlemm's Canal OcclusionNCT04360161
Observing the Morphology of Schlemm's Canal and Crystalline Lens in Different Age
A study testing swept-source optical coherence tomography in people with Schlemm's Canal Occlusion, run by Wenzhou Medical University at 1 site in China.
Trial summary
The aim of this study is to quantify and observe the morphology of trabecular meshwork (TM), Schlemm's canal (SC), ciliary body and crystalline lens before and after cycloplegia in patients with different ages using swept-source optical coherence tomography. Read more about this study
- Who is it for?
- Ages 7 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Schlemm's Canal Occlusion
- What is being tested?
- swept-source optical coherence tomography
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteChina
- Study dates
- 8 Aug 2019to 20 Jan 2020
- 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 7 to 60 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- healthy patients who can cooperated with the swept-source OCT measurements
Who cannot join
- history of ocular disease
- presence of central nervous system or systemic disease
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Morphology of Schlemm's Canal and Crystalline Lens in Different Age: a Swept-source Optical Coherence Tomography Study
The aim of this study is to quantify and observe the morphology of trabecular meshwork (TM), Schlemm's canal (SC), ciliary body and crystalline lens before and after cycloplegia in patients with different ages using swept-source optical coherence tomography.
- Conditions
- Schlemm's Canal Occlusion
- Being tested
- swept-source optical coherence tomography
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
swept-source optical coherence tomographyDevice
Aswe pt-source OCT (CASIA SS-1000; Tomey Corporation, Nagoya, Japan), which is specifically designed for anterior segment imaging using a 1310 nm wavelength with a scan speed of 30,000 A-scans per second and an axial resolution of <10 μm.
| Study group | Role | What they receive |
|---|---|---|
| Healthy participants | Experimental | Swept-source optical coherence tomography A device testing TM/SC and Lens morphology Receives: Device: swept-source optical coherence tomography |
What is being measured
The primary outcome is the main question the study is designed to answer.
area of Schlemm's canal and trabecular meshwork
The area of Schlemm's canal and trabecular meshwork was manually measured and the relationship between the parameters and age was analyzed.
Measured: up to 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Apr 2020
- Study start8 Aug 2019
- Primary completion20 Dec 2019
- Study completion20 Jan 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Schlemm's Canal OcclusionStudies 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
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 80 participants (actual)
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, Study director, Eye Hospital of Wenzhou Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04360161
- Sponsor's protocol ID
- TM/SC/Lens-LZL
- Status last verified
- Apr 2020
- First submitted
- 21 Apr 2020
- Last updated
- 24 Apr 2020
- Results posted
- 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 24 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Morphology of Schlemm's Canal and Crystalline Lens in Different Age: a Swept-source Optical Coherence Tomography Study
- ClinicalTrials.gov ID
- NCT04360161
- Acronym / sponsor ID
- TM/SC/Lens-LZL
- Conditions
- Schlemm's Canal Occlusion
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Wenzhou Medical UniversityUniversity, hospital or other
- Study start
- 8 Aug 2019 (actual)
- Primary completion
- 20 Dec 2019 (actual)
- Study completion
- 20 Jan 2020 (actual)
- First posted
- 24 Apr 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 observe the morphology of trabecular meshwork (TM), Schlemm's canal (SC), ciliary body and crystalline lens before and after cycloplegia in patients with different ages using swept-source optical coherence tomography.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Healthy participants | Experimental | Device: swept-source optical coherence tomographySwept-source optical coherence tomography A device testing TM/SC and Lens morphology |
Who may qualify
- Ages
- 7 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (1 listed)
- healthy patients who can cooperated with the swept-source OCT measurements
Key exclusion criteria (2 listed)
- history of ocular disease
- presence of central nervous system or systemic disease
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 |
|---|---|---|
| swept-source optical coherence tomographyAswe pt-source OCT (CASIA SS-1000; Tomey Corporation, Nagoya, Japan), which is specifically designed for anterior segment imaging using a 1310 nm wavelength with a scan speed of 30,000 A-scans per second and an axial resolution of <10 μm. | Device | Healthy participants |
Primary outcome
area of Schlemm's canal and trabecular meshwork
Time frame: up to 6 months
The area of Schlemm's canal and trabecular meshwork was manually measured and the relationship between the parameters and age was analyzed.
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 24 Apr 2020.
- Individual participant dataSharing planned: No
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 study director
Eye Hospital of Wenzhou Medical University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing swept-source optical coherence tomography in people with Schlemm's Canal Occlusion, run by Wenzhou Medical University at 1 site 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 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 24 Apr 2020. 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 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?
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?
area of Schlemm's canal and trabecular meshwork (time frame: up to 6 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 24 Apr 2020.