High MyopiaNCT05034016
The Exploratory Clinical Trials on the Primary Safety and Effectiveness of High Myopic Posterior Scleral Fixation System
A study testing High Myopic Posterior Scleral Fixation System in people with High Myopia and Macular Schisis, run by GuangZhou WeiShiBo Biotechnology Co., ltd at 1 site in China.
Trial summary
The purpose of this study is to assess the primary safety and efficacy of High Myopic Posterior Scleral Fixation System in the treatment of macular schisis caused by high myopia. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- High Myopia, Macular Schisis
- What is being tested?
- High Myopic Posterior Scleral Fixation System
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteChina
- Study dates
- 1 Jun 2020to 24 Apr 2022
- 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 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 18~65, male or female;
- Refractive ranges from -6.00d to -25.00d;
- The axial length of the operative eye was 26-32mm;
- Macular cleavage 200-1000μm;
- Corrected visual acuity of the operative eye < 0.3;
- Able to understand the purpose of the test, voluntarily participate and sign the informed consent form.
Who cannot join
- Known allergy to silica gel and patients with scar constitution;
- Ocular inflammation;
- Fundus hemorrhage;
- Macular hole;
- Macular cleavage of the contralateral eye greater than 200μm;
- Corrected visual acuity of contralateral eye < 0.4;
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- Opacity of the refractive medium;
- Eye tumor;
- History of hyperthyroidism;
- Other ophthalmic concomitant diseases that cannot be controlled, such as diabetic retinopathy, hypertensive fundus lesions, optic nerve atrophy, etc.;
- Severe impairment of liver and kidney function and/or severe systemic diseases (such as cardiovascular, respiratory, digestive, nervous, endocrine, genitourinary, etc., depending on the tolerance of surgery);
- Women who are pregnant (determined by a blood pregnancy test at the first visit), who are preparing for pregnancy during the test, and who are breastfeeding;
- a history of drug abuse or alcohol abuse;
- participate in other drug or medical device clinical trials within 30 days prior to the screening of this clinical trial;
- Any condition of the subject that the study physician considers to be an impediment to the clinical trial (e.g. subject's susceptibility to mental stress, uncontrollable mood, depression, etc.);
- Poor compliance of the subject, unable to complete the test process as required.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
The First Affiliated Hospital of Guangzhou University of traditional Chinese Medicine
Guangzhou, Guangdong, 510030
About this study
Official title: High Myopic Posterior Scleral Fixation System
The purpose of this study is to assess the primary safety and efficacy of High Myopic Posterior Scleral Fixation System in the treatment of macular schisis caused by high myopia.
Read the detailed description
Posterior Scleral Reinforcement（PSR） is the only surgical method that can delay the the development of high myopia. However, The surgical method is restricted by the material source limitation and macular ischemia in the eye after reinforcement. The investigators have designed a new posterior scleral fixation system，Its basic material is medical silicone，The product is designed to solve the problem of material source limitation and macular ischemia in the eye after reinforcement.
- Conditions
- High Myopia, Macular Schisis
- Being tested
- High Myopic Posterior Scleral Fixation System
- Keywords
- Posterior scleral reinforcement, Macular ischemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
High Myopic Posterior Scleral Fixation SystemDevice
Also called HM
Implant HM into the eye through posterior scleral reinforcement
| Study group | Role | What they receive |
|---|---|---|
| HM experimental group | Experimental | Intraocular implant test product Receives: Device: High Myopic Posterior Scleral Fixation System |
| Natural observation control group | No intervention | Natural observation of the disease changes, no surgical intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Macular reduction rate
24 weeks after implantation of the High Myopic Posterior Scleral Fixation System
Measured: 24 weeks
Secondary outcomes (3)
Best corrected visual acuity
ETDRS table
Measured: Baseline (Before surgery), 1 day, 1 week, 4 weeks, 12 weeks, 24 weeks,
Axial length
A-scan
Measured: Baseline (Before surgery), 24 weeks after surgery
Diopter
Refractometer
Measured: Baseline (Before surgery), 24 weeks after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Sep 2021
- Study start1 Jun 2020
- Primary completion31 Dec 2021 (estimated)
- Study completion24 Apr 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for High MyopiaStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- GuangZhou WeiShiBo Biotechnology Co., ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Wenbing Wei, MD,Ph.D, Study chair, Beijing Tongren Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05034016
- Sponsor's protocol ID
- TREC2019-30.A2
- Status last verified
- Aug 2021
- First submitted
- 26 Aug 2021
- Last updated
- 5 Sep 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- High Myopic Posterior Scleral Fixation System
- ClinicalTrials.gov ID
- NCT05034016
- Acronym / sponsor ID
- TREC2019-30.A2
- Conditions
- High Myopia, Macular Schisis
- Keywords
- Posterior scleral reinforcement, Macular ischemia
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- GuangZhou WeiShiBo Biotechnology Co., ltdIndustry (pharma, biotech, devices)
- Study start
- 1 Jun 2020 (actual)
- Primary completion
- 31 Dec 2021 (estimated)
- Study completion
- 24 Apr 2022 (estimated)
- First posted
- 5 Sep 2021 (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 purpose of this study is to assess the primary safety and efficacy of High Myopic Posterior Scleral Fixation System in the treatment of macular schisis caused by high myopia.
Detailed description
Posterior Scleral Reinforcement（PSR） is the only surgical method that can delay the the development of high myopia. However, The surgical method is restricted by the material source limitation and macular ischemia in the eye after reinforcement. The investigators have designed a new posterior scleral fixation system，Its basic material is medical silicone，The product is designed to solve the problem of material source limitation and macular ischemia in the eye after reinforcement.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| HM experimental group | Experimental | Device: High Myopic Posterior Scleral Fixation SystemIntraocular implant test product |
| Natural observation control group | No intervention | –Natural observation of the disease changes, no surgical intervention |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Age 18~65, male or female;
- Refractive ranges from -6.00d to -25.00d;
- The axial length of the operative eye was 26-32mm;
- Macular cleavage 200-1000μm;
- Corrected visual acuity of the operative eye < 0.3;
Key exclusion criteria (16 listed)
- Known allergy to silica gel and patients with scar constitution;
- Ocular inflammation;
- Fundus hemorrhage;
- Macular hole;
- Macular cleavage of the contralateral eye greater than 200μm;
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 |
|---|---|---|
| High Myopic Posterior Scleral Fixation SystemAlso: HMImplant HM into the eye through posterior scleral reinforcement | Device | HM experimental group |
Primary outcome
Macular reduction rate
Time frame: 24 weeks
24 weeks after implantation of the High Myopic Posterior Scleral Fixation System
3 secondary outcomes
Best corrected visual acuity
Time frame: Baseline (Before surgery), 1 day, 1 week, 4 weeks, 12 weeks, 24 weeks,
Axial length
Time frame: Baseline (Before surgery), 24 weeks after surgery
Diopter
Time frame: Baseline (Before surgery), 24 weeks after surgery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Sep 2021.
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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.
Wenbing Wei, MD,Ph.D study chair
Beijing Tongren Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing High Myopic Posterior Scleral Fixation System in people with High Myopia and Macular Schisis, run by GuangZhou WeiShiBo Biotechnology Co., ltd 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 6 inclusion and 16 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 5 Sep 2021. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Qianying Gao, MD,Ph.D (020-28687088, kevin.gao@vesber.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Macular reduction rate (time frame: 24 weeks). 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 Sep 2021.