High MyopiaPhase 2NCT03381079
Efficacy and Safety of Posterior Scleral Reinforcement on Controlling Myopia in Adults With High Myopia
A Phase 2 study testing Posterior scleral reinforcement in people with High Myopia and Posterior Scleral Reinforcement, run by Beijing Tongren Hospital.
Trial summary
This study will evaluate the efficacy and safety of posterior scleral reinforcement on controlling myopia progression, including change in refraction, axial elongation as well as sight-threatening complications, in adults with high myopia. Read more about this study
- Who is it for?
- Ages 18 to 40 years
- Conditions the study is for
- High Myopia, Posterior Scleral Reinforcement, Adults
- What is being tested?
- Posterior scleral reinforcement
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- No sites listed yet
- Study dates
- 1 Apr 2018to 31 Dec 2020
- Phase
- Phase 2
- 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 40 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Cycloplegic spherical equivalent less than -6.0 D
- Myopia progression greater than 1.0 D per year
- Normal IOP, no strabismus or any other ocular pathological changes
- no any other ocular or systematic diseases that may affect refractive development
Who cannot join
- Currently or history using other interventions to control myopia progression (acupuncture, drugs, contact lens, ear needles and so on)
- Unable to cooperate with the ocular examination,questionnaire survey,or orthokeratology wearing
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Posterior Scleral Reinforcement for Adults With High Myopia
This study will evaluate the efficacy and safety of posterior scleral reinforcement on controlling myopia progression, including change in refraction, axial elongation as well as sight-threatening complications, in adults with high myopia. Half the adults will receive posterior scleral reinforcement, while the other half will receive no surgerical treatment.
- Conditions
- High Myopia, Posterior Scleral Reinforcement, Adults, Axial Elongation, Myopia Progression
- Being tested
- Posterior scleral reinforcement
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Posterior scleral reinforcementProcedure or surgery
Posterior scleral reinforcement (pPSR) is a procedure applied with autologous or biological material or synthetic materials reinforcing pole of the sclera after eyeball, in order to prevent or alleviate myopic development.
| Study group | Role | What they receive |
|---|---|---|
| Surgical group | Experimental | In this arm, the adults with high myopia will be given posterior scleral reinforcement. Receives: Procedure: Posterior scleral reinforcement |
| Control group | No intervention | In this arm, the adults with high myopia will not be given any surgical treatment. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cycloplegic autorefraction
Level of myopia and myopia progression as assessed by autorefraction
Measured: 2 years
Axial length
Longth of the eyeball as assessed by IOL Master or Lenstar
Measured: 2 years
Secondary outcomes (2)
Number of participants with treatment-related adverse events
Bleeding, inflammation or retinal detachment as assessed by B scan, slitlamp, etc.
Measured: 2 years
Visual acuity
An index for visual function measured by visual acuity chart
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Dec 2017
- Study start1 Apr 2018 (estimated)
- Primary completion1 Oct 2020 (estimated)
- Study completion31 Dec 2020 (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.
- More trials run by Beijing Tongren HospitalThe 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
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Beijing Tongren Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Shi-Ming Li, Beijing Tongren Hospital
- Investigators
- Ningli Wang, PhD, Study chair, Beijing Tongren Eye Center, Beijing Tongren Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03381079
- Sponsor's protocol ID
- TRECKY2017-049
- Status last verified
- Dec 2017
- First submitted
- 12 Dec 2017
- Last updated
- 22 Dec 2017
- 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 22 Dec 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Posterior Scleral Reinforcement for Adults With High Myopia
- ClinicalTrials.gov ID
- NCT03381079
- Acronym / sponsor ID
- TRECKY2017-049
- Conditions
- High Myopia, Posterior Scleral Reinforcement, Adults, Axial Elongation, Myopia Progression
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Beijing Tongren HospitalUniversity, hospital or other
- Study start
- 1 Apr 2018 (estimated)
- Primary completion
- 1 Oct 2020 (estimated)
- Study completion
- 31 Dec 2020 (estimated)
- First posted
- 21 Dec 2017 (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.
This study will evaluate the efficacy and safety of posterior scleral reinforcement on controlling myopia progression, including change in refraction, axial elongation as well as sight-threatening complications, in adults with high myopia. Half the adults will receive posterior scleral reinforcement, while the other half will receive no surgerical treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Surgical group | Experimental | Procedure: Posterior scleral reinforcementIn this arm, the adults with high myopia will be given posterior scleral reinforcement. |
| Control group | No intervention | –In this arm, the adults with high myopia will not be given any surgical treatment. |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Cycloplegic spherical equivalent less than -6.0 D
- Myopia progression greater than 1.0 D per year
- Normal IOP, no strabismus or any other ocular pathological changes
- no any other ocular or systematic diseases that may affect refractive development
Key exclusion criteria (2 listed)
- Currently or history using other interventions to control myopia progression (acupuncture, drugs, contact lens, ear needles and so on)
- Unable to cooperate with the ocular examination,questionnaire survey,or orthokeratology wearing
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 |
|---|---|---|
| Posterior scleral reinforcementPosterior scleral reinforcement (pPSR) is a procedure applied with autologous or biological material or synthetic materials reinforcing pole of the sclera after eyeball, in order to prevent or alleviate myopic development. | Procedure or surgery | Surgical group |
Primary outcome
Cycloplegic autorefraction
Time frame: 2 years
Level of myopia and myopia progression as assessed by autorefraction
Axial length
Time frame: 2 years
Longth of the eyeball as assessed by IOL Master or Lenstar
2 secondary outcomes
Number of participants with treatment-related adverse events
Time frame: 2 years
Visual acuity
Time frame: 2 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Dec 2017.
- 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.
Ningli Wang, PhD study chair
Beijing Tongren Eye Center, Beijing Tongren Hospital
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Posterior scleral reinforcement in people with High Myopia and Posterior Scleral Reinforcement, run by Beijing Tongren Hospital.
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: status not confirmed, as of the sponsor's last update on 22 Dec 2017. Status can change between updates, so confirm with the study contact before making plans.
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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 Shi-Ming Li, PhD (+86-10-58269920, lishiming81@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cycloplegic autorefraction (time frame: 2 years). 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 22 Dec 2017.