High MyopiaNCT02915133
The Relationship Between Structure and Visual Function in Myopia Foveoschisis
An observational study of High Myopia, run by Sun Yat-sen University at 1 site in China.
Trial summary
Macular foveoschisis (MF) is a common complication of pathological myopia, which is characterized by choroid-retinal degeneration and vision impairment. Although pars plana vitrectomy (PPV) is the primary method for MF treatment, there is still a large proportion of recurrent MF due to the extremely long global axial… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- High Myopia
- What is being tested?
- macular buckling surgery
- Type of treatment
- Surgery or procedure
- How many people
- 20 participants
- Where
- 1 siteChina
- Study dates
- Oct 2016to 18 Sep 2021
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Consecutive participants with high myopia associated macular foveoschsis, who scheduled for surgery at Zhongshan Ophthalmic Center, Sun Yat-sen University.
Who may be able to join
- axial length ≥ 26.5 mm or refractive error (spherical equivalent) ≥ 8.0 diopter;
- macular foveoschisis that requires surgical intervention.
Who cannot join
- ocular trauma or surgery history;
- glaucoma, diabetic retinopathy;
- intraocular active hemorrhage or inflammation;
- unable to coordinate the OCT, mfERG, or other ophthalmological examinations.
Trial locations and contacts
1 site in 1 country.
China1 site
Zhongshan Ophthalmic Center, Sun Yat-sen University
Guangzhou, Guangdong, 510060
About this study
Official title: Correlation of Structural and Visual Function Changes in Myopia Foveoschisis Patients Undergoing Macular Buckle Surgery
Macular foveoschisis (MF) is a common complication of pathological myopia, which is characterized by choroid-retinal degeneration and vision impairment. Although pars plana vitrectomy (PPV) is the primary method for MF treatment, there is still a large proportion of recurrent MF due to the extremely long global axial length and posterior staphyloma. Macular buckling (MB) surgery aims at counteracting the traction exerted by the posterior staphyloma, and has been proven an effective method for treating MF. Optical Coherence Tomography (OCT) is widely used for the structural analysis of MF. Multifocol electroretinogram (mfERG) is an objective examination for visual evaluation. To our knowledge, there is a lack of data on the comprehensive visual function evaluations of MF patients associated with OCT findings. Our clinical trial aims to provide the structural and functional relationship in MF patients undergoing MB surgery, and find out potential factors to determine the visual prognosis.
- Conditions
- High Myopia
- Being tested
- macular buckling surgery
- Keywords
- high myopia, myopia foveoschisis, macular buckling
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
macular buckling surgeryProcedure or surgery
Participants with high myopia foveoschisis are scheduled to macular buckling (MB) surgery.
| Study group | Role | What they receive |
|---|---|---|
| MF-MB | Consecutive participants with high myopic foveoschisis are scheduled to macular buckling (MB) surgery. Receives: Procedure: macular buckling surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
change from baseline OCT at 6 months
Measured: 6 month postoperatively
change from multifocal ERG at 6 months
Measured: 6 month postoperatively
Secondary outcomes (1)
change from Best-corrected visual acuity (BCVA) at 6 months
Measured: 6 month postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Sep 2016 (estimated)
- Study startOct 2016
- Primary completionDec 2020 (estimated)
- Study completion18 Sep 2021 (estimated)
Why it stopped: study changed waiting renew
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 Sun Yat-sen UniversityThe 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
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sun Yat-sen University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Lin Lu, Sun Yat-sen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02915133
- Sponsor's protocol ID
- 2016HM-MF
- Status last verified
- Sep 2019
- First submitted
- 4 Sep 2016
- Last updated
- 19 Sep 2019
- Results posted
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Correlation of Structural and Visual Function Changes in Myopia Foveoschisis Patients Undergoing Macular Buckle Surgery
- ClinicalTrials.gov ID
- NCT02915133
- Acronym / sponsor ID
- 2016HM-MF
- Conditions
- High Myopia
- Keywords
- high myopia, myopia foveoschisis, macular buckling
- Study type
- Observational
- Recruitment status
- SuspendedReason stopped: study changed waiting renew
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Sun Yat-sen UniversityUniversity, hospital or other
- Study start
- Oct 2016
- Primary completion
- Dec 2020 (estimated)
- Study completion
- 18 Sep 2021 (estimated)
- First posted
- 26 Sep 2016 (estimated)
- 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.
Macular foveoschisis (MF) is a common complication of pathological myopia, which is characterized by choroid-retinal degeneration and vision impairment. Although pars plana vitrectomy (PPV) is the primary method for MF treatment, there is still a large proportion of recurrent MF due to the extremely long global axial length and posterior staphyloma. Macular buckling (MB) surgery aims at counteracting the traction exerted by the posterior staphyloma, and has been proven an effective method for treating MF. Optical Coherence Tomography (OCT) is widely used for the structural analysis of MF. Multifocol electroretinogram (mfERG) is an objective examination for visual evaluation. To our knowledge, there is a lack of data on the comprehensive visual function evaluations of MF patients associated with OCT findings. Our clinical trial aims to provide the structural and functional relationship in MF patients undergoing MB surgery, and find out potential factors to determine the visual prognosis.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| MF-MB | – | Procedure: macular buckling surgeryConsecutive participants with high myopic foveoschisis are scheduled to macular buckling (MB) surgery. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Consecutive participants with high myopia associated macular foveoschsis, who scheduled for surgery at Zhongshan Ophthalmic Center, Sun Yat-sen University.
Key inclusion criteria (2 listed)
- axial length ≥ 26.5 mm or refractive error (spherical equivalent) ≥ 8.0 diopter;
- macular foveoschisis that requires surgical intervention.
Key exclusion criteria (4 listed)
- ocular trauma or surgery history;
- glaucoma, diabetic retinopathy;
- intraocular active hemorrhage or inflammation;
- unable to coordinate the OCT, mfERG, or other ophthalmological examinations.
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 |
|---|---|---|
| macular buckling surgeryParticipants with high myopia foveoschisis are scheduled to macular buckling (MB) surgery. | Procedure or surgery | MF-MB |
Primary outcome
change from baseline OCT at 6 months
Time frame: 6 month postoperatively
change from multifocal ERG at 6 months
Time frame: 6 month postoperatively
1 secondary outcome
change from Best-corrected visual acuity (BCVA) at 6 months
Time frame: 6 month postoperatively
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Sep 2019.
- 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.
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 High Myopia, run by Sun Yat-sen 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 2 inclusion and 4 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: paused, as of the sponsor's last update on 19 Sep 2019. 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?
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 from baseline OCT at 6 months (time frame: 6 month postoperatively). 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 19 Sep 2019.