Hypermyopic FoveoschisisNCT05628909
Silicone Oil Tamponade for Vitrectomy of Hypermyopic Foveoschisis.
A study testing PPV with SO tamponade, PPV with fovea-sparing ILMP and gas tamponade and PPV with gas tamponade in people with Hypermyopic Foveoschisis, run by Peking University People's Hospital at 1 site in China.
Trial summary
The purpose of this study is to explore the efficiency and safety of the surgical procedure of pars plana vitrectomy with silicone oil tamponade and without internal limiting membrane peeling for myopic foveoschisis eyes with high risk of macular hole formation. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hypermyopic Foveoschisis
- What is being tested?
- PPV with SO tamponade, PPV with fovea-sparing ILMP and gas tamponade and PPV with gas tamponade
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 159 participants
- Where
- 1 siteChina
- Study dates
- 29 Oct 2022to 31 Dec 2024
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- patients with spherical ≥ -8 diopters or axial length ≥ 26.5mm.
- The foveoshisis combined with foveal detachment was showed on the OCT image. The foveal detachment height≥ 250 um ,and the thickness of sensory retina of foveal detachment was ≤100 um;
- patients signed the ICF.
- patients with BCVA ≤0.5,and with visual disturbance symptoms.
Who cannot join
- patients with macular hole
- accompanied or secondary of other fundus disease
- received vitrectomy due to other diseases
- glaucoma cannot be controled by medication
- patients with other retinal or choroidal disease that may affect VA
- poor patients compliance
- poor condition that cannot undertake the surgery
- optical opacities which make it difficult to exam fundus or measure on OCT
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Peking University People's Hospital
Beijing, Beijing Municipality, 100044
Mingwei Zhao, 13801057408, dr_mingweizhao@163.com
About this study
Official title: A Prospective, Randomized, Controlled, Multicentered Study of Vitrectomy With Silicone Oil Tamponade for Hypermyopic Foveoschisis.
The purpose of this study is to explore the efficiency and safety of the surgical procedure of pars plana vitrectomy with silicone oil tamponade and without internal limiting membrane peeling for myopic foveoschisis eyes with high risk of macular hole formation.
- Conditions
- Hypermyopic Foveoschisis
- Being tested
- PPV with SO tamponade, PPV with fovea-sparing ILMP and gas tamponade, PPV with gas tamponade
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PPV with SO tamponadeProcedure or surgery
Patients randomized into silicone oil group were received pars plana vitrectomy surgery with silicone oil tamponade and without internal limiting membrane peeling. And silicone oil tamponade was removed at least 12 months after the primary surgery with completely resolved of foveoschisis.
PPV with fovea-sparing ILMP and gas tamponadeProcedure or surgery
Patients randomized into gas group 1 were received pars plana vitrectomy surgery with fovea-sparing internal limiting membrane peeling and gas tamponade.
PPV with gas tamponadeProcedure or surgery
Patients randomized into gas group 2 were received pars plana vitrectomy surgery without internal limiting membrane peeling and gas tamponade.
| Study group | Role | What they receive |
|---|---|---|
| Silicone oil group | Experimental | Patients randomized into this group were received pars plana vitrectomy surgery with silicone oil tamponade and without internal limiting membrane peeling. And silicone oil tamponade was removed at least 12 months after the primary surgery with completely resolved of foveoschisis. Receives: Procedure: PPV with SO tamponade |
| Gas group 1 | Active comparator | Patients randomized into this group were received pars plana vitrectomy surgery with fovea-sparing internal limiting membrane peeling and gas tamponade. Receives: Procedure: PPV with fovea-sparing ILMP and gas tamponade |
| Gas group 2 | Active comparator | Patients randomized into this group were received pars plana vitrectomy surgery with gas tamponade and without internal limiting membrane peeling. Receives: Procedure: PPV with gas tamponade |
What is being measured
The primary outcome is the main question the study is designed to answer.
Complete resolved rate of foveoschisis observed on OCT image.
The compete resolved of foveoschisis was evaluated using OCT image.
Measured: 18 months
Secondary outcomes (2)
Best corrected visual acuity (BCVA) change compared with baseline BCVA.
Best corrected visual acuity (BCVA) change compared with baseline BCVA by ETDRS chart.
Measured: 18 months
The posoperative macular hole formation rate.
The posoperative macular hole formation rate of different groups
Measured: 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Nov 2022
- Study start29 Oct 2022
- Primary completion31 Dec 2024 (estimated)
- Study completion31 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hypermyopic FoveoschisisStudies of the same condition, open and under way.
- More trials run by Peking University People's 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 159 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peking University People's Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Beijing Tongren Hospital, Peking Union Medical College Hospital, The First Affiliated Hospital of Zhengzhou University, Henan Provincial People's Hospital, Beijing Friendship Hospital, Xinhua Hospital, Shanghai Jiao Tong University School of Medicine, Huaxi Hospital, Shenzhen Eye Hospital, The First Affiliated Hospital with Nanjing Medical University, Beijing Hospital, Peking University Third Hospital, Aier Eye Hospital, Beijing, Peking University First Hospital, Xuanwu Hospital, Beijing, China-Japan Friendship Hospital, Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine, Eye & ENT Hospital of Fudan University, Zhongshan Ophthalmic Center, Sun Yat-sen University, The Eye Hospital of Wenzhou Medical University, Zhejiang Provincial People's Hospital, The First People's Hospital of Xuzhou, The First Affiliated Hospital of Dalian Medical University, Second Hospital of Jilin University, Xinjiang Production and Construction Corps Hospital, The Affiliated Hospital of Inner Mongolia Medical University, The Affiliated Hospital Of Guizhou Medical University, Tianjin Medical University Eye Hospital, Tianjin Medical University General Hospital, Xinqiao Hospital of Chongqing, Anhui Provincial Hospital, Shengjing Hospital, Lanzhou University Second Hospital, Fourth People's Hospital of Shenyang, The Second Hospital of Hebei Medical University, The Second Affiliated Hospital of Harbin Medical University, The Affiliated Eye Hospital of Nanjing Medical University, Second Xiangya Hospital of Central South University, Shandong Eye Hospital, Renmin Hospital of Wuhan University, First Affiliated Hospital of Harbin Medical University, Shanghai 10th People's Hospital, Wuhan General Hospital of Guangzhou Military Command, Southwest Hospital, China, First Affiliated Hospital of Kunming Medical University, First Hospital of China Medical University, Wuxi People's Hospital, The First Affiliated Hospital Of Southwest University, China, Wuhan TongJi Hospital, Shanghai Shi Bei Hospital, Tianjin Eye Hospital, Second Affiliated Hospital, Zhejiang University, School of Medicine, Xi'an People's Hospital (Xi'an Fourth Hospital)
- Responsible party
- Principal investigator, Mingwei Zhao, Peking University People's Hospital
- Investigators
- Mingwei Zhao, M.D., Principal investigator, Peking University People's HospitalYuou Yao, M.D., Study director, Peking University People's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05628909
- Sponsor's protocol ID
- SOME
- Status last verified
- Nov 2022
- First submitted
- 8 Nov 2022
- Last updated
- 29 Nov 2022
- 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 29 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Randomized, Controlled, Multicentered Study of Vitrectomy With Silicone Oil Tamponade for Hypermyopic Foveoschisis.
- ClinicalTrials.gov ID
- NCT05628909
- Acronym / sponsor ID
- SOME
- Conditions
- Hypermyopic Foveoschisis
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 159 participants (estimated)
- Lead sponsor
- Peking University People's HospitalUniversity, hospital or other
- Collaborators
- Beijing Tongren Hospital, Peking Union Medical College Hospital, The First Affiliated Hospital of Zhengzhou University, Henan Provincial People's Hospital, Beijing Friendship Hospital, Xinhua Hospital, Shanghai Jiao Tong University School of Medicine, Huaxi Hospital, Shenzhen Eye Hospital, The First Affiliated Hospital with Nanjing Medical University, Beijing Hospital, Peking University Third Hospital, Aier Eye Hospital, Beijing, Peking University First Hospital, Xuanwu Hospital, Beijing, China-Japan Friendship Hospital, Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine, Eye & ENT Hospital of Fudan University, Zhongshan Ophthalmic Center, Sun Yat-sen University, The Eye Hospital of Wenzhou Medical University, Zhejiang Provincial People's Hospital, The First People's Hospital of Xuzhou, The First Affiliated Hospital of Dalian Medical University, Second Hospital of Jilin University, Xinjiang Production and Construction Corps Hospital, The Affiliated Hospital of Inner Mongolia Medical University, The Affiliated Hospital Of Guizhou Medical University, Tianjin Medical University Eye Hospital, Tianjin Medical University General Hospital, Xinqiao Hospital of Chongqing, Anhui Provincial Hospital, Shengjing Hospital, Lanzhou University Second Hospital, Fourth People's Hospital of Shenyang, The Second Hospital of Hebei Medical University, The Second Affiliated Hospital of Harbin Medical University, The Affiliated Eye Hospital of Nanjing Medical University, Second Xiangya Hospital of Central South University, Shandong Eye Hospital, Renmin Hospital of Wuhan University, First Affiliated Hospital of Harbin Medical University, Shanghai 10th People's Hospital, Wuhan General Hospital of Guangzhou Military Command, Southwest Hospital, China, First Affiliated Hospital of Kunming Medical University, First Hospital of China Medical University, Wuxi People's Hospital, The First Affiliated Hospital Of Southwest University, China, Wuhan TongJi Hospital, Shanghai Shi Bei Hospital, Tianjin Eye Hospital, Second Affiliated Hospital, Zhejiang University, School of Medicine, Xi'an People's Hospital (Xi'an Fourth Hospital)
- Study start
- 29 Oct 2022 (actual)
- Primary completion
- 31 Dec 2024 (estimated)
- Study completion
- 31 Dec 2024 (estimated)
- First posted
- 29 Nov 2022 (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 explore the efficiency and safety of the surgical procedure of pars plana vitrectomy with silicone oil tamponade and without internal limiting membrane peeling for myopic foveoschisis eyes with high risk of macular hole formation.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Silicone oil group | Experimental | Procedure: PPV with SO tamponadePatients randomized into this group were received pars plana vitrectomy surgery with silicone oil tamponade and without internal limiting membrane peeling. And silicone oil tamponade was removed at least 12 months after the primary surgery with completely resolved of foveoschisis. |
| Gas group 1 | Active comparator | Procedure: PPV with fovea-sparing ILMP and gas tamponadePatients randomized into this group were received pars plana vitrectomy surgery with fovea-sparing internal limiting membrane peeling and gas tamponade. |
| Gas group 2 | Active comparator | Procedure: PPV with gas tamponadePatients randomized into this group were received pars plana vitrectomy surgery with gas tamponade and without internal limiting membrane peeling. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- patients with spherical ≥ -8 diopters or axial length ≥ 26.5mm.
- The foveoshisis combined with foveal detachment was showed on the OCT image. The foveal detachment height≥ 250 um ,and the thickness of sensory retina of foveal detachment was ≤100 um;
- patients signed the ICF.
- patients with BCVA ≤0.5,and with visual disturbance symptoms.
Key exclusion criteria (8 listed)
- patients with macular hole
- accompanied or secondary of other fundus disease
- received vitrectomy due to other diseases
- glaucoma cannot be controled by medication
- patients with other retinal or choroidal disease that may affect VA
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 |
|---|---|---|
| PPV with SO tamponadePatients randomized into silicone oil group were received pars plana vitrectomy surgery with silicone oil tamponade and without internal limiting membrane peeling. And silicone oil tamponade was removed at least 12 months after the primary surgery with completely resolved of foveoschisis. | Procedure or surgery | Silicone oil group |
| PPV with fovea-sparing ILMP and gas tamponadePatients randomized into gas group 1 were received pars plana vitrectomy surgery with fovea-sparing internal limiting membrane peeling and gas tamponade. | Procedure or surgery | Gas group 1 |
| PPV with gas tamponadePatients randomized into gas group 2 were received pars plana vitrectomy surgery without internal limiting membrane peeling and gas tamponade. | Procedure or surgery | Gas group 2 |
Primary outcome
Complete resolved rate of foveoschisis observed on OCT image.
Time frame: 18 months
The compete resolved of foveoschisis was evaluated using OCT image.
2 secondary outcomes
Best corrected visual acuity (BCVA) change compared with baseline BCVA.
Time frame: 18 months
The posoperative macular hole formation rate.
Time frame: 18 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Nov 2022.
- 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.
Mingwei Zhao, M.D. principal investigator
Peking University People's Hospital
Yuou Yao, M.D. study director
Peking University People's 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 PPV with SO tamponade, PPV with fovea-sparing ILMP and gas tamponade and PPV with gas tamponade in people with Hypermyopic Foveoschisis, run by Peking University People's Hospital 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 4 inclusion and 8 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 29 Nov 2022. 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 Mingwei Zhao, M.D. (13801057408, dr_mingweizhao@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Complete resolved rate of foveoschisis observed on OCT image. (time frame: 18 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 29 Nov 2022.