Silicone Oil Tamponade for Vitrectomy of Hypermyopic Foveoschisis.
NCT ID: NCT05628909
Last Updated: 2022-11-29
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
159 participants
INTERVENTIONAL
2022-10-29
2024-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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Silicone oil group
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.
PPV with SO tamponade
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.
Gas group 1
Patients randomized into this group were received pars plana vitrectomy surgery with fovea-sparing internal limiting membrane peeling and gas tamponade.
PPV with fovea-sparing ILMP and gas tamponade
Patients randomized into gas group 1 were received pars plana vitrectomy surgery with fovea-sparing internal limiting membrane peeling and gas tamponade.
Gas group 2
Patients randomized into this group were received pars plana vitrectomy surgery with gas tamponade and without internal limiting membrane peeling.
PPV with gas tamponade
Patients randomized into gas group 2 were received pars plana vitrectomy surgery without internal limiting membrane peeling and gas tamponade.
Interventions
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PPV with SO tamponade
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 tamponade
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 tamponade
Patients randomized into gas group 2 were received pars plana vitrectomy surgery without internal limiting membrane peeling and gas tamponade.
Eligibility Criteria
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Inclusion Criteria
* 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.
Exclusion Criteria
* 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
18 Years
ALL
No
Sponsors
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Beijing Tongren Hospital
OTHER
Peking Union Medical College Hospital
OTHER
The First Affiliated Hospital of Zhengzhou University
OTHER
Henan Provincial People's Hospital
OTHER
Beijing Friendship Hospital
OTHER
Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
OTHER
Huaxi Hospital
OTHER
Shenzhen Eye Hospital
OTHER
The First Affiliated Hospital with Nanjing Medical University
OTHER
Beijing Hospital
OTHER_GOV
Peking University Third Hospital
OTHER
Aier Eye Hospital, Beijing
UNKNOWN
Peking University First Hospital
OTHER
Xuanwu Hospital, Beijing
OTHER
China-Japan Friendship Hospital
OTHER
Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine
OTHER
Eye & ENT Hospital of Fudan University
OTHER
Zhongshan Ophthalmic Center, Sun Yat-sen University
OTHER
The Eye Hospital of Wenzhou Medical University
OTHER
Zhejiang Provincial People's Hospital
OTHER
The First People's Hospital of Xuzhou
OTHER
The First Affiliated Hospital of Dalian Medical University
OTHER
Second Hospital of Jilin University
OTHER
Xinjiang Production and Construction Corps Hospital
UNKNOWN
The Affiliated Hospital of Inner Mongolia Medical University
OTHER
The Affiliated Hospital Of Guizhou Medical University
OTHER
Tianjin Medical University Eye Hospital
OTHER
Tianjin Medical University General Hospital
OTHER
Xinqiao Hospital of Chongqing
OTHER
Anhui Provincial Hospital
OTHER_GOV
Shengjing Hospital
OTHER
Lanzhou University Second Hospital
OTHER
The Fourth People's Hospital of Shenyang
UNKNOWN
The Second Hospital of Hebei Medical University
OTHER
The Second Affiliated Hospital of Harbin Medical University
OTHER
The Affiliated Eye Hospital of Nanjing Medical University
UNKNOWN
Second Xiangya Hospital of Central South University
OTHER
Shandong Eye Hospital
OTHER
Renmin Hospital of Wuhan University
OTHER
First Affiliated Hospital of Harbin Medical University
OTHER
Shanghai 10th People's Hospital
OTHER
Wuhan General Hospital of Guangzhou Military Command
OTHER
Southwest Hospital, China
OTHER
First Affiliated Hospital of Kunming Medical University
OTHER
First Hospital of China Medical University
OTHER
Wuxi People's Hospital
OTHER
The First Affiliated Hospital Of Southwest University, China
UNKNOWN
Wuhan TongJi Hospital
OTHER
Shanghai Shi Bei Hospital
UNKNOWN
Tianjin Eye Hospital
OTHER
Second Affiliated Hospital, School of Medicine, Zhejiang University
OTHER
Xi'an People's Hospital (Xi'an Fourth Hospital)
OTHER
Peking University People's Hospital
OTHER
Responsible Party
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Mingwei Zhao
Chief of Opthalmology department
Principal Investigators
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Mingwei Zhao, M.D.
Role: PRINCIPAL_INVESTIGATOR
Peking University People's Hospital
Yuou Yao, M.D.
Role: STUDY_DIRECTOR
Peking University People's Hospital
Locations
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Peking University People's Hospital
Beijing, Beijing Municipality, China
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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SOME
Identifier Type: -
Identifier Source: org_study_id
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