Back to resultsSilicone Oil Tamponade for Vitrectomy of Hypermyopic Foveoschisis.
Primary Purpose
Hypermyopic Foveoschisis
Status
Recruiting
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
PPV with SO tamponade
PPV with fovea-sparing ILMP and gas tamponade
PPV with gas tamponade
Sponsored by
About this trial
This is an interventional treatment trial for Hypermyopic Foveoschisis
Eligibility Criteria
Inclusion Criteria: 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. Exclusion Criteria: 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
Sites / Locations
- Peking University People's HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Active Comparator
Active Comparator
Arm Label
Silicone oil group
Gas group 1
Gas group 2
Arm Description
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.
Patients randomized into this group were received pars plana vitrectomy surgery with fovea-sparing internal limiting membrane peeling and gas tamponade.
Patients randomized into this group were received pars plana vitrectomy surgery with gas tamponade and without internal limiting membrane peeling.
Outcomes
Primary Outcome Measures
Complete resolved rate of foveoschisis observed on OCT image.
The compete resolved of foveoschisis was evaluated using OCT image.
Secondary Outcome Measures
Best corrected visual acuity (BCVA) change compared with baseline BCVA.
Best corrected visual acuity (BCVA) change compared with baseline BCVA by ETDRS chart.
The posoperative macular hole formation rate.
The posoperative macular hole formation rate of different groups
Full Information
NCT ID
NCT05628909
First Posted
November 8, 2022
Last Updated
November 26, 2022
Sponsor
Peking University People's Hospital
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, Second Hospital of Lanzhou University, The 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, School of Medicine, Zhejiang University, Xi'an People's Hospital
1. Study Identification
Unique Protocol Identification Number
NCT05628909
Brief Title
Silicone Oil Tamponade for Vitrectomy of Hypermyopic Foveoschisis.
Official Title
A Prospective, Randomized, Controlled, Multicentered Study of Vitrectomy With Silicone Oil Tamponade for Hypermyopic Foveoschisis.
Study Type
Interventional
2. Study Status
Record Verification Date
November 2022
Overall Recruitment Status
Recruiting
Study Start Date
October 29, 2022 (Actual)
Primary Completion Date
December 31, 2024 (Anticipated)
Study Completion Date
December 31, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Peking University People's Hospital
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, Second Hospital of Lanzhou University, The 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, School of Medicine, Zhejiang University, Xi'an People's Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypermyopic Foveoschisis
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
159 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Silicone oil group
Arm Type
Experimental
Arm Description
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.
Arm Title
Gas group 1
Arm Type
Active Comparator
Arm Description
Patients randomized into this group were received pars plana vitrectomy surgery with fovea-sparing internal limiting membrane peeling and gas tamponade.
Arm Title
Gas group 2
Arm Type
Active Comparator
Arm Description
Patients randomized into this group were received pars plana vitrectomy surgery with gas tamponade and without internal limiting membrane peeling.
Intervention Type
Procedure
Intervention Name(s)
PPV with SO tamponade
Intervention Description
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.
Intervention Type
Procedure
Intervention Name(s)
PPV with fovea-sparing ILMP and gas tamponade
Intervention Description
Patients randomized into gas group 1 were received pars plana vitrectomy surgery with fovea-sparing internal limiting membrane peeling and gas tamponade.
Intervention Type
Procedure
Intervention Name(s)
PPV with gas tamponade
Intervention Description
Patients randomized into gas group 2 were received pars plana vitrectomy surgery without internal limiting membrane peeling and gas tamponade.
Primary Outcome Measure Information:
Title
Complete resolved rate of foveoschisis observed on OCT image.
Description
The compete resolved of foveoschisis was evaluated using OCT image.
Time Frame
18 months
Secondary Outcome Measure Information:
Title
Best corrected visual acuity (BCVA) change compared with baseline BCVA.
Description
Best corrected visual acuity (BCVA) change compared with baseline BCVA by ETDRS chart.
Time Frame
18 months
Title
The posoperative macular hole formation rate.
Description
The posoperative macular hole formation rate of different groups
Time Frame
18 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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.
Exclusion Criteria:
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Mingwei Zhao, M.D.
Phone
13801057408
Email
dr_mingweizhao@163.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mingwei Zhao, M.D.
Organizational Affiliation
Peking University People's Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Yuou Yao, M.D.
Organizational Affiliation
Peking University People's Hospital
Official's Role
Study Director
Facility Information:
Facility Name
Peking University People's Hospital
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100044
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mingwei Zhao
Phone
13801057408
Email
dr_mingweizhao@163.com
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Silicone Oil Tamponade for Vitrectomy of Hypermyopic Foveoschisis.
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