Silicone Oil Tamponade for Vitrectomy of Hypermyopic Foveoschisis.
Sponsor
Peking University People's Hospital (Other)
Overall Status
Recruiting
CT.gov ID
NCT05628909
Collaborator
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), Peking University Third Hospital (Other), Aier Eye Hospital, Beijing (Other), 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 (Other), 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), Shengjing Hospital (Other), Second Hospital of Lanzhou University (Other), The Fourth People's Hospital of Shenyang (Other), 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 (Other), 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), The First Affiliated Hospital of Kunming Medical College (Other), First Hospital of China Medical University (Other), Wuxi People's Hospital (Other), The First Affiliated Hospital Of Southwest University, China (Other), Wuhan TongJi Hospital (Other), Shanghai Shi Bei Hospital (Other), Tianjin Eye Hospital (Other), Second Affiliated Hospital, School of Medicine, Zhejiang University (Other), Xi'an People's Hospital (Other)
159
1
3
26.1
6.1
Study Details
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Study Design
Study Type:
Interventional
Anticipated Enrollment
:
159 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
A Prospective, Randomized, Controlled, Multicentered Study of Vitrectomy With Silicone Oil Tamponade for Hypermyopic Foveoschisis.
Actual Study Start Date
:
Oct 29, 2022
Anticipated Primary Completion Date
:
Dec 31, 2024
Anticipated Study Completion Date
:
Dec 31, 2024
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: 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. |
Procedure: 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.
|
| Active Comparator: Gas group 1 Patients randomized into this group were received pars plana vitrectomy surgery with fovea-sparing internal limiting membrane peeling and gas tamponade. |
Procedure: 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.
|
| Active Comparator: Gas group 2 Patients randomized into this group were received pars plana vitrectomy surgery with gas tamponade and without internal limiting membrane peeling. |
Procedure: PPV with gas tamponade
Patients randomized into gas group 2 were received pars plana vitrectomy surgery without internal limiting membrane peeling and gas tamponade.
|
Outcome Measures
Primary Outcome Measures
- Complete resolved rate of foveoschisis observed on OCT image. [18 months]
The compete resolved of foveoschisis was evaluated using OCT image.
Secondary Outcome Measures
- Best corrected visual acuity (BCVA) change compared with baseline BCVA. [18 months]
Best corrected visual acuity (BCVA) change compared with baseline BCVA by ETDRS chart.
- The posoperative macular hole formation rate. [18 months]
The posoperative macular hole formation rate of different groups
Eligibility Criteria
Criteria
Ages Eligible for Study:
18 Years
and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Peking University People's Hospital | Beijing | Beijing | China | 100044 |
Sponsors and Collaborators
- Peking University People's Hospital
- 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
- The First Affiliated Hospital of Kunming Medical College
- 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
Investigators
- Principal Investigator: Mingwei Zhao, M.D., Peking University People's Hospital
- Study Director: Yuou Yao, M.D., Peking University People's Hospital
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.Responsible Party:
Mingwei Zhao,
Chief of Opthalmology department,
Peking University People's Hospital
ClinicalTrials.gov Identifier:
NCT05628909
Other Study ID Numbers:
- SOME
First Posted:
Nov 29, 2022
Last Update Posted:
Nov 29, 2022
Last Verified:
Nov 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No