Silicone Oil Tamponade for Vitrectomy of Hypermyopic Foveoschisis.

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.

Conditions

• Hypermyopic Foveoschisis

Interventions

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.

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.

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.

Sponsors & Collaborators

• Beijing Tongren Hospital

  collaborator OTHER

• Peking Union Medical College Hospital

  collaborator OTHER

• The First Affiliated Hospital of Zhengzhou University

  collaborator OTHER

• Henan Provincial People's Hospital

  collaborator OTHER

• Beijing Friendship Hospital

  collaborator OTHER

• Xinhua Hospital, Shanghai Jiao Tong University School of Medicine

  collaborator OTHER

• Huaxi Hospital

  collaborator OTHER

• Shenzhen Eye Hospital

  collaborator OTHER

• The First Affiliated Hospital with Nanjing Medical University

  collaborator OTHER

• Beijing Hospital

  collaborator OTHER_GOV

• Peking University Third Hospital

  collaborator OTHER

• Aier Eye Hospital, Beijing

  collaborator UNKNOWN

• Peking University First Hospital

  collaborator OTHER

• Xuanwu Hospital, Beijing

  collaborator OTHER

• China-Japan Friendship Hospital

  collaborator OTHER

• Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine

  collaborator OTHER

• Eye & ENT Hospital of Fudan University

  collaborator OTHER

• Zhongshan Ophthalmic Center, Sun Yat-sen University

  collaborator OTHER

• The Eye Hospital of Wenzhou Medical University

  collaborator OTHER

• Zhejiang Provincial People's Hospital

  collaborator OTHER

• The First People's Hospital of Xuzhou

  collaborator OTHER

• The First Affiliated Hospital of Dalian Medical University

  collaborator OTHER

• Second Hospital of Jilin University

  collaborator OTHER

• Xinjiang Production and Construction Corps Hospital

  collaborator UNKNOWN

• The Affiliated Hospital of Inner Mongolia Medical University

  collaborator OTHER

• The Affiliated Hospital Of Guizhou Medical University

  collaborator OTHER

• Tianjin Medical University Eye Hospital

  collaborator OTHER

• Tianjin Medical University General Hospital

  collaborator OTHER

• Xinqiao Hospital of Chongqing

  collaborator OTHER

• Anhui Provincial Hospital

  collaborator OTHER_GOV

• Shengjing Hospital

  collaborator OTHER

• Lanzhou University Second Hospital

  collaborator OTHER

• The Fourth People's Hospital of Shenyang

  collaborator UNKNOWN

• The Second Hospital of Hebei Medical University

  collaborator OTHER

• The Second Affiliated Hospital of Harbin Medical University

  collaborator OTHER

• The Affiliated Eye Hospital of Nanjing Medical University

  collaborator UNKNOWN

• Second Xiangya Hospital of Central South University

  collaborator OTHER

• Shandong Eye Hospital

  collaborator OTHER

• Renmin Hospital of Wuhan University

  collaborator OTHER

• First Affiliated Hospital of Harbin Medical University

  collaborator OTHER

• Shanghai 10th People's Hospital

  collaborator OTHER

• Wuhan General Hospital of Guangzhou Military Command

  collaborator OTHER

• Southwest Hospital, China

  collaborator OTHER

• First Affiliated Hospital of Kunming Medical University

  collaborator OTHER

• First Hospital of China Medical University

  collaborator OTHER

• Wuxi People's Hospital

  collaborator OTHER

• The First Affiliated Hospital Of Southwest University, China

  collaborator UNKNOWN

• Wuhan TongJi Hospital

  collaborator OTHER

• Shanghai Shi Bei Hospital

  collaborator UNKNOWN

• Tianjin Eye Hospital

  collaborator OTHER

• Second Affiliated Hospital, School of Medicine, Zhejiang University

  collaborator OTHER

• Xi'an People's Hospital (Xi'an Fourth Hospital)

  collaborator OTHER

• Peking University People's Hospital

  lead OTHER

Principal Investigators

• Mingwei Zhao, M.D. · Peking University People's Hospital

• Yuou Yao, M.D. · Peking University People's Hospital

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2022-10-29

Primary Completion

2024-12-31

Completion

2024-12-31

Countries

• China

Study Locations