Silicone Oil Tamponade for Vitrectomy of Hypermyopic Foveoschisis.

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.

Study Overview

• Status: Recruiting
• Conditions: Hypermyopic Foveoschisis
• Intervention / Treatment: Procedure: PPV with SO tamponade; Procedure: PPV with fovea-sparing ILMP and gas tamponade; Procedure: PPV with gas tamponade

• Study Type: Interventional
• Enrollment (Anticipated): 159
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Mingwei Zhao, M.D.; Phone Number: 13801057408; Email: dr_mingweizhao@163.com

Study Locations

• China
  • Beijing
    • Beijing, Beijing, China, 100044
      • Recruiting
      • Peking University People's Hospital
      • Contact: Mingwei Zhao; Phone Number: 13801057408; Email: dr_mingweizhao@163.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

3

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Complete resolved rate of foveoschisis observed on OCT image.	The compete resolved of foveoschisis was evaluated using OCT image.	18 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Best corrected visual acuity (BCVA) change compared with baseline BCVA.	Best corrected visual acuity (BCVA) change compared with baseline BCVA by ETDRS chart.	18 months
The posoperative macular hole formation rate.	The posoperative macular hole formation rate of different groups	18 months

Collaborators and Investigators

• Sponsor: Peking University People's Hospital
• Collaborators: The First Affiliated Hospital with Nanjing Medical University; Peking University First Hospital; Beijing Friendship Hospital; Peking Union Medical College Hospital; The Second Hospital of Hebei Medical University; Peking University Third Hospital; Zhongshan Ophthalmic Center, Sun Yat-sen University; Southwest Hospital, China; Second Affiliated Hospital, School of Medicine, Zhejiang University; Shengjing Hospital; Shanghai 10th People's Hospital; Xuanwu Hospital, Beijing; Beijing Tongren Hospital; Eye & ENT Hospital of Fudan University; Beijing Hospital; The First Affiliated Hospital of Zhengzhou University; China-Japan Friendship Hospital; Henan Provincial People's Hospital; Xinhua Hospital, Shanghai Jiao Tong University School of Medicine; Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine; Tianjin Medical University General Hospital; Renmin Hospital of Wuhan University; Xinqiao Hospital of Chongqing; The Affiliated Hospital Of Guizhou Medical University; The First Affiliated Hospital of Kunming Medical College; First Hospital of China Medical University; Shandong Eye Hospital; Zhejiang Provincial People's Hospital; The Second Affiliated Hospital of Harbin Medical University; Second Xiangya Hospital of Central South University; Second Hospital of Jilin University; Wuhan TongJi Hospital; The Affiliated Hospital of Inner Mongolia Medical University; The First Affiliated Hospital of Dalian Medical University; Huaxi Hospital; First Affiliated Hospital of Harbin Medical University; Anhui Provincial Hospital; Wuxi People's Hospital; The First People's Hospital of Xuzhou; Tianjin Eye Hospital; Shenzhen Eye Hospital; Aier Eye Hospital, Beijing; The Eye Hospital of Wenzhou Medical University; Xinjiang Production and Construction Corps Hospital; Tianjin Medical University Eye Hospital; Second Hospital of Lanzhou University; The Fourth People's Hospital of Shenyang; The Affiliated Eye Hospital of Nanjing Medical University; Wuhan General Hospital of Guangzhou Military Command; The First Affiliated Hospital Of Southwest University, China; Shanghai Shi Bei Hospital; 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 record dates

Study Major Dates

• Study Start (Actual): October 29, 2022
• Primary Completion (Anticipated): December 31, 2024
• Study Completion (Anticipated): December 31, 2024

Study Registration Dates

• First Submitted: November 8, 2022
• First Submitted That Met QC Criteria: November 26, 2022
• First Posted (Actual): November 29, 2022

Study Record Updates

• Last Update Posted (Actual): November 29, 2022
• Last Update Submitted That Met QC Criteria: November 26, 2022
• Last Verified: November 1, 2022

More Information

Terms related to this study

• Other Study ID Numbers: SOME

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No