A Prospective Multicenter Study of Different Surgical Methods in the Treatment of High Myopic Macular Schisis (Recovery)

A Prospective Multicenter Study of Different Surgical Methods for the Treatment of Macular Schisis in High Myopia Based on the Real World

In view of the current problem of treating high myopic macular schisis, the main purpose of our study is to find out the most appropriate time of surgical intervention, to compare the effectiveness and safety of various surgical methods in the treatment of high myopic macular schisis, and to find out the advantages and disadvantages of each surgical method in the treatment of MF. As well as the outcomes and complications of long-term follow-up.

Study Overview

• Status: Unknown
• Conditions: Macular Schisis
• Intervention / Treatment: Procedure: PPV+/-Cat; Procedure: PPV+/-Cat+Gas; Procedure: PPV+ILM+/-Cat+/-Gas; Procedure: PPV+ILM+/-Cat+/-Oil; Procedure: PSR; Procedure: PSR+ PPV+ILM+/-Cat+/-Oil （or Gas）; Procedure: Gas

• Study Type: Interventional
• Enrollment (Anticipated): 400
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Shanghai
    • Shanghai, Shanghai, China, 200000
      • Recruiting
      • Shanghai Aier Eye Hospital
      • Contact: Jiasong Yang; Phone Number: +8618113024536; Email: cammel@qq.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years to 76 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. diopter ≤-6.00D or axial length ≥ 26.00mm;
2. OCT showed macular schisis with or without macular retinal detachment;
3. agreed to participate in this project and signed informed consent form.

Exclusion Criteria:

1. OCT confirmed full-thickness macular hole with or without macular retinal detachment；
2. submacular active or inactive CNV;
3. previous vitreoretinal surgery and anti-glaucoma surgery；
4. with rhegmatogenous retinal detachment, ocular trauma, glaucoma, corneal opacity and other ophthalmic diseases;
5. complicated with severe systemic disease can not tolerate surgery or follow-up;
6. do not agree to participate the project or disagree with the follow-up.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Factorial Assignment
• Masking: None (Open Label)

Number of Arms

8

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Control
Active Comparator: PPV+/-Cat	Procedure: PPV+/-Cat; pars plana vitrectomy+/-cataract
Active Comparator: PPV+/-Cat+Gas	Procedure: PPV+/-Cat+Gas; pars plana vitrectomy+/-cataract+gas tamponade
Active Comparator: PPV+ILM+/-Cat+/-Gas	Procedure: PPV+ILM+/-Cat+/-Gas; pars plana vitrectomy+internal limiting membrane peeling+/-cataract+/-gas tamponade
Active Comparator: PPV+ILM+/-Cat+/-Oil	Procedure: PPV+ILM+/-Cat+/-Oil; pars plana vitrectomy+internal limiting membrane peeling+/-cataract+/-silicone oil tamponade
Active Comparator: PSR	Procedure: PSR; posterior scleral reinforcement
Active Comparator: PSR+ PPV+ILM+/-Cat+/-Oil （or Gas）	Procedure: PSR+ PPV+ILM+/-Cat+/-Oil （or Gas）; posterior scleral reinforcement+pars plana vitrectomy+internal limiting membrane peeling+/-cataract+/-silicone oil tamponade (or gas)
Active Comparator: Gas	Procedure: Gas; gas tamponade alone

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
foveal thickness	measured by OCT	change from baseline foveal thickness at 3, 6, 9, 12 months
retinal thickness of the most significant schisis	measured by OCT	change from baseline at 3, 6, 9, 12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
best corrected visual acuity	BCVA	change from baseline at 3, 6, 9, 12 months
mf-ERG	multifocal-ERG	change from baseline at 3, 6, 9, 12 months
Visual quality questionnaire	Visual quality questionnaire	change from baseline at 3, 6, 9, 12 months
axial length	axial length measured by IOL Master	change from baseline at 3, 6, 9, 12 months

Collaborators and Investigators

• Sponsor: Aier School of Ophthalmology, Central South University
• Investigators: Study Chair: Weisheng Li, Shanghai Aier Eye Hospital

Publications and helpful links

General Publications

• Dolar-Szczasny J, Swiech-Zubilewicz A, Mackiewicz J. A Review of Current Myopic Foveoschisis Management Strategies. Semin Ophthalmol. 2019;34(3):146-156. doi: 10.1080/08820538.2019.1610180. Epub 2019 May 6.

Study record dates

Study Major Dates

• Study Start (Actual): October 7, 2019
• Primary Completion (Anticipated): October 7, 2021
• Study Completion (Anticipated): June 7, 2022

Study Registration Dates

• First Submitted: October 24, 2019
• First Submitted That Met QC Criteria: October 29, 2019
• First Posted (Actual): October 31, 2019

Study Record Updates

• Last Update Posted (Actual): October 31, 2019
• Last Update Submitted That Met QC Criteria: October 29, 2019
• Last Verified: October 1, 2019

More Information

Terms related to this study

• Other Study ID Numbers: AM1901D3

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