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

Not Applicable

• Conditions: Macular Schisis
• Interventions: Procedure: PPV+ILM+/-Cat+/-Oil; Procedure: PPV+/-Cat; Procedure: PSR+ PPV+ILM+/-Cat+/-Oil （or Gas）; Procedure: PPV+/-Cat+Gas; Procedure: PSR; Procedure: Gas; Procedure: PPV+ILM+/-Cat+/-Gas

• Registration Number: NCT04146350
• Lead Sponsor: Aier School of Ophthalmology, Central South University

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2019-10
• Study Start: 2019-10-07
• Study First Submitted: 2019-10-24
• Study First Submitted QC: 2019-10-29
• Last Update Submitted: 2019-10-29
• Study First Posted: 2019-10-31
• Last Update Posted: 2019-10-31
• Primary Completion: 2021-10-07
• Study Completion: 2022-06-07

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 400

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: FACTORIAL

Arm && Interventions

Group	Intervention	Description
PPV+ILM+/-Cat+/-Oil	PPV+ILM+/-Cat+/-Oil	-
PPV+/-Cat	PPV+/-Cat	-
PSR+ PPV+ILM+/-Cat+/-Oil （or Gas）	PSR+ PPV+ILM+/-Cat+/-Oil （or Gas）	-
PPV+/-Cat+Gas	PPV+/-Cat+Gas	-
PSR	PSR	-
Gas	Gas	-
PPV+ILM+/-Cat+/-Gas	PPV+ILM+/-Cat+/-Gas	-

Primary Outcome Measures

Name	Time	Method
retinal thickness of the most significant schisis	change from baseline at 3, 6, 9, 12 months	measured by OCT
foveal thickness	change from baseline foveal thickness at 3, 6, 9, 12 months	measured by OCT

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Shanghai Aier Eye Hospital; 🇨🇳 Shanghai, Shanghai, China