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

Aier School of Ophthalmology, Central South University

Status: Unknown

Conditions: Macular Schisis

Treatments: Procedure: PSR; Procedure: PPV+ILM+/-Cat+/-Oil; Procedure: PPV+ILM+/-Cat+/-Gas; Procedure: PPV+/-Cat; Procedure: PPV+/-Cat+Gas; Procedure: Gas; Procedure: PSR+ PPV+ILM+/-Cat+/-Oil （or Gas）

Study type: Interventional

Funder types: Other

Identifiers

NCT04146350

AM1901D3

Details and patient eligibility

About

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.

Enrollment: 400 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Factorial Assignment

Masking: None (Open label)

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400 participants in 8 patient groups

Control

No Intervention group

PPV+/-Cat

Active Comparator group

Treatment:

Procedure: PPV+/-Cat

PPV+/-Cat+Gas

Active Comparator group

Treatment:

Procedure: PPV+/-Cat+Gas

PPV+ILM+/-Cat+/-Gas

Active Comparator group

Treatment:

Procedure: PPV+ILM+/-Cat+/-Gas

PPV+ILM+/-Cat+/-Oil

Active Comparator group

Treatment:

Procedure: PPV+ILM+/-Cat+/-Oil

PSR

Active Comparator group

Treatment:

Procedure: PSR

PSR+ PPV+ILM+/-Cat+/-Oil （or Gas）

Active Comparator group

Treatment:

Procedure: PSR+ PPV+ILM+/-Cat+/-Oil （or Gas）

Gas

Active Comparator group

Treatment:

Procedure: Gas