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

A

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)

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

Trial contacts and locations

1

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Central trial contact

Wensheng Li; Jiasong Yang

Data sourced from clinicaltrials.gov

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