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Clinical Trials/NCT04146350
NCT04146350
Unknown
Not Applicable

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

Aier School of Ophthalmology, Central South University1 site in 1 country400 target enrollmentOctober 7, 2019
ConditionsMacular Schisis

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Macular Schisis
Sponsor
Aier School of Ophthalmology, Central South University
Enrollment
400
Locations
1
Primary Endpoint
retinal thickness of the most significant schisis
Last Updated
6 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
October 7, 2019
End Date
June 7, 2022
Last Updated
6 years ago
Study Type
Interventional
Study Design
Factorial
Sex
All

Investigators

Sponsor
Aier School of Ophthalmology, Central South University
Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

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

Outcomes

Primary Outcomes

retinal thickness of the most significant schisis

Time Frame: change from baseline at 3, 6, 9, 12 months

measured by OCT

foveal thickness

Time Frame: change from baseline foveal thickness at 3, 6, 9, 12 months

measured by OCT

Secondary Outcomes

  • Visual quality questionnaire(change from baseline at 3, 6, 9, 12 months)
  • axial length(change from baseline at 3, 6, 9, 12 months)
  • best corrected visual acuity(change from baseline at 3, 6, 9, 12 months)
  • mf-ERG(change from baseline at 3, 6, 9, 12 months)

Study Sites (1)

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