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

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

Status

UNKNOWN

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT04146350

Acronym

Recovery

Enrollment

400

Registered

2019-10-31

Start date

2019-10-07

Completion date

2022-06-07

Last updated

2019-10-31

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Macular Schisis

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.

Interventions

PROCEDUREPPV+/-Cat

pars plana vitrectomy+/-cataract

PROCEDUREPPV+/-Cat+Gas

pars plana vitrectomy+/-cataract+gas tamponade

PROCEDUREPPV+ILM+/-Cat+/-Gas

pars plana vitrectomy+internal limiting membrane peeling+/-cataract+/-gas tamponade

PROCEDUREPPV+ILM+/-Cat+/-Oil

pars plana vitrectomy+internal limiting membrane peeling+/-cataract+/-silicone oil tamponade

PROCEDUREPSR

posterior scleral reinforcement

PROCEDUREPSR+ PPV+ILM+/-Cat+/-Oil （or Gas）

posterior scleral reinforcement+pars plana vitrectomy+internal limiting membrane peeling+/-cataract+/-silicone oil tamponade (or gas)

PROCEDUREGas

gas tamponade alone

Study design

Allocation

NON_RANDOMIZED

Intervention model

FACTORIAL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 80 Years

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.

Design outcomes

Primary

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

Secondary

Measure	Time frame	Description
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
Visual quality questionnaire	change from baseline at 3, 6, 9, 12 months	Visual quality questionnaire

Countries

China

Contacts

Primary ContactJiasong Yang

cammel@qq.com+8618113024536

Backup ContactWensheng Li

drlws@qq.com+8618650424985

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026