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

Macular Schisis Clinical Trial

— Recovery  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04146350
• Other study ID #: AM1901D3
• Status: Recruiting
• Phase: N/A
• Start date: October 7, 2019
• Est. completion date: June 7, 2022

Study information

• Verified date: October 2019
• Source: Aier School of Ophthalmology, Central South University
• Contact: Jiasong Yang
• Phone: +8618113024536
• Email: cammel[@]qq.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 400
• Est. completion date: June 7, 2022
• Est. primary completion date: October 7, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Macular Schisis

Intervention

Procedure:
• PPV+/-Cat
pars plana vitrectomy+/-cataract
• PPV+/-Cat+Gas
pars plana vitrectomy+/-cataract+gas tamponade
• PPV+ILM+/-Cat+/-Gas
pars plana vitrectomy+internal limiting membrane peeling+/-cataract+/-gas tamponade
• PPV+ILM+/-Cat+/-Oil
pars plana vitrectomy+internal limiting membrane peeling+/-cataract+/-silicone oil tamponade
• PSR
posterior scleral reinforcement
• PSR+ PPV+ILM+/-Cat+/-Oil (or Gas)
posterior scleral reinforcement+pars plana vitrectomy+internal limiting membrane peeling+/-cataract+/-silicone oil tamponade (or gas)
• Gas
gas tamponade alone

Locations

Country	Name	City	State
China	Shanghai Aier Eye Hospital	Shanghai	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Aier School of Ophthalmology, Central South University

Country where clinical trial is conducted

China, 

References & Publications (1)

Dolar-Szczasny J, Swiech-Zubilewicz A, Mackiewicz J. A Review of Current Myopic Foveoschisis Management Strategies. Semin Ophthalmol. 2019;34(3):146-156. doi: 10.1080/08820538.2019.1610180. Epub 2019 May 6. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	foveal thickness	measured by OCT	change from baseline foveal thickness at 3, 6, 9, 12 months
Primary	retinal thickness of the most significant schisis	measured by OCT	change from baseline at 3, 6, 9, 12 months
Secondary	best corrected visual acuity	BCVA	change from baseline at 3, 6, 9, 12 months
Secondary	mf-ERG	multifocal-ERG	change from baseline at 3, 6, 9, 12 months
Secondary	Visual quality questionnaire	Visual quality questionnaire	change from baseline at 3, 6, 9, 12 months
Secondary	axial length	axial length measured by IOL Master	change from baseline at 3, 6, 9, 12 months