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

NCT ID: NCT04146350

Last Updated: 2019-10-31

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

400 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-10-07

Study Completion Date

2022-06-07

Brief Summary

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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.

Detailed Description

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Conditions

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Macular Schisis

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

FACTORIAL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Control

Group Type NO_INTERVENTION

No interventions assigned to this group

PPV+/-Cat

Group Type ACTIVE_COMPARATOR

PPV+/-Cat

Intervention Type PROCEDURE

pars plana vitrectomy+/-cataract

PPV+/-Cat+Gas

Group Type ACTIVE_COMPARATOR

PPV+/-Cat+Gas

Intervention Type PROCEDURE

pars plana vitrectomy+/-cataract+gas tamponade

PPV+ILM+/-Cat+/-Gas

Group Type ACTIVE_COMPARATOR

PPV+ILM+/-Cat+/-Gas

Intervention Type PROCEDURE

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

PPV+ILM+/-Cat+/-Oil

Group Type ACTIVE_COMPARATOR

PPV+ILM+/-Cat+/-Oil

Intervention Type PROCEDURE

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

PSR

Group Type ACTIVE_COMPARATOR

PSR

Intervention Type PROCEDURE

posterior scleral reinforcement

PSR+ PPV+ILM+/-Cat+/-Oil （or Gas）

Group Type ACTIVE_COMPARATOR

PSR+ PPV+ILM+/-Cat+/-Oil （or Gas）

Intervention Type PROCEDURE

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

Gas

Group Type ACTIVE_COMPARATOR

Gas

Intervention Type PROCEDURE

gas tamponade alone

Interventions

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PPV+/-Cat

pars plana vitrectomy+/-cataract

Intervention Type PROCEDURE

PPV+/-Cat+Gas

pars plana vitrectomy+/-cataract+gas tamponade

Intervention Type PROCEDURE

PPV+ILM+/-Cat+/-Gas

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

Intervention Type PROCEDURE

PPV+ILM+/-Cat+/-Oil

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

Intervention Type PROCEDURE

PSR

posterior scleral reinforcement

Intervention Type PROCEDURE

PSR+ PPV+ILM+/-Cat+/-Oil （or Gas）

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

Intervention Type PROCEDURE

Gas

gas tamponade alone

Intervention Type PROCEDURE

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Aier School of Ophthalmology, Central South University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Weisheng Li

Role: STUDY_CHAIR

Shanghai Aier Eye Hospital

Locations

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Shanghai Aier Eye Hospital

Shanghai, Shanghai Municipality, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Jiasong Yang

Role: CONTACT

Phone: +8618113024536

Email: [email protected]

Wensheng Li

Role: CONTACT

Phone: +8618650424985

Email: [email protected]

Facility Contacts

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Jiasong Yang

Role: primary

Wensheng Li

Role: backup

References

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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.

Reference Type BACKGROUND
PMID: 31060414 (View on PubMed)

Other Identifiers

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AM1901D3

Identifier Type: -

Identifier Source: org_study_id