NCT04146350

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
400

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Oct 2019

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 7, 2019

Completed
17 days until next milestone

First Submitted

Initial submission to the registry

October 24, 2019

Completed
7 days until next milestone

First Posted

Study publicly available on registry

October 31, 2019

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 7, 2021

Completed
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 7, 2022

Completed
Last Updated

October 31, 2019

Status Verified

October 1, 2019

Enrollment Period

2 years

First QC Date

October 24, 2019

Last Update Submit

October 29, 2019

Conditions

Macular Schisis

Outcome Measures

Primary Outcomes (2)

  • foveal thickness

    measured by OCT

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

  • retinal thickness of the most significant schisis

    measured by OCT

    change from baseline at 3, 6, 9, 12 months

Secondary Outcomes (4)

  • best corrected visual acuity

    change from baseline at 3, 6, 9, 12 months

  • mf-ERG

    change from baseline at 3, 6, 9, 12 months

  • Visual quality questionnaire

    change from baseline at 3, 6, 9, 12 months

  • axial length

    change from baseline at 3, 6, 9, 12 months

Study Arms (8)

Control

NO INTERVENTION

PPV+/-Cat

ACTIVE COMPARATOR
Procedure: PPV+/-Cat

PPV+/-Cat+Gas

ACTIVE COMPARATOR
Procedure: PPV+/-Cat+Gas

PPV+ILM+/-Cat+/-Gas

ACTIVE COMPARATOR
Procedure: PPV+ILM+/-Cat+/-Gas

PPV+ILM+/-Cat+/-Oil

ACTIVE COMPARATOR
Procedure: PPV+ILM+/-Cat+/-Oil

PSR

ACTIVE COMPARATOR
Procedure: PSR

PSR+ PPV+ILM+/-Cat+/-Oil （or Gas）

ACTIVE COMPARATOR
Procedure: PSR+ PPV+ILM+/-Cat+/-Oil （or Gas）

Gas

ACTIVE COMPARATOR
Procedure: Gas

Interventions

PPV+/-CatPROCEDURE

pars plana vitrectomy+/-cataract

PPV+/-Cat
PPV+/-Cat+GasPROCEDURE

pars plana vitrectomy+/-cataract+gas tamponade

PPV+/-Cat+Gas
PPV+ILM+/-Cat+/-GasPROCEDURE

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

PPV+ILM+/-Cat+/-Gas
PPV+ILM+/-Cat+/-OilPROCEDURE

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

PPV+ILM+/-Cat+/-Oil
PSRPROCEDURE

posterior scleral reinforcement

PSR
PSR+ PPV+ILM+/-Cat+/-Oil （or Gas）PROCEDURE

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

PSR+ PPV+ILM+/-Cat+/-Oil （or Gas）
GasPROCEDURE

gas tamponade alone

Gas

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Shanghai Aier Eye Hospital

Shanghai, Shanghai Municipality, 200000, China

RECRUITING

Related 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.

    PMID: 31060414BACKGROUND

MeSH Terms

Interventions

Gases

Intervention Hierarchy (Ancestors)

Inorganic Chemicals

Study Officials

  • Weisheng Li

    Shanghai Aier Eye Hospital

    STUDY CHAIR

Central Study Contacts

Jiasong Yang

CONTACT

+8618113024536cammel@qq.com

Wensheng Li

CONTACT

+8618650424985drlws@qq.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
FACTORIAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 24, 2019

First Posted

October 31, 2019

Study Start

October 7, 2019

Primary Completion

October 7, 2021

Study Completion

June 7, 2022

Last Updated

October 31, 2019

Record last verified: 2019-10

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)