NCT03586193

Brief Summary

High myopic schisis (HMF) has the clinical feature of separation between retinal layers. It is sometimes accompanied with foveal retinal detachment, macular lamellar hole, epiretinal membrane and vitreous retraction. HMF may develop to macular hole, macular detachment and will damage the visual function. Pars plana vitrectomy (PPV) is a commonly used surgery in the treatment of HMF. PPV together with internal limiting membrane (ILM) peeling and long-term gas tamponade was reported to be safe and effective. But nowadays there was no available long-term gas in our country. Also, whether ILM peeling is necessary remains controversial, Indole cyanine green (ICG)was proved to have potential toxicity to the retina and the ILM peeling has the risk of causing secondary macular hole. We propose to make a prospective nonrandomized controlled study to evaluate the safety and efficiency of using PPV alone in the treatment of HMF.

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
40

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started May 2018

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

May 1, 2018

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

June 15, 2018

Completed
28 days until next milestone

First Posted

Study publicly available on registry

July 13, 2018

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2018

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 31, 2019

Completed
Last Updated

July 13, 2018

Status Verified

July 1, 2018

Enrollment Period

8 months

First QC Date

June 15, 2018

Last Update Submit

July 2, 2018

Conditions

Retinal DiseaseMacular Retinoschisis

Outcome Measures

Primary Outcomes (1)

  • The morphologic change of macular area

    The thickness of the macular fovea in optical coherence tomography (OCT)

    OCT will be done one day before surgery and one week, one month, three months and six months after surgery

Secondary Outcomes (3)

  • The best corrected visual acuity (BCVA) change

    One day before surgery and one week, one month, three months and six months after surgery

  • The best corrected near visual acuity (BCNVA) change

    One day before surgery and one week, one month, three months and six months after surgery

  • The visual function change

    One day before surgery and one week, one month, three months and six months after surgery

Study Arms (1)

patients with HMF

Patients who are diagnosed as high myopic macular schisis and agree to receive pars plana vitrectomy as the treatment are planned to allocated in this group

Procedure: Pars plana vitrectomy

Interventions

Pars plana vitrectomyPROCEDURE

pars plana vitrectomy without ICG staining and ILM peeling

patients with HMF

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Study population will be selected from the in-patients in Shanghai Aier Eye Hospital.

You may qualify if:

  • Patients diagnosed as high myopic macular retinoschisis, with axial length more than 26.5mm.
  • Morphologic manifestation in OCT shows split between retinal layers in macular area.
  • Patients without severe systemic disease and can tolerate surgery.

You may not qualify if:

  • Patients also have other ocular disease, including glaucoma, keratitis,uveitis, retinal detachment,etc.
  • Patients with nystagmus or have difficult to open the eye.
  • Patients with severe systemic disease and cannot tolerate surgery.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Shanghai Aier Eye hospital

Shanghai, 200000, China

RECRUITING

Related Publications (3)

  • Chang JS, Flynn HW Jr, Engelbert M, Shane AR, Smiddy WE, Chang S. Pars plana vitrectomy in patients with myopic macular retinoschisis. Br J Ophthalmol. 2014 Apr;98(4):534-7. doi: 10.1136/bjophthalmol-2013-304578. Epub 2014 Jan 10.

    PMID: 24414402BACKGROUND

  • Zhang Z, Wei Y, Jiang X, Zhang S. PARS PLANA VITRECTOMY AND WIDE INTERNAL LIMITING MEMBRANE PEELING WITH PERFLUOROPROPANE TAMPONADE FOR HIGHLY MYOPIC FOVEOSCHISIS-ASSOCIATED MACULAR HOLE. Retina. 2017 Feb;37(2):274-282. doi: 10.1097/IAE.0000000000001146.

    PMID: 27429390RESULT

  • Rey A, Jurgens I, Maseras X, Carbajal M. Natural course and surgical management of high myopic foveoschisis. Ophthalmologica. 2014;231(1):45-50. doi: 10.1159/000355324. Epub 2013 Nov 12.

    PMID: 24246446RESULT

MeSH Terms

Conditions

Retinal Diseases

Condition Hierarchy (Ancestors)

Eye Diseases

Study Officials

  • Wensheng Li, Doctor

    Shanghai Aier Eye Hospital

    STUDY DIRECTOR

Central Study Contacts

Zhuyun Qian, Doctor

CONTACT

+8613817109809qianzhuyun552@126.com

Wensheng Li, Doctor

CONTACT

+8618650424985drlws@qq.com

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 15, 2018

First Posted

July 13, 2018

Study Start

May 1, 2018

Primary Completion

December 31, 2018

Study Completion

May 31, 2019

Last Updated

July 13, 2018

Record last verified: 2018-07

Data Sharing

IPD Sharing
Will share

all individual participant data (IPD) that underlie results

Shared Documents
STUDY PROTOCOL, SAP, ICF, CSR
Time Frame
After this study is finished the data will become available for 1year.
Access Criteria
The analytical data will be accessed in published articles.

Locations

CN(1)