Pars Plana Vitrectomy Alone in the Treatment of Macular Schisis in High Myopic Eyes

NCT ID: NCT03586193

Last Updated: 2018-07-13

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

Total Enrollment

40 participants

Study Classification

OBSERVATIONAL

Study Start Date

2018-05-01

Study Completion Date

2019-05-31

Brief Summary

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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.

Detailed Description

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Conditions

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Retinal Disease Macular Retinoschisis

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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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

Pars plana vitrectomy

Intervention Type PROCEDURE

pars plana vitrectomy without ICG staining and ILM peeling

Interventions

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Pars plana vitrectomy

pars plana vitrectomy without ICG staining and ILM peeling

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

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

Role: STUDY_DIRECTOR

Shanghai Aier Eye Hospital

Locations

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Shanghai Aier Eye hospital

Shanghai, , China

Site Status RECRUITING

Countries

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China

Central Contacts

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Zhuyun Qian, Doctor

Role: CONTACT

+8613817109809 ext. +8618650424985

Wensheng Li, Doctor

Role: CONTACT

+8618650424985 ext. +8618650424985

Facility Contacts

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Zhuyun Qian, Doctor

Role: primary

+8613817109809 ext. +8618650424985

Wensheng Li, Doctor

Role: backup

+8618650424985 ext. +8618650424985

References

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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.

Reference Type BACKGROUND
PMID: 24414402 (View on PubMed)

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.

Reference Type RESULT
PMID: 27429390 (View on PubMed)

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.

Reference Type RESULT
PMID: 24246446 (View on PubMed)

Other Identifiers

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SHIRB2018014

Identifier Type: -

Identifier Source: org_study_id

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