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

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

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03586193
Enrollment
40
Registered
2018-07-13
Start date
2018-05-01
Completion date
2019-05-31
Last updated
2018-07-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Macular Retinoschisis, Retinal Disease

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.

Interventions

PROCEDUREPars plana vitrectomy

pars plana vitrectomy without ICG staining and ILM peeling

Sponsors

Aier School of Ophthalmology, Central South University
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
The morphologic change of macular areaOCT will be done one day before surgery and one week, one month, three months and six months after surgeryThe thickness of the macular fovea in optical coherence tomography (OCT)

Secondary

MeasureTime frameDescription
The best corrected visual acuity (BCVA) changeOne day before surgery and one week, one month, three months and six months after surgeryThe BCVA of all involved patients
The best corrected near visual acuity (BCNVA) changeOne day before surgery and one week, one month, three months and six months after surgeryThe BCNVA of all involved patients
The visual function changeOne day before surgery and one week, one month, three months and six months after surgeryThe contrast sensitivity of all involved patients

Countries

China

Contacts

Primary ContactZhuyun Qian, Doctor
qianzhuyun552@126.com+8613817109809
Backup ContactWensheng Li, Doctor
drlws@qq.com+8618650424985

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026