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

• Conditions: Retinal Disease; Macular Retinoschisis
• Interventions: Procedure: Pars plana vitrectomy

• Registration Number: NCT03586193
• Lead Sponsor: Aier School of Ophthalmology, Central South University

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2018-05-01
• Study First Submitted: 2018-06-15
• Status Verified: 2018-07
• Study First Submitted QC: 2018-07-02
• Last Update Submitted: 2018-07-02
• Study First Posted: 2018-07-13
• Last Update Posted: 2018-07-13
• Primary Completion: 2018-12-31
• Study Completion: 2019-05-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 40

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
patients with HMF	Pars plana vitrectomy	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

Primary Outcome Measures

Name	Time	Method
The morphologic change of macular area	OCT will be done one day before surgery and one week, one month, three months and six months after surgery	The thickness of the macular fovea in optical coherence tomography (OCT)

Secondary Outcome Measures

Name	Time	Method
The best corrected visual acuity (BCVA) change	One day before surgery and one week, one month, three months and six months after surgery	The BCVA of all involved patients
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 BCNVA of all involved patients
The visual function change	One day before surgery and one week, one month, three months and six months after surgery	The contrast sensitivity of all involved patients

Trial Locations

Locations (1)

Shanghai Aier Eye hospital; 🇨🇳 Shanghai, China