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

Retinal Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03586193
• Other study ID #: SHIRB2018014
• Status: Recruiting
• Start date: May 1, 2018
• Est. completion date: May 31, 2019

Study information

• Verified date: July 2018
• Source: Aier School of Ophthalmology, Central South University
• Contact: Zhuyun Qian, Doctor
• Phone: +8613817109809
• Email: qianzhuyun552[@]126.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: May 31, 2019
• Est. primary completion date: December 31, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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.

Related Conditions & MeSH terms

• Macular Retinoschisis
• Retinal Disease
• Retinal Diseases
• Retinoschisis

Intervention

Procedure:
• Pars plana vitrectomy
pars plana vitrectomy without ICG staining and ILM peeling

Locations

Country	Name	City	State
China	Shanghai Aier Eye hospital	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Aier School of Ophthalmology, Central South University

Country where clinical trial is conducted

China, 

References & 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. — View Citation

Rey A, Jürgens 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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	The best corrected visual acuity (BCVA) change	The BCVA of all involved patients	One day before surgery and one week, one month, three months and six months after surgery
Secondary	The best corrected near visual acuity (BCNVA) change	The BCNVA of all involved patients	One day before surgery and one week, one month, three months and six months after surgery
Secondary	The visual function change	The contrast sensitivity of all involved patients	One day before surgery and one week, one month, three months and six months after surgery