Clinical trial NCT03586193: Pars Plana Vitrectomy Alone in the Treatment of Macular Schisis in High Myopic Eyes
Official title: Application of Pars Plana Vitrectomy in the Treatment of Macular Schisis in High Myopic Eyes
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Retinal Disease
Macular Retinoschisis
Lead sponsor: Aier School of Ophthalmology, Central South University
Sponsor class: OTHER
First posted: 2018-07-13
Enrollment: 40
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Study population will be selected from the in-patients in Shanghai Aier Eye Hospital.

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.


Eligibility criteria: 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.

Primary outcomes:
measure: The morphologic change of macular area
timeFrame: OCT will be done one day before surgery and one week, one month, three months and six months after surgery
Secondary outcomes:
measure: The best corrected visual acuity (BCVA) change
timeFrame: One day before surgery and one week, one month, three months and six months after surgery
measure: The best corrected near visual acuity (BCNVA) change
timeFrame: One day before surgery and one week, one month, three months and six months after surgery
measure: The visual function change
timeFrame: One day before surgery and one week, one month, three months and six months after surgery
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Shanghai Aier Eye hospital
Study officials:
affiliation: Shanghai Aier Eye Hospital
name: Wensheng Li, Doctor
role: STUDY_DIRECTOR
References:
citation: 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.
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.
citation: 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.