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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Pars plana vitrectomy | Procedure | pars plana vitrectomy without ICG staining and ILM peeling |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| The best corrected near visual acuity (BCNVA) change |
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Inclusion Criteria:
Exclusion Criteria:
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Study population will be selected from the in-patients in Shanghai Aier Eye Hospital.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Zhuyun Qian, Doctor | Contact | +8613817109809 | +8618650424985 | qianzhuyun552@126.com |
| Wensheng Li, Doctor | Contact | +8618650424985 | +8618650424985 | drlws@qq.com |
| Name | Affiliation | Role |
|---|---|---|
| Wensheng Li, Doctor | Shanghai Aier Eye Hospital | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Shanghai Aier Eye hospital | Recruiting | Shanghai | 200000 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 24414402 | Background | 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. | |
| 27429390 | Result | 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. |
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all individual participant data (IPD) that underlie results
After this study is finished the data will become available for 1year.
The analytical data will be accessed in published articles.
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| ID | Term |
|---|---|
| D012164 | Retinal Diseases |
| ID | Term |
|---|---|
| D005128 | Eye Diseases |
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The BCNVA of all involved patients
| One day before surgery and one week, one month, three months and six months after surgery |
| 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 |
| 24246446 | Result | 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. |