Vitrectomy combined with lens capsule flap transplantation in the treatment of high myopia macular hole retinal detachment: study protocol for a prospective randomised controlled trial
Introduction Vitrectomy combined with internal limiting membrane (ILM) peeling, flap or tamponade is widely used in the treatment of macular diseases, such as macular hole (MH) and high myopia macular hole retinal detachment (HMMHRD). However, movement of the ILM to a suitable position to prevent di...
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BMJ Publishing Group
2022-07-01
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| Series: | BMJ Open |
| Online Access: | https://bmjopen.bmj.com/content/12/7/e064299.full |
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| author | Xun Xu Tianwei Qian Hao Zhou Weijun Wang Ying Fan Lin Xue Xia Wu Qiaoyun Gong Luyao Ye |
| author_facet | Xun Xu Tianwei Qian Hao Zhou Weijun Wang Ying Fan Lin Xue Xia Wu Qiaoyun Gong Luyao Ye |
| author_sort | Xun Xu |
| collection | DOAJ |
| description | Introduction Vitrectomy combined with internal limiting membrane (ILM) peeling, flap or tamponade is widely used in the treatment of macular diseases, such as macular hole (MH) and high myopia macular hole retinal detachment (HMMHRD). However, movement of the ILM to a suitable position to prevent displacement is a difficult operation. Improving visual function after surgery remains controversial. Compared with ILM, the thicker and more flexible lens capsule is easy to obtain and operate. Previous studies have confirmed the effectiveness of lens capsule flap in the treatment of MH. This study aims to evaluate the efficacy and safety of vitrectomy combined with lens capsule flap transplantation in the treatment of HMMHRD.Methods and analysis This single-centre, single-blind, prospective, randomised clinical trial will include 54 patients with HMMHRD who will first undergo phacoemulsification and intraocular lens implantation and then vitrectomy combined with lens capsule flap transplantation (experimental group) or ILM tamponade (control group). Study participants will be randomly allocated in a 1:1 ratio to experimental and control groups. Follow-up will be conducted 1, 3 and 7 days and 1, 3 and 6 months after surgery in both groups. Necessary examinations will be performed at each follow-up visit. Measurement outcomes include postoperative situation of macular hole closure, best-corrected visual acuity, macular retinal function and macular retinal sensitivity. The primary outcome is type I closure rate of MH 6 months after operation. Intergroup comparisons of the proportions of patients with type I closure of MH will be performed with Fisher’s exact test.Ethics and dissemination Full ethics approval for this study was obtained from the Ethics Committee of Shanghai General Hospital, Shanghai Jiaotong University, Shanghai, China. The outcomes of the trial will be disseminated through peer-reviewed journals and at scientific conferences.Trial registration number ChiCTR2200057836. |
| format | Article |
| id | doaj-art-2788d2c646d84b8997bc60aa9effb962 |
| institution | Kabale University |
| issn | 2044-6055 |
| language | English |
| publishDate | 2022-07-01 |
| publisher | BMJ Publishing Group |
| record_format | Article |
| series | BMJ Open |
| spelling | doaj-art-2788d2c646d84b8997bc60aa9effb9622025-01-31T12:45:08ZengBMJ Publishing GroupBMJ Open2044-60552022-07-0112710.1136/bmjopen-2022-064299Vitrectomy combined with lens capsule flap transplantation in the treatment of high myopia macular hole retinal detachment: study protocol for a prospective randomised controlled trialXun Xu0Tianwei Qian1Hao Zhou2Weijun Wang3Ying Fan4Lin Xue5Xia Wu6Qiaoyun Gong7Luyao Ye84 China National GeneBank-Shenzhen, BGI-Shenzhen, Shenzhen, ChinaNational Clinical Research Center for Eye Diseases, Shanghai, People`s Republic of ChinaDepartment of Orthopedics, The Second Affiliated Hospital of Zhejiang University School of Medicine, Hangzhou, Zhejiang, People`s Republic of ChinaShanghai Engineering Center for Precise Diagnosis and Treatment of Eye Disease, Shanghai, People`s Republic of ChinaShanghai Engineering Center for Precise Diagnosis and Treatment of Eye Disease, Shanghai, People`s Republic of ChinaDepartment of Ophthalmology, Shanghai General Hospital, Shanghai, ChinaSchool of Public Health, Kunming Medical University, Kunming, Yunnan, ChinaDepartment of Ophthalmology, Shanghai General Hospital, Shanghai, ChinaDepartment of Preventative Ophthalmology, Shanghai Eye Disease Prevention and Treatment Center, Shanghai, ChinaIntroduction Vitrectomy combined with internal limiting membrane (ILM) peeling, flap or tamponade is widely used in the treatment of macular diseases, such as macular hole (MH) and high myopia macular hole retinal detachment (HMMHRD). However, movement of the ILM to a suitable position to prevent displacement is a difficult operation. Improving visual function after surgery remains controversial. Compared with ILM, the thicker and more flexible lens capsule is easy to obtain and operate. Previous studies have confirmed the effectiveness of lens capsule flap in the treatment of MH. This study aims to evaluate the efficacy and safety of vitrectomy combined with lens capsule flap transplantation in the treatment of HMMHRD.Methods and analysis This single-centre, single-blind, prospective, randomised clinical trial will include 54 patients with HMMHRD who will first undergo phacoemulsification and intraocular lens implantation and then vitrectomy combined with lens capsule flap transplantation (experimental group) or ILM tamponade (control group). Study participants will be randomly allocated in a 1:1 ratio to experimental and control groups. Follow-up will be conducted 1, 3 and 7 days and 1, 3 and 6 months after surgery in both groups. Necessary examinations will be performed at each follow-up visit. Measurement outcomes include postoperative situation of macular hole closure, best-corrected visual acuity, macular retinal function and macular retinal sensitivity. The primary outcome is type I closure rate of MH 6 months after operation. Intergroup comparisons of the proportions of patients with type I closure of MH will be performed with Fisher’s exact test.Ethics and dissemination Full ethics approval for this study was obtained from the Ethics Committee of Shanghai General Hospital, Shanghai Jiaotong University, Shanghai, China. The outcomes of the trial will be disseminated through peer-reviewed journals and at scientific conferences.Trial registration number ChiCTR2200057836.https://bmjopen.bmj.com/content/12/7/e064299.full |
| spellingShingle | Xun Xu Tianwei Qian Hao Zhou Weijun Wang Ying Fan Lin Xue Xia Wu Qiaoyun Gong Luyao Ye Vitrectomy combined with lens capsule flap transplantation in the treatment of high myopia macular hole retinal detachment: study protocol for a prospective randomised controlled trial BMJ Open |
| title | Vitrectomy combined with lens capsule flap transplantation in the treatment of high myopia macular hole retinal detachment: study protocol for a prospective randomised controlled trial |
| title_full | Vitrectomy combined with lens capsule flap transplantation in the treatment of high myopia macular hole retinal detachment: study protocol for a prospective randomised controlled trial |
| title_fullStr | Vitrectomy combined with lens capsule flap transplantation in the treatment of high myopia macular hole retinal detachment: study protocol for a prospective randomised controlled trial |
| title_full_unstemmed | Vitrectomy combined with lens capsule flap transplantation in the treatment of high myopia macular hole retinal detachment: study protocol for a prospective randomised controlled trial |
| title_short | Vitrectomy combined with lens capsule flap transplantation in the treatment of high myopia macular hole retinal detachment: study protocol for a prospective randomised controlled trial |
| title_sort | vitrectomy combined with lens capsule flap transplantation in the treatment of high myopia macular hole retinal detachment study protocol for a prospective randomised controlled trial |
| url | https://bmjopen.bmj.com/content/12/7/e064299.full |
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