Corneal Flap Transplantation for Macular Hole Repair of High Myopia
Study Details
Study Description
Brief Summary
The goal of this clinical trial is to learn about an innovative surgical technique for macular hole repair. This technique is for patients with high myopia using pars plana vitrectomy (PPV) combined with corneal flap transplantation. The main questions it aims to answer are:
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Is the innovative surgical technique useful for patients?
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Is the surgical technique safe for patients?
Participants will:
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Undergo PPV combined with corneal flap transplantation to cover the macular hole.
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Maintain a prone position for 2 weeks postoperatively.
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Be observed by visual acuity, slit lamp, optical coherence tomography (OCT) and fundus photography for 1 year after surgery.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
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N/A |
Detailed Description
We describe an innovative surgical technique for macular hole repair using pars plana vitrectomy (PPV) combined with corneal flap transplantation. The corneal flap was sealed with autologous blood. The vitreous cavity was then filled with perfluoropropane (C3F8) or sterile air.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: corneal flap transplantation Patients with macular holes underwent a 25-gauge, 3-port pars plana vitrectomy . Fluid-air exchange was performed in patients with pathologic myopia suffering from macular holes with retinal detachment. We used a flute needle to drain the subretinal fluid. A corneal flap was obtained by small incision lenticule extraction (SMILE). Stripping pliers were applied to spread corneal flap over the macular hole. A drop of fresh autologous whole blood was dripped over the corneal flap to immobilise it. The vitreous cavity was filled with 14% perfluoropropane (C3F8) for macular holes with retinal detachment . The surgical incision was self-closed or sutured with a 6-0 polyglactin 910 suture . The patients were instructed to maintain a prone position for 2 weeks postoperatively. |
Procedure: corneal flap transplantation
Patients with macular holes underwent a 25-gauge, 3-port pars plana vitrectomy . Fluid-air exchange was performed in patients with pathologic myopia suffering from macular holes with retinal detachment. We used a flute needle to drain the subretinal fluid. A corneal flap was obtained by small incision lenticule extraction (SMILE). Stripping pliers were applied to spread corneal flap over the macular hole. A drop of fresh autologous whole blood was dripped over the corneal flap to immobilise it. The vitreous cavity was filled with 14% perfluoropropane (C3F8) for macular holes with retinal detachment . The surgical incision was self-closed or sutured with a 6-0 polyglactin 910 suture . The patients were instructed to maintain a prone position for 2 weeks postoperatively.
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Outcome Measures
Primary Outcome Measures
- best-corrected visual acuity [one month to one year after surgery]
the best-corrected visual acuity of the patients after surgery
- complications [one month to one year after surgery]
inflammation, infection, rejection reaction, ocular hypertension, ocular hypotension, recrudescent macular hole, parafoveal atrophy, corrugations or irregularities, choroidal neovascularisation, retinal detachment, cystoid macular oedema, reactive pigment epithelial hyperplasia, displacement, or opacification of the corneal flap
- closure of the macular holes [one month to one year after surgery]
closure of the macular holes observed using optical coherence tomography
- reattachment of the retina [one month to one year after surgery]
reattachment of the retina observed using optical coherence tomography
Eligibility Criteria
Criteria
Inclusion Criteria:
- Patients with macular hole and retinal detachment caused by pathologic myopia.
Exclusion Criteria:
- Patients with previous retinal surgery, trauma, other ocular diseases that could affect the vision, for example choroidal neovascularization, diabetic retinopathy, or opaque corneas were excluded.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Department of Ophthalmology, Affiliated Hangzhou First People's Hospital, Zhejiang University School of Medicine, Hangzhou, China | Hangzhou | Zhejiang | China | 310006 |
Sponsors and Collaborators
- First People's Hospital of Hangzhou
Investigators
- Study Chair: Yongping Hu, MD, Affiliated Hangzhou First People's Hospital, Zhejiang University School of Medicine, Hangzhou, China
Study Documents (Full-Text)
None provided.More Information
Publications
- Chen SN, Yang CM. Perfluorocarbon Liquid-Assisted Neurosensory Retinal Free Flap for Complicated Macular Hole Coexisting with Retinal Detachment. Ophthalmologica. 2019;242(4):222-233. doi: 10.1159/000502443. Epub 2019 Sep 18.
- Li M, Tang J, Jia Z, Yao Y, Jin E, Wang Z, Hu J, Sun G, Yin H, Liang J, Li X, Jiang Y, Qu J, Zhao M. Long-term follow-up of primary silicone oil tamponade for retinal detachment secondary to macular hole in highly myopic eyes: a prognostic factor analysis. Eye (Lond). 2021 Feb;35(2):625-631. doi: 10.1038/s41433-020-0922-0. Epub 2020 May 6.
- Ling L, Liu Y, Zhou B, Gao F, Hu Z, Tian M, Xing Y, Ji K, Sun T, Zhou W. Inverted Internal Limiting Membrane Flap Technique versus Internal Limiting Membrane Peeling for Vitrectomy in Highly Myopic Eyes with Macular Hole-Induced Retinal Detachment: An Updated Meta-Analysis. J Ophthalmol. 2020 Aug 24;2020:2374650. doi: 10.1155/2020/2374650. eCollection 2020.
- Lyu J, Xia F, Zhao P. Intraoperative Perfluorocarbon Liquid Tamponade Technique for Treatment of Extensive Retinal Detachment Secondary to a Myopic Macular Hole. Retina. 2023 Apr 1;43(4):698-704. doi: 10.1097/IAE.0000000000003429. Epub 2023 Mar 22.
- Peng J, Chen C, Zhang H, Zhang L, Liu J, Ren J, Zhao P. LONG-TERM SURGICAL OUTCOMES OF LENS CAPSULAR FLAP TRANSPLANTATION IN THE MANAGEMENT OF REFRACTORY MACULAR HOLE. Retina. 2021 Apr 1;41(4):726-734. doi: 10.1097/IAE.0000000000002922.
- Takeuchi J, Kataoka K, Shimizu H, Tomita R, Kominami T, Ushida H, Kaneko H, Ito Y, Terasaki H. INTRAOPERATIVE AND POSTOPERATIVE MONITORING OF AUTOLOGOUS NEUROSENSORY RETINAL FLAP TRANSPLANTATION FOR A REFRACTORY MACULAR HOLE ASSOCIATED WITH HIGH MYOPIA. Retina. 2021 May 1;41(5):921-930. doi: 10.1097/IAE.0000000000003000.
- Tsai DC, Huang YH, Chen SJ. Parafoveal atrophy after human amniotic membrane graft for macular hole in patients with high myopia. Br J Ophthalmol. 2021 Jul;105(7):1002-1010. doi: 10.1136/bjophthalmol-2019-315603. Epub 2020 Jul 31.
- Yadav NK, Venkatesh R, Thomas S, Pereira A, Shetty KB. Novel Method of Plugging the Hole: Anatomical and Functional Outcomes of Human Amniotic Membrane-Assisted Macular Hole Surgery. J Curr Ophthalmol. 2020 Dec 12;32(4):361-367. doi: 10.4103/JOCO.JOCO_189_20. eCollection 2020 Oct-Dec.
- Zhu K, Lei B, Wong W, Zhang J, Guo Y, Chen H, Song F, Chang Q, Xu G, Zhang Y. COMPARISON OF THE INTERNAL LIMITING MEMBRANE INSERTION TECHNIQUE AND THE INVERTED INTERNAL LIMITING MEMBRANE FLAP TECHNIQUE WITH VITRECTOMY TO TREAT MACULAR HOLE-ASSOCIATED RETINAL DETACHMENT. Retina. 2021 Jan 1;41(1):37-44. doi: 10.1097/IAE.0000000000002804.
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