Corneal Flap Transplantation for Macular Hole Repair of High Myopia
NCT ID: NCT05875909
Last Updated: 2023-05-25
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
NA
30 participants
INTERVENTIONAL
2022-02-23
2025-12-31
Brief Summary
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* Is the innovative surgical technique useful for patients?
* Is the surgical technique safe for patients?
Participants will:
* Undergo PPV combined with corneal flap transplantation to cover the macular hole.
* Maintain a prone position for 2 weeks postoperatively.
* Be observed by visual acuity, slit lamp, optical coherence tomography (OCT) and fundus photography for 1 year after surgery.
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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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.
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.
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
18 Years
80 Years
ALL
No
Sponsors
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First People's Hospital of Hangzhou
OTHER
Responsible Party
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Principal Investigators
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Yongping Hu, MD
Role: STUDY_CHAIR
Affiliated Hangzhou First People's Hospital, Zhejiang University School of Medicine, Hangzhou, China
Locations
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Department of Ophthalmology, Affiliated Hangzhou First People's Hospital, Zhejiang University School of Medicine, Hangzhou, China
Hangzhou, Zhejiang, China
Countries
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References
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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.
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.
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.
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.
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.
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.
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.
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.
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.
Other Identifiers
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2022-025
Identifier Type: -
Identifier Source: org_study_id
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