Corneal Flap Transplantation for Macular Hole Repair of High Myopia

NCT05875909 | Unknown

• 1 other identifier: 2022-025
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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:

• 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.

Conditions

Retinal Perforations; Myopia, Degenerative

Keywords

corneal flap transplantation; femtosecond laser small incision lenticule extraction; macular hole; surgical technique

Outcome Measures

Primary Outcomes (4)

• best-corrected visual acuity

  the best-corrected visual acuity of the patients after surgery

  one month to one year after surgery

• complications

  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

  one month to one year after surgery

• closure of the macular holes

  closure of the macular holes observed using optical coherence tomography

  one month to one year after surgery

• reattachment of the retina

  reattachment of the retina observed using optical coherence tomography

  one month to one year after surgery

Study Arms (1)

corneal flap transplantation

EXPERIMENTAL

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

Interventions

corneal flap transplantation PROCEDURE

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

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients with macular hole and retinal detachment caused by pathologic myopia.

You may not qualify if:

• 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.

Sponsors & Collaborators

• First People's Hospital of Hangzhou: lead

Study Sites (1)

Department of Ophthalmology, Affiliated Hangzhou First People's Hospital, Zhejiang University School of Medicine, Hangzhou, China

Hangzhou, Zhejiang, 310006, China

Location

Related Publications (9)

• 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.

  PMID: 32310627 BACKGROUND

• 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.

  PMID: 32908680 BACKGROUND

• 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.

  PMID: 32732611 BACKGROUND

• 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.

  PMID: 33553838 BACKGROUND

• 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.

  PMID: 33079787 BACKGROUND

• 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.

  PMID: 31533121 BACKGROUND

• 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.

  PMID: 32737034 BACKGROUND

• 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.

  PMID: 32376975 BACKGROUND

• 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.

  PMID: 35174806 BACKGROUND

MeSH Terms

Conditions

Retinal Perforations; Myopia, Degenerative

Condition Hierarchy (Ancestors)

Retinal Diseases; Eye Diseases; Myopia; Refractive Errors

Study Officials

• Yongping Hu, MD

  Affiliated Hangzhou First People's Hospital, Zhejiang University School of Medicine, Hangzhou, China

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 17, 2023
• First Posted: May 25, 2023
• Study Start: February 23, 2022
• Primary Completion: December 31, 2024
• Study Completion: December 31, 2025
• Last Updated: May 25, 2023

Record last verified: 2023-04

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)