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Retinal PerforationsNCT05875909

Corneal Flap Transplantation for Macular Hole Repair of High Myopia

A study testing corneal flap transplantation in people with Retinal Perforations and Myopia, Degenerative, run by First People's Hospital of Hangzhou at 1 site in China.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 80 years
Conditions the study is for
Retinal Perforations, Myopia, Degenerative
What is being tested?
corneal flap transplantation
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
30 participants
Where
1 siteChina
Study dates
23 Feb 2022to 31 Dec 2025
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

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

Who cannot join

  • 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.

Trial locations and contacts

1 site in 1 country.

China1 site

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

    Hangzhou, Zhejiang, 310006

Other trials in China

About this study

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.
Read the 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.

Being tested
corneal flap transplantation
Keywords
corneal flap transplantation, femtosecond laser small incision lenticule extraction, macular hole, surgical technique
Medical subject headings
Retinal Perforations, Myopia, Degenerative

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • corneal flap transplantationProcedure or surgery

    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.

Study groups in NCT05875909
Study groupRoleWhat they receive
corneal flap transplantationExperimentalPatients 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.
Receives: Procedure: corneal flap transplantation

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. best-corrected visual acuity

    the best-corrected visual acuity of the patients after surgery

    Measured: one month to one year after surgery

  2. 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

    Measured: one month to one year after surgery

  3. closure of the macular holes

    closure of the macular holes observed using optical coherence tomography

    Measured: one month to one year after surgery

  4. reattachment of the retina

    reattachment of the retina observed using optical coherence tomography

    Measured: one month to one year after surgery

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted25 May 2023
  2. Study start23 Feb 2022
  3. Primary completion31 Dec 2024 (estimated)
  4. Study completion31 Dec 2025 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
30 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05875909
Sponsor's protocol ID
2022-025
Status last verified
Apr 2023
First submitted
17 May 2023
Last updated
25 May 2023
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: The data will be used as part of other studies.

Publications

  • 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.

    PubMed 32310627

  • 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.

    PubMed 32908680

  • 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.

    PubMed 32732611

  • 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.

    PubMed 33553838

  • 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.

    PubMed 33079787

  • 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.

    PubMed 31533121

  • 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.

    PubMed 32737034

  • 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.

    PubMed 32376975

  • 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.

    PubMed 35174806

Questions about this trial

What is this clinical trial studying?

A study testing corneal flap transplantation in people with Retinal Perforations and Myopia, Degenerative, run by First People's Hospital of Hangzhou at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 25 May 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

best-corrected visual acuity (time frame: one month to one year after surgery). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05875909, which also lists 9 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 May 2023.

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