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Corneal Flap Transplantation for Macular Hole Repair of High Myopia

Corneal Flap Transplantation for Macular Hole Repair of High Myopia

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05875909
Enrollment
30
Registered
2023-05-25
Start date
2022-02-23
Completion date
2025-12-31
Last updated
2023-05-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Myopia, Degenerative, Retinal Perforations

Keywords

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

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.

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.

Interventions

PROCEDUREcorneal 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.

Sponsors

First People's Hospital of Hangzhou
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
best-corrected visual acuityone month to one year after surgerythe best-corrected visual acuity of the patients after surgery
complicationsone month to one year after surgeryinflammation, 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 holesone month to one year after surgeryclosure of the macular holes observed using optical coherence tomography
reattachment of the retinaone month to one year after surgeryreattachment of the retina observed using optical coherence tomography

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026