Corneal Flap Transplantation for Macular Hole Repair of High Myopia

Study Overview
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Brief Summary
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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
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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.

Official Title
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Corneal Flap Transplantation for Macular Hole Repair of High Myopia

Conditions
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Retinal Perforations, Myopia, Degenerative

Intervention / Treatment
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* Procedure: corneal flap transplantation


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: corneal flap transplantation<br>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<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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corneal flap transplantation, femtosecond laser small incision lenticule extraction, macular hole, surgical technique