Corneal Flap Transplantation for Macular Hole Repair of High Myopia

Not Applicable

Active, not recruiting

• Conditions: Retinal Perforations; Myopia, Degenerative
• Interventions: Procedure: corneal flap transplantation

• Registration Number: NCT05875909
• Lead Sponsor: First People's Hospital of Hangzhou

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.

Study Timeline

• Study Start: 2022-02-23
• Status Verified: 2023-04
• Study First Submitted: 2023-05-17
• Study First Submitted QC: 2023-05-17
• Last Update Submitted: 2023-05-17
• Study First Posted: 2023-05-25
• Last Update Posted: 2023-05-25
• Primary Completion: 2024-12-31
• Study Completion: 2025-12-31

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 30

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
corneal flap transplantation	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.

Primary Outcome Measures

Name	Time	Method
reattachment of the retina	one month to one year after surgery	reattachment of the retina observed using optical coherence tomography
best-corrected visual acuity	one month to one year after surgery	the best-corrected visual acuity of the patients after surgery
complications	one month to one year after surgery	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
closure of the macular holes	one month to one year after surgery	closure of the macular holes observed using optical coherence tomography

Trial Locations

Locations (1)

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