Corneal Flap Transplantation for Macular Hole Repair of High Myopia

Zhejiang University

Status: Active, not recruiting

Conditions: Myopia, Degenerative; Retinal Perforations

Treatments: Procedure: corneal flap transplantation

Study type: Interventional

Funder types: Other

Identifiers

NCT05875909

2022-025

Details and patient eligibility

About

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.

Full 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.

Enrollment: 30 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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30 participants in 1 patient group

corneal flap transplantation

Experimental group

Description:

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.

Treatment:

Procedure: corneal flap transplantation