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Corneal Flap Transplantation for Macular Hole Repair of High Myopia

NCT05875909 · Status: ACTIVE_NOT_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2023-05-25

No results posted yet for this study

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.

Conditions

  • Retinal Perforations
  • Myopia, Degenerative

Interventions

PROCEDURE

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.

Sponsors & Collaborators

  • First People's Hospital of Hangzhou

    lead OTHER

Principal Investigators

  • Yongping Hu, MD · Affiliated Hangzhou First People's Hospital, Zhejiang University School of Medicine, Hangzhou, China

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-02-23
Primary Completion
2024-12-31
Completion
2025-12-31

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05875909 on ClinicalTrials.gov