Corneal Flap Transplantation for Macular Hole Repair of High Myopia

May 17, 2023 updated by: First People's Hospital of Hangzhou

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.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Estimated)

30

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Zhejiang
      • Hangzhou, Zhejiang, China, 310006
        • Department of Ophthalmology, Affiliated Hangzhou First People's Hospital, Zhejiang University School of Medicine, Hangzhou, China

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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.
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
best-corrected visual acuity
Time Frame: one month to one year after surgery
the best-corrected visual acuity of the patients after surgery
one month to one year after surgery
complications
Time Frame: 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
one month to one year after surgery
closure of the macular holes
Time Frame: one month to one year after surgery
closure of the macular holes observed using optical coherence tomography
one month to one year after surgery
reattachment of the retina
Time Frame: one month to one year after surgery
reattachment of the retina observed using optical coherence tomography
one month to one year after surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

First People's Hospital of Hangzhou

Investigators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 23, 2022

Primary Completion (Estimated)

December 31, 2024

Study Completion (Estimated)

December 31, 2025

Study Registration Dates

First Submitted

May 17, 2023

First Submitted That Met QC Criteria

May 17, 2023

First Posted (Actual)

May 25, 2023

Study Record Updates

Last Update Posted (Actual)

May 25, 2023

Last Update Submitted That Met QC Criteria

May 17, 2023

Last Verified

April 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2022-025

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

The data will be used as part of other studies.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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