Clinical trial NCT05875909: Corneal Flap Transplantation for Macular Hole Repair of High Myopia
Official title: Corneal Flap Transplantation for Macular Hole Repair of High Myopia
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Retinal Perforations
Myopia, Degenerative
Keywords: corneal flap transplantation
femtosecond laser small incision lenticule extraction
macular hole
surgical technique
Lead sponsor: First People's Hospital of Hangzhou
Sponsor class: OTHER
First posted: 2023-05-25
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: best-corrected visual acuity
timeFrame: one month to one year after surgery
measure: complications
timeFrame: one month to one year after surgery
measure: closure of the macular holes
timeFrame: one month to one year after surgery
measure: reattachment of the retina
timeFrame: one month to one year after surgery
Secondary outcomes:
Other outcomes:
Locations:
city: Hangzhou
country: China
facility: Department of Ophthalmology, Affiliated Hangzhou First People's Hospital, Zhejiang University School of Medicine, Hangzhou, China
state: Zhejiang
Study officials:
affiliation: Affiliated Hangzhou First People's Hospital, Zhejiang University School of Medicine, Hangzhou, China
name: Yongping Hu, MD
role: STUDY_CHAIR
References:
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citation: Li M, Tang J, Jia Z, Yao Y, Jin E, Wang Z, Hu J, Sun G, Yin H, Liang J, Li X, Jiang Y, Qu J, Zhao M. Long-term follow-up of primary silicone oil tamponade for retinal detachment secondary to macular hole in highly myopic eyes: a prognostic factor analysis. Eye (Lond). 2021 Feb;35(2):625-631. doi: 10.1038/s41433-020-0922-0. Epub 2020 May 6.
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