An interventional study of corneal flap transplantation in Retinal Perforations and Myopia, Degenerative, sponsored by First People's Hospital of Hangzhou. Active, not recruiting at 1 site in China. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2023-05-25.
Sponsored by First People's Hospital of Hangzhou · Not applicable, Interventional, and Treatment
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:
Participants will:
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.
139 studies on the registry are indexed under Retinal Perforations; 22 are open to participants now.
This study's planned enrollment of 30 is below the median of 50 across 94 interventional studies indexed under Retinal Perforations.
Browse Retinal Perforations studies →First People's Hospital of Hangzhou is the lead sponsor of 73 studies on the registry; 28 are open to participants now.
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Exclusion Criteria:
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.
best-corrected visual acuity
the best-corrected visual acuity of the patients after surgery
Time frame: one month to one year after surgery
complications
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
Time frame: one month to one year after surgery
closure of the macular holes
closure of the macular holes observed using optical coherence tomography
Time frame: one month to one year after surgery
reattachment of the retina
reattachment of the retina observed using optical coherence tomography
Time frame: one month to one year after surgery
Plan to share: No — The data will be used as part of other studies.
This study is active, not recruiting, as verified in Apr 2023. You cannot join it, but the record below documents what was studied.
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First People's Hospital of Hangzhou