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Minimal Vitrectomy and ILM Flap with Sodium Hyaluronate Gel for MH (ILM MH)
The purpose of this clinical trial is to compare the prognostic validity of two different surgical approaches: minimal posterior pole vitrectomy combined with a sodium hyaluronate gel-covered internal limiting membrane(ILM) flap with balanced saline filling and postoperative supine position, versus conventional vitrectomy combined with ILM flap flap coverage with sterile air filling and postoperative prone position. The main question it aims to answer is: Whether patients with macular hole have the same or even better prognosis with minimal posterior pole vitrectomy combined with sodium hyaluronate gel covered flip ILM flap accompanied by balanced salt solution filling accompanied by postoperative supine position than with conventional macular hole surgery. Participants will: The control group undergoes conventional vitrectomy combined with internal limbal flap coverage accompanied by sterile air filling of the vitreous cavity and three days of postoperative surgery in strict supine position. The study group undergoes minimal posterior pole vitrectomy combined with sodium hyaluronate gel-assisted flap of the inner border membrane accompanied by 24 hours of postoperative surgical treatment in a non-strict supine position. Participants of this study come to Sichuan Provincial People's Hospital for follow-up examinations at 1 day, 3 days, 1 week, 1 month, 3 months, and 6 months postoperatively in the 23rd clinic of the Sichuan Provincial People's Hospital for review of visual acuity, intraocular pressure, fundus photography, optical coherence tomography angiography, microfluidic field of view (at 6 months postoperatively), and slit-lamp examination.
Details
| Lead sponsor | Jie Zhong |
|---|---|
| Phase | NA |
| Status | ENROLLING_BY_INVITATION |
| Enrolment | 52 |
| Start date | Fri Nov 01 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| Completion | Wed Jun 30 2027 00:00:00 GMT+0000 (Coordinated Universal Time) |
Conditions
- Macular Hole
- Macular Hole Surgery
- Idiopathic Macular Hole
- Macular Hole of Left Eye (Disorder)
- Macular Hole of Right Eye (Disorder)
Interventions
- minimal posterior pole vitrectomy combined with a sodium hyaluronate gel-covered internal limiting membrane(ILM) flap with balanced saline filling and postoperative supine position
- Conventional vitrectomy combined with inner limiting membrane flap flip coverage with sterile air filling and postoperative prone position
Countries
China