This study evaluates the surgical outcomes of inverted internal limiting membrane insertion combined with air tamponade in the treatment of macular hole retinal detachment (MHRD) in high myopia, and also to compare the treatment efficacy and safety between different surgical approaches of MHRD
This study uses a new surgical method (vitrectomy combined with inverted internal limiting membrane insertion and intraocular sterilized air tamponade) to assess its effectiveness and safety on the prognosis of macular hole retinal detachment secondary to high myopia, and also compares this new type of surgery with the current commonly used surgery (vitrectomy combined with internal limiting membrane peeling + silicone oil infusion).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
38
the surgical method of standard 3-port 23 gauge pars plana vitrectomy + internal limiting membrane peeling + air-fluid exchange + silicone oil infusion
the surgical method of standard 3-port 23 gauge pars plana vitrectomy + internal limiting membrane peeling + inverted internal limiting membrane insertion + air-fluid exchange
Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine
Shanghai, Shanghai Municipality, China
RECRUITINGMacular hole closure rate
Fundus examination combined with optical coherence tomography (OCT) are performed 3 months after surgery.
Time frame: 3 months after operation
Best corrected visual acuity
Best corrected visual acuity are performed 6 months after the surgery.
Time frame: 6 months after the operation
Best corrected visual acuity
Best corrected visual acuity are performed 12 months after the surgery.
Time frame: 12 months after the operation
Reattachment rate of retinal detachment
Use fundus examination combined with B-scan ultrasound, optical coherence tomography (OCT) to observe the reattachment rate of retinal detachment within 12 months after the surgery.(The reattachment rate assessment is performed 12 months after the first surgery among the patients with air tamponade. The reattachment rate assessment is performed 12 months after the first surgery among the patients with silicone oil tamponade, and the silicone oil removal is performed 6 months after the previous surgery.)
Time frame: 6 months after the operation
Reattachment rate of retinal detachment
Use fundus examination combined with B-scan ultrasound, optical coherence tomography (OCT) to observe the reattachment rate of retinal detachment within 12 months after the surgery.(The reattachment rate assessment is performed 12 months after the first surgery among the patients with air tamponade. The reattachment rate assessment is performed 12 months after the first surgery among the patients with silicone oil tamponade, and the silicone oil removal is performed 6 months after the previous surgery.)
Time frame: 12 months after the operation
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Postoperative complication rate of ocular adverse events
Evaluate the ocular adverse events within 12 months after operation.
Time frame: Within 12 months after operation
Postoperative complication rate of the non ocular adverse events
Evaluate the non ocular adverse events within 12 months after operation.
Time frame: Within 12 months after operation
Postoperative complication rate of severe adverse events
Evaluate the severe adverse events within 12 months after operation.
Time frame: Within 12 months after operation