The purpose of this study is to assess the primary safety and efficacy of High Myopic Posterior Scleral Fixation System in the treatment of macular schisis caused by high myopia.
Posterior Scleral Reinforcement(PSR) is the only surgical method that can delay the the development of high myopia. However, The surgical method is restricted by the material source limitation and macular ischemia in the eye after reinforcement. The investigators have designed a new posterior scleral fixation system,Its basic material is medical silicone,The product is designed to solve the problem of material source limitation and macular ischemia in the eye after reinforcement.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
20
Implant HM into the eye through posterior scleral reinforcement
The First Affiliated Hospital of Guangzhou University of traditional Chinese Medicine
Guangzhou, Guangdong, China
RECRUITINGMacular reduction rate
24 weeks after implantation of the High Myopic Posterior Scleral Fixation System
Time frame: 24 weeks
Best corrected visual acuity
ETDRS table
Time frame: Baseline (Before surgery), 1 day, 1 week, 4 weeks, 12 weeks, 24 weeks,
Axial length
A-scan
Time frame: Baseline (Before surgery), 24 weeks after surgery
Diopter
Refractometer
Time frame: Baseline (Before surgery), 24 weeks after surgery
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