high myopia
Conditions
Interventions
Experimental group:Implant test instrument group
Control group:Naturalistic observation
Sponsors
Beijing Tongren Hospital, CMU
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Age 18-75 years, no gender restriction; 2. Refractive error of the target eye between -6.00 D and -30.00 D; 3. Axial length of the target eye 26-36 mm; 4. Height of macular foveal schisis in the target eye 200-1000 µm; 5. Corrected vision of the target eye <=0.3; 6. Able to understand the purpose of the study, voluntarily participate, and sign the informed consent form.
Exclusion criteria
Exclusion criteria: 1. Known allergy to silicone gel, patients with allergic constitution or keloid-prone constitution; 2. Inflammation in both eyes; 3. Retinal hemorrhage in both eyes; 4. Macular holes in both eyes; 5. Corrected vision in the contralateral eye <0.2; 6. Opacities in the refractive media of both eyes; 7. Tumors in both eyes; 8. Patients with hyperthyroidism; 9. Uncontrollable other concomitant ocular diseases such as diabetic retinopathy, hypertensive retinopathy, optic atrophy, etc.; 10. Severe liver and kidney dysfunction and/or severe systemic diseases (such as cardiovascular, respiratory, digestive, nervous, endocrine, genitourinary system diseases, etc., with severity judged based on surgical tolerance); 11. History of intraocular surgery (such as vitrectomy or posterior scleral reinforcement, etc.); 12. Pregnant women (determined by a blood pregnancy test at the first visit), preparing for pregnancy during the trial, or breastfeeding; 13. History of drug abuse or alcoholism; 14. Participation in another drug or medical device clinical trial within 30 days before this clinical trial screening; 15. Any condition that the investigator believes may interfere with the clinical trial (such as susceptibility to mental stress, uncontrollable emotions, depression, poor compliance, etc.).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The proportion of subjects with a reduction of >=50% in foveoschisis height at 52 weeks after implantation (52-week treatment efficacy rate).; | — |
Secondary
| Measure | Time frame |
|---|---|
| Macular splitting stability (macular fovea splitting height increase <<=100µm);best corrected visual acuity;diopter;Axial length; | — |
Countries
China
Contacts
Public ContactWenbing Wei
Beijing Tongren Hospital, affiliated with Capital Medical University
Outcome results
None listed