Rhegmatogenous retinal detachment, RRD
Conditions
Interventions
Experimental group:The test group will implant the FCB on the sclera of the study eye corresponding to the hole, press the sclera with normal saline, and close the hole with laser or intraoperative cr
Control group:The control group sutured the silicone sponge to the sclera of the study eye corresponding to the hole to form a pressure ridge to reposition the retina, and used laser or intraoperative
Sponsors
Peking Union Medical College Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: (1) Age 18 to 75 years, male or female; (2) meet the diagnosis criteria of RRD: 1) a single hole or several adjacent holes in one quadrant with a diameter of <2 PD or <3 PD, grade PVR-B and below; 2) oval hole, grade PVR-B and below. (3) be able to understand the purpose of the trial, volunteer to participate and sign the informed consent.
Exclusion criteria
Exclusion criteria: (1) Those who are allergic to silicone gel, patients with keloid constitution; (2) Subjects with active ocular infection in either eye (e.g. uveitis, endophthalmitis, acute conjunctivitis, etc.); (3) Patients with glaucoma; (4) Subjects with the anterior edge of the study eye hole within 11 mm of the limbus; (5) Subjects with vitreous hemorrhage or opacity of refractive media in the study eye (which affects the observation of the fundus, and the fundus photography and OCT examination cannot be performed); (6) Intraocular tumors in the study eye; (7) Patients with hyperthyroidism; (8) Other uncontrolled ocular comorbidities such as diabetic retinopathy, grade III hypertensive retinal bleeding, optic nerve atrophy, etc.; (9) Severe hepatic and renal insufficiency and/or severe systemic diseases (such as cardiovascular system, respiratory system, digestive system, nervous system, endocrine system, urinary and reproductive system diseases, etc., the severity is judged by whether to tolerate surgery); (10) The study eye has a history of vitrectomy, scleral buckle surgery or intraocular lens implantation surgery; (11) Women who are already pregnant (determined by a blood pregnancy test at the first visit), planning to become pregnant during the trial, or are breastfeeding; (12) History of drug abuse or alcoholism; (13) Participated in other drug or medical device clinical trials within 30 days before this clinical trial screening; (14) Any condition that the study doctor believes would interfere with the clinical trial (e.g., subjects prone to mental tension, emotional instability, depression, poor compliance, etc.).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The rate of retinal reattachment at 12 weeks after implantation of the test product; | — |
Countries
China
Contacts
Public ContactWeihong Yu
Peking Union Medical College Hospital
Outcome results
None listed