Clinical trial NCT04571788: Treating Rhegmatogenous Retinal Detachment by Foldable Capsular Buckle
Official title: Treating Rhegmatogenous Retinal Detachment by Foldable Capsular Buckle (FCB): a Randomized, Controlled, Single-blind and Multicenter Study
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Rhegmatogenous Retinal Detachment
Surgery
Keywords: Rhegmatogenous Retinal Detachment
Foldable Capsular Buckle
Surgery
Lead sponsor: Aier School of Ophthalmology, Central South University
Sponsor class: OTHER
First posted: 2020-10-01
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients who meet the diagnostic criteria for RRD (single fissure in one quadrant of \<2 PD or adjacent multiple fissures of \<3 PD, below PVR-B grade).

Brief summary: To evaluate the efﬁcacy and safety of treating rhegmatogenous retinal detachment (RRD) using foldable capsular buckle (FCB). It is a multi-center clinical ,randomized, controlled, and single-blind clinical study.

Detailed description: The purpose of this study is to compare the safety, effectiveness, and operability of FCB scleral buckling and silicone scleral buckling in the treatment of RRD. It is a multi-center clinical study and is designed according to a randomized, controlled, and single-blind clinical research protocol. Before surgery, the retinal tear in the FCB group and the control group of RRD patients should be examined and precise positioned by fundus photography, and the relevant results will be determined by the third-party reading center to confirm that the patients can accept such surgery.

The key instrument required by the FCB group is FCB. During FCB implantation, 1 ml of basic Ringer's solution will be injected as FCB, and then the balloon filled, so that the outer surface of the balloon is in close contact with the sclera, and the top The function of scleral compression helps to close the hiatus. The key surgical instrument used in the control group is silicone, but it does not require ring surgery. Silicone is also fixed to the outer surface of the sclera. After the conjunctiva and Tenon 's sac separated, the primary endpoint will be evaluated three months after surgery, and both groups will be followed up to one year after surgery. Relevant data will be collected and kept by full-time personnel, and then the statistical analysis of the data will be used to evaluate the safety, effectiveness, and operability of FCB implantation, and compare the treatment effect with the control group.

Eligibility criteria: Inclusion Criteria:

* 18-65 years of age, regardless of gender.
* The axial length of the operative eye ≤26 mm (myopia \<600 degrees).
* Meet diagnostic criteria for RRD (a single lacuna of \<2 PD in one quadrant or multiple adjacent lacunae of \<3 PD, up to PVR-B grade).
* Be able to understand the purpose of the study, participate voluntarily and sign an informed consent form.

Exclusion Criteria:

* Patients with known allergies to silicone, scarred bodies.
* Intraocular inflammation.
* PVR-C and above.
* Cracked hole with crimped edges, with pulling.
* Obvious vitreous pulling and retinal fixation folds.
* the lacunae are large or scattered and the scleral ridge formed by the estimated FCB does not fully encompass the lacunae.
* Other associated ophthalmic diseases beyond control, such as glaucoma, tertiary nuclear cataracts and macular diseases.
* Severe hepatic and renal impairment and/or severe systemic diseases (e.g. cardiovascular, respiratory, digestive, neurological, endocrine, genitourinary, etc.).
* Females who are already pregnant (determined by urine pregnancy study at the first visit), who are preparing for pregnancy during the study and who are lactating.
* History of substance abuse or alcoholism.
* Have participated in another clinical study of a drug or medical device within 30 days prior to the screening of this clinical study.
* Any condition of the patient that the research doctor believes would hinder clinical research (e.g. the patient is prone to stress, uncontrolled emotions, depression, etc.).
* Those who do not agree to be selected or do not agree to be followed up.

Primary outcomes:
measure: fundus photography
timeFrame: 12 weeks after surgery
measure: Optical Coherence Tomography, OCT
timeFrame: 24 weeks after surgery
Secondary outcomes:
Other outcomes:
Locations:
city: Changsha
country: China
facility: Aier School of Ophthalmology, Central South University
state: Hunan
Study officials:
affiliation: Aier School of Ophthalmology, Central South University
name: Shibo Tang, Prof
role: PRINCIPAL_INVESTIGATOR
References: