Treating Rhegmatogenous Retinal Detachment by Foldable Capsular Buckle

NCT04571788 | Unknown

• 1 other identifier: AIER2019IRB10
• Study Type: observational
• Target: 150
• Locations: 1 country
• Sites: 1

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.

Conditions

Rhegmatogenous Retinal Detachment; Surgery

Keywords

Rhegmatogenous Retinal Detachment; Foldable Capsular Buckle; Surgery

Outcome Measures

Primary Outcomes (2)

• fundus photography

  The retinal repositioning will be observed and the images will be reviewed by a third-party film review committee for final results.

  12 weeks after surgery

• Optical Coherence Tomography, OCT

  Check to see if the retina is reset.The macula is defined as a central depression within a diameter of 5.5 mm.

  24 weeks after surgery

Study Arms (2)

FCB group

FCB group received FCB implantation

Procedure: Foldable Capsular Buckle

Control group

Control group undergoes silicone scleral pad surgery

Procedure: Silicone scleral padding

Interventions

Foldable Capsular Buckle PROCEDURE

Intraoperatively, the location and size of the fissure hole is located under the microscope to determine the location and extent of the conjunctival incision. Once local infiltration anesthesia is complete, a 2 ml needle is inserted into the outer surface of the sclera \>10 mm behind the corneoscleral rim, and a cotton swab is used to apply light pressure on the side of the wound to help drain the fluid. Under the microscope, the emptied and folded FCB was inserted vertically into the external scleral channel and the drainage valve was sutured with 5.0 non-absorbable sutures 8-10 mm behind the angular scleral rim. The balloon was then filled with 1 ml of alkaline Ringer's solution using a 1 ml syringe through the drainage valve. Subconjunctival injection of tobramycin and dexamethasone was followed by gentle pressure and bandaging of the eye.

FCB group

Silicone scleral padding PROCEDURE

Intraoperatively, the location and size of the fissure is located under the microscope to determine the location and extent of the incision of the bulbar conjunctiva. When the fissure hole is located microscopically, a retrobulbar block anesthesia is performed and fluid is released according to the degree of retinal detachment. Silicone was then implanted on the scleral surface as an external cushion and intraocular pressure was applied, and the opening was finally sutured, with laser closure performed within a week after surgery. After the surgery, subconjunctival injection of tobramycin and dexamethasone was routinely performed, and the operated eye was bandaged, with observation of the fundus and closure of the aperture.

Control group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• 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).

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Aier School of Ophthalmology, Central South University: lead

Study Sites (1)

Aier School of Ophthalmology, Central South University

Changsha, Hunan, China

RECRUITING

Study Officials

• Shibo Tang, Prof

  Aier School of Ophthalmology, Central South University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Qianying Gao, Prof

CONTACT

00-86-020-28687088; technology@vesber.com

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Target Duration: 52 Weeks
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 6, 2020
• First Posted: October 1, 2020
• Study Start: September 1, 2019
• Primary Completion: December 1, 2021
• Study Completion: December 1, 2021
• Last Updated: October 1, 2020

Record last verified: 2020-09

Locations

CN (1)