Treating Rhegmatogenous Retinal Detachment by Foldable Capsular Buckle
NCT ID: NCT04571788
Last Updated: 2020-10-01
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
UNKNOWN
150 participants
OBSERVATIONAL
2019-09-01
2021-12-01
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Foldable Capsular Scleral Buckling Versus Vitrectomy in Medium-complex Rhegmatogenous Retinal Detachment Treatment
NCT06610786
Suprachoroidal Buckling for the Management of Rhegmatogenous Retinal Detachment
NCT04518696
Flexibility, Efficacy, and Safety of a Foldable Capsular Vitreous Body in the Treatment of Severe Retinal Detachment
NCT01261533
The Exploratory Clinical Trials for the Feasibility, Primary Safety and Efficacy of Foldable Capsular Vitreous Body
NCT00910702
Internal Limiting Membrane Peeling on Retinal Displacement
NCT04655781
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
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.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
OTHER
PROSPECTIVE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
FCB group
FCB group received FCB implantation
Foldable Capsular Buckle
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.
Control group
Control group undergoes silicone scleral pad surgery
Silicone scleral padding
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.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Foldable Capsular Buckle
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.
Silicone scleral padding
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.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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
* 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.
18 Years
65 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Aier School of Ophthalmology, Central South University
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Shibo Tang, Prof
Role: PRINCIPAL_INVESTIGATOR
Aier School of Ophthalmology, Central South University
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Aier School of Ophthalmology, Central South University
Changsha, Hunan, China
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
AIER2019IRB10
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.