An observational study in Rhegmatogenous Retinal Detachment and Surgery, sponsored by Aier School of Ophthalmology, Central South University. Status unknown at 1 site in China. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2020-10-01.
Sponsored by Aier School of Ophthalmology, Central South University · Observational
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.
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.
199 studies on the registry are indexed under Retinal Detachment; 29 are open to participants now.
This study's planned enrollment of 150 is above the median of 60 across 58 observational studies indexed under Retinal Detachment.
Browse Retinal Detachment studies →Aier School of Ophthalmology, Central South University is the lead sponsor of 18 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
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).
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
FCB group received FCB implantation
Procedure: Foldable Capsular Buckle
Control group undergoes silicone scleral pad surgery
Procedure: Silicone scleral padding
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.
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.
fundus photography
The retinal repositioning will be observed and the images will be reviewed by a third-party film review committee for final results.
Time frame: 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.
Time frame: 24 weeks after surgery
Started Sep 2019 (actual). Primary completion is estimated for Dec 2021, 27 months after the start.
Of 22 observational studies under Retinal Detachment, half reached primary completion within 33 months of starting (the median), counting those still running; a quarter within 9 and three quarters within 42. This study's planned 27 months is below that.
How these figures are worked out, and which studies are left out of them.
This study is status unknown, as verified in Sep 2020. You cannot join it, but the record below documents what was studied.
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Aier School of Ophthalmology, Central South University