Rhegmatogenous Retinal DetachmentNCT04571788
Treating Rhegmatogenous Retinal Detachment by Foldable Capsular Buckle
An observational study of Rhegmatogenous Retinal Detachment and Surgery, run by Aier School of Ophthalmology, Central South University at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Rhegmatogenous Retinal Detachment, Surgery
- What is being tested?
- Foldable Capsular Buckle and Silicone scleral padding
- Type of treatment
- Injection or infusion, Surgery or procedure
- How many people
- 150 participants
- Where
- 1 siteChina
- Study dates
- 1 Sep 2019to 1 Dec 2021
- How long will I take part?
- 52 Weeks
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Adult, Older adult
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).
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Aier School of Ophthalmology, Central South University
Changsha, Hunan
Shibo Tang, Prof, 00-86-0755-23809666, tangshibo@vip.163.com
About this study
Official title: Treating Rhegmatogenous Retinal Detachment by Foldable Capsular Buckle (FCB): a Randomized, Controlled, Single-blind and Multicenter Study
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.
Read the 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.
- Conditions
- Rhegmatogenous Retinal Detachment, Surgery
- Being tested
- Foldable Capsular Buckle, Silicone scleral padding
- Keywords
- Rhegmatogenous Retinal Detachment, Foldable Capsular Buckle, Surgery
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Foldable Capsular BuckleProcedure or surgery
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 paddingProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| FCB group | FCB group received FCB implantation Receives: Procedure: Foldable Capsular Buckle | |
| Control group | Control group undergoes silicone scleral pad surgery Receives: Procedure: Silicone scleral padding |
What is being measured
The primary outcome is the main question the study is designed to answer.
fundus photography
The retinal repositioning will be observed and the images will be reviewed by a third-party film review committee for final results.
Measured: 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.
Measured: 24 weeks after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Oct 2020
- Study start1 Sep 2019
- Primary completion1 Dec 2021 (estimated)
- Study completion1 Dec 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Rhegmatogenous Retinal DetachmentStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 150 participants (estimated)
- Target duration
- 52 Weeks
Sponsor and investigators
- Lead sponsor
- Aier School of Ophthalmology, Central South University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Shibo Tang, Prof, Principal investigator, Aier School of Ophthalmology, Central South University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04571788
- Sponsor's protocol ID
- AIER2019IRB10
- Status last verified
- Sep 2020
- First submitted
- 6 Sep 2020
- Last updated
- 1 Oct 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Treating Rhegmatogenous Retinal Detachment by Foldable Capsular Buckle (FCB): a Randomized, Controlled, Single-blind and Multicenter Study
- ClinicalTrials.gov ID
- NCT04571788
- Acronym / sponsor ID
- AIER2019IRB10
- Conditions
- Rhegmatogenous Retinal Detachment, Surgery
- Keywords
- Rhegmatogenous Retinal Detachment, Foldable Capsular Buckle, Surgery
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Aier School of Ophthalmology, Central South UniversityUniversity, hospital or other
- Study start
- 1 Sep 2019 (actual)
- Primary completion
- 1 Dec 2021 (estimated)
- Study completion
- 1 Dec 2021 (estimated)
- First posted
- 1 Oct 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Target follow-up
- 52 Weeks
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| FCB group | – | Procedure: Foldable Capsular BuckleFCB group received FCB implantation |
| Control group | – | Procedure: Silicone scleral paddingControl group undergoes silicone scleral pad surgery |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Age groups
- Adult, Older adult
- 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).
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (13 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Foldable Capsular BuckleIntraoperatively, 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. | Procedure or surgery | FCB group |
| Silicone scleral paddingIntraoperatively, 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. | Procedure or surgery | Control group |
Primary outcome
fundus photography
Time frame: 12 weeks after surgery
The retinal repositioning will be observed and the images will be reviewed by a third-party film review committee for final results.
Optical Coherence Tomography, OCT
Time frame: 24 weeks after surgery
Check to see if the retina is reset.The macula is defined as a central depression within a diameter of 5.5 mm.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Oct 2020.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Shibo Tang, Prof principal investigator
Aier School of Ophthalmology, Central South University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Rhegmatogenous Retinal Detachment and Surgery, run by Aier School of Ophthalmology, Central South University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 1 Oct 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Qianying Gao, Prof (00-86-020-28687088, technology@vesber.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
fundus photography (time frame: 12 weeks after surgery). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Oct 2020.