Rhegmatogenous Retinal DetachmentFCSBNCT06610786
Foldable Capsular Scleral Buckling Versus Vitrectomy in Medium-complex Rhegmatogenous Retinal Detachment Treatment
A study testing foldable capsular scleral buckling and vitrectomy in people with Rhegmatogenous Retinal Detachment, run by Eye & ENT Hospital of Fudan University at 1 site in China.
Trial summary
The objective of the study is to evaluate: 1. Safety and efficacy of a novel foldable capsular scleral buckle (FCSB) in scleral buckling for primary rhegmatogenous retinal detachment (RRD) of medium complexity. 2. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Rhegmatogenous Retinal Detachment
- What is being tested?
- foldable capsular scleral buckling and vitrectomy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteChina
- Study dates
- 1 Dec 2024to 1 Dec 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- One or more retinal holes which cannot be treated sufficiently with a single silicon sponge or silicone band (e.g. large holes, multiple holes, multiple holes of varying anterior-posterior localisation, massive traction)
Who cannot join
- simple rhegmatogenous retinal detachment which can be treated with a single silicon sponge or silicone band (e.g. single holes, no traction, limit retinal detachment)
- Complicated RRD, including macular hole within the arcade, PVR C or D, severe cataract, severe vitreous hemorrhage, unclear macular hole,
- Combined with other eye diseases that affect vision prognosis.
- History of other eye surgeries including cataract surgery.
- Presence of systemic diseases that may affect postoperative observation and follow-up.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site
EyeEntFudan
Shanghai, Shanghai Municipality, 200031
Zhongcui Sun, PhD, +8621-64377134-2501, zhongcui.sun@aliyun.com
ruiping Gu, phD, +8621-64377134-2501, pingruigu@126.com
About this study
Official title: The Use of FCSB in Medium-complex RRD - a Safety and Efficacy Evaluation
The objective of the study is to evaluate:
- Safety and efficacy of a novel foldable capsular scleral buckle (FCSB) in scleral buckling for primary rhegmatogenous retinal detachment (RRD) of medium complexity.
- Comparison between FCSB and pars plana vitrectomy in therapeutic effects and complications in the treatment of primary RRD of medium complexity.
Read the detailed description
Pars plana vitrectomy (PPV) and scleral buckling (SB) are major choices in treating rhegmatogenous retinal detachment (RRD) of medium complexity. PPV is more prevailed since it improved internal search for breaks and elimination of vitreous traction. SB has unmatched advantages over PPV such as earlier rehabilitation, free from prolonged positioning, less complicated cataract or glaucoma. The novel foldable capsular scleral buckle (FCSB) can create a big bulge by pressing on the sclera and seal the break in bullous RRD without scleral drainage. In the study, differences of anatomic and functional results between PPV and FCSB in treating primary RRD of medium complexity are evaluated.
- Conditions
- Rhegmatogenous Retinal Detachment
- Being tested
- foldable capsular scleral buckling, vitrectomy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
foldable capsular scleral bucklingProcedure or surgery
Using foldable capsular vitreous body as a novel scleral buckle material to treat the primary rhegmatogenous retinal detachment (RRD) of medium complexity
vitrectomyProcedure or surgery
Using vitrectomy to treat primary rhegmatogenous retinal detachment (RRD) of medium complexity.
| Study group | Role | What they receive |
|---|---|---|
| FCSB | Experimental | Using foldable capsular scleral buckle surgery to treat primary rhegmatogenous retinal detachment (RRD) of medium complexity Receives: Procedure: foldable capsular scleral buckling |
| PPV | Active comparator | Using pars plana vitrectomy to treat primary rhegmatogenous retinal detachment (RRD) of medium complexity Receives: Procedure: vitrectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
anatomic success rate
The success rate of retinal reattachment
Measured: From enrollment to the end of treatment at 6 months
metamorphopsia
metamorphopsia is measured by M chart
Measured: From enrollment to the end of treatment at 6 months
Visual Results
Best-Corrected Visual Acuity, and is measured by Snellen Chart, EDTRS Chart and charts designed for people with low vision
Measured: From enrollment to the end of treatment at 6 months
Secondary outcomes (2)
The number of surgeries that achieved successful final retinal reattachment
The number of surgeries the patient undergoes to achieve final retinal reattachment
Measured: From enrollment to the end of treatment at 6 months
Surgical Complications
Surgical Complications, included EOM dysfunction，Choroidal detachment，Clinical CME，Macular pucker，Postoperative IOP \>21 mmHg with medications
Measured: From enrollment to the end of treatment at 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Sep 2024
- Study start1 Dec 2024 (estimated)
- Primary completion1 Dec 2025 (estimated)
- Study completion1 Dec 2029 (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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Eye & ENT Hospital of Fudan University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06610786
- Sponsor's protocol ID
- FCSB
- Acronym
- FCSB
- Status last verified
- Sep 2024
- First submitted
- 11 Sep 2024
- Last updated
- 24 Sep 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Use of FCSB in Medium-complex RRD - a Safety and Efficacy Evaluation
- ClinicalTrials.gov ID
- NCT06610786
- Acronym / sponsor ID
- FCSB / FCSB
- Conditions
- Rhegmatogenous Retinal Detachment
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Eye & ENT Hospital of Fudan UniversityUniversity, hospital or other
- Study start
- 1 Dec 2024 (estimated)
- Primary completion
- 1 Dec 2025 (estimated)
- Study completion
- 1 Dec 2029 (estimated)
- First posted
- 24 Sep 2024 (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.
The objective of the study is to evaluate:
- Safety and efficacy of a novel foldable capsular scleral buckle (FCSB) in scleral buckling for primary rhegmatogenous retinal detachment (RRD) of medium complexity.
- Comparison between FCSB and pars plana vitrectomy in therapeutic effects and complications in the treatment of primary RRD of medium complexity.
Detailed description
Pars plana vitrectomy (PPV) and scleral buckling (SB) are major choices in treating rhegmatogenous retinal detachment (RRD) of medium complexity. PPV is more prevailed since it improved internal search for breaks and elimination of vitreous traction. SB has unmatched advantages over PPV such as earlier rehabilitation, free from prolonged positioning, less complicated cataract or glaucoma. The novel foldable capsular scleral buckle (FCSB) can create a big bulge by pressing on the sclera and seal the break in bullous RRD without scleral drainage. In the study, differences of anatomic and functional results between PPV and FCSB in treating primary RRD of medium complexity are evaluated.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| FCSB | Experimental | Procedure: foldable capsular scleral bucklingUsing foldable capsular scleral buckle surgery to treat primary rhegmatogenous retinal detachment (RRD) of medium complexity |
| PPV | Active comparator | Procedure: vitrectomyUsing pars plana vitrectomy to treat primary rhegmatogenous retinal detachment (RRD) of medium complexity |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- One or more retinal holes which cannot be treated sufficiently with a single silicon sponge or silicone band (e.g. large holes, multiple holes, multiple holes of varying anterior-posterior localisation, massive traction)
Key exclusion criteria (5 listed)
- simple rhegmatogenous retinal detachment which can be treated with a single silicon sponge or silicone band (e.g. single holes, no traction, limit retinal detachment)
- Complicated RRD, including macular hole within the arcade, PVR C or D, severe cataract, severe vitreous hemorrhage, unclear macular hole,
- Combined with other eye diseases that affect vision prognosis.
- History of other eye surgeries including cataract surgery.
- Presence of systemic diseases that may affect postoperative observation and follow-up.
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 scleral bucklingUsing foldable capsular vitreous body as a novel scleral buckle material to treat the primary rhegmatogenous retinal detachment (RRD) of medium complexity | Procedure or surgery | FCSB |
| vitrectomyUsing vitrectomy to treat primary rhegmatogenous retinal detachment (RRD) of medium complexity. | Procedure or surgery | PPV |
Primary outcome
anatomic success rate
Time frame: From enrollment to the end of treatment at 6 months
The success rate of retinal reattachment
metamorphopsia
Time frame: From enrollment to the end of treatment at 6 months
metamorphopsia is measured by M chart
Visual Results
Time frame: From enrollment to the end of treatment at 6 months
Best-Corrected Visual Acuity, and is measured by Snellen Chart, EDTRS Chart and charts designed for people with low vision
2 secondary outcomes
The number of surgeries that achieved successful final retinal reattachment
Time frame: From enrollment to the end of treatment at 6 months
Surgical Complications
Time frame: From enrollment to the end of treatment at 6 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Sep 2024.
- Individual participant dataSharing planned: No
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing foldable capsular scleral buckling and vitrectomy in people with Rhegmatogenous Retinal Detachment, run by Eye & ENT Hospital of Fudan 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 1 inclusion and 5 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: opening soon, as of the sponsor's last update on 24 Sep 2024. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
anatomic success rate (time frame: From enrollment to the end of treatment at 6 months). The study lists 3 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 24 Sep 2024.