Retina DetachmentNCT03908515
Multi-center Clinical Observation of FCVB in Guangdong Province
An observational study of Retina Detachment and Eye Injuries, run by Sun Yat-sen University at 1 site in China.
Trial summary
This study provides further theoretical guidance for clinical application of FCVB through observing and collecting various indicators before and after surgical treatment of the FCVB in the real world. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Retina Detachment, Eye Injuries, Eye Atrophy
- What is being tested?
- Foldable Capsular Vitreous Body (FCVB)
- Type of treatment
- Pill or oral medicine, Medical device
- How many people
- 100 participants
- Where
- 1 siteChina
- Study dates
- 1 May 2019to 31 May 2020
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: patients are scheduled for FCVB implantation surgery
Who may be able to join
- Patients with the diagnose that severe retinal detachment and cannot be cured with existing vitreous substitutes, or silicone oil dependent eye accompanied with silicone oil emulsification, or eyeball atrophy meanwhile patients strongly demand keeping eyeball.
- Patients agree to receive FCVB implantation surgery.
Who cannot join
- Patients whose urine pregnancy test are positive.
- Patients whose FCVB have been removed and switched to other alternative treatments.
- Patients whom the investigator consider are not suitable for this clinical trial.
Trial locations and contacts
1 site in 1 country.
China1 site
Zhongshan Ophthalmic Center of Sun yat-sen Universtiy
Guangzhou, Guangdong, 510000
About this study
This study provides further theoretical guidance for clinical application of FCVB through observing and collecting various indicators before and after surgical treatment of the FCVB in the real world.
Read the detailed description
- Research purpose: Collect and analyze the medical data in clinical work, in order to provide further theoretical guidance for the clinical application of FCVB.
- Inclusion criteria: 1) Patients with severe retinal detachment, cannot be cured with existing vitreous substitutes, and are scheduled for FCVB implantation surgery; 2) Patients with silicone oil dependent eye, silicone oil emulsification, and chooses FCVB surgery; 3) Patients whose eyeball Atrophy, and strongly demand eye protection.
- Exclusion criteria: 1) Patients with positive urine pregnancy test; 2) Patients with FCVB removed and switched to other alternative treatments; 3) Patients the investigator consider are not suitable for this clinical trial.
- Endpoint Primary endpoint: Changes in corneal transverse diameter and ocular protrusion after 1 year of FCVB implantation. Secondary endpoints: visual acuity and intraocular pressure; local inflammatory response and complications evaluation; satisfaction investigated by questionnaire survey.
- Process Before surgery, collecting the patient's medical history and pre-operative related specialist examination data and subjective opinions of doctors on surgical indications. Recording the surgical procedure, intraoperative complications. After surgery (3 days, 1 week, 2 weeks, 4 weeks, 3 months, 6 months after surgery, 1 year and 1 year follow-up every year), using visual acuity chart, slit lamp microscope, ophthalmoscope, intraocular pressure, Hertel exophthalmometer, vernier caliper to observe the patient's visual acuity, local inflammatory reaction, intraocular pressure and eyeball atrophy changes.
- Efficacy evaluation Main indicators: the changes of corneal transverse diameter and ocular protrusion were observed 1 year after FCVB implantation. Secondary indicators: visual acuity and intraocular pressure; local inflammatory response and complications evaluation; satisfaction investigated through questionnaire survey.
- Safety evaluation Adverse events that occurred during all studies.
- Termination criteria During the clinical trial, the clinical trial shall be terminated in any of the following cases; (1) FCVB cannot be implanted (2) Subjects who fail to comply with the program requirements (including loss of follow-up) are subject to termination by the study physician; (3) a female patient who is intentionally pregnant or a female subject who has been confirmed to have been pregnant; (4) Participated in other clinical trials after participating in this clinical trial; (5) Adverse events or serious adverse events occurred during the trial and were unable to continue participating in the study; (6) The subject withdraws the informed consent or requests termination of the trial for some objective reason.
- Conditions
- Retina Detachment, Eye Injuries, Eye Atrophy, Silicone Emulsion
- Being tested
- Foldable Capsular Vitreous Body (FCVB)
- Keywords
- Foldable Capsular Vitreous Body, Retina detachment, eye atrophy
- Medical subject headings
- Retinal Detachment, Eye Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Foldable Capsular Vitreous Body (FCVB)Device
FCVB can be regarded as an artificial vitreous and consists of a thin vitreous-shaped capsule, a drain tube, and a valve. After foldable implantation into the eye, then silicone oil is injected into the capsule which inflated to support the retina. The capsular material of FCVB is silicone rubber. The capsule was fabricated a computer simulation of the human and rabbit vitreous cavities. The control of the intraocular pressure is achieved with adjusting the amount of injected medium through the tube-valve system. After the medium was injected into the capsule through the tube-valve system, the valve was subsequently fixed onto the sclera surface similar to the glaucoma valve.
What is being measured
The primary outcome is the main question the study is designed to answer.
Corneal transverse diameter change
Determine the degree of eyeball atrophy through the change of transverse Diameter of the cornea
Measured: Corneal transverse diameter change from 1day before surgery to 1 year after surgery
Ocular protrusion change
Determine the degree of eyeball atrophy through the ocular protrusion change
Measured: Ocular protrusion change from 1day before surgery to 1 year after surgery
Secondary outcomes (4)
Visual acuity
Postoperative visual acuity
Measured: 3 days, 1 week, 2 weeks, 4 weeks, 3 months, 6 months after surgery, 1 year after surgery
Intraocular pressure
Postoperative intraocular pressure
Measured: 3 days, 1 week, 2 weeks, 4 weeks, 3 months, 6 months after surgery, 1 year after surgery
Local inflammatory response
Evaluation of postoperative complications
Measured: 3 days, 1 week, 2 weeks, 4 weeks, 3 months, 6 months after surgery, 1 year after surgery
Patients satisfaction
Postoperative patients satisfaction
Measured: 3 days, 1 week, 2 weeks, 4 weeks, 3 months, 6 months after surgery, 1 year after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Apr 2019
- Study start1 May 2019 (estimated)
- Primary completion31 May 2019 (estimated)
- Study completion31 May 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Retina DetachmentStudies of the same condition, open and under way.
- More trials run by Sun Yat-sen UniversityThe sponsor's other registered studies.
- 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
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sun Yat-sen University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Xiaofeng Lin, Sun Yat-sen University
- Investigators
- Xiaofeng Lin, PhD, Study chair, Zhongshan Ophthalmic Center, Sun Yat-sen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03908515
- Sponsor's protocol ID
- FCVB 2019
- Status last verified
- Apr 2019
- First submitted
- 5 Apr 2019
- Last updated
- 16 Apr 2019
- Results posted
- No
- 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 16 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multi-center Clinical Observation of FCVB in Guangdong Province
- ClinicalTrials.gov ID
- NCT03908515
- Acronym / sponsor ID
- FCVB 2019
- Conditions
- Retina Detachment, Eye Injuries, Eye Atrophy, Silicone Emulsion
- Keywords
- Foldable Capsular Vitreous Body, Retina detachment, eye atrophy
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Sun Yat-sen UniversityUniversity, hospital or other
- Study start
- 1 May 2019 (estimated)
- Primary completion
- 31 May 2019 (estimated)
- Study completion
- 31 May 2020 (estimated)
- First posted
- 9 Apr 2019 (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.
This study provides further theoretical guidance for clinical application of FCVB through observing and collecting various indicators before and after surgical treatment of the FCVB in the real world.
Detailed description
- Research purpose: Collect and analyze the medical data in clinical work, in order to provide further theoretical guidance for the clinical application of FCVB.
- Inclusion criteria: 1) Patients with severe retinal detachment, cannot be cured with existing vitreous substitutes, and are scheduled for FCVB implantation surgery; 2) Patients with silicone oil dependent eye, silicone oil emulsification, and chooses FCVB surgery; 3) Patients whose eyeball Atrophy, and strongly demand eye protection.
- Exclusion criteria: 1) Patients with positive urine pregnancy test; 2) Patients with FCVB removed and switched to other alternative treatments; 3) Patients the investigator consider are not suitable for this clinical trial.
- Endpoint Primary endpoint: Changes in corneal transverse diameter and ocular protrusion after 1 year of FCVB implantation. Secondary endpoints: visual acuity and intraocular pressure; local inflammatory response and complications evaluation; satisfaction investigated by questionnaire survey.
- Process Before surgery, collecting the patient's medical history and pre-operative related specialist examination data and subjective opinions of doctors on surgical indications. Recording the surgical procedure, intraoperative complications. After surgery (3 days, 1 week, 2 weeks, 4 weeks, 3 months, 6 months after surgery, 1 year and 1 year follow-up every year), using visual acuity chart, slit lamp microscope, ophthalmoscope, intraocular pressure, Hertel exophthalmometer, vernier caliper to observe the patient's visual acuity, local inflammatory reaction, intraocular pressure and eyeball atrophy changes.
- Efficacy evaluation Main indicators: the changes of corneal transverse diameter and ocular protrusion were observed 1 year after FCVB implantation. Secondary indicators: visual acuity and intraocular pressure; local inflammatory response and complications evaluation; satisfaction investigated through questionnaire survey.
- Safety evaluation Adverse events that occurred during all studies.
- Termination criteria During the clinical trial, the clinical trial shall be terminated in any of the following cases; (1) FCVB cannot be implanted (2) Subjects who fail to comply with the program requirements (including loss of follow-up) are subject to termination by the study physician; (3) a female patient who is intentionally pregnant or a female subject who has been confirmed to have been pregnant; (4) Participated in other clinical trials after participating in this clinical trial; (5) Adverse events or serious adverse events occurred during the trial and were unable to continue participating in the study; (6) The subject withdraws the informed consent or requests termination of the trial for some objective reason.
Study design
- Observational model
- Other
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- patients are scheduled for FCVB implantation surgery
Key inclusion criteria (2 listed)
- Patients with the diagnose that severe retinal detachment and cannot be cured with existing vitreous substitutes, or silicone oil dependent eye accompanied with silicone oil emulsification, or eyeball atrophy meanwhile patients strongly demand keeping eyeball.
- Patients agree to receive FCVB implantation surgery.
Key exclusion criteria (3 listed)
- Patients whose urine pregnancy test are positive.
- Patients whose FCVB have been removed and switched to other alternative treatments.
- Patients whom the investigator consider are not suitable for this clinical trial.
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 Vitreous Body (FCVB)FCVB can be regarded as an artificial vitreous and consists of a thin vitreous-shaped capsule, a drain tube, and a valve. After foldable implantation into the eye, then silicone oil is injected into the capsule which inflated to support the retina. The capsular material of FCVB is silicone rubber. The capsule was fabricated a computer simulation of the human and rabbit vitreous cavities. The control of the intraocular pressure is achieved with adjusting the amount of injected medium through the tube-valve system. After the medium was injected into the capsule through the tube-valve system, the valve was subsequently fixed onto the sclera surface similar to the glaucoma valve. | Device | – |
Primary outcome
Corneal transverse diameter change
Time frame: Corneal transverse diameter change from 1day before surgery to 1 year after surgery
Determine the degree of eyeball atrophy through the change of transverse Diameter of the cornea
Ocular protrusion change
Time frame: Ocular protrusion change from 1day before surgery to 1 year after surgery
Determine the degree of eyeball atrophy through the ocular protrusion change
4 secondary outcomes
Visual acuity
Time frame: 3 days, 1 week, 2 weeks, 4 weeks, 3 months, 6 months after surgery, 1 year after surgery
Intraocular pressure
Time frame: 3 days, 1 week, 2 weeks, 4 weeks, 3 months, 6 months after surgery, 1 year after surgery
Local inflammatory response
Time frame: 3 days, 1 week, 2 weeks, 4 weeks, 3 months, 6 months after surgery, 1 year after surgery
Patients satisfaction
Time frame: 3 days, 1 week, 2 weeks, 4 weeks, 3 months, 6 months after surgery, 1 year after surgery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Apr 2019.
- 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. This study is not recruiting at the moment.
Xiaofeng Lin, PhD study chair
Zhongshan Ophthalmic Center, Sun Yat-sen 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 Retina Detachment and Eye Injuries, run by Sun Yat-sen 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 2 inclusion and 3 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 16 Apr 2019. 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 Xiaofeng Lin, PhD (02087330000, linxiaof@mail.sysu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Corneal transverse diameter change (time frame: Corneal transverse diameter change from 1day before surgery to 1 year 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 16 Apr 2019.