Multi-center Clinical Observation of FCVB in Guangdong Province

Eye Injuries Clinical Trial

Official title:

Multi-center Clinical Observation of FCVB in Guangdong Province

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03908515
• Other study ID #: FCVB 2019
• Status: Not yet recruiting
• Start date: May 1, 2019
• Est. completion date: May 31, 2020

Study information

• Verified date: April 2019
• Source: Sun Yat-sen University
• Contact: Xiaofeng Lin, PhD
• Phone: 02087330000
• Email: linxiaof[@]mail.sysu.edu.cn
• Is FDA regulated: No
• Study type: Observational

Clinical 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.

Description:

1. Research purpose: Collect and analyze the medical data in clinical work, in order to provide further theoretical guidance for the clinical application of FCVB.

2. 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.

3. 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.

4. 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.

5. 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.

6. 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.

7. Safety evaluation Adverse events that occurred during all studies.

8. 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 100
• Est. completion date: May 31, 2020
• Est. primary completion date: May 31, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. 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.

2. Patients agree to receive FCVB implantation surgery.

Exclusion Criteria:

1. Patients whose urine pregnancy test are positive.

2. Patients whose FCVB have been removed and switched to other alternative treatments.

3. Patients whom the investigator consider are not suitable for this clinical trial.

Related Conditions & MeSH terms

• Atrophy
• Eye Atrophy
• Eye Injuries
• Retina Detachment
• Retinal Detachment
• Silicone Emulsion

Intervention

Device:
• 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.

Locations

Country	Name	City	State
China	Zhongshan Ophthalmic Center of Sun yat-sen Universtiy	Guangzhou	Guangdong

Sponsors (1)

Lead Sponsor	Collaborator
Sun Yat-sen University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Corneal transverse diameter change	Determine the degree of eyeball atrophy through the change of transverse Diameter of the cornea	Corneal transverse diameter change from 1day before surgery to 1 year after surgery
Primary	Ocular protrusion change	Determine the degree of eyeball atrophy through the ocular protrusion change	Ocular protrusion change from 1day before surgery to 1 year after surgery
Secondary	Visual acuity	Postoperative visual acuity	3 days, 1 week, 2 weeks, 4 weeks, 3 months, 6 months after surgery, 1 year after surgery
Secondary	Intraocular pressure	Postoperative intraocular pressure	3 days, 1 week, 2 weeks, 4 weeks, 3 months, 6 months after surgery, 1 year after surgery
Secondary	Local inflammatory response	Evaluation of postoperative complications	3 days, 1 week, 2 weeks, 4 weeks, 3 months, 6 months after surgery, 1 year after surgery
Secondary	Patients satisfaction	Postoperative patients satisfaction	3 days, 1 week, 2 weeks, 4 weeks, 3 months, 6 months after surgery, 1 year after surgery