Multi-center Clinical Observation of FCVB in Guangdong Province

NCT03908515 | Unknown

• 1 other identifier: FCVB 2019
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Retina Detachment; Eye Injuries; Eye Atrophy; Silicone Emulsion

Keywords

Foldable Capsular Vitreous Body; Retina detachment; eye atrophy

Outcome Measures

Primary Outcomes (2)

• 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

• 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 Outcomes (4)

• Visual acuity

  3 days, 1 week, 2 weeks, 4 weeks, 3 months, 6 months after surgery, 1 year after surgery

• Intraocular pressure

  3 days, 1 week, 2 weeks, 4 weeks, 3 months, 6 months after surgery, 1 year after surgery

• Local inflammatory response

  3 days, 1 week, 2 weeks, 4 weeks, 3 months, 6 months after surgery, 1 year after surgery

• Patients satisfaction

  3 days, 1 week, 2 weeks, 4 weeks, 3 months, 6 months after surgery, 1 year after surgery

Interventions

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.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

patients are scheduled for FCVB implantation surgery

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Sun Yat-sen University: lead

Study Sites (1)

Zhongshan Ophthalmic Center of Sun yat-sen Universtiy

Guangzhou, Guangdong, 510000, China

Location

MeSH Terms

Conditions

Retinal Detachment; Eye Injuries

Condition Hierarchy (Ancestors)

Retinal Diseases; Eye Diseases; Facial Injuries; Craniocerebral Trauma; Trauma, Nervous System; Nervous System Diseases; Wounds and Injuries

Study Officials

• Xiaofeng Lin, PhD

  Zhongshan Ophthalmic Center, Sun Yat-sen University

  STUDY CHAIR

Central Study Contacts

Xiaofeng Lin, PhD

CONTACT

02087330000; linxiaof@mail.sysu.edu.cn

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: associate dean of Zhongshan Ophthalmic Center, Sun Yat-sen University

Study Record Dates

• First Submitted: April 5, 2019
• First Posted: April 9, 2019
• Study Start: May 1, 2019
• Primary Completion: May 31, 2019
• Study Completion: May 31, 2020
• Last Updated: April 16, 2019

Record last verified: 2019-04

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)