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Multi-center Clinical Observation of FCVB in Guangdong Province

NCT03908515 · Status: UNKNOWN · Type: OBSERVATIONAL · Enrollment: 100

Last updated 2019-04-16

No results posted yet for this study

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

Interventions

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.

Sponsors & Collaborators

  • Sun Yat-sen University

    lead OTHER

Principal Investigators

  • Xiaofeng Lin, PhD · Zhongshan Ophthalmic Center, Sun Yat-sen University

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-05-01
Primary Completion
2019-05-31
Completion
2020-05-31

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03908515 on ClinicalTrials.gov