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Completed

NCT Number: NCT03390244

Foldable Capsular Vitreous Body Implantation Study

This study is intended to evaluate the clinical usefulness of the FCVB in its on-label use, but in a different racial type than studies till now (Asians only). The device will be inserted in Caucasian patients with permanent loss of functional vision (visual acuity hand movements or less), where a permanent use of repeat silicone oil is required to maintain the eye pressure.

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Key information

Conditions

Vitreoretinal Surgery

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University Hospitals Leuven (UZLeuven)

Leuven, Vl-Brabant, B3000, Belgium

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patients aged over 18
  • Axial length between 16 and 28 mm (according the guidelines from the manufacturer)
  • Loss of functional vision in study eye
  • Visual acuity of 0.4 or better in fellow eye
  • Requirement of (repeated) long-term silicone oil tamponade to maintain eye pressure and keep the retina attached

Exclusion criteria

  • Visual acuity beyond 0.4 in non-study eye
  • Severe general disease that is evaluated to impact live expectancy beyond the duration of the study follow-up (3 years)
  • Retinal detachment under silicone oil fill
  • Patients with a silica gel allergy or scar diathesis
  • Patients with serious heart, lung, liver, or kidney dysfunction
  • Patients with proliferative diabetic retinopathy, endophthalmia, uveitis and other uncontrollable eye diseases, or a contralateral eye that had intraocular retinal surgery
  • Patients with history of drug abuse or alcoholism
  • Patients are had participating in other drug or medical device clinical trials before screening for this trial
  • Pregnancy, preparation for pregnancy during clinical trial, or breast-feeding
  • Belief by any of the research doctors that a patient's condition would hinder the clinical trial, such as a patient prone to mental stress, loss of control of mood, or depression

Treatment and study plan

Foldable Capsular Vitreous Body Implant

Device

Vitrectomy augmented with the implantation of the FCVB implant

Primary outcomes

  1. Intra-ocular pressure

    Time frame: 3 years

    Evaluation of the device as long-term solution for maintenance the intra-ocular pressure, potentially reducing the number of surgeries (silicone oil exchanges) for the patient

Sponsors and collaborators

Lead sponsor

Universitaire Ziekenhuizen KU Leuven

Other

Registry information

Acronym: FCVB

Important dates

Study start
2017
Primary completion
2020
Study completion
2020
First posted
Jan 4, 2018
Registry last updated
Aug 18, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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