VividFlo System Validation Study

ConditionGlaucoma

Trial statusNot yet recruiting

Trial phaseNot applicable

Trial typeInterventional

Biological sexAll

Age18+

SponsorVividWhite Pty Ltd

About this trial

This is a 10-participant study to assess the VividFlo System and surgical implantation using a modified technique.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Be 18 years of age or older.

Be able to understand all study instructions, and willing to comply with all study procedures and the visit schedule.

Provide written, informed consent to participate.

Diagnosed by the investigator, based upon untreated intraocular pressure, disc appearance and visual field abnormalities.

Disqualifiers

Advanced glaucomatous optic neuropathy that threatens fixation, in the opinion of the investigator.

Acute Angle Closure Glaucoma (AACG).

Chronic Angle Closure Glaucoma (CACG) where the eye is phakic.

Congenital glaucoma. Juvenile Open-Angle Glaucoma or Congenital Glaucoma.

Trial design

Design model

Single group

Treatments tested in this trial

VividFlo System
Device
Subconjunctival surgical implantation of the VividFlo Glaucoma Implant (VW-51) in one eye using the VividFlo System and a partial-thickness scleral flap technique.

Treatment groups

10 Participants

are divided into 1 treatment group

Group A: VividFlo SystemExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

Primary Outcome

The proportion of study eyes that meet all the following criteria: 1. Mean diurnal IOP at 12 months is: \<=21 mmHg; and \>=6 mmHg; and reduced by \>=20% compared to baseline. 2. The number of topical IOP-lowering medications at 12 months is the same or fewer than at baseline. 3. At any time during the study, there has been no requirement for: further glaucoma surgery (indicated for efficacy or safety); or systemic/oral IOP-lowering medication for treatment of elevated IOP in the study eye. 4. There have been no adverse events of special significance, defined as: conjunctival erosion; loss of light perception or reduction in best-corrected visual acuity equivalent to doubling of minimum angle of resolution; \>=20% reduction in mean retinal nerve fibre layer attributed to glaucoma; \>=20% reduction in central corneal endothelial cell density attributed to the implant; or Uveitis, Glaucoma and Hyphaema Syndrome.

Time frame

12 months

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

VividWhite Pty Ltd

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: