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PRESERFLO® MicroShunt Extension Study
trial testing PRESERFLO® MicroShunt in Primary Open-angle Glaucoma in 279 participants. Completed in 24 November 2022.
| Lead sponsor | InnFocus Inc. |
|---|---|
| Status | Completed |
| Study type | OBSERVATIONAL |
| Enrollment | 279 |
| Start date | 22 May 2020 |
| Primary completion | 24 November 2022 |
| Estimated completion | 24 November 2022 |
| Sites | 23 locations across France, Italy, United Kingdom, United States, Spain |
InnFocus Inc.
Adults 40 to 85, any sex, with Primary Open-angle Glaucoma. Patients with the condition only — healthy volunteers not accepted.
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Sight-threatening Adverse events (AEs) that were started after enrollment in the INN-005-EXT study through Month 60.
| Group | Value | 95% CI |
|---|---|---|
| MicroShunt Treatment Group | 4 | |
| Trabeculectomy Control Arm | 0 |
Time frame: Adverse events (AEs) and Serious Adverse Events (SAEs) were reported for all events that started after enrollment in the INN-005 EXT study through Month 60.. Reporting threshold: 5%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.
| Reaction | System | MicroShunt Treatment Group | Trabeculectomy Control Arm |
|---|---|---|---|
| Erosion of the Device through the Conjunctiva | Eye disorders | — | — |
| Choroidal Hemorrhage | Eye disorders | — | — |
| Central Retinal Artery Occlusion | Eye disorders | — | — |
| Pseudophakic Bullous Keratopathy | Eye disorders | — | — |
| Endothelial Cell Loss | Eye disorders | — | — |
| Reaction | System | MicroShunt Treatment Group | Trabeculectomy Control Arm |
|---|---|---|---|
| Increased IOP Requiring Treatment | Eye disorders | — | — |
| Worsening in the Visual Field Mean Deviation | Eye disorders | — | — |
| Cataract Progression | Eye disorders | — | — |
| Dry Eye | Eye disorders | — | — |
| Loss 2 or More Lines of BCVA | Eye disorders | — | — |
| Posterior Capsule Opacification | Eye disorders | — | — |
| Bleb Related Complications | Eye disorders | — | — |
| Diplopia | Eye disorders | — | — |
| Encapsulated Bleb | Eye disorders | — | — |
| Ptosis | Eye disorders | — | — |
| Hypotony | Eye disorders | — | — |
| Epiretinal Membrane | Eye disorders | — | — |
| Meibomian Gland Disease | Eye disorders | — | — |
Most-reported serious reactions: Erosion of the Device through the Conjunctiva, Choroidal Hemorrhage, Central Retinal Artery Occlusion, Pseudophakic Bullous Keratopathy, Endothelial Cell Loss.
Data from ClinicalTrials.gov NCT04333433 adverse events section.
This prospective, concurrent controlled, open-label, multicenter study is designed to collect additional safety data through 5 years of follow-up for subjects randomized to either the treatment arm (PRESERFLO® MicroShunt with MMC) or the control arm (Trabeculectomy with MMC) of the INN-005 clinical study.
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
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