N/A Completed N=527 Randomized Single-blind Treatment

InnFocus MicroShunt Versus Trabeculectomy Study

Open-angle glaucoma

Source: ClinicalTrials.gov NCT01881425 ↗

Enrolled (actual)

527

Serious AEs

3.0%

Results posted

Oct 2022

Primary outcomePrimary: Number of Participants With > 20% Decrease in Mean Diurnal Intraocular Pressure — 216; 96 Participants

Summary

Assess the safety and effectiveness of the InnFocus MicroShunt when used to lower intraocular pressure (IOP) in subjects with primary open angle glaucoma where the IOP is not controlled when using maximum tolerated glaucoma medications.

Outcome Measures

Outcome	Result	p-value
PRIMARY Number of Participants With > 20% Decrease in Mean Diurnal Intraocular Pressure	216; 96	—
PRIMARY Number of Participants With > 20% Decrease in Diurnal Intraocular Pressure	200; 85	—
SECONDARY Mean Diurnal Intraocular Pressure Change	-6.55; -9.85	—
SECONDARY Number of Participants With Postoperative Interventions at 12 Months	161; 89	—
SECONDARY Participants With Postoperative Interventions at 24 Months	219; 93	—

Eligibility Criteria

Inclusion Criteria: - POAG on maximum tolerated glaucoma meds - Medicated ≥15mmHg and ≤40mmHg - Exclusion Criteria: - Previous conjunctival incisional ophthalmic surgery - Anticipated need for additional ocular surgery during the study - Secondary glaucoma - Any condition that prevents the device implantation or trabeculectomy in the superior region of the study eye

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT01881425). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.