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Completed

NCT Number: NCT01881425

InnFocus MicroShunt Versus Trabeculectomy Study

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.

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Key information

Age range

40 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Pole Ophtalmologique de la Clinique Mutualiste, Pessac, Bordeaux, France

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About this study

This clinical trial is a prospective, randomized, controlled, multicenter, study. After informed consent is obtained, patients will be evaluated for eligibility based on glaucoma severity, eye health, and visual acuity.

Clinical follow up will be scheduled over the course of the 24 month study, and examinations will be repeated to monitor eye health. At the 1 and 2 year follow up, diurnal (IOP taken in the morning, mid-day, and afternoon in the same day) IOP evaluation will be done. Annual follow up will occur up to 2 years. The primary effectiveness endpoint is 20% or greater reduction in IOP from pre-op medicated IOP at 12 months.

Who can participate

Healthy volunteers accepted: No

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

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

Treatment and study plan

Glaucoma Surgery

Procedure

An initial pocket is created under the conjunctiva and Tenon's capsule and the wound bed is treated for two minutes with mitomycin C (MMC, 0.2 mg/ml)soaked sponges. This is done using a "fornix-based" conjunctival incision at the corneoscleral junction. A partial thickness scleral flap with its base at the corneoscleral junction after cauterization of the flap area, and a window opening is created under the flap with a Kelly-punch to remove a portion of the sclera, Schlemm's canal and the trabecular meshwork to enter the anterior chamber. An iridectomy is done in many cases to prevent future blockage of the sclerostomy. The scleral flap is then sutured loosely back in place with several sutures. The conjunctiva is closed in a watertight fashion at the end of the procedure.

InnFocus MicroShunt

Device

An initial pocket is created under the conjunctiva and Tenon's capsule and the wound bed is treated for two minutes with mitomycin C (MMC, 0.2 mg/ml)soaked sponges. This is done using a "fornix-based" conjunctival incision at the corneoscleral junction. After cauterization of the flap area, a knife is used to create a shallow pocket at the scleral surface and an opening into the AC. The device is then threaded through the track until the proximal end is in the anterior chamber and the fin of the device is pushed into the shallow scleral pocket. The device is checked to observe aqueous flow and the distal end placed under the Tenons/conjunctiva. The conjunctiva is closed in a watertight fashion at the end of the procedure.

Primary outcomes

  1. Number of Participants With > 20% Decrease in Mean Diurnal Intraocular Pressure

    Time frame: 12 months

    The primary effectiveness outcome is ≥ 20% reduction in mean diurnal IOP without increasing number of glaucoma medications from baseline to 12 months follow-up

  2. Number of Participants With > 20% Decrease in Diurnal Intraocular Pressure

    Time frame: 24 months

    The primary effectiveness outcome is ≥ 20% reduction in mean diurnal IOP without increasing number of glaucoma medications from baseline to 24 months follow-up

Secondary outcomes

  1. Mean Diurnal Intraocular Pressure Change

    Time frame: 12 months

    Secondary Effectiveness Endpoint #1 is the mean diurnal change in IOP from Screening at 12 months.

  2. Mean Diurnal Intraocular Pressure Change

    Time frame: 24 months

    Secondary Effectiveness Endpoint #1 is the mean diurnal change in IOP from Screening at 24 months

  3. Number of Participants With Postoperative Interventions at 12 Months

    Time frame: 12 months

    The Secondary Effectiveness Endpoint #2 was having any physical or medical postoperative intervention (other than eye massage) intended to alter IOP by the Month 12 follow-up visit.

  4. Participants With Postoperative Interventions at 24 Months

    Time frame: 24 months

    The Secondary Effectiveness Endpoint #2 was having any physical or medical postoperative intervention (other than eye massage) intended to alter IOP by the Month 24 follow-up visit.

Sponsors and collaborators

Lead sponsor

InnFocus Inc.

Industry

Registry information

Official study title

A Randomized Study Comparing the Safety and Efficacy of the InnFocus MicroShunt® Glaucoma Drainage System to Standard Trabeculectomy In Subjects With Primary Open Angle Glaucoma

Acronym: IMS

Important dates

Study start
2015
Primary completion
2020
Study completion
2020
First posted
Jun 19, 2013
Registry last updated
Oct 26, 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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