Recruitment

Recruitment Status
Completed
Estimated Enrollment
100

Inclusion Criteria

Disc rim or peripapillary retinal nerve fiber layer hemorrhages.
Localized abnormalities of the peripapillary retinal nerve fiber layer, especially at the inferior or superior poles.
Subject has mild to moderate primary open glaucoma where the intraocular pressure is not adequately controlled on maximum tolerated medical therapy and has intraocular pressure greater than or equal to 18mmHg and less than or equal to 35mmHg while on glaucoma medications and/or where glaucoma progression warrants surgery.
...
Disc rim or peripapillary retinal nerve fiber layer hemorrhages.
Localized abnormalities of the peripapillary retinal nerve fiber layer, especially at the inferior or superior poles.
Subject has mild to moderate primary open glaucoma where the intraocular pressure is not adequately controlled on maximum tolerated medical therapy and has intraocular pressure greater than or equal to 18mmHg and less than or equal to 35mmHg while on glaucoma medications and/or where glaucoma progression warrants surgery.
Optic disc neural rim asymmetry of the two eyes consistent with loss of neural tissue.
Diffuse thinning, focal narrowing, or notching of the optic disc rim, especially at the inferior or superior poles.

Exclusion Criteria

Severe anterior or posterior blepharitis.
Central corneal thickness that is less than 450 microns or greater than 620 microns.
Fellow eye with poorer than 20/200 best-corrected visual acuity (BCVA)
...
Severe anterior or posterior blepharitis.
Central corneal thickness that is less than 450 microns or greater than 620 microns.
Fellow eye with poorer than 20/200 best-corrected visual acuity (BCVA)
Angle closure glaucoma or narrow anatomical chamber angle as identified by gonioscopy and classified as Shaffer Grade 0 or 1.
Conditions associated with elevated episcleral venous pressure such as active thyroid orbitopathy, cavernous sinus fistula, Sturge-Weber syndrome, orbital tumors, orbital congestive disease.
Active scleritis
Fellow eye with poorer than 20/200 best-corrected visual acuity (BCVA)
Secondary glaucoma such as post-trauma, pseudo-exfoliative, etc.
Any condition that prevents the investigational device implantation or trabeculectomy in the superior region of the study eye (e.g., peripheral anterior synechiae, scleral staphyloma or conjunctival scarring).
Pseudo-exfoliative glaucoma
Bacterial corneal ulcers
Iridocorneal endothelial syndrome.
Epithelial or fibrous downgrowth.
Prior laser peripheral iridotomy.
Disorders that pose a fall risk, as well as compromise ability to take a visual field exam and take glaucoma medications (e.g., Parkinson's disease),
Previous cyclodestructive procedure.
Intraocular silicone oil.
Clinically significant sequelae from trauma (e.g., chemical burns, blunt trauma, etc.)
Severe dry eye syndrome
Chemotherapy within six months of the screening visit.
Previous incisional ophthalmic surgery, excluding uncomplicated clear corneal phacoemulsification (cataract) surgery at least 6 months prior to enrollment.
Bacteremia or septicemia
Unwilling to discontinue contact lens use after surgery.
Need for glaucoma surgery combined with other ocular procedures or anticipated need for additional ocular surgery during the investigational period.
A requirement of general anesthesia for the procedure.
immunodeficiency concerns.
Active iris neovascularization, active proliferative retinopathy or other ophthalmic disease that could confound study results.
Severe myopia
Prior laser peripheral iridotomy.
Use of oral hypotensive glaucoma medications for treatment of the fellow eye.
Prior argon laser, selective laser, or micropulse trabeculoplasty within 90 days of enrollment.
Prior retinal laser procedure conducted for any purpose other than treatment of retinal tear or hole.
known corticosteroid responders whose pressure increases would not allow them to withstand the postop corticosteroid regimen.
Known allergy or other contraindication to Mitomycin C (MMC) drug.
Angle closure glaucoma or narrow anatomical chamber angle as identified by gonioscopy and classified as Shaffer Grade 0 or 1.
Chronic ocular inflammatory disease.
Presence of an anterior chamber IOL (AC-IOL).
Endophthalmitis
Previous cyclodestructive procedure.
Severe anterior or posterior blepharitis.
Use of oral hypotensive glaucoma medications for treatment of the fellow eye.
Inability to obtain accurate IOP measurement throughout the study. For example: a history of corneal surgery, corneal opacities or disease/pathology (Active corneal infection or Fuchs dystrophy are examples.).
uncontrolled systemic disease (e.g. diabetes, hypertension) that could compromise their participation in the study.
Orbital cellulitis
Previous incisional ophthalmic surgery, excluding uncomplicated clear corneal phacoemulsification (cataract) surgery at least 6 months prior to enrollment.
Bacterial conjunctivitis
Ocular steroid use in the planned study eye or systemic steroid use anytime within three months of the procedure. (This would not include the use of inhaled or dermatologic steroids.)
Uveitis
inability to discontinue use of blood thinners within the surgeon's standard preoperative or postoperative instructions.
Diagnosed degenerative visual disorders not associated with existing glaucoma condition (e.g., advanced dry or wet macular degeneration or other retinal disorders, central retinal artery or vein occlusion) or choroidopathy (e.g., choroidal detachment, effusion, choroiditis, or neovascularization).
inability to reliably complete visual field testing over the course of the study,

Summary

Conditions
Primary Open Angle Glaucoma
Type
Interventional
Design
  • Allocation: N/A
  • Intervention Model: Single Group Assignment
  • Masking: None (Open Label)
  • Primary Purpose: Treatment

Participation Requirements

Age
Between 18 years and 85 years
Gender
Both males and females

Description

The purpose of this study is to collect additional safety and effectiveness data on the InnFocus MicroShunt (MIDI Arrow) in subjects suffering from primary open angle glaucoma who are inadequately controlled on maximum tolerated medical therapy with intraocular pressure ≥ 18 mm Hg and ≤ 35 mm Hg and...

The purpose of this study is to collect additional safety and effectiveness data on the InnFocus MicroShunt (MIDI Arrow) in subjects suffering from primary open angle glaucoma who are inadequately controlled on maximum tolerated medical therapy with intraocular pressure ≥ 18 mm Hg and ≤ 35 mm Hg and/or where glaucoma progression warrants surgery.

Inclusion Criteria

Disc rim or peripapillary retinal nerve fiber layer hemorrhages.
Localized abnormalities of the peripapillary retinal nerve fiber layer, especially at the inferior or superior poles.
Subject has mild to moderate primary open glaucoma where the intraocular pressure is not adequately controlled on maximum tolerated medical therapy and has intraocular pressure greater than or equal to 18mmHg and less than or equal to 35mmHg while on glaucoma medications and/or where glaucoma progression warrants surgery.
...
Disc rim or peripapillary retinal nerve fiber layer hemorrhages.
Localized abnormalities of the peripapillary retinal nerve fiber layer, especially at the inferior or superior poles.
Subject has mild to moderate primary open glaucoma where the intraocular pressure is not adequately controlled on maximum tolerated medical therapy and has intraocular pressure greater than or equal to 18mmHg and less than or equal to 35mmHg while on glaucoma medications and/or where glaucoma progression warrants surgery.
Optic disc neural rim asymmetry of the two eyes consistent with loss of neural tissue.
Diffuse thinning, focal narrowing, or notching of the optic disc rim, especially at the inferior or superior poles.

Exclusion Criteria

Severe anterior or posterior blepharitis.
Central corneal thickness that is less than 450 microns or greater than 620 microns.
Fellow eye with poorer than 20/200 best-corrected visual acuity (BCVA)
...
Severe anterior or posterior blepharitis.
Central corneal thickness that is less than 450 microns or greater than 620 microns.
Fellow eye with poorer than 20/200 best-corrected visual acuity (BCVA)
Angle closure glaucoma or narrow anatomical chamber angle as identified by gonioscopy and classified as Shaffer Grade 0 or 1.
Conditions associated with elevated episcleral venous pressure such as active thyroid orbitopathy, cavernous sinus fistula, Sturge-Weber syndrome, orbital tumors, orbital congestive disease.
Active scleritis
Fellow eye with poorer than 20/200 best-corrected visual acuity (BCVA)
Secondary glaucoma such as post-trauma, pseudo-exfoliative, etc.
Any condition that prevents the investigational device implantation or trabeculectomy in the superior region of the study eye (e.g., peripheral anterior synechiae, scleral staphyloma or conjunctival scarring).
Pseudo-exfoliative glaucoma
Bacterial corneal ulcers
Iridocorneal endothelial syndrome.
Epithelial or fibrous downgrowth.
Prior laser peripheral iridotomy.
Disorders that pose a fall risk, as well as compromise ability to take a visual field exam and take glaucoma medications (e.g., Parkinson's disease),
Previous cyclodestructive procedure.
Intraocular silicone oil.
Clinically significant sequelae from trauma (e.g., chemical burns, blunt trauma, etc.)
Severe dry eye syndrome
Chemotherapy within six months of the screening visit.
Previous incisional ophthalmic surgery, excluding uncomplicated clear corneal phacoemulsification (cataract) surgery at least 6 months prior to enrollment.
Bacteremia or septicemia
Unwilling to discontinue contact lens use after surgery.
Need for glaucoma surgery combined with other ocular procedures or anticipated need for additional ocular surgery during the investigational period.
A requirement of general anesthesia for the procedure.
immunodeficiency concerns.
Active iris neovascularization, active proliferative retinopathy or other ophthalmic disease that could confound study results.
Severe myopia
Prior laser peripheral iridotomy.
Use of oral hypotensive glaucoma medications for treatment of the fellow eye.
Prior argon laser, selective laser, or micropulse trabeculoplasty within 90 days of enrollment.
Prior retinal laser procedure conducted for any purpose other than treatment of retinal tear or hole.
known corticosteroid responders whose pressure increases would not allow them to withstand the postop corticosteroid regimen.
Known allergy or other contraindication to Mitomycin C (MMC) drug.
Angle closure glaucoma or narrow anatomical chamber angle as identified by gonioscopy and classified as Shaffer Grade 0 or 1.
Chronic ocular inflammatory disease.
Presence of an anterior chamber IOL (AC-IOL).
Endophthalmitis
Previous cyclodestructive procedure.
Severe anterior or posterior blepharitis.
Use of oral hypotensive glaucoma medications for treatment of the fellow eye.
Inability to obtain accurate IOP measurement throughout the study. For example: a history of corneal surgery, corneal opacities or disease/pathology (Active corneal infection or Fuchs dystrophy are examples.).
uncontrolled systemic disease (e.g. diabetes, hypertension) that could compromise their participation in the study.
Orbital cellulitis
Previous incisional ophthalmic surgery, excluding uncomplicated clear corneal phacoemulsification (cataract) surgery at least 6 months prior to enrollment.
Bacterial conjunctivitis
Ocular steroid use in the planned study eye or systemic steroid use anytime within three months of the procedure. (This would not include the use of inhaled or dermatologic steroids.)
Uveitis
inability to discontinue use of blood thinners within the surgeon's standard preoperative or postoperative instructions.
Diagnosed degenerative visual disorders not associated with existing glaucoma condition (e.g., advanced dry or wet macular degeneration or other retinal disorders, central retinal artery or vein occlusion) or choroidopathy (e.g., choroidal detachment, effusion, choroiditis, or neovascularization).
inability to reliably complete visual field testing over the course of the study,

Tracking Information

NCT #
NCT02177123
Collaborators
Not Provided
Investigators
Study Director: Guy Van de Weyer, Optometrist InnFocus Inc.
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