Recruitment

Recruitment Status
Completed
Estimated Enrollment
100

Inclusion Criteria

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.
Disc rim or peripapillary retinal nerve fiber layer hemorrhages.
...
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.
Disc rim or peripapillary retinal nerve fiber layer hemorrhages.
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.
Localized abnormalities of the peripapillary retinal nerve fiber layer, especially at the inferior or superior poles.

Exclusion Criteria

Severe anterior or posterior blepharitis.
Active iris neovascularization, active proliferative retinopathy or other ophthalmic disease that could confound study results.
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.).
...
Severe anterior or posterior blepharitis.
Active iris neovascularization, active proliferative retinopathy or other ophthalmic disease that could confound study results.
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.
Severe dry eye syndrome
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).
Previous cyclodestructive procedure.
Angle closure glaucoma or narrow anatomical chamber angle as identified by gonioscopy and classified as Shaffer Grade 0 or 1.
Previous incisional ophthalmic surgery, excluding uncomplicated clear corneal phacoemulsification (cataract) surgery at least 6 months prior to enrollment.
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.)
Use of oral hypotensive glaucoma medications for treatment of the fellow eye.
Bacteremia or septicemia
Prior argon laser, selective laser, or micropulse trabeculoplasty within 90 days of enrollment.
Pseudo-exfoliative glaucoma
Central corneal thickness that is less than 450 microns or greater than 620 microns.
Unwilling to discontinue contact lens use after surgery.
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),
Bacterial conjunctivitis
Severe anterior or posterior blepharitis.
immunodeficiency concerns.
Secondary glaucoma such as post-trauma, pseudo-exfoliative, etc.
A requirement of general anesthesia for the procedure.
Angle closure glaucoma or narrow anatomical chamber angle as identified by gonioscopy and classified as Shaffer Grade 0 or 1.
Fellow eye with poorer than 20/200 best-corrected visual acuity (BCVA)
Chemotherapy within six months of the screening visit.
Prior laser peripheral iridotomy.
inability to discontinue use of blood thinners within the surgeon's standard preoperative or postoperative instructions.
Orbital cellulitis
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).
Epithelial or fibrous downgrowth.
Chronic ocular inflammatory disease.
Fellow eye with poorer than 20/200 best-corrected visual acuity (BCVA)
Prior retinal laser procedure conducted for any purpose other than treatment of retinal tear or hole.
Known allergy or other contraindication to Mitomycin C (MMC) drug.
Need for glaucoma surgery combined with other ocular procedures or anticipated need for additional ocular surgery during the investigational period.
Conditions associated with elevated episcleral venous pressure such as active thyroid orbitopathy, cavernous sinus fistula, Sturge-Weber syndrome, orbital tumors, orbital congestive disease.
Presence of an anterior chamber IOL (AC-IOL).
Endophthalmitis
Use of oral hypotensive glaucoma medications for treatment of the fellow eye.
Clinically significant sequelae from trauma (e.g., chemical burns, blunt trauma, etc.)
Active scleritis
Prior laser peripheral iridotomy.
Bacterial corneal ulcers
Severe myopia
Previous cyclodestructive procedure.
Previous incisional ophthalmic surgery, excluding uncomplicated clear corneal phacoemulsification (cataract) surgery at least 6 months prior to enrollment.
known corticosteroid responders whose pressure increases would not allow them to withstand the postop corticosteroid regimen.
Intraocular silicone oil.
Uveitis
Iridocorneal endothelial syndrome.
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

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.
Disc rim or peripapillary retinal nerve fiber layer hemorrhages.
...
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.
Disc rim or peripapillary retinal nerve fiber layer hemorrhages.
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.
Localized abnormalities of the peripapillary retinal nerve fiber layer, especially at the inferior or superior poles.

Exclusion Criteria

Severe anterior or posterior blepharitis.
Active iris neovascularization, active proliferative retinopathy or other ophthalmic disease that could confound study results.
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.).
...
Severe anterior or posterior blepharitis.
Active iris neovascularization, active proliferative retinopathy or other ophthalmic disease that could confound study results.
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.
Severe dry eye syndrome
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).
Previous cyclodestructive procedure.
Angle closure glaucoma or narrow anatomical chamber angle as identified by gonioscopy and classified as Shaffer Grade 0 or 1.
Previous incisional ophthalmic surgery, excluding uncomplicated clear corneal phacoemulsification (cataract) surgery at least 6 months prior to enrollment.
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.)
Use of oral hypotensive glaucoma medications for treatment of the fellow eye.
Bacteremia or septicemia
Prior argon laser, selective laser, or micropulse trabeculoplasty within 90 days of enrollment.
Pseudo-exfoliative glaucoma
Central corneal thickness that is less than 450 microns or greater than 620 microns.
Unwilling to discontinue contact lens use after surgery.
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),
Bacterial conjunctivitis
Severe anterior or posterior blepharitis.
immunodeficiency concerns.
Secondary glaucoma such as post-trauma, pseudo-exfoliative, etc.
A requirement of general anesthesia for the procedure.
Angle closure glaucoma or narrow anatomical chamber angle as identified by gonioscopy and classified as Shaffer Grade 0 or 1.
Fellow eye with poorer than 20/200 best-corrected visual acuity (BCVA)
Chemotherapy within six months of the screening visit.
Prior laser peripheral iridotomy.
inability to discontinue use of blood thinners within the surgeon's standard preoperative or postoperative instructions.
Orbital cellulitis
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).
Epithelial or fibrous downgrowth.
Chronic ocular inflammatory disease.
Fellow eye with poorer than 20/200 best-corrected visual acuity (BCVA)
Prior retinal laser procedure conducted for any purpose other than treatment of retinal tear or hole.
Known allergy or other contraindication to Mitomycin C (MMC) drug.
Need for glaucoma surgery combined with other ocular procedures or anticipated need for additional ocular surgery during the investigational period.
Conditions associated with elevated episcleral venous pressure such as active thyroid orbitopathy, cavernous sinus fistula, Sturge-Weber syndrome, orbital tumors, orbital congestive disease.
Presence of an anterior chamber IOL (AC-IOL).
Endophthalmitis
Use of oral hypotensive glaucoma medications for treatment of the fellow eye.
Clinically significant sequelae from trauma (e.g., chemical burns, blunt trauma, etc.)
Active scleritis
Prior laser peripheral iridotomy.
Bacterial corneal ulcers
Severe myopia
Previous cyclodestructive procedure.
Previous incisional ophthalmic surgery, excluding uncomplicated clear corneal phacoemulsification (cataract) surgery at least 6 months prior to enrollment.
known corticosteroid responders whose pressure increases would not allow them to withstand the postop corticosteroid regimen.
Intraocular silicone oil.
Uveitis
Iridocorneal endothelial syndrome.
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.