Recruitment

Recruitment Status
Completed
Estimated Enrollment
100

Inclusion Criteria

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.
Diffuse thinning, focal narrowing, or notching of the optic disc rim, 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.
Localized abnormalities of the peripapillary retinal nerve fiber layer, especially at the inferior or superior poles.
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.

Exclusion Criteria

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

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

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.
Diffuse thinning, focal narrowing, or notching of the optic disc rim, 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.
Localized abnormalities of the peripapillary retinal nerve fiber layer, especially at the inferior or superior poles.
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.

Exclusion Criteria

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

Tracking Information

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