Recruitment

Recruitment Status
Completed
Estimated Enrollment
100

Inclusion Criteria

Disc rim or peripapillary retinal nerve fiber layer hemorrhages.
Optic disc neural rim asymmetry of the two eyes consistent with loss of neural tissue.
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.
Optic disc neural rim asymmetry of the two eyes consistent with loss of neural tissue.
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.

Exclusion Criteria

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

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.
Optic disc neural rim asymmetry of the two eyes consistent with loss of neural tissue.
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.
Optic disc neural rim asymmetry of the two eyes consistent with loss of neural tissue.
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.

Exclusion Criteria

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

Tracking Information

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