Post Market Study of the InnFocus MicroShunt
Last updated on April 2022Recruitment
- 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.
- Optic disc neural rim asymmetry of the two eyes consistent with loss of neural tissue.
- ...
- 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.
- 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.
- Diffuse thinning, focal narrowing, or notching of the optic disc rim, especially at the inferior or superior poles.
Exclusion Criteria
- inability to reliably complete visual field testing over the course of the study,
- Orbital cellulitis
- A requirement of general anesthesia for the procedure.
- ...
- inability to reliably complete visual field testing over the course of the study,
- Orbital cellulitis
- A requirement of general anesthesia for the procedure.
- Severe dry eye syndrome
- Clinically significant sequelae from trauma (e.g., chemical burns, blunt trauma, etc.)
- Angle closure glaucoma or narrow anatomical chamber angle as identified by gonioscopy and classified as Shaffer Grade 0 or 1.
- 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).
- Fellow eye with poorer than 20/200 best-corrected visual acuity (BCVA)
- 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.
- 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),
- Unwilling to discontinue contact lens use after surgery.
- known corticosteroid responders whose pressure increases would not allow them to withstand the postop corticosteroid regimen.
- Active scleritis
- Previous cyclodestructive procedure.
- Active iris neovascularization, active proliferative retinopathy or other ophthalmic disease that could confound study results.
- Known allergy or other contraindication to Mitomycin C (MMC) drug.
- Epithelial or fibrous downgrowth.
- Chronic ocular inflammatory disease.
- 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 myopia
- Use of oral hypotensive glaucoma medications for treatment of the fellow eye.
- 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).
- Prior laser peripheral iridotomy.
- Need for glaucoma surgery combined with other ocular procedures or anticipated need for additional ocular surgery during the investigational period.
- Bacterial corneal ulcers
- Bacteremia or septicemia
- Previous incisional ophthalmic surgery, excluding uncomplicated clear corneal phacoemulsification (cataract) surgery at least 6 months prior to enrollment.
- Chemotherapy within six months of the screening visit.
- Pseudo-exfoliative glaucoma
- Severe anterior or posterior blepharitis.
- 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.)
- Conditions associated with elevated episcleral venous pressure such as active thyroid orbitopathy, cavernous sinus fistula, Sturge-Weber syndrome, orbital tumors, orbital congestive disease.
- immunodeficiency concerns.
- Uveitis
- Angle closure glaucoma or narrow anatomical chamber angle as identified by gonioscopy and classified as Shaffer Grade 0 or 1.
- Secondary glaucoma such as post-trauma, pseudo-exfoliative, etc.
- Iridocorneal endothelial syndrome.
- Fellow eye with poorer than 20/200 best-corrected visual acuity (BCVA)
- Endophthalmitis
- Central corneal thickness that is less than 450 microns or greater than 620 microns.
- Previous incisional ophthalmic surgery, excluding uncomplicated clear corneal phacoemulsification (cataract) surgery at least 6 months prior to enrollment.
- uncontrolled systemic disease (e.g. diabetes, hypertension) that could compromise their participation in the study.
- Bacterial conjunctivitis
- Use of oral hypotensive glaucoma medications for treatment of the fellow eye.
- Prior laser peripheral iridotomy.
- Intraocular silicone oil.
- inability to discontinue use of blood thinners within the surgeon's standard preoperative or postoperative instructions.
- Previous cyclodestructive procedure.
- Presence of an anterior chamber IOL (AC-IOL).
- Severe anterior or posterior blepharitis.
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.
- Optic disc neural rim asymmetry of the two eyes consistent with loss of neural tissue.
- ...
- 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.
- 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.
- Diffuse thinning, focal narrowing, or notching of the optic disc rim, especially at the inferior or superior poles.
Exclusion Criteria
- inability to reliably complete visual field testing over the course of the study,
- Orbital cellulitis
- A requirement of general anesthesia for the procedure.
- ...
- inability to reliably complete visual field testing over the course of the study,
- Orbital cellulitis
- A requirement of general anesthesia for the procedure.
- Severe dry eye syndrome
- Clinically significant sequelae from trauma (e.g., chemical burns, blunt trauma, etc.)
- Angle closure glaucoma or narrow anatomical chamber angle as identified by gonioscopy and classified as Shaffer Grade 0 or 1.
- 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).
- Fellow eye with poorer than 20/200 best-corrected visual acuity (BCVA)
- 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.
- 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),
- Unwilling to discontinue contact lens use after surgery.
- known corticosteroid responders whose pressure increases would not allow them to withstand the postop corticosteroid regimen.
- Active scleritis
- Previous cyclodestructive procedure.
- Active iris neovascularization, active proliferative retinopathy or other ophthalmic disease that could confound study results.
- Known allergy or other contraindication to Mitomycin C (MMC) drug.
- Epithelial or fibrous downgrowth.
- Chronic ocular inflammatory disease.
- 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 myopia
- Use of oral hypotensive glaucoma medications for treatment of the fellow eye.
- 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).
- Prior laser peripheral iridotomy.
- Need for glaucoma surgery combined with other ocular procedures or anticipated need for additional ocular surgery during the investigational period.
- Bacterial corneal ulcers
- Bacteremia or septicemia
- Previous incisional ophthalmic surgery, excluding uncomplicated clear corneal phacoemulsification (cataract) surgery at least 6 months prior to enrollment.
- Chemotherapy within six months of the screening visit.
- Pseudo-exfoliative glaucoma
- Severe anterior or posterior blepharitis.
- 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.)
- Conditions associated with elevated episcleral venous pressure such as active thyroid orbitopathy, cavernous sinus fistula, Sturge-Weber syndrome, orbital tumors, orbital congestive disease.
- immunodeficiency concerns.
- Uveitis
- Angle closure glaucoma or narrow anatomical chamber angle as identified by gonioscopy and classified as Shaffer Grade 0 or 1.
- Secondary glaucoma such as post-trauma, pseudo-exfoliative, etc.
- Iridocorneal endothelial syndrome.
- Fellow eye with poorer than 20/200 best-corrected visual acuity (BCVA)
- Endophthalmitis
- Central corneal thickness that is less than 450 microns or greater than 620 microns.
- Previous incisional ophthalmic surgery, excluding uncomplicated clear corneal phacoemulsification (cataract) surgery at least 6 months prior to enrollment.
- uncontrolled systemic disease (e.g. diabetes, hypertension) that could compromise their participation in the study.
- Bacterial conjunctivitis
- Use of oral hypotensive glaucoma medications for treatment of the fellow eye.
- Prior laser peripheral iridotomy.
- Intraocular silicone oil.
- inability to discontinue use of blood thinners within the surgeon's standard preoperative or postoperative instructions.
- Previous cyclodestructive procedure.
- Presence of an anterior chamber IOL (AC-IOL).
- Severe anterior or posterior blepharitis.
Tracking Information
- NCT #
- NCT02177123
- Collaborators
- Not Provided
- Investigators
- Study Director: Guy Van de Weyer, Optometrist InnFocus Inc.