| Eligibility |
Inclusion Criteria:
1. 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.
2. Primary open angle glaucoma diagnosis based on glaucomatous optic nerve damage as
evidenced by any of the following optic disc or retinal nerve fiber layer structural
abnormalities documented on slit lamp stereo biomicroscopy or in stereo disc photos:
1. Diffuse thinning, focal narrowing, or notching of the optic disc rim, especially
at the inferior or superior poles.
2. Localized abnormalities of the peripapillary retinal nerve fiber layer,
especially at the inferior or superior poles.
3. Optic disc neural rim asymmetry of the two eyes consistent with loss of neural
tissue.
4. Disc rim or peripapillary retinal nerve fiber layer hemorrhages.
4) Subject willing to comply with study requirements. 5) Subject who has signed an approved
informed consent form
Exclusion Criteria:
1. Active iris neovascularization, active proliferative retinopathy or other ophthalmic
disease that could confound study results.
2. Iridocorneal endothelial syndrome.
3. Epithelial or fibrous downgrowth.
4. Secondary glaucoma such as post-trauma, pseudo-exfoliative, etc.
5. Chronic ocular inflammatory disease.
6. Prior argon laser, selective laser, or micropulse trabeculoplasty within 90 days of
enrollment.
7. 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.).
8. Severe anterior or posterior blepharitis.
9. Previous incisional ophthalmic surgery, excluding uncomplicated clear corneal
phacoemulsification (cataract) surgery at least 6 months prior to enrollment.
10. Prior laser peripheral iridotomy.
11. Fellow eye with poorer than 20/200 best-corrected visual acuity (BCVA)
12. Angle closure glaucoma or narrow anatomical chamber angle as identified by gonioscopy
and classified as Shaffer Grade 0 or 1.
13. Previous cyclodestructive procedure.
14. Use of oral hypotensive glaucoma medications for treatment of the fellow eye.
15. Severe anterior or posterior blepharitis.
16. Unwilling to discontinue contact lens use after surgery.
17. Previous incisional ophthalmic surgery, excluding uncomplicated clear corneal
phacoemulsification (cataract) surgery at least 6 months prior to enrollment.
18. Presence of an anterior chamber IOL (AC-IOL).
19. Prior laser peripheral iridotomy.
20. Need for glaucoma surgery combined with other ocular procedures or anticipated need
for additional ocular surgery during the investigational period.
21. Fellow eye with poorer than 20/200 best-corrected visual acuity (BCVA)
22. Known allergy or other contraindication to Mitomycin C (MMC) drug.
23. Angle closure glaucoma or narrow anatomical chamber angle as identified by gonioscopy
and classified as Shaffer Grade 0 or 1.
24. 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).
25. 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).
26. Central corneal thickness that is less than 450 microns or greater than 620 microns.
27. Previous cyclodestructive procedure.
28. Prior retinal laser procedure conducted for any purpose other than treatment of
retinal tear or hole.
29. Conditions associated with elevated episcleral venous pressure such as active thyroid
orbitopathy, cavernous sinus fistula, Sturge-Weber syndrome, orbital tumors, orbital
congestive disease.
30. Clinically significant sequelae from trauma (e.g., chemical burns, blunt trauma, etc.)
31. Ocular pathology or medical condition for which, in the investigator's judgment, the
following factors would either place the subject at increased risk of complications or
contraindicate device implantation or interfere with compliance to elements of the
study protocol (e.g., ophthalmic examinations, follow-up visits),
1. inability to reliably complete visual field testing over the course of the study,
2. uncontrolled systemic disease (e.g. diabetes, hypertension) that could compromise
their participation in the study.
3. 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),
4. inability to discontinue use of blood thinners within the surgeon's standard
preoperative or postoperative instructions.
5. immunodeficiency concerns.
6. known corticosteroid responders whose pressure increases would not allow them to
withstand the postop corticosteroid regimen.
32. Intraocular silicone oil.
33. 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.)
34. Chemotherapy within six months of the screening visit.
35. Use of oral hypotensive glaucoma medications for treatment of the fellow eye.
36. A requirement of general anesthesia for the procedure.
37. Bacterial conjunctivitis
38. Bacterial corneal ulcers
39. Endophthalmitis
40. Orbital cellulitis
41. Bacteremia or septicemia
42. Active scleritis
43. Uveitis
44. Severe dry eye syndrome
45. Severe myopia
46. Pseudo-exfoliative glaucoma
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