Please select the eligibility criteria that correspond to the clinical trial below.
Title: The Safety and Effectiveness of the Hydrus Aqueous Implant for Lowering Intraocular Pressure in Glaucoma Patients Undergoing Cataract Surgery, A Prospective, Multicenter, Randomized, Controlled Clinical Trial
Brief Summary: This clinical trial is a prospective, randomized, controlled, multicenter, study. After informed consent is obtained, patients will be evaluated for eligibility based on glaucoma severity, eye health, and visual acuity. Following successful screening, use of all topical glaucoma medications will be stopped for a period of "washout" to establish a qualifying medication-free intraocular pressure (IOP) value. Clinical follow up will be scheduled over the course of the 24 month study, and examinations will be repeated to monitor eye health. At the 1 and 2 year follow up, those patients on ocular hypotensive medications will be instructed to washout, and then have the diurnal (IOP taken in the morning, mid-day, and afternoon in the same day) IOP evaluation. Annual follow up will occur up to 5 years. The primary effectiveness endpoint is a decrease in diurnal IOP from baseline compared to the 24 months diurnal IOP following medication washout.


Options:
A: Inclusion Criteria:

1. Age 40-85 years
2. Open angle glaucoma (including pseudo exfoliative glaucoma)
3. Open angles (≥ Shaffer grade II)
4. Inadequately controlled IOP requiring surgical intervention
5. Visually significant cataract
6. Willing to complete quality of life questionnaires
7. Capable of informed consent and available for at least 1 year follow-up

Exclusion Criteria:

1. Any form of angle closure glaucoma
2. Secondary open angle glaucomas
3. Absence of clear angle landmarks on gonioscopy
4. Other ocular disease that may affect assessments of visual acuity, visual field, or accurate tonometry
5. Previous angle surgery or filtering procedure
6. Steroid use within the preceding 3 months
7. Presence of significant co-morbidities
B: Inclusion Criteria:

* Age 18 to 85 years
* Intraocular pressure greater than or equal to 18 mm Hg and less than or equal to 40 mm Hg
* Previous trabeculectomy, cataract extraction with intraocular lens implantation, or both

Exclusion Criteria:

* Unwilling or unable to give consent, unwilling to accept randomization, or unable to return for scheduled protocol visits
* Pregnant or nursing women
* No light perception vision
* Active iris neovascularization or active proliferative retinopathy
* Iridocorneal endothelial syndrome
* Epithelial or fibrous downgrowth
* Aphakia
* Vitreous in the anterior chamber for which a vitrectomy is anticipated
* Chronic or recurrent uveitis
* Severe posterior blepharitis
* Unwilling to discontinue contact lens use after surgery
* Previous cyclodestructive procedure, scleral buckling procedure, or presence of silicone oil
* Conjunctival scarring precluding a trabeculectomy superiorly
* Need for glaucoma surgery combined with other ocular procedures (eg cataract surgery, penetrating keratoplasty, or retinal surgery) or anticipated need for additional ocular surgery
C: Inclusion Criteria: - POAG on maximum tolerated glaucoma meds - Medicated ≥15mmHg and ≤40mmHg - Exclusion Criteria: - Previous conjunctival incisional ophthalmic surgery - Anticipated need for additional ocular surgery during the study - Secondary glaucoma - Any condition that prevents the device implantation or trabeculectomy in the superior region of the study eye
D: Inclusion Criteria:

* An operable age-related cataract
* A diagnosis of POAG treated with 1 to 4 hypotensive medications
* Medicated IOP ≤ 31 mmHg
* Diurnal IOP ≥ 22 mmHg and ≤ 34 mmHg

Exclusion Criteria:

* Congenital or developmental glaucoma
* Previous argon laser trabeculoplasty
* Ab-interno or ab-externo device implanted in or through Schlemm's Canal
* Use of oral hypotensive medication for glaucoma for treatment of fellow eye

Answer: D