Results of Patients With Glaucoma Undergoing Minimally Invasive Glaucoma Surgery in Conjunction With Cataract Surgery

This study is designed to determine how well patients with glaucoma can see following cataract surgery with a special type of lens called an extended-depth-of-focus (EDOF) lens. This lens is intended to reduced the patients need for glasses following cataract surgery. Patients will also undergo a minimally invasive type of glaucoma surgery using a special type of stent to reduce eye pressure, with the goal of better glaucoma control and the reduction in the need for medications to control eye pressure.

Inclusion Criteria:Male or female subjects 45 years of age or olderA visually significant age-related cataract in both eyesDiagnosis of mild OAGVF characteristics consistent with glaucoma with mean deviation not worse than -6.00 dB and without fixation threatening scotoma AND/OR with nerve abnormalities consistent with glaucoma (rim notching, rim thinning, disc hemorrhage, nerve fiber layer loss)Medicated IOP ≤25 mmHg on 1-3 hypotensive medicationsGlaucoma must be judged as stable by investigator based on review of subject medical recordsStable VF at least 1 year prior to surgeryStable nerve fiber layer at least 1 year prior to surgeryIOP stable on current medication regimen at least 3 months prior to surgeryShaffer grade of ≥ III in all angle quadrantsPotential of best corrected visual acuity at distance in the investigator's judgement of at least 0.1 logMAR (20/25) postoperativelyAble and willing to comply with follow up visitsUnderstands and signs the informed consentBoth eyes of the subject should undergo surgery within 21 days of each other to ensure adequate timing for final visit window of 90 days ± 21 days post operativelyExclusion Criteria:Previous incisional glaucoma surgery or cilio-ablative surgeryPrior laser trabeculoplasty within 90 days of surgeryPseudoexfoliative, angle closure, uveitic, congenital, traumatic, angle recession, or neovascular glaucoma.Moderate glaucoma with VF mean deviation between -6.00 dB and -12.00 dBSevere and/or progressive glaucoma defined asVF mean deviation worse than -12.00 dBConsistent worsening of visual field on review of subject medical recordsConsistent and progressive thinning of nerve fiber layer on review of subject medical recordsUncontrolled IOP on maximum glaucoma medicationsHistorically poor IOP control with medical therapySevere focal notching of the optic nerve rimExpectation for future need of incisional glaucoma surgeryOcular pathology or other medical condition which, in the investigator's judgment places the subject at increased risk of complications or significant vision loss during study periodOcular pathology that in the investigator's judgment may impact visual acuity postoperatively, i.e., significant ocular surface disease, corneal scarring, blepharitis, epiretinal membrane, macular degeneration, history of significant ocular trauma with sequela, etc.Pregnant or breastfeeding womenPrior refractive surgery e.g., LASIK, RK, PRK, etc.Subjects with significant complications during surgical procedure e.g., broken capsule, Hydrus Microstent complication, will be exited from the trialSubjects who experience visually significant complications related to the Hydrus Microstent during the study period will be exited from the trial