Visual Outcomes and Patient Satisfaction in Subjects With Stable Open-angle Glaucoma Undergoing Concurrent Minimally Invasive Glaucoma Surgery and IOL Implantation With an Extended-depth-of-focus IOL
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.
• Male or female subjects 45 years of age or older
• A visually significant age-related cataract in both eyes
• Diagnosis of mild OAG
‣ VF 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 medications
• Glaucoma must be judged as stable by investigator based on review of subject medical records
‣ Stable VF at least 1 year prior to surgery
⁃ Stable nerve fiber layer at least 1 year prior to surgery
⁃ IOP stable on current medication regimen at least 3 months prior to surgery
• Shaffer grade of ≥ III in all angle quadrants
• Potential of best corrected visual acuity at distance in the investigator's judgement of at least 0.1 logMAR (20/25) postoperatively
• Able and willing to comply with follow up visits
• Understands and signs the informed consent
• Both 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 operatively