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.
To evaluate the range of vision and patient reported outcomes in subjects implanted with Clareon Vivity IOL undergoing concurrent MIGS with the Hydrus Microstent
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
25
Cataract surgery with implantation of the Vivity IOL along with concurrent implantation of the Hydrus Microstent
Vold Vision P.L.L.C.
Fayetteville, Arkansas, United States
RECRUITINGMean Photopic Monocular Best Corrected Distance Visual Acuity (DCVA) (4 meters) logMAR
Visual acuity measurement
Time frame: 3 months
Mean Photopic Monocular Best Distance Corrected Intermediate Visual Acuity (DCIVA) (66 cm) logMAR
Visual acuity measurement
Time frame: 3 months
Mean Photopic Monocular Uncorrected Distance Visual Acuity (UCDVA) (4 meters) logMAR
Visual acuity measurement
Time frame: 3 months
Mean Photopic Monocular Uncorrected Intermediate Visual Acuity (UCIVA) (66 cm) logMAR
Visual acuity measurement
Time frame: 3 months
Mean Photopic Binocular Best Corrected Distance Visual Acuity (DCVA) (4 meters) logMAR
Visual acuity measurement
Time frame: 3 months
Mean Photopic Binocular Best Distance Corrected Intermediate Visual Acuity (DCIVA) (66 cm) logMAR
Visual acuity measurement
Time frame: 3 months
Mean Photopic Binocular Uncorrected Distance Visual Acuity (UCDVA) (4 meters) logMAR
Visual acuity measurement
Time frame: 3 months
Mean Photopic Binocular Uncorrected Intermediate Visual Acuity (UCIVA) (66 cm) logMAR
Visual acuity measurement
Time frame: 3 months
Mean Refractive Spherical Equivalent
Average refractive error or residual spectacle prescription remaining following procedure (diopters)
Time frame: 3 months
Mean Absolute Prediction Error
Average prescription remaining compared to preoperative prediction (diopters)
Time frame: 3 months
Mean post-op refractive astigmatism and the distribution of post-op refractive astigmatism at ≤0.25D, ≤0.50D, ≤0.75D, and ≤1.00D
Examining the distribution or remaining astigmatism in subjects
Time frame: 3 months
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