Clinical Outcomes of a Non-Diffractive Extended Depth-of-Focus IOL in Eyes with Mild Glaucoma

**Background:** Modern refractive cataract surgery increasingly uses presbyopia-correcting intraocular lenses (IOLs) to reduce spectacle dependence. However, patients with glaucoma have traditionally been considered poor candidates for such IOLs due to concerns about further reducing contrast sensitivity. The non-diffractive, wavefront-shaping extended depth-of-focus (EDOF) IOL (AcrySof IQ Vivity) uses X-WAVE technology to stretch and shift the wavefront without splitting light, aiming to provide a continuous range of vision with minimal photic phenomena and preserved contrast sensitivity. This study is the first to evaluate its use specifically in eyes with mild glaucoma.

**Methods:** This prospective, open-label, interventional study was conducted at a single site (Sioux Falls, SD) and approved by the University of South Dakota Institutional Board. It enrolled 52 eyes of 26 patients (mean age 69.4 ± 6.6 years; 54% female) with mild (pre-perimetric) open-angle glaucoma and visually significant cataracts. All patients were bilaterally implanted with the non-diffractive EDOF IOL (toric or non-toric). Seventy-seven percent (n=20) also received a trabecular microbypass stent (iStent inject) at the time of surgery. Exclusion criteria included secondary glaucoma, prior refractive surgery, or ocular comorbidities that could affect postoperative best-corrected visual acuity. Baseline testing included 24-2 SITA Fast Humphrey Visual Field, OCT retinal nerve fiber layer, and OCT macula. The refractive target was plano (0.00 D) in both eyes using Barrett Universal II/Barrett Toric Calculator. Primary outcome measures at the 4-month postoperative visit (range 3–5 months) included binocular corrected and uncorrected distance visual acuity (CDVA, UDVA) at 20 feet on ETDRS charts, uncorrected intermediate visual acuity (UIVA) at 66 cm, uncorrected near visual acuity (UNVA) at 40 cm, and mesopic contrast sensitivity using the Pelli-Robson chart. A subjective questionnaire adapted from the Patient Reported Spectacle Independence Questionnaire (PRSIQ) assessed satisfaction and spectacle independence.

**Key Results:** At 4 months, the mean binocular UDVA was 0.03 ± 0.12 LogMAR, with 85% (n=22) achieving ≥20/25 and 65% achieving ≥20/20. Mean CDVA was −0.06 ± 0.07 LogMAR, with 96% (n=25) achieving ≥20/20. Mean binocular UIVA was 0.17 ± 0.12 LogMAR, with 77% achieving ≥20/32 and 46% ≥20/25. Mean binocular UNVA was 0.31 ± 0.17 LogMAR, with 65% achieving J3 or better and 46% achieving J2 or better. Mean refractive spherical equivalent was −0.27 ± 0.35 D; 83% (n=43) were within ±0.50 D and 96% (n=50) within ±1.00 D. Mean binocular mesopic contrast sensitivity was 1.78 ± 0.17; 92% had ≥1.6 and 62% had ≥1.8. Mean intraocular pressure decreased from 18.5 ± 4.6 mmHg at baseline to 13.3 ± 2.9 mmHg at 4 months. On the subjective questionnaire, mean satisfaction score was 1.8 ± 1.2 (1=very satisfied, 5=very dissatisfied). Regarding glare/halos in dim light, mean response was 2.6 ± 1.3 (1=not at all, 5=extremely), with 65% reporting no or very little bother. Eighty-five percent (n=22) said they would choose the same lens again. Spectacle independence was high: 92% never wore glasses for daytime driving or TV; 50% never for computer use; 38% never for mobile phone use; and 8% never for reading small print.

**Clinical Implications:** This study demonstrates that the non-diffractive, wavefront-shaping EDOF IOL can be safely implanted in eyes with mild, pre-perimetric open-angle glaucoma, achieving favorable uncorrected distance and intermediate visual acuity, good contrast sensitivity (comparable to monofocal IOLs), and high patient satisfaction with low rates of photic phenomena. These findings challenge the traditional reluctance to use presbyopia-correcting IOLs in glaucoma patients, suggesting that this IOL may be a viable option for carefully selected patients with mild disease. Limitations include the lack of a control group, small sample size, exclusion of moderate-to-advanced glaucoma, and absence of pupillometry. Further studies with longer follow-up and comparison groups are warranted.