Quality of vision clinical outcomes for a new fully-refractive extended depth of focus Intraocular Lens.

BACKGROUND/OBJECTIVE: To evaluate the visual performance of a purely refractive extended depth of focus (EDF) intraocular lens (IOL). SUBJECTS/METHODS: A prospective, multi-center, randomized, subject/evaluator-masked study. Subjects were bilaterally implanted with the EDF test (Model ZEN00V, N = 60) or an enhanced monofocal control (Model ICB00, N = 57) IOL. Monocular corrected distance (CDVA), intermediate (DCIVA), near acuities (DCNVA) and patient reported visual symptoms were evaluated at the 6-month visit. Monocular mesopic contrast sensitivity (CS) and depth of focus (DOF) testing were assessed at 3 months. RESULTS: CDVA (Mean ± SD) was -0.06 ± 0.08 for test and -0.05 ± 0.08 logMAR for control groups. DCIVA was 0.13 ± 0.08 for test and 0.18 ± 0.14 logMAR for control groups (p = 0.0127). DCNVA was 0.37 ± 0.10 for test and 0.43 ± 0.16 logMAR for control groups (p = 0.0137). Test lens was statistically superior for intermediate and near. Overall, 91.7% (halos), 95.0% (starbursts) and 95.0% (glare) of test lens patients reported that they did not experience, were not bothered, or were slightly bothered by specific visual symptoms, compared to 98.2%, 100% and 96.5% in the control group. The DOF range over which monocular visual acuity was 0.20 logMAR or better was -1.6 D for the test lens. Mesopic CS was comparable between both groups, falling within 0.11 log units for all measured cycles per degree with and without glare. CONCLUSION: The EDF IOL demonstrated extended range of vision and statistically superior intermediate and near performance compared to the monofocal IOL. Distance visual acuity, contrast sensitivity and dysphotopsia profile were similar to the monofocal IOL.

Tolerance to refractive error with a new extended depth of focus intraocular lens.

PURPOSE: To evaluate the tolerance to refractive errors of a new purely refractive extended depth of focus (EDF) intraocular lens (IOL) using preclinical and clinical metrics. METHODS: Preclinical evaluation included computer simulations of visual acuity (sVA) and dysphotopsia profile of different IOL designs (refractive EDF, diffractive EDF, multifocal, standard, and enhanced monofocals) using an appropriate eye model with and without ±0.50 D defocus and/or +0.75 D of astigmatism. Patients bilaterally implanted with a refractive EDF (Model ZEN00V) or an enhanced monofocal (Model ICB00) IOL from a prospective, randomized study were included. At the 6-month postoperative visit, uncorrected and corrected distance vision (UDVA and CDVA), visual symptoms, satisfaction and dependency on glasses were evaluated in a subgroup of patients with absolute residual refractive error of >0.25 D in one or both eyes. RESULTS: In the presence of defocus and astigmatism, sVA was comparable for all except the multifocal IOL design. The refractive EDF was more tolerant to myopic outcomes and maintained a monofocal-like dysphotopsia profile with defocus. Binocular logMAR UDVA was -0.03 ± 0.08 for ZEN00V and -0.02 ± 0.11 for ICB00. 100% ZEN00V and 97% ICB00 patients did not need glasses and were satisfied with their distance vision. Monocular CDVA, contrast sensitivity and visual symptoms were also similar between both groups. CONCLUSIONS: The clinical outcomes of the refractive EDF IOL demonstrated high quality distance vision and dysphotopsia comparable to a monofocal IOL, even in the presence of refractive error, thus matching the design expectations of the EDF IOL.

Post-Market Evaluation of Rotational Stability and Visual Performance of a New Toric Intraocular Lens with Frosted Haptics.

Purpose: To evaluate 3-month rotational stability, and visual and refractive outcomes of a toric intraocular lens (IOL) with frosted haptics. Patients and Methods: A post-market, prospective, multi-center, single-arm, open-label study conducted at seven clinical sites in the United States. Two hundred and two eyes of 133 subjects with unilateral or bilateral cataracts and corneal astigmatism were implanted with the Tecnis Toric II IOL, Models ZCU150 to 600 (Johnson & Johnson Surgical Vision, Inc.). Lens axis misalignment/rotation, visual acuity, manifest refraction, and surgeon and patient satisfaction were evaluated 3 months postoperatively. Lens rotation was determined with operative and postoperative visit photographs and was analyzed by two independent masked analysts. Results: Mean absolute lens rotation was 0.82° ± 1.00° and 0.94° ± 0.71° at 1 day (n = 189 eyes) and 3 months (n = 185 eyes), respectively. Absolute lens rotation was ≤5° in 98.9% and 100% of eyes at 1 day and 3 months, respectively. At 3 months, postoperative monocular uncorrected and corrected distance visual acuities were 0.004 ± 0.115 LogMAR (20/20) and -0.066 ± 0.092 LogMAR (20/17), mean spherical equivalent was -0.25 D ± 0.35 D and residual refractive cylinder was +0.27 D ± 0.33 D. Surgeons were satisfied/very satisfied with overall clinical outcomes and rotational stability in 99% of eyes, and with uncorrected distance vision in 98.5% of eyes. Conclusion: The study results demonstrate that the Tecnis Toric II IOL has excellent rotational stability with a high percentage of study eyes being within 5° of intended orientation. The study lens demonstrated excellent uncorrected distance visual acuity, reduction of cylinder, and exceptional patient and surgeon satisfaction.

Reproducibility of the Magnitude of Lens Rotation Following Implantation of a Toric Intraocular Lens with Modified Haptics.

Purpose: To evaluate the reproducibility of magnitude of postoperative IOL rotation following implantation of a toric intraocular lens (IOL) with modified haptics, in comparison with a Proof-of-Concept (POC) study of prototype IOLs featuring the same haptic design. Patients and Methods: A post-market, prospective, multicenter, single-arm, open-label clinical study was conducted. TECNIS Toric II IOL (Johnson & Johnson Vision, Irvine, CA, USA, Models ZCU150 to 600) were implanted in 125 subjects and evaluated at 1-day and 1-week postoperatively. An objective photographic method was used to determine postoperative IOL rotation. Uncorrected distance visual acuity (UCDVA), postoperative astigmatism, and surgeon satisfaction were also assessed. Rotation data were compared to the POC study in which two prototype non-toric monofocal IOLs, one with the same haptic design as Model ZCU, were studied. Results: Mean absolute rotation was 0.82° ± 1.0° and 0.84° ± 0.92°at 1-day and 1-week visits, respectively. The percentage of eyes with ≤5° of absolute rotation was 98.9% and 99.5% at the 1-day and 1-week visits, respectively. The magnitude of rotation was similar to the POC study prototype IOLs. At 1-week, mean monocular UCDVA was 0.026 ± 0.135 (~20/21) logMAR and mean residual manifest refractive cylinder was 0.30 D ± 0.35 D. The mean signed axis difference (postoperative minus operative) of the TECNIS Toric II IOL was 0.23° ± 1.27° at 1-day and -0.07° ± 1.25° at 1-week, indicating a clockwise drift. At 1-week, surgeons were very satisfied or satisfied with overall clinical outcomes and rotational stability in 98% of implanted eyes. Conclusion: The TECNIS Toric II IOL, with frosted, squared haptics, demonstrated low magnitude of postoperative IOL rotation, excellent uncorrected distance vision, and minimal residual astigmatism. The POC study design was supported, demonstrating that prototype non-toric monofocal IOLs can predict clinical performance of toric IOLs with the same haptic design.

Prospective multicenter trial of a small-aperture intraocular lens in cataract surgery.

PURPOSE: To evaluate the clinical acceptability of monocular implantation of the small-aperture (IC-8) intraocular lens (IOL) in 1 eye and an aspheric monofocal IOL in the fellow eye of bilateral cataract patients over 6 months postoperatively. SETTING: Twelve clinics in Austria, Belgium, Germany, Italy, Spain, and Norway. DESIGN: Prospective case series. METHODS: The visual acuity, depth of focus, contrast sensitivity, patient satisfaction, visual symptoms, and adverse events were assessed in patients who had bilateral cataract surgery followed by implantation of the small-aperture IOL in 1 eye and an aspheric monofocal IOL in the fellow eye. Uncorrected distance (UDVA), intermediate (UIVA), and near (UNVA) visual acuities were reported in Snellen notation. RESULTS: The study comprised 105 patients. At 6 months, the UDVA, UIVA, and UNVA in eyes with the small-aperture IOL were 20/23, 20/24, and 20/30, respectively. Ninety-nine percent, 95%, and 79% of patients achieved 20/32 or better binocular UDVA, UIVA, and UNVA, respectively. Ninety-three patients (95.9%) reported they would have the procedure again versus 4 patients (4.1%) who reported they would not have the procedure again. In eyes with the small-aperture IOL, the target-corrected defocus curve measured with 0.75 diopter (D) of myopia extended the range of functional near vision by an additional diopter without loss of distance vision compared with the distance-corrected defocus curves. The mean UIVA and UNVA remained at 20/25 and 20/32, respectively, for up to 1.5 D of residual astigmatism in eyes with the small-aperture IOL. CONCLUSION: The small-aperture IOL showed excellent visual performance, safety, patient satisfaction, and tolerance to residual astigmatism 6 months after implantation.

Contrast Sensitivity in Patients With Emmetropic Presbyopia Before and After Small-Aperture Inlay Implantation.

PURPOSE: To develop a normative contrast sensitivity function and examine the postoperative contrast sensitivity outcomes for emmetropic patients with presbyopia implanted with a KAMRA intracorneal inlay (AcuFocus Inc., Irvine, CA) in their non-dominant eyes. METHODS: A prospective, non-randomized, multicenter clinical trial was conducted on 507 patients between 45 and 60 years of age who were monocularly implanted with the KAMRA inlay. A predetermined subgroup of 335 patients in the contrast sensitivity substudy were measured preoperatively and postoperatively with the Functional Acuity Contrast Test (FACT) chart in the Optec 6500 Vision Tester (Stereo Optical Co., Chicago, IL) under monocular and binocular, photopic and mesopic without glare, and binocular mesopic with glare conditions each over four spatial frequencies (3, 6, 12, and 18 cycles per degree for photopic conditions and 1.5, 3, 6, and 12 cycles per degree for mesopic conditions). Normative ranges were developed using 1.96 standard deviations from the preoperative mean logCS (log10 unit of contrast sensitivity). RESULTS: The preoperative contrast sensitivity measurements were used to develop the normative contrast sensitivity curves. Postoperatively, contrast sensitivity was stable both monocularly and binocularly and average contrast sensitivity remained within the normative ranges. Postoperative contrast sensitivity was mildly reduced monocularly but not binocularly, and the ratio of area under logCS function comparing postoperative to preoperative values was above 90% for all but one condition. CONCLUSIONS: Normative contrast sensitivity curves for a presbyopic population are established to provide a referent in the investigation of the impact of other presbyopia-correcting ophthalmic procedures on contrast sensitivity. [J Refract Surg. 2016;32(6):386-393.].

The Small-Aperture IC-8 Intraocular Lens: A New Concept for Added Depth of Focus in Cataract Patients.

PURPOSE: To evaluate visual performance of subjects implanted monocularly with a small-aperture hydrophobic intraocular lens (IC-8 IOL). DESIGN: A prospective, noncomparative, multicenter case series. METHODS: A series of 12 patients, presenting for cataract surgery, were implanted monocularly with a single-piece hydrophobic acrylic intraocular with a centrally located opaque annular mask measuring 3.23 mm in total diameter with a 1.36 mm central aperture. Uncorrected distance, intermediate, and near visual acuities (UDVA, UIVA, and UNVA); depth of focus; and subjective symptoms were evaluated for 12 months after implantation. Mean ± standard deviation visual acuity is reported in logMAR. RESULTS: The mean monocular UDVA, UIVA, and UNVA improved significantly from 0.42 ± 0.18, 0.52 ± 0.22 and 0.66 ± 0.23 preoperatively to 0.06 ± 0.08 (P < .0001), 0.07 ± 0.11 (P < .0001), and 0.11 ± 0.15 (P < .0001) at 1 month, respectively, and remained stable until 12 months. At 12 months, 100%, 100%, and 92% of patients achieved 20/32 or better binocularly for UDVA, UIVA, and UNVA, respectively. One hundred percent of eyes maintained 20/40 or better visual acuity over a range of +0.50 diopter to -1.50 diopters of defocus. Subjects implanted with the IC-8 IOL perceived a small magnitude of visual symptoms and rated their symptoms on the lower end of the severity scale. CONCLUSION: Early results demonstrate that monocular IC-8 intraocular lens implantation provides a continuous, broad range of vision and excellent acuity across all focal distances.

Comparison of Contrast Sensitivity and Through Focus in Small-Aperture Inlay, Accommodating Intraocular Lens, or Multifocal Intraocular Lens Subjects.

PURPOSE: To compare monocular and binocular mesopic contrast sensitivity and through focus following monocular implantation with KAMRA small-aperture inlay (AcuFocus, Irvine, California, USA) vs binocular implantation with an accommodating or multifocal intraocular lens (IOL) implant. DESIGN: Three-treatment randomized clinical trial of presbyopia-correcting IOLs with comparison to results from a previous nonrandomized multicenter clinical trial on the KAMRA corneal inlay. METHODS: Study population of 507 subjects with KAMRA inlays; predetermined subgroups included 327 subjects that underwent contrast sensitivity testing and another 114 subjects for defocus curve testing, along with 78 subjects randomized between bilateral Crystalens Advanced Optics (AO) (Bausch + Lomb Surgical, Aliso Viejo, California, USA), AcrySof IQ ReSTOR +3.0 D (Alcon Laboratories, Fort Worth, Texas, USA), or Tecnis +4D Multifocal (MF) (Abbott Medical Optics, Santa Ana, California, USA) IOL. RESULTS: KAMRA inlay subjects demonstrated improved intermediate and near vision with minimal to no change to distance vision, better contrast sensitivity in the inlay eye when compared to the multifocals, and better binocular contrast sensitivity when compared to all 3 intraocular lenses. Crystalens AO was superior in uncorrected intermediate vision compared to the KAMRA inlay, but not in distance-corrected intermediate, and was worse in near vision. The multifocals were superior in near vision at their respective optimum near focus points, but worse in intermediate vision compared to both KAMRA inlay and Crystalens AO. CONCLUSIONS: The demonstrated performance of these devices should be considered, along with subjects' visual demands and expectations, degree of crystalline lens dysfunction, and other ocular characteristics, in guiding the selection of small-aperture corneal inlay or specific intraocular lens in the correction of presbyopia.

The perceived visual direction of monocular objects in random-dot stereograms is influenced by perceived depth and allelotropia.

The proposed influence of objects that are visible to both eyes on the perceived direction of an object that is seen by only one eye is known as the "capture of binocular visual direction". The purpose of this study was to evaluate whether stereoscopic depth perception is necessary for the "capture of binocular visual direction" to occur. In one pair of experiments, perceived alignment between two nearby monocular lines changed systematically with the magnitude and direction of horizontal but not vertical disparity. In four of the five observers, the effect of horizontal disparity on perceived alignment depended on which eye viewed the monocular lines. In additional experiments, the perceived alignment between the monocular lines changed systematically with the magnitude and direction of both horizontal and vertical disparities when the monocular line separation was increased from 1.1 degrees to 3.3 degrees . These results indicate that binocular capture depends on the perceived depth that results from horizontal retinal image disparity as well as allelotropia, or the averaging of local-sign information. Our data suggest that, during averaging, different weights are afforded to the local-sign information in the two eyes, depending on whether the separation between binocularly viewed targets is horizontal or vertical.