Pre-clinical methods to evaluate photic phenomena in intraocular lenses.

A new system and methodology are introduced to evaluate photic phenomena induced by different intraocular lens (IOL) technologies using a "see-through" IOL analyzer system in phakic subjects. Nineteen phakic subjects looked through the Groningen IOL Telescope type 1 (GIT1) system under different conditions. Four different IOL designs with different clinical levels of photic phenomena were evaluated by the subjects.

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), TECNIS PureSee™ 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.

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, TECNIS PureSee™ IOL, N = 60) or an enhanced monofocal control (Model ICB00, TECNIS Eyhance™ IOL, N = 57) 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.

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.

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.

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.

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.

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.