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A comparative evaluation of three extended depth of focus intraocular lenses

Published in Isofocal ISOPURE by Lesieur in 2023

Purpose: To compare the refractive and visual performance of three Extended Depth of Focus (EDOF) intraocular lenses (IOLs) after uncomplicated cataract surgery.

Setting: Centre IRIDIS, Albi, France.

Design: Comparative retrospective study.

Methods: Patients with cataracts and without other eye diseases were enrolled for monocular implantation of EDOF IOLs on the dominated eye by the same surgeon between 2018 and 2021, using either the IsoPure (BVI-PhysIOL, Belgium), the Synthesis+ (Cutting Edge, France), or the Lucidis (SAV-IOL, Swiss). Refraction, Uncorrected Distance Visual Acuity (UDVA), Corrected Distance VA (CDVA), Uncorrected Near VA (UNVA), Distance-Corrected Near VA (DCNVA), 25% Contrast CDVA, and Defocus Curve were assessed 3-months postoperatively.

Results: A total of 64 eyes of 64 patients were included in this study (IsoPure n = 22; Synthesis+ n = 20, Lucidis n = 22). CDVA, 25% Contrast CDVA and DCNVA were significantly better for Lucidis than IsoPure or Synthesis+. No significant difference was observed for CDVA and 25% Contrast CDVA between IsoPure and Synthesis+. DCNVA was significantly better for Lucidis and Synthesis+ with respectively 0.08 LogMAR ± 0,09 and 0.29 LogMAR ± 0.13, compared to 0.40 LogMAR ± 0.17 for IsoPure (p < 0.05).

Conclusions: Lucidis showed more efficient distance, low contrast, and near vision than IsoPure and Synthesis+. Synthesis+ seems to be more efficient in intermediate vision than other groups. Each EDOF IOLs provided good distance vision without creating spontaneous complaints of photic phenomena. Refractive EDOF IOLs, especially Lucidis, are efficient for patients wishing to improve their vision without dysphotopsia.

An innovative EDOF Isofocal technology

Published in Isofocal by Bilbao-Calabuig in 2020

Purpose: To clinically evaluate a new extended depth of focus intraocular lens (ISOPURE, PhysIOL) with optic design modification based on a unique polynomial concept to improve intermediate vision while keeping the quality of distance vision equal to a monofocal lens.

Methods: 18 patients (11 female, 7 male, mean age of 69.4 years) with bilateral cataract and regular corneal astigmatism ≤ 1.0 D underwent bilateral cataract surgery with ISOPURE implantation. Patients were followed for up to 6 months. Measured parameters were uncorrected (UDVA) and corrected distance visual acuity (CDVA), uncorrected (UIVA) and distance-corrected intermediate visual acuity at 80 cm and 66 cm (DCI80VA, DCI66VA) subjective refraction, defocus curve, tolerance of cylinder induction, and contrast sensitivity. The data from all implanted eyes (all-eyes) and a subset only including the first eye implanted for each patient were analysed.

Results: The mean manifest refraction spherical equivalent (MRSE) decreased from 1.05 D pre-operatively to 0.15 D at the 4 - 6 month assessment, with 80.6% of eyes within ±0.50 D of emmetropia. At the final follow-up, mean (SD) monocular CDVA was 0.06 (0.04) logMAR, DCI80VA was 0.18 (0.08) logMAR and DCI66VA was 0.27 (0.13) logMAR. Despite a cylinder induction of 0.50 D, uncorrected distance visual acuity of 0.02 logMAR was still achieved.

Conclusion: The ISOPURE intraocular lens provides excellent distance corrected visual acuity for far and intermediate distances along with high contrast sensitivity and good tolerance of residual refractive cylinder.

Clinical and Aberrometric Evaluation of a New Monofocal IOL with Intermediate Vision Improvement

Published in Isofocal ISOPURE by Bova in 2022

Purpose: The aim of the study was to evaluate the visual outcomes, aberrometric results, and subjective and objective optical qualities 12 months after implantation of a new monofocal intraocular lens (Physiol IsoPure 1.2.3) in comparison with a standard monofocal intraocular lens (Tecnis PCB00).

Materials and methods: Cataract patients without ocular comorbidities had bilateral implantation of the IsoPure IOL or the PCB00 IOL. One month after eye surgery, the visual acuity and monocular defocus curve were assessed. Twelve months after surgery, the visual acuity, binocular defocus curve, contrast sensitivity, and subjective/objective optical quality were assessed. Furthermore, wavefront analysis was performed. The primary endpoint was the best distance correct/uncorrected visual acuity at intermediate and far distances. The secondary endpoint was an aberration evaluation of the IOLs and contrast sensitivity.

Results: The study comprised a total of 42 patients (84 eyes). Monocular and binocular uncorrected and corrected distance were similar between groups, and uncorrected intermediate visual acuity was significantly higher in the IsoPure group. There was no difference in contrast sensitivity and subjective and objective optical qualities. The optical aberrations at 3.0 and 5.0 mm aperture diameters were similar in both groups.

Conclusion: The IsoPure IOL, based on greater depth of focus than the aspheric monofocal IOL, may offer a good option for the distance and intermediate vision without increasing optical aberrations and any photic phenomena.

Clinical Outcomes of a New Non-Diffractive Extended Depth-of-Focus Intraocular Lens Targeted for Mini-Monovision

Published in Isofocal ISOPURE by Tomagova in 2023

Purpose: To assess visual acuity, binocular defocus curve, spectacle independence, and photic phenomena after bilateral same-day cataract surgery with implantation of an extended depth-of-focus intraocular lens (IOL) with mini-monovision.

Methods: Single-center retrospective study including 124 eyes from 62 patients who underwent bilateral implantation of an isofocal EDOF lens [Isopure® (BVI)] with mini-monovision (-0.50 D). Refraction, visual acuity at different distances, binocular defocus curves, spectacle independence, and subjective ratings of picture-referenced photic phenomena were assessed one to two months postoperatively.

Results: The mean postoperative refractive spherical equivalent was -0.15±0.41D in the dominant eyes and -0.46±0.35D in the mini-monovision eyes (p<0.01). Overall, 98.4% and 87.7% of the eyes were within ±1.00D and ±0.50D of the target refraction, respectively. Postoperative monocular corrected distance visual acuity was -0.04±0.07 logMAR. Binocular uncorrected visual acuity was -0.02±0.07, 0.13±0.11and 0.40±0.20 logMAR for far, intermediate and near, respectively. At the visual acuity threshold of 0.20 logMAR (or better) the defocus curve ranged from -1.6D to +0.9D. Reported spectacle-independence was 96% for far distance, 95% for intermediate, and 34% for near. Five percent of patients reported halos, 16% starburst, and 16% glare. Only 7% of all patients considered them bothersome.

Conclusion: In patients undergoing same-day bilateral cataract surgery, an isofocal EDOF lens provided an extended range of functional vision, up to 63 cm, resulting in useful uncorrected near vision, good uncorrected intermediate vision, and excellent uncorrected distance vision. Subjective patient satisfaction in terms of spectacle independence and photic phenomena was high.

Enhanced Monofocal Intraocular Lenses: A Retrospective, Comparative Study between Three Different Models

Published in Isofocal ISOPURE by Mencucci in 2023

The purpose of this study was to compare the visual performance and optical quality between three new enhanced monofocal intraocular lenses (IOLs). This retrospective study included patients affected by cataracts with corneal astigmatism less than 0.75 D and no ocular comorbidities who underwent cataract surgery with bilateral implantation of Tecnis Eyhance ICB00 (Johnson & Johnson Vision Care, Inc., Jacksonville, FL, USA), Vivinex Impress XY1-EM (Hoya Surgical Optics, Singapore) or IsoPure 123 (PhysIOL, Liege, Belgium) IOLs. Three months postoperatively, monocular and binocular uncorrected and corrected distant, and intermediate and near visual acuities were measured. Binocular defocus curve, photopic contrast sensitivity, Point Spread Function (PSF), low order aberrations (LOAs), high order aberrations (HOAs), objective scatter index (OSI), halo and glare perception were also evaluated. This study included a total of 72 eyes from 36 patients. Visual acuity outcomes, PSF, LOAs, HOAs and OSI were similar between groups. There were no statistically significant differences in terms of photopic contrast sensitivity, halo or glare perception. In patients without ocular comorbidities, the Eyhance ICB00 IOL, the Vivinex Impress IOL and the Isopure IOL—even though based on different optical properties—provided similar results in terms of visual acuity, contrast sensitivity and intraocular aberrations, with no influence on photic phenomena.

Prospective Randomized Single-Masked Study of Bilateral Isofocal Optic-Design or Monofocal Intraocular Lenses

Published in Isofocal ISOPURE by Ang in 2023

Purpose: To assess refractive and visual outcomes of bilateral implantation of an isofocal optic-design intraocular lens (IOL) or a monofocal IOL following cataract surgery.

Methods: A total of 127 patients were recruited into a prospective, single-masked, randomized trial. Sixty-five patients bilaterally implanted with the Isopure Isofocal IOL and 62 patients with the Micropure Monofocal IOL were followed for 4-6 months. Refraction, monocular and binocular uncorrected-distance-visual acuity, corrected-distance-visual acuity (CDVA), uncorrected-intermediate-visual acuity and distance-corrected-intermediate-visual acuity (DCIVA, 66/80 cm), uncorrected-near-visual acuity, and distance-corrected-near-visual acuity (DCNVA, 40 cm) were evaluated. Binocular defocus curve, binocular contrast sensitivity (photopic, mesopic with/without glare), and glare and halo phenomena were also measured.

Results: 99.23% of eyes were within ±1.00D and 84.62% of eyes within ±0.50D for the Isopure patients and 98.39% and 82.26% for the Micropure patients, respectively. The mean spherical-equivalent was -0.06 ± 0.36D and 0.10 ± 0.32D for the Isopure and Micropure patients, respectively. 98.5% and 100% of patients implanted with the Isopure and Micropure IOLs showed a cumulative binocular CDVA value ≥20/20, respectively. 80% and 67.70% of patients implanted with the Isopure presented a binocular DCIVA ≥20/25 at 80 and 66 cm, respectively. These percentages were 46.8% and 40.3% with the Micropure IOL, respectively. For Isopure, 7.7%, 30.8%, and 58.5% of patients presented a DCNVA ≥20/25, ≥20/32 and ≥20/40, respectively. These values were lower for the Micropure: 1.6%, 19.4% and 46.8%, respectively. Defocus curves showed similar good visual acuity at distance for both lenses with better intermediate vision for the Isopure. Both groups presented good contrast sensitivity, and the size and intensity of halo and glare phenomena were similar between the two. No adverse-events were reported.

Conclusion: Our trial shows that both IOLs provide excellent visual acuity and contrast sensitivity for far vision with similar photic phenomena, and the Isopure IOL improved unaided intermediate vision performance.

Visual Performance at Different Distances After Implantation of an Isofocal Optic Design Intraocular Lens

Published in Isofocal by Bernabeu-Arias in 2023

Purpose: To evaluate refractive and visual outcomes at different distances after implantation of an isofocal optic design intraocular lens (IOL) following cataract surgery.

Methods: This multicentric, retrospective/prospective, open-label, observational study considered 183 eyes of 109 patients who were implanted with the ISOPURE 123 (PhysIOL) IOL. The main outcome measures were refractive error and monocular and binocular uncorrected distance visual acuity (UDVA), corrected distance visual acuity (CDVA), uncorrected intermediate visual acuity (UIVA), and distance-corrected intermediate visual acuity (DCIVA) at 66 and 80 cm, uncorrected near visual acuity (UNVA), and distance-corrected near visual acuity (DCNVA) at 40 cm. Binocular visual acuity at different vergences (defocus curve) was also measured. Patients were evaluated at least 120 days postoperatively.

Results: A total of 95.7% of the eyes were within ±1.00 diopter (D) and 73.2% of the eyes were within ±0.50 D; the mean postoperative spherical equivalent was -0.12 ± 0.42 D. There were 90.54% and 98.57% of patients presenting a cumulative binocular UDVA and CDVA value of 20/25 or better, respectively; 80.65% and 50.0% of patients presented a binocular DCIVA value of 20/25 or better at 80 and 66 cm, respectively; and 41.94% of patients presented a binocular DCNVA value of 20/40 or better. The through-focus curve showed good visual acuity at far and intermediate distances with a depth of focus value of 1.50 D. No adverse events were reported.

Conclusions: The current study shows that this isofocal optic design IOL provides excellent visual performance for far vision and functional intermediate vision with an extended range of vision. This lens is an effective option for providing functional intermediate vision and correcting aphakia.

Visual Performance of a Polynomial Extended Depth of Focus Intraocular Lens

Published in Isofocal ISOPURE by Stodulka in 2021

Purpose: To clinically evaluate a new extended depth of focus intraocular lens (ISOPURE, PhysIOL) with optic design modification based on a unique polynomial concept to improve intermediate vision while keeping the quality of distance vision equal to a monofocal lens.

Methods: 18 patients (11 female, 7 male, mean age of 69.4 years) with bilateral cataract and regular corneal astigmatism ≤ 1.0 D underwent bilateral cataract surgery with ISOPURE implantation. Patients were followed for up to 6 months. Measured parameters were uncorrected (UDVA) and corrected distance visual acuity (CDVA), uncorrected (UIVA) and distance-corrected intermediate visual acuity at 80 cm and 66 cm (DCI80VA, DCI66VA) subjective refraction, defocus curve, tolerance of cylinder induction, and contrast sensitivity. The data from all implanted eyes (all-eyes) and a subset only including the first eye implanted for each patient were analysed.

Results: The mean manifest refraction spherical equivalent (MRSE) decreased from 1.05 D pre-operatively to ?0.15 D at the 4 - 6 month assessment, with 80.6% of eyes within ±0.50 D of emmetropia. At the final follow-up, mean (SD) monocular CDVA was ?0.06 (0.04) logMAR, DCI80VA was 0.18 (0.08) logMAR and DCI66VA was 0.27 (0.13) logMAR. Despite a cylinder induction of ?0.50 D, uncorrected distance visual acuity of 0.02 logMAR was still achieved.

Conclusion: The ISOPURE intraocular lens provides excellent distance corrected visual acuity for far and intermediate distances along with high contrast sensitivity and good tolerance of residual refractive cylinder.