Monocular Corrected Distance Visual Acuity Research Articles

Clinical Comparison of a Small-Aperture Intraocular Lens Versus a Monofocal Control.

To evaluate range of visual acuity, visual quality, and safety of the IC-8 small-aperture (SA) intraocular lens (IOL) (Apthera; Bausch & Lomb, Inc) in patients with cataract. This was a prospective, multicenter, open-label, parallel-group, non-randomized, examiner-masked, 12-month clinical study conducted at 21 sites in the United States. Included patients (N = 453) received either the SA IOL (targeted to -0.75 diopters) in one eye and a monofocal or monofocal toric IOL (targeted to plano) in the fellow eye (SA IOL group, n = 343) or bilateral monofocal/monofocal toric IOLs (control group, n = 110). At 6 months, the SA IOL group achieved superior binocular uncorrected intermediate and near visual acuity (P < .0001) and equivalent binocular uncorrected distance visual acuity versus the control group. In SA IOL eyes, 99.1% achieved monocular corrected distance visual acuity of 0.3 logarithm of the minimum angle of resolution or better. The SA IOL and control groups had comparable binocular photopic and mesopic contrast sensitivities at 6 months both with and without glare. The SA IOL group reported few visual symptoms overall, although at higher rates than in the control group. The SA IOL group exhibited improved intermediate and near vision, comparable distance vision and binocular contrast sensitivities, and few visual symptoms or adverse events versus the bilateral monofocal/monofocal toric IOL group, suggesting that the SA IOL is an effective option for presbyopia correction at the time of cataract surgery. [J Refract Surg. 2024;40(11):e824-e835.].

Visual, Refractive, Functional, and Patient Satisfaction Outcomes After Implantation of a New Trifocal Diffractive Intraocular Lens.

To describe the visual, refractive, functional, and patient satisfaction outcomes of the Clareon® PanOptix® trifocal intraocular lens (IOL). This was a prospective longitudinal descriptive study. Patients who underwent cataract surgery with implantation of Clareon® PanOptix® (Alcon Laboratories, Inc.) were included. Monocular refractive outcomes and visual acuity at distance, intermediate, and near were evaluated 1- and 6-months post-op. Binocular contrast sensitivity (M&S® Technologies), binocular defocus curve, and patient satisfaction with the IOL Satisfaction (IOLSAT) and Questionnaire for Visual Disturbance (QUVID) questionaries were assessed at 6-month post-op. Seventy-six Clareon® PanOptix® were implanted bilaterally in 38 patients. The mean age of the patients was 67.63±5.18 years. At 1-month post-op, the monocular Corrected Distance Visual Acuity (CDVA), CIVA and CNVA were 0.00±0.09, 0.02±0.17, and 0.12±0.12 LogMAR, respectively, and CDVA and CNVA were stable at 6-month post-op (p>0.05). No statistical differences were found in post-op spherical equivalent at 1 and 6 months (-0.08±0.27 D and -0.05±0.24 D; p=0.351). A 100% of eyes were within ±0.5 D at 1 month and 6-month post-op. Binocular defocus curve shows three peaks of maximum visual acuity (VA) at 0D (-0.04±0.08 LogMAR), at -1.50D, and -2.50 D (0.01±0.10 LogMAR and 0.03±0.07 LogMAR, respectively). Contrast sensitivity decreased at high spatial frequencies. In patient satisfaction, IOLSAT questionary reveals 78.94% patients "Never" or "Rarely" Needing Glasses and according QUVID questionnaire, 100% of patients report no hazy vision. The PanOptix® IOL platform with the new material Clareon® provides good visual outcomes for distance, intermediate, and near vision, with adequate contrast sensitivity and low visual disturbances.

Three Patient-Reported Outcomes Questionnaires in Japanese Patients Undergoing Cataract Surgery with Trifocal IOL Implantation.

To analyze the patient-reported-outcomes obtained after trifocal intraocular lens (IOL) bilateral implantation in Japanese patients using three different validated questionnaires. Fifty-three patients implanted with the FineVision HP IOLs (Beaver-Visitec International, Inc. USA) were enrolled in this prospective-study. At 3-months, refraction (spherical equivalent [SE] and cylinder), logMAR uncorrected distance visual acuity (UDVA), and corrected distance visual acuity (CDVA) were obtained. Specifically, patient-reported-outcomes were evaluated using the NEI VFQ-25, the Catquest-9SF, and the PRSIQ questionnaires. The mean SE and refractive cylinder were 0.00±0.22D and -0.07±0.23D, respectively. A 98.11% of eyes were within ±0.50D and 100% were within ±1.00D of the SE. A 93.40% of the eyes showed equal or less than 0.50D of astigmatism and 100% of eyes equal or less than 1.00D. The mean value for monocular UDVA was -0.05±0.07 logMAR and the mean value for monocular CDVA was -0.07±0.06 logMAR. 87.74% and 92.45% of the eyes showed 20/20 or better monocular UDVA and CDVA, respectively, with 97.17% and 98.11% showing 20/25 or better for UDVA and CDVA, respectively. The NEI VFQ-25 outcomes showed very high scores across all categories, with mean general vision, distance and near activities values of 86.70±6.35, 96.23±7.72 and 92.14±10.74, respectively. The outcomes for the Catquest-9SF questionnaire showed that 90.57% of patients did not report difficulty in their everyday-life with their sight, and 100% of them were "very or quite satisfied" with their sight at present. The PRSIQ outcomes revealed that 100%, 98.11% and 98.11% of patients did not need glasses or contacts for far, intermediate and near vision, respectively. The results of the patient-reported-outcomes questionnaires indicated that patients implanted bilaterally with the FineVision HP IOL have high vision and health related quality-of-life scores, with a high spectacle independence rate and high patient satisfaction.

Visual Outcomes and Patient Satisfaction After Bilateral Refractive Lens Exchange With a Trifocal Intraocular Lens in 5,226 Patients With Presbyopia.

To assess visual and refractive outcomes and visual function after bilateral RayOne Trifocal toric and nontoric intraocular lens (IOL) (Rayner) implantation in patients with presbyopia. Charts of patients with presbyopia who underwent refractive lens exchange with bilateral implantation of the RayOne Trifocal IOL (toric and non-toric) were retrospectively reviewed. Visual and refractive outcomes were evaluated at 3 months. Patient satisfaction, spectacle independence, and visual disturbance profile were assessed by questionnaires. A total of 5,226 patients were assigned to one of two groups: 1,010 patients had toric IOL implantation (toric group) and 4,216 patients received the non-toric model (non-toric group). Mean ± standard deviation visual acuity at 3 months for the toric group was binocular uncorrected distance visual acuity (UDVA) of 0.07 ± 0.11 logMAR, monocular corrected distance visual acuity (CDVA) of 0.05 ± 0.07 logMAR, binocular uncorrected near visual acuity (UNVA) at 40 cm of 0.10 ± 0.09 logMAR, binocular uncorrected intermediate visual acuity (UIVA) at 40 cm of 0.13 ± 0.12 logMAR, postoperative spherical equivalent (SE) of -0.21 ± 0.47 diopters (D), and cylinder of -0.34 ± 0.40 D. The non-toric group had binocular UDVA of 0.04 ± 0.08 logMAR, monocular CDVA of 0.05 ± 0.07 logMAR, binocular UNVA of 0.10 ± 0.08 logMAR, binocular UIVA of 0.13 ± 0.11 logMAR, SE of -0.08 ± 0.38 D, and cylinder of -0.28 ± 0.34 D. No statistically significant differences were found in achieving spectacle independence and there were high levels of satisfaction in both groups. In this retrospective analysis with more than 5,000 patients, both the toric and non-toric RayOne Trifocal IOL models provided good visual performance at all distances, resulting in excellent levels of spectacle independence and patient satisfaction. [J Refract Surg. 2024;40(7):e468-e479.].

Visual and refractive outcomes after bilateral implantation of an enhanced monofocal intraocular lens: prospective study.

To evaluate visual and refractive outcomes, as well as patient satisfaction after bilateral implantation of an enhanced monofocal intraocular lens (IOL) with emmetropia as a target refraction. San Carlos Hospital, Madrid, Spain. Prospective, monocentric, noncomparative study. Adults 21 years or older suitable for cataract surgery and with corneal astigmatism <1.50 diopters (D) were bilaterally implanted with the RayOne EMV IOL and followed up for 3 months. Outcomes measures included refraction, monocular and binocular uncorrected distance visual acuity, corrected distance visual acuity (CDVA), uncorrected intermediate visual acuity, distance-corrected intermediate visual acuity (DCIVA), and defocus curve, aberrometry, and satisfaction. Visual symptoms were assessed using the CatQuest-9SF questionnaire. 50 eyes of 25 patients were included. At month 3, the mean manifest spherical equivalent was -0.39 ± 0.28 D, with all eyes within 1.00 D. Binocularly, uncorrected, at distance, 68% of patients could read ≤0.0 logMAR and 95% ≤0.2 logMAR; at intermediate 59% of patients could read ≤0.1 and 100% ≤0.2 logMAR. Mean monocular CDVA was -0.03 ± 0.06 logMAR and mean monocular DCIVA was 0.28 ± 0.07 logMAR. Binocular defocus curve demonstrated a visual acuity ≤0.2 logMAR over a 2 D range from +1.00 D to -1.25 D. Satisfaction was good in 96% of patients. Bilateral implantation of an enhanced monofocal IOL with emmetropia as a target provided excellent binocular CDVA and good DCIVA, with a high level of satisfaction.

Clinical Results of a Monofocal Aspheric Bitoric Intraocular Lens with Plate Haptics in Hyperopic Eyes.

To assess the refractive and visual outcomes of hyperopic and astigmatic eyes implanted with a monofocal, aspheric, bitoric intraocular lens (IOL) with plate haptics following cataract surgery. The study evaluated 51 eyes implanted with the AT TORBI 709M IOL (Carl Zeiss Meditec AG, Jena, Germany) during a follow-up of 12-months. Refractive error, rotational stability, monocular uncorrected distance visual acuity (UDVA), monocular corrected distance visual acuity (CDVA), and contrast sensitivity were analyzed at 1-, 6-, and 12-months post-surgery. At 12 months, the cumulative CDVA was 20/25 in 94.12% of eyes and 20/32 or better in 98.04%. The UDVA was the same as, or better than, the CDVA in 88.24% of eyes. The mean logMAR UDVA and CDVA values were 0.06 ± 0.11 and 0.00 ± 0.08, respectively. In addition, 92.16% of eyes were within ±0.50D and 98.04% were within ±1.00D of a spherical equivalent, and 86.27% of eyes had refractive astigmatism ≤0.50D and 100% were ≤1.00D. The mean spherical equivalent was 0.21 ± 0.31D and the mean refractive cylinder 0.34 ± 0.27D. The IOL rotation was 1.18 ± 1.35 degrees and all eyes had a rotation ≤5 degrees. The log contrast sensitivity functions were good and similar for all spatial frequencies during follow-up. Our results demonstrate that implantation of the AT TORBI 709M IOL in hyperopic and astigmatic eyes is effective and safe. The visual and refractive outcomes were good, showing excellent rotational stability.

Refractive Predictability of a Swept Source Optical Coherence Tomography Biometer in Long and Short Eyes Implanted with Extended Depth of Focus Intraocular Lenses.

To determine the refractive predictability of Argos (Movu, a Santec company) measurements and the Barrett Universal II formula in long and short eyes implanted with an extended depth of focus (EDOF) intraocular lens (IOL). This retrospective, non-interventional study included 86 eyes (55 long and 31 short) of 55 patients. Preoperative biometry was performed using the Argos. Preoperative IOL power formulas were the preprogrammed Barrett Universal II (BUII). Data were collected for refractive outcomes, postoperative prediction error (directional and absolute), and monocular corrected distance visual acuity (CDVA, Snellen). The mean absolute prediction error for BUII was 0.27 ± 0.26 D overall, 0.24 ± 0.20 D in long eyes, and 0.33 ± 0.33 D in short eyes. Overall, the percentage of eyes with ≤ 0.5 D prediction error was 84% for BUII. In long eyes, the percentage of eyes with ≤ 0.5 D prediction error was 90% for BUII. In short eyes, the percentage of eyes with ≤ 0.5 D prediction error was 74% for BUII. The percentage of eyes with ≤ 0.5 D of MRSE was 89% for long eyes and 94% for short eyes. Visual acuities were excellent in both long and short eyes, with > 90% of eyes 20/25 or better in each group. The prediction error of Argos using BUII was low in long and short eyes at one month after EDOF IOL implantation.

Digital Therapy for Visual Acuity and Binocular Function in Children with Anisometropic Amblyopia.

Amblyopia affects development of children's monocular vision and binocular function and becomes a largely intractable problem with increasing aging. This study is to investigate the binocular function and evaluate efficacy of digital therapy in children 8-13 years of age with anisometropic amblyopia. The patients in the digital therapy group performed the training with the digital amblyopia therapeutic software. The visual acuity and binocular function (perceptual eye position [PEP], suppression, and stereopsis) were examined at the first visit and 3-month post-treatment. Twenty-three cases in the control group and 25 cases in the digital therapy group were enrolled. The results revealed that 3-month digital therapy can effectively improve corrected distance visual acuity (CDVA) and improve the binocular function, including PEP, suppression, and second-order stereopsis in children with anisometropic amblyopia, 8-13 years of age. Digital therapy for amblyopia can effectively improve monocular CDVA of amblyopic eyes and binocular function in older children with anisometropic amblyopia.

Long-term trifocal toric intraocular lens outcomes in Asian eyes after cataract surgery.

To determine the visual and refractive outcomes of trifocal toric intraocular lens (IOL) implantation in Asian eyes with cataract and astigmatism. Asian Eye Institute, Makati City, Philippines. Prospective study. 187 eyes were implanted with the FineVision POD FT IOL and followed for 2 years. The measurements included subjective refraction, uncorrected distance visual acuity (UDVA), corrected distance visual acuity (CDVA), uncorrected intermediate visual acuity (UIVA), distance-corrected intermediate visual acuity (DCIVA), uncorrected near visual acuity (UNVA), distance-corrected near visual acuity (DCNVA), defocus curve, photopic and mesopic contrast sensitivity, and rotational stability. The mean spherical equivalent and cylinder values were, respectively, -0.07 ± 0.34 diopters (D) and -0.48 ± 0.31 D at the 2-year follow-up. At this same follow-up, 69.4% of patients had monocular CDVA and 79.3% had binocular UDVA ≤0.0 logMAR. For intermediate vision, monocular DCIVA reached 74.1%, while binocular UIVA was 86.2% ≤ 0.1 logMAR. Near vision showed 63% for monocular DCNVA and 70.7% for binocular UNVA ≤0.1 logMAR. The mean values at this follow-up were 0.02 ± 0.08, 0.08 ± 0.10, and 0.10 ± 0.12 logMAR for CDVA, DCIVA, and DCNVA, respectively. At the visual acuity threshold of ≤0.20 logMAR, the binocular defocus curve extended up to -3.75 D. Stable contrast sensitivity values were obtained at the different follow-ups. The mean IOL rotation was ≤2 degrees. The FineVision POD FT IOL yielded good visual outcomes at far, near, and intermediate distances with accurate refractive outcomes and good rotational stability in Asian eyes.

First European results of a new refractive lenticular extraction procedure-SmartSight by SCHWIND eye-tech-solutions.

To evaluate vision 3 months after SmartSight lenticule extraction treatments. Case series. This case series of patients were treated at Specialty Eye Hospital Svjetlost in Zagreb, Croatia. Sixty eyes of 31 patients consecutively treated with SmartSight lenticule extraction were assessed. The mean age of the patients was 33 ± 6 years (range 23-45 years) at the time of treatment with a mean spherical equivalent refraction of -5.10 ± 1.35 D and mean astigmatism of 0.46 ± 0.36 D. Monocular corrected distance visual acuity (CDVA), uncorrected distance visual acuity (UDVA) were assessed pre- and post-operatively. Ocular and corneal wavefront aberrations have been postoperatively compared to the preoperative baseline values. Changes in ocular wavefront refraction, as well as changes in keratometric readings are reported. At 3 months post-operatively, mean UDVA was 20/20 ± 2. Spherical equivalent showed a low myopic residual refraction of -0.37 ± 0.58 D with refractive astigmatism of 0.46 ± 0.26 D postoperatively. There was a slight improvement of 0.1 Snellen lines at 3-months follow-up. Compared to the preoperative status, ocular aberrations (at 6 mm diameter) did not change at 3 months follow-up; whereas corneal aberrations increased (+0.22 ± 0.21 µm for coma; +0.17 ± 0.19 µm for spherical aberration; and +0.32 ± 0.26 µm for HOA-RMS). The same correction was determined using changes in ocular wavefront refraction, as well as changes in keratometric readings. Lenticule extraction after SmartSight is safe and efficacious in the first 3 months postoperatively. The post-operative outcomes indicate improvements in vision.

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

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. 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. 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. 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.

Visual performance, safety and patient satisfaction after bilateral implantation of a trifocal intraocular lens in presbyopic patients without cataract

BackgroundThe aim was to evaluate the safety and efficacy of a trifocal intraocular lens (IOL) for the correction of presbyopia and to assess patient satisfaction.MethodsRecords from three centres were reviewed to select presbyopic patients having undergone bilateral refractive lens exchange and implantation of the AT LISA tri 839MP multifocal IOL. Postoperatively, monocular and binocular distance, intermediate and near visual acuities, corrected and uncorrected, and subjective refraction were measured. Patients also completed a quality of life questionnaire. Safety evaluation included IOL stability and postoperative complications.Results72 eyes (36 patients) were analysed. No clinically significant difference between pre- and postoperative corrected distance visual acuity (CDVA) was found for monocular or binocular measurements. Mean postoperative monocular CDVA was 0.02 ± 0.04 logMAR. Mean refractive values all improved statistically significantly compared with preoperative baseline (p ≤ 0.0064). Overall, 82.4% of eyes had spherical equivalent within ± 0.5 D and 97.1% within ± 1.0 D of emmetropia with a mean accuracy of -0.10 ± 0.41 D. Spectacle independence for distance, intermediate and near visual acuity was 87.5%, 84.4% and 78.1% respectively, and 78.1% of patients were satisfied with their postoperative, spectacle-free vision. Eight eyes received Nd:YAG laser treatment. No other IOL-related safety issues were reported.ConclusionAT LISA tri 839MP multifocal IOL bilaterally implanted in presbyopic patients provided excellent distance, intermediate and near visual outcomes with very accurate correction of refraction. These results were associated with a high level of spectacle independence and patient satisfaction.Trial registrationTrial registered on https://clinicaltrials.gov/ under the identification NCT03790592 (31/12/2018).

Refractive and Visual Outcomes of a Monofocal Non-Constant Aberration Aspheric Intraocular Lens.

PurposeTo evaluate the refractive and visual outcomes following cataract surgery and implantation of a new monofocal non-constant aberration aspheric intraocular lens (IOL).MethodsNinety eyes of 86 patients who underwent implantation the CT LUCIA 621P IOL (Carl Zeiss Meditec AG) were retrospectively analyzed in this study. Main outcome measures were refractive error and monocular corrected distance visual acuity (CDVA) and monocular uncorrected distance visual acuity (UDVA) values. Patients were evaluated at 1-month post-surgery and intra- and post-operative complications were recorded.ResultsEighty percent of the eyes showed a CDVA of 20/25 or better before surgery. The postoperative mean values of monocular distance Snellen decimal UDVA and CDVA were 0.64±0.22 and 0.89±0.13, respectively. All eyes showed the same or better difference between UDVA and CDVA. In relation to the postoperative spherical equivalent, the highest percentage of eyes, 31.11%, was for the range between −0.50 and −0.14D followed by 22.22% for the ±0.13D range. Ninety percent of the eyes were within ±1.00 D and 73.33% of eyes within ±0.50 D. The mean postoperative spherical equivalent was −0.18±0.55D. 37.78% and 76.67% of the eyes showed a value ≤0.50 D and ≤1.00D, respectively, being the mean postoperative refractive cylinder −0.81±0.50D. No adverse events were reported in whole sample intra and postoperatively.ConclusionThe present study shows that cataract surgery with an monofocal non-constant aberration aspheric IOL implantation resulted in good visual performance and refractive outcomes. This lens may be considered as a valid choice for patients in a standard-routine cataract surgery practice.

Femtosecond laser-assisted anterior capsulotomy in children undergoing cataract surgery: a large case series

ObjectiveTo evaluate safety and postoperative visual outcomes of low-energy femtosecond laser-assisted (FLA) anterior capsulotomy in paediatric cataract surgery.Methods and analysisWe report a retrospective single-centre consecutive case series of 51 eyes...

Twelve-month outcomes of a new refractive lenticular extraction procedure

BackgroundTo evaluate the 12-month refractive and visual outcomes of Small Incision Guided Human-cornea Treatment (SmartSight®, SCHWIND eye-tech-solutions, Kleinostheim, Germany) in the treatment of myopia corrections with low to moderate astigmatism with the use of a new femtosecond laser system. Methods221 eyes of 114 patients consecutively treated with SmartSight lenticule extraction were assessed. The mean age of the patients was 28±6 years at the time of treatment with a mean spherical equivalent refraction of -6.26±2.17D and mean astigmatism of 0.92±0.68D. Monocular corrected distance visual acuity (CDVA), uncorrected distance visual acuity (UDVA) were assessed pre- and post-operatively. Refractive changes have been determined in terms of changes in refraction, as well as changes in keratometric readings. The changes in central epithelial thickness have been determined. ResultsAt twelve months post-operatively, mean UDVA was 20/21±2. Spherical equivalent showed a residual refraction of +0.48±0.31D with refractive astigmatism of 0.13±0.18D postoperatively. There was a slight decrease of -0.1 Snellen lines at 12-months follow-up. The same correction was determined using changes in refraction, as well as changes in keratometric readings. The central epithelial thickness increased by +3±2µm. Spherical equivalent correction within ±0.50D was achieved in 199 eyes (90%), and cylindrical correction in 221 (100%). Preoperative corrected distance visual acuity (CDVA) was 20/20 or better in 213 eyes (96%), and postoperative uncorrected (UDVA) was 20/20 or better in 205 eyes (93%). No eye had lost two or more Snellen lines of CDVA. ConclusionsMyopic astigmatism correction with SmartSight provided good results for efficacy, safety, predictability, and visual outcomes at the twelve months of follow up. The central epithelial thickness barely increased by 3±2µm.

Effectiveness and Safety of the Clareon Monofocal Intraocular Lens: Outcomes from a 12-Month Single-Arm Clinical Study in a Large Sample.

PurposeThis study assessed effectiveness and safety of the novel Clareon intraocular lens (IOL; model SY60CL; Alcon Vision LLC).Patients and MethodsThis was a prospective, single-arm, unmasked clinical trial at 16 investigative clinical sites in the United States. Included were adults ≥22 years who required cataract extraction by phacoemulsification. Following phacoemulsification, 350 subjects received SY60CL IOL unilaterally; 342 completed the study. Monocular best corrected distance visual acuity (CDVA) and uncorrected distance visual acuity (UDVA) were evaluated. The primary effectiveness endpoint was the percentage of subjects with CDVA ≤0.3 logMAR at month 12. Safety was assessed by monitoring adverse events (AEs). Visual acuity and safety outcomes were compared with historical safety and performance endpoint (SPE) rates.ResultsAt 12 months post-implantation, 99.7% of subjects receiving the SY60CL IOL achieved monocular CDVA ≤0.3 logMAR (primary effectiveness endpoint; 1-sided 95% upper confidence limit >SPE rate); 99.7% and 86.8% of subjects achieved monocular CDVA of ≤0.34 (20/40 Snellen or better) and ≤0.04 logMAR (20/20 Snellen or better), respectively. At 12 months, >95% of subjects achieved mean monocular UDVA ≤0.3 logMAR; 97.1% and 57.6% of subjects achieved monocular CDVA of ≤0.34 and ≤0.04 logMAR, respectively. Mean monocular CDVA and UDVA were −0.05 and 0.04 logMAR, respectively. AEs were within SPE limits. The most common nonserious ocular AE was posterior capsule opacification (5.4%). Serious AEs were <1%, and no serious ocular AEs were assessed as related to the device. There were no observations for IOL glistenings at 12 months.ConclusionResults of this study supported effectiveness and safety of the SY60CL IOL. Visual acuity outcomes with the SY60CL IOL exceeded the SPE rates for monocular CDVA and AEs were within the limit of historic SPE rates. (Model number SY60WF is the Clareon lens approved by the FDA.)

Vision outcomes with a new monofocal IOL.

The aim of this study was to compare the distance, intermediate, and near visual performance of a new IOL (ICB00, Eyhance, Tecnis) and classic monofocal IOL (SN60WF IQ AcrySof, Alcon) after unilateral implantation. Sixty-three patients were unilaterally implanted with the ICB00 Eyhance IOL (study group) and 65 patients with the SN60WF IQ AcrySof (control group). Visual performance was assessed with monocular corrected distance visual acuity (CDVA) and uncorrected distance visual acuity (UDVA) at 4m, corrected intermediate visual acuity (CIVA) and uncorrected intermediate visual acuity (UIVA) at 60cm, and corrected near visual acuity (CNVA) and uncorrected near visual acuity (UNVA) at 40cm. CDVA, UDVA, CNVA, and UNVA values did not differ significantly between the study and control groups (0.02 ± 0.02 vs. 0.03 ± 0.02, p = 0.523; 0.05 ± 0.13 vs. 0.05 ± 0.15, p = 0.637; 0.46 ± 0.17 vs. 0.46 ± 0.15, p = 0.821; and 0.47 ± 0.21 vs. 0.49 ± 0.25, p = 0.612; respectively), whereas the study group showed significantly better results for CIVA (0.28 ± 0.12 vs. 0.38 ± 0.13, p = 0.001) and UIVA (0.31 ± 0.16 vs. 0.41 ± 0.12, p = 0.001). The Eyhance IOL, which features a new optical design based on a continuous power profile, was determined to be superior to a classic monofocal IOL for intermediate visual acuity and not inferior for corrected and uncorrected distance and near visual acuity.

Visual Performance of a Polynomial Extended Depth of Focus Intraocular Lens

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 safety and efficacy of a hydrophilic acrylic intraocular lens in a real-world population: a 1-year follow-up retro-prospective study

BackgroundThis multicentre, retro-prospective real-world study evaluated the visual, refractive and safety outcomes of a monofocal lens 1 year after implantation in cataract patients with or without pre-existing ocular pathologies.MethodsRecords from 4 centres in Germany and Sweden were reviewed to select eyes with aged-related cataracts, having undergone crystalline lens extraction by phacoemulsification and implantation of a CT ASPHINA 409 IOL. Preoperative, 1-month and 3-month postoperative data was collected retrospectively. In addition, included patients attended a prospective visit 12 months or later after surgery. The examination included: monocular uncorrected (UDVA) and corrected distance visual acuity (CDVA), subjective refraction, slit-lamp examination, optical biometry, intraocular pressure (IOP), endothelial cell count and postoperative complications.Results282 eyes, including 94 with pre-existing ocular pathologies, were analysed. Twelve months after the surgery, 95% of eyes achieved monocular CDVA equal or better than 0.3 logMAR, mean postoperative CDVA was 0.06 ± 0.17 logMAR, and mean UDVA 0.31 ± 0.29 logMAR. Visual acuity outcomes were better in eyes with no pre-existing ocular pathologies, but both groups showed a statistically significant improvement after surgery compared with preoperative values (p ≤ 0.002). The mean sphere and spherical equivalent values also improved significantly postoperatively (p = 0.003). Overall, 62.1% of eyes had spherical equivalent within ±0.5 D and 80.9% within ±1.0 D. The IOL was stable in the capsular bag as demonstrated by tilt and decentration measurements. IOP, corneal status, and endothelial cell count values were in the normal range. Nd:YAG treatment was performed on 9.9% of the eyes.ConclusionThe implantation of the monofocal CT ASPHINA 409 IOL was beneficial to restore vision in eyes with or without concomitant ocular pathology such as macular degeneration, glaucoma, Sicca syndrome, epiretinal membrane, cornea guttata, or amblyopia. Good to excellent long-term visual and refractive outcomes, and a low rate of complications in both healthy and pathological eyes were found 12 months after the surgery.Trial registrationTrial registered on under the identification NCT03145103 (date of registration 9 May 2017).

Innovative trifocal (quadrifocal) presbyopia-correcting IOLs: 1-year outcomes from an international multicenter study.

To evaluate visual acuity (VA) and safety of the new AcrySof IQ PanOptix presbyopia-correcting IOL at 12 months postimplantation. Seventeen sites in Europe, Australia, and South America. Prospective, single-arm, nonmasked, nonrandomized study. Of 167 patients enrolled, 149 received study IOLs in both eyes; 145 completed the study. Binocular uncorrected distance VA (UDVA; 4 m), monocular corrected distance VA (CDVA), binocular distance-corrected intermediate VA (DCIVA; 60 cm and 80 cm), binocular uncorrected near VA (UNVA; 40 cm), and binocular defocus curves were evaluated. Safety was assessed by monitoring adverse events (AEs). Of 149 patients, 92 patients (62%) were women and 139 patients (93%) were white; mean ± SD age was 68.9 ± 9.3 years. At 12 months, mean binocular UDVA was 0.02 ± 0.11 logarithm of the minimum angle of resolution (logMAR); monocular CDVA was 0.01 ± 0.13 logMAR (first eye) and 0.01 ± 0.10 logMAR (second eye); binocular DCIVA was 0.04 ± 0.12 logMAR and 0.08 ± 0.14 logMAR at 60 cm and 80 cm, respectively; and binocular UNVA was 0.07 ± 0.11 logMAR. At 6 months, mean binocular defocus curve VA (0.00 diopter [D] to -3.00 D) ranged from -0.04 to 0.13 logMAR. Binocular VA at distance (0.00 D), intermediate (-1.50 D), and near (-2.50 D) was -0.04 ± 0.11 logMAR, 0.07 ± 0.13 logMAR, and 0.07 ± 0.13 logMAR, respectively. Serious ocular AE rates were 1.4% or less in first and second eyes. Posterior capsulotomy rates were 3.4% (first eye) and 2.7% (second eye). The study IOL provided good VA outcomes. Defocus curve showed VA of 20/25 Snellen or better from near to intermediate distance. Rates of serious and nonserious AEs were low.