Binocular Corrected Distance Visual Acuity Research Articles

Visual performance and patient preference with bilateral implantation of an extended depth of focus or combined implantation of an extended depth of focus/trifocal intraocular lens

PurposeEvaluate postoperative visual performance in patients with bilaterally implanted AT LARA or AT LARA/AT LISA tri (Carl Zeiss AG, Jena, Germany) intraocular lenses.MethodsMulticentered, comparative, open-label, retrospective/prospective study. Post-IOL implantation, patients were prospectively enrolled into this study; preoperative patient data were collected retrospectively. Follow-up was at 2–4 and 5–8 months post-surgery. The primary endpoint was binocular best corrected distance visual acuity (CDVA). The study was retrospectively registered on clinicaltrials.gov (#NCT05462067).ResultsSeventy-one patients (142 eyes) were enrolled; 67 patients (134 eyes) have 5–8 months data. The mean binocular CDVA at 2–4 months was -0.10 ± 0.06 logMAR in the bilateral AT LARA group (“bilateral”) and -0.11 ± 0.09 logMAR in the combined implantation AT LARA/ AT LISA tri group (“combined implantation”); (P = 0.4856). At 5–8 months, mean binocular CDVA was -0.13 ± 0.06 logMAR in the bilateral group and -0.11 ± 0.09 in the combined implantation group (P = 0.4003). At 5–8 months, more eyes in the bilateral group attained 0.2 logMAR or better binocular uncorrected intermediate VA (UIVA; 67 cm) than those in the combined implantation group (100% vs. 94%, respectively). The bilateral group achieved a mean of 0.24 ± 0.11 logMAR in uncorrected near VA (UCNVA), compared to a mean of 0.16 ± 0.12 logMAR in the combined implantation group at 5–8 months (P = 0.0041).ConclusionsA combined implantation approach (AT LARA in the distance dominant eye/AT LISA tri in the non-dominant eye) produced similar CDVA outcomes but better UCNVA as bilateral implantation with the AT LARA. UIVA was comparable between groups. No new safety concerns were reported.

A comparative study of two presbyopia-correcting intraocular lenses combining bifocal and extended depth-of-focus profiles.

To compare the visual performance of two presbyopia-correcting intraocular lenses (IOLs) that combine both bifocal and extended depth-of-focus profiles, Artis® Symbiose® Plus (Symbiose Plus; Cristalens Industrie, Lannion, France) and Tecnis® Synergy® (Synergy; Johnson & Johnson Vision, Santa Ana, CA, USA). The medical records of patients with cataract bilaterally implanted with either Symbiose Plus or Synergy between January 2022 and January 2023 were assessed. The principal measures of postoperative findings included uncorrected distance visual acuity (UDVA), corrected distance visual acuity (CDVA), uncorrected intermediate visual acuity (UIVA), uncorrected near (40 and 33cm) visual acuity (UNVA), objective optical quality (OOQ) parameters, distance-corrected defocus curve analysis, and surveys of subjective satisfaction. Total of 96 eyes from 48 patients were enrolled. Each group was equally composed of 24 patients, 48 eyes. There were no significant differences between the two groups on baseline characteristics. Both IOLs displayed excellent binocular UDVA, CDVA, and UNVA (40 and 33cm) with no statistical difference (p = 0.467(UDVA), p = 0.584(CDVA), p = 0.096(40-cm UNVA), and p = 0.621(33-cm UNVA)). However, with regard to UIVA, the Synergy group showed significantly superior results (p < 0.001). In contrast, the Symbiose Plus group showed significantly better results on OOQ parameters and patient-reported quality of vision survey outcomes (both p < 0.001). Both IOLs provided a decent continuous range of vision from near to far distance.

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.

Head-to-Head Comparison of Intermediate Vision of Two Monofocal Intraocular Lenses.

To compare intermediate visual outcomes in patients previously implanted with bilateral Clareon monofocal IOLs versus bilateral Eyhance IOLs. This was a non-interventional, single-center, examiner-masked, comparative study. Participants were cataract patients presenting at least 3 months after uncomplicated, bilateral implantation of either Clareon or Eyhance non-toric and toric IOLs. Outcomes measures included binocular distance-corrected intermediate visual acuity (DCIVA), binocular corrected distance visual acuity (CDVA), binocular best-corrected defocus curve, postoperative mean residual spherical equivalent (MRSE), and residual astigmatism. A total of 620 eyes of 310 subjects (155 subjects per group) were evaluated. The mean difference in DCIVA was 0.05 logMAR between the Eyhance and Clareon IOLs which was significant (p < 0.01), but within the 0.1 logMAR non-inferiority margin. Mean CDVA of the Clareon group was 0.01 ± 0.03 logMAR compared to 0.02 ± 0.03 logMAR of the Eyhance Group (p > 0.05). Defocus curves from +1.0 D to -3.0 D were not clinically nor statistically different between the Clareon and Eyhance groups (p > 0.05). The results of this study show that bilateral implantation of Clareon monofocal IOLs and Eyhance monofocal IOLs lead to similar distance and intermediate visual outcomes.

Clinical Performance of a Hydrophobic Acrylic Diffractive Trifocal Intraocular Lens in a Japanese Population.

In this study, clinical performance of a hydrophobic acrylic diffractive trifocal intraocular lens (IOL) with double C-loop haptics was evaluated in Japanese cataract eyes. Twenty-three patients had bilateral cataract surgery with the implantation of a trifocal IOL with double C-loop haptics. Postoperative examinations at 6months included assessing uncorrected distance visual acuity (UDVA), corrected distance visual acuity (CDVA) at 5m, uncorrected intermediate visual acuity (UIVA), distance-corrected intermediate visual acuity (DCIVA) at 80cm, uncorrected near visual acuity (UNVA) and distance-corrected near visual acuity (DCNVA) at 40cm. Binocular defocus, contrast sensitivity, spectacle independence, symptoms of photic phenomena and quality of vision (QOV) were also observed. Twenty-three patients received 46 IOLs binocularly. Manifest refraction spherical equivalent was - 0.227 ± 0.385 D (mean ± standard deviation) at 6months postoperatively. Binocular UDVA, binocular UIVA and binocular UNVA were - 0.101 ± 0.065, - 0.021 ± 0.079 and 0.022 ± 0.095 logMAR units, respectively. Binocular CDVA, binocular DCIVA and binocular DCNVA were - 0.151 ± 0.044, - 0.042 ± 0.067 and - 0.011 ± 0.080 logMAR, respectively. Binocular CDVA of 0.00 logMAR or better was obtained in the defocus from - 3.0 D until + 0.5 D. Only 8.7% of patients required the use of spectacles postoperatively. There were no symptoms of glare, halo and light disturbance in 78.3%, 56.5% and 69.6% of patients, respectively. QOV scores significantly improved postoperatively (P < 0.0001). The hydrophobic acrylic trifocal IOL with double C-loop haptics provides good visual performance at all distances and produces high spectacle independence rate and patient satisfaction. NCT04699266 (Clinicaltrials.gov).

Early patient-reported outcomes of cataract surgery with implantation of the trifocal liberty 677MY intraocular lens: A pilot study.

To report our first clinical and patient-reported outcomes in the early postoperative period with a new model of trifocal diffractive intraocular lens (IOL). Pilot prospective analysis of the results of 26 eyes of 13 patients (age, 44-79 years) undergoing cataract surgery with implantation of the trifocal diffractive IOL Liberty 677MY (Medicontur Medical Engineering Ltd., Zsámbék, Hungary). The following clinical outcomes were evaluated during the first postoperative month: measurement of distance, intermediate and near visual acuity, binocular defocus curve, and level of spectacle independence, patient satisfaction, perception of photic phenomena, and difficulty in performing several vision-related daily tasks by means of a questionnaire. Mean binocular LogMAR uncorrected distance, intermediate and near visual acuities were -0.03 ± 0.13, 0.21 ± 0.16, and 0.16 ± 0.09, respectively. Furthermore, 100.0%, 84.6% and 92.3% of patients achieved a binocular corrected distance, distance-corrected intermediate and distance-corrected near visual acuity of 20/32 or better, respectively. In the defocus curve, visual acuities were better than 0.2 logMAR for defocus levels between +1.00 and -3.00 D. Spectacle independence was referred by all patients, with any of them reporting dissatisfaction with the outcome of the surgery. The postoperative vision did not lead to difficulties in the daily life in 92.3% of patients. Bothersome halos, glare or starbursts were only reported by only 7.7% of patients. The trifocal IOL evaluated provides a successful visual rehabilitation with minimal photic phenomena associated, leading to high levels of spectacle independence and patient satisfaction.

Clinical Performance of Extended Depth of Focus (EDOF) Intraocular Lenses - A Retrospective Comparative Study of Mini Well Ready and Symfony.

PurposeExtended depth of focus intraocular (EDOF) IOLs form a bridge between single- and multifocal IOL design. This study aimed to compare clinical outcomes obtained after implanting two different optical designs of EDOF IOLs: the Mini Well Ready (SIFI Medtech, Catania, Italy) and Tecnis Symfony (Abbott Laboratories, Illinois, USA).MethodsThe retrospective observational study included 61 patients (122 eyes) who underwent bilateral implantation of the Mini Well Ready IOL (32 patients) or the Tecnis Symfony IOL (29 patients). The following preoperative and postoperative parameters were evaluated: spherical equivalent, anterior astigmatism, pupil size, monocular and binocular uncorrected distance visual acuity (UDVA) and corrected distance visual acuity (CDVA), monocular and binocular uncorrected intermediate visual acuity (UIVA) and distance-corrected intermediate visual acuity (DCIVA), monocular and binocular uncorrected near visual acuity (UNVA) and distance-corrected near visual acuity (DCNVA). In the 6 months postoperative period, defocus curve, contrast sensitivity, photopic phenomena, and posterior capsule opacification were assessed.ResultsThe patients receiving the Tecnis Symfony had slightly better monocular and binocular UDVA and CDVA than with the Mini Well Ready IOL, the differences were not statistically significant. Whereas the UIVA, DCIVA, UNVA, DCNVA, UNVA and DCNVA values were higher in the Mini Well Ready group, the differences were not significant. There were no significant between-group differences regarding the defocus curve for the vast majority of tested vergences. Dysphotopsias postoperatively were assessed at 6 months.ConclusionPatients receiving both the Mini Well Ready and Symfony IOLs had excellent visual acuity outcomes and spectacle independence.

Safety and Efficacy of AGN-190584 in Individuals With Presbyopia

AGN-190584 (Allergan, an AbbVie company) is an optimized topical formulation of pilocarpine hydrochloride, 1.25%, designed for managing presbyopia and enhanced with a proprietary vehicle. To evaluate the efficacy and safety of pilocarpine hydrochloride, 1.25%, in individuals with presbyopia. This vehicle-controlled, participant- and investigator-masked, randomized, phase 3 clinical study, GEMINI 1, enrolled individuals with presbyopia, aged 40 to 55 years, at 36 sites in the United States from December 21, 2018, to October 31, 2019. Analysis took place between February 2020 and December 2021. AGN-190584 or the AGN-190584 formulation vehicle was administered bilaterally, once daily for 30 days. The proportion of participants with improvement of 3 or more lines in mesopic, high-contrast, binocular distance-corrected near visual acuity (DCNVA) at hours 3 and 6 on day 30 were the primary and key secondary efficacy end points, respectively. Safety measures included adverse events. Of 323 participants who were randomized, 235 (72.8%) were female and 292 (90.4%) were White. The mean (SD) age was 49.6 (3.5) years, and the baseline mean (SD) mesopic DCNVA was 29.2 (6.3) letters. A total of 163 individuals were randomized to AGN-190584 and 160 were randomized to vehicle. GEMINI 1 met its primary and key secondary efficacy end points. On day 30, hour 3, the percentage of participants with improvement of 3 or more lines in mesopic DCNVA was 30.7% (50 of 163) in the AGN-190584 group and 8.1% (13 of 160) in the vehicle group (difference, 22.5% [95% CI, 14.3%-30.8%]; adjusted P < .001). At hour 6, those percentages were 18.4% (30 of 163) and 8.8% (14 of 160), respectively (difference, 9.7% [95% CI, 2.3%-17.0%]; adjusted P = .01). At hour 8, the between-group difference in 3 or more lines of mesopic DCNVA gains was not statistically significant, but clinically relevant prespecified outcome measures demonstrated AGN-190584 superiority to vehicle in least-squares mean (SE) mesopic DCNVA change from baseline at hour 8 (5.4 [0.51] vs 3.6 [0.52] letters; P = .009) and photopic distance-corrected intermediate visual acuity at hour 8 (3.9 [0.44] vs 2.4 [0.45] letters; P = .01) and hour 10 (3.5 [0.46] vs 1.7 [0.47] letters; P = .004). No participants with mesopic DCNVA improvement of 3 or more lines at hour 3 had losses of more than 5 letters in mesopic, high-contrast, binocular-corrected distance visual acuity. The onset of effect was at 15 minutes. AGN-190584 demonstrated an acceptable safety and tolerability profile. AGN-190584 demonstrated superiority over vehicle in mesopic DCNVA on day 30, hours 3 and 6, with an acceptable safety profile. AGN-190584 is a safe and efficacious topical therapy for presbyopia through 30 days. ClinicalTrials.gov Identifier: NCT03804268.

Comparative analysis of visual outcome with 3 intraocular lenses: monofocal, enhanced monofocal, and extended depth of focus.

To compare the visual performance, spectacle independence, and subjective visual quality of 3 intraocular lenses (IOLs): monofocal, enhanced monofocal, and extended depth of focus. Ophthalmology Department, San Raffaele Scientific Institute, Milan, Italy. Prospective case series. Patients without ocular comorbidities and corneal astigmatism <0.75 diopters (D) undergoing cataract surgery with bilateral implantation of monofocal Tecnis ZCB00, enhanced monofocal Eyhance ICB00, and extended depth-of-focus Symfony ZXR00 IOLs were included. 6 months postoperatively, the following parameters were analyzed: subjective and objective refraction; monocular and binocular corrected distance (4 m) and uncorrected distance (UDVA) visual acuity; corrected distance, intermediate (66 cm), and near (40 cm) visual acuities, as well as uncorrected intermediate (UIVA) and uncorrected near (UNVA) visual acuities; photopic contrast sensitivity; binocular defocus curve; halo and glare perception; and spectacle independence. 150 eyes of 75 patients (25 patients per IOL group) were evaluated. Monocular and binocular UDVA was excellent in all 3 groups. Eyhance achieved binocular UIVA similar to that of Symfony, the latter showing the highest binocular UNVA. The defocus curves at -1.0 D were equivalent for both Eyhance and Symfony, whereas contrast sensitivity was similar in all 3 groups. The Eyhance spectacle independence score was comparable with Symfony for intermediate distance activities, the latter, however, achieved the worst results for halos and glare. Enhanced monofocal Eyhance was not inferior to Symfony as regards intermediate distance visual outcome and spectacle independence, and also provided lower subjective perception of halos and glare.

Clinical outcomes of a monofocal intraocular lens with enhanced intermediate function compared with an extended depth-of-focus intraocular lens.

To compare clinical outcomes of a new monofocal intraocular lens (IOL) with enhanced intermediate function and an extended depth-of-focus (EDoF) IOL. Asan Medical Center, Seoul, Korea. Nonrandomized prospective comparative case series. Patients presenting for cataract surgery and meeting all inclusion and exclusion criteria were implanted with a new monofocal IOL with enhanced intermediate function (Tecnis Eyhance ICB00) or an EDoF IOL (Tecnis Symfony ZXR00) bilaterally. Uncorrected (UDVA), uncorrected intermediate (UIVA), uncorrected near (UNVA), and corrected distance visual acuity (CDVA), defocus curves, and contrast sensitivity were compared after 3 months. Patients were administered questionnaires regarding visual symptoms, spectacle independence, overall satisfaction, and lens recommendations. 24 patients (48 eyes) were enrolled in the Eyhance group and 20 patients (40 eyes) in the Symfony group. Monocular and binocular UDVA, UIVA, and CDVA were similar in the 2 groups. Monocular UNVA and spectacle independence for near distance were better in the Symfony group, whereas binocular UNVA did not differ significantly in the 2 groups. Contrast sensitivity, glare and halo, satisfaction, and recommendation rates were similar in the 2 groups. Although some dissatisfaction and severe glare and halo were reported in the Symfony group, none of these was reported in the Eyhance group. Bilateral implantation of the Eyhance ICB00 IOL provided comparable clinical performances as bilateral implantation of the Symfony ZXR00 IOL. Binocular UNVA was similar, although spectacle independence was higher in the Symfony group, but this was at the expense of more glare and halos.

A comparison of clinical outcomes and optical performance between monofocal and new monofocal with enhanced intermediate function intraocular lenses: a case-control study

BackgroundTo compare clinical outcomes and optical performance of a new monofocal with enhanced intermediate function intraocular lenses (IOLs) with that of conventional monofocal IOLs.MethodsSixty eyes of 30 patients who underwent phacoemulsification with bilateral implantation of the ICB00 (15 patients) or ZCB00 (15 patients) IOLs were enrolled. Binocular corrected distance visual acuity (CDVA), distance corrected near visual acuity (DCNVA), and distance corrected intermediate visual acuity (DCIVA) were measured at 4 weeks after surgery. Patient satisfaction for overall, near, intermediate, and distance vision were assessed. The binocular defocus curves were measured. The root mean square of modulation transfer function (MTFRMS) was measured in the optical bench study.ResultsThe mean binocular DCIVA was significantly better in the ICB00 group (0.01 logMAR) compared to the ZCB00 group (0.13 logMAR), but CDVA and DCNVA were not. The patient satisfaction for near and intermediate vision was significantly higher in the ICB00 group compared to the ZCB00. However, there was no difference in patient satisfaction for overall and distance vision between two groups. The defocus curves showed that mean visual acuity of the ICB00 group was significantly better than that of the ZCB00 group at between − 1.00 D to − 3.00 D of defocus. The ICB00 IOL had higher MTFRMS values at between − 0.50 D to − 2.00 D of defocus compared to the ZCB00 IOL.ConclusionsThe ICB00 IOL provides better binocular intermediate vision and higher satisfaction for near and intermediate vision than the ZCB00 IOL while maintaining excellent distance vision.

Return of phacoemulsification after emergency status related to COVID-19: experience of a tertiary referral center.

To present a protocol of priority criteria for phacoemulsification after the backlog due to severe acute respiratory syndrome coronavirus (SARS-CoV)-2 pandemic status. Ophthalmology department of Centro Hospitalar e Universitário do Porto (CHUP), Oporto, Portugal. Cross-sectional, nonrandomized, retrospective study. Data of all patients waiting for cataract surgery were analyzed at the beginning of May 2020, after 2 months without performing elective surgery. The waiting time since surgical inscription was considered an independent and overriding factor. In addition, higher priority was given to patients with white or brunescent cataracts and patients with low visual acuity: corrected distance visual acuity (CDVA) of 20/200 or less in binocular patients or CDVA of 20/63 or less in monocular patients. Criteria of medium priority included patients who remained with anisometropia and patients with glaucoma or low to moderate risk for chronic angle closure. Data of scheduled surgeries in the following months were then analyzed. A total of 717 patients were waiting for phacoemulsification. One hundred ninety-one patients (26.64%) were on the waiting list more than 4.5 months; the medium waiting time was 3.51 ± 1.57 months. According to both priority criteria and waiting time, 348 (48.6%) were categorized as priority cases. A total of 158 patients (22.0%) met the highest priority; 61 patients (8.5%) met the medium priority criteria. In 129 patients (18.0%), priority was considered based solely on higher waiting time. This algorithm allowed surgeons to operate on all priority cases within the first 3 months. The presented protocol showed to be effective, providing a timely surgical opportunity for priority cases.

Comparative evaluation of visual outcomes after bilateral implantation of an advanced or conventional monofocal intraocular lens.

To assess the clinical outcomes and patient satisfaction of the Tecnis Eyhance, an advanced monofocal intraocular lens (IOL), compared to a conventional monofocal IOL. Retrospective case-control study. This study included 120 eyes of 60 patients (30 patients in each group) who underwent bilateral cataract surgery either with the implantation of conventional monofocal IOLs (Tecnis PCB00), as a control group, or advanced monofocal IOLs (Tecnis Eyhance ICB00). Ophthalmological evaluation included the measurement of binocular corrected distance visual acuity (CDVA), monocular and binocular uncorrected distance visual acuity (UDVA), and uncorrected intermediate VA (UIVA). In addition the binocular defocus curve was analyzed. Furthermore a subjective questionnaire (Catquest-9SF) was used to assess vision and life quality. The average binocular UDVA was 20/22 in the ICB00 group and 20/20 in the PCB00 model (p = 0.62). The average monocular UIVA was 20/32 in the ICB00 group and 20/40 in the control group (p < 0.001). We found the binocular UIVA, had a mean value of 20/30 in the ICB00, compared to 20/40 in the control group (p < 0.001). The reported dysphotopsia was not significantly different between both groups (p = 0.56). Regarding the life quality questionnaire, the ICB00 group showed less difficulty in activities requiring intermediate vision. Our results demonstrated a significant improvement in visual acuity for intermediate distance in the ICB00 group compared to the control group, without compromising distance visual acuity. We also found a greater capability for intermediate distance activities (namely for computer use and reading price tags) when comparing ICB00 patients with the control group.

Femtosecond laser-assisted cataract surgery compared with phacoemulsification: the FACT non-inferiority RCT.

Cataract surgery is one of the most common operations. Femtosecond laser-assisted cataract surgery (FLACS) is a technique that automates a number of operative steps. To compare FLACS with phacoemulsification cataract surgery (PCS). Multicentre, outcome-masked, randomised controlled non-inferiority trial. Three collaborating NHS hospitals. A total of 785 patients with age-related cataract in one or both eyes were randomised between May 2015 and September 2017. FLACS (n = 392 participants) or PCS (n = 393 participants). The primary outcome was uncorrected distance visual acuity in the study eye after 3 months, expressed as the logarithm of the minimum angle of resolution (logMAR): 0.00 logMAR (or 6/6 if expressed in Snellen) is normal (good visual acuity). Secondary outcomes included corrected distance visual acuity, refractive outcomes (within 0.5 dioptre and 1.0 dioptre of target), safety and patient-reported outcome measures at 3 and 12 months, and resource use. All trial follow-ups were performed by optometrists who were masked to the trial intervention. A total of 353 (90%) participants allocated to the FLACS arm and 317 (81%) participants allocated to the PCS arm attended follow-up at 3 months. The mean uncorrected distance visual acuity was similar in both treatment arms [0.13 logMAR, standard deviation 0.23 logMAR, for FLACS, vs. 0.14 logMAR, standard deviation 0.27 logMAR, for PCS, with a difference of -0.01 logMAR (95% confidence interval -0.05 to 0.03 logMAR; p = 0.63)]. The mean corrected distance visual acuity values were again similar in both treatment arms (-0.01 logMAR, standard deviation 0.19 logMAR FLACS vs. 0.01 logMAR, standard deviation 0.21 logMAR PCS; p = 0.34). There were two posterior capsule tears in the PCS arm. There were no significant differences between the treatment arms for any secondary outcome at 3 months. At 12 months, the mean uncorrected distance visual acuity was 0.14 logMAR (standard deviation 0.22 logMAR) for FLACS and 0.17 logMAR (standard deviation 0.25 logMAR) for PCS, with a difference between the treatment arms of -0.03 logMAR (95% confidence interval -0.06 to 0.01 logMAR; p = 0.17). The mean corrected distance visual acuity was 0.003 logMAR (standard deviation 0.18 logMAR) for FLACS and 0.03 logMAR (standard deviation 0.23 logMAR) for PCS, with a difference of -0.03 logMAR (95% confidence interval -0.06 to 0.01 logMAR; p = 0.11). There were no significant differences between the arms for any other outcomes, with the exception of the mean binocular corrected distance visual acuity with a difference of -0.02 logMAR (95% confidence interval -0.05 to 0.00 logMAR) (p = 0.036), which favoured FLACS. There were no significant differences between the arms for any health, social care or societal costs. For the economic evaluation, the mean cost difference was £167.62 per patient higher for FLACS (95% of iterations between -£14.12 and £341.67) than for PCS. The mean QALY difference (FLACS minus PCS) was 0.001 (95% of iterations between -0.011 and 0.015), which equates to an incremental cost-effectiveness ratio (cost difference divided by QALY difference) of £167,620. Although the measurement of outcomes was carried out by optometrists who were masked to the treatment arm, the participants were not masked. The evidence suggests that FLACS is not inferior to PCS in terms of vision after 3 months' follow-up, and there were no significant differences in patient-reported health and safety outcomes after 12 months' follow-up. In addition, the statistically significant difference in binocular corrected distance visual acuity was not clinically significant. FLACS is not cost-effective. To explore the possible differences in vision in patients without ocular co-pathology. Current Controlled Trials ISRCTN77602616. This project was funded by the National Institute for Health Research (NIHR) Health Technology Assessment programme and will be published in full in Health Technology Assessment; Vol. 25, No. 6. See the NIHR Journals Library website for further project information. Moorfields Eye Charity (grant references GR000233 and GR000449 for the endothelial cell counter and femtosecond laser used).

Visual Outcomes after Bilateral Implantation of an Extended Depth of Focus Intraocular Lens: A Multicenter Study.

PurposeTo evaluate visual performance after bilateral implantation of an extended depth of focus (EDOF) intraocular lens (IOL).MethodsThis multicenter, prospective, observational study included 100 patients who underwent bilateral cataract surgery with a toric or non-toric EDOF IOL (Tecnis Symfony), and 96 patients completed the final assessment at 4 to 6 months. Binocular corrected distance visual acuity and uncorrected distance visual acuity (UDVA), uncorrected intermediate visual acuity (UIVA), and uncorrected near visual acuity (UNVA), spectacle independence, visual symptoms, and patient satisfaction were evaluated.ResultsMean decimal visual acuity results showed a binocular corrected distance visual acuity of 1.10 ± 0.18, UDVA of 1.04 ± 0.17, UIVA of 0.96 ± 0.16, and UNVA of 0.68 ± 0.18. Binocular UDVA and UIVA were 0.8 (decimal) or better in 98% and 94% of patients, respectively. Binocular UNVA was 0.63 (decimal) or better in 76% of patients. Overall, 76% of the patients achieved spectacle independence across all distances, and more than 85% reported no or mild dysphotoptic phenomena. On a scale of 0 to 10, the median patient satisfaction score was 9 for far, 9.5 for intermediate, and 8 for near vision.ConclusionsThe Symfony EDOF IOL provided excellent distance, intermediate visual outcome, and functional near visual acuity. The visual results were associated with prominent levels of spectacle independence and patient satisfaction.

Repeatability of Aberrometry-Based Automated Subjective Refraction in Healthy and Keratoconus Subjects.

Purpose To compare the intersession repeatability of the Eye Refract, a new instrument to perform aberrometry-based automated subjective refraction, on healthy and keratoconus subjects. Materials and Methods A cross-sectional and randomized study was performed. A total of 64 participants were evaluated in the study, selecting one eye per participant randomly. The sample was divided into two different groups: 33 healthy subjects (38.85 ± 13.21 years) and 31 with keratoconus (37.29 ± 11.37 years). Three refractions per participant with the Eye Refract were performed on three different days, without cycloplegia. The repeatability analysis of refractive variables (M, J0, and J45), binocular corrected distance visual acuity (BCDVA), and spent time in refraction was performed in terms of repeatability (Sr), its 95% confidence interval (r), and intraclass correlation coefficient (ICC). Results There were no statistically significant differences (P ≥ 0.05) between sessions in both groups for all refractive variables (M, J0, and J45) and BCDVA. Spent time in refraction was reduced as the sessions went by (P < 0.05). The Eye Refract was more repeatable for refractive errors assessment in healthy subjects (M : Sr = 0.27 D; J0 : Sr = 0.09 D; J45 : Sr = 0.06 D) compared to those with keratoconus (M : Sr = 0.65 D; J0 : Sr = 0.29 D; J45 : Sr = 0.24 D), while it was similar for BCDVA. Conclusions The Eye Refract offered better repeatability to assess refractive errors in healthy subjects compared to those with keratoconus. Despite measurements being also consistent in keratoconus subjects, they should be treated with caution in clinical practice.

Visual outcomes and safety after bilateral implantation of a trifocal presbyopia correcting intraocular lens in a Korean population: a prospective single-arm study

BackgroundTo investigate the 3-month postoperative performance and safety after implantation of a trifocal intraocular lens (IOL) in a Korean population.MethodsThis was a clinical, prospective, multicenter, single-arm study. Forty-four subjects (88 eyes) with bilateral cataract with expected postoperative corneal astigmatism of < 1.00 diopter (D) and no ocular disease or eye condition underwent bilateral implantation of the AcrySof IQ® PanOptix IOL (TFNT00). Postoperative examination at 3 months included binocular defocus curve; binocular best corrected distance visual acuity (BCDVA); monocular/binocular uncorrected VA (UCVA) at distance (4 m), intermediate (60 cm), and near (40 cm); contrast sensitivity under photopic conditions with/without glare; and subjective outcomes, including satisfaction and spectacle independence.ResultsBinocular defocus curve at 3 months after bilateral implantation showed VA of 0.1 logMAR or better from + 0.5 D through − 2.5 D. Binocular BCDVA mean ± SD at 4 m was − 0.05 ± 0.07 logMAR. Binocular and monocular UCVA was 0.03 ± 0.1 and 0.08 ± 0.12 logMAR (4 m), − 0.00 ± 0.11 and 0.05 ± 0.13 logMAR (60 cm), and 0.03 ± 0.12 and 0.09 ± 0.13 logMAR (40 cm), respectively. Contrast sensitivity with glare was 1.67 ± 0.13, 1.91 ± 0.17, 1.54 ± 0.21, and 1.14 ± 0.20 log units at 3, 6, 12, and 18 cycles/degree, respectively. At near and intermediate distances, 84 and 77% of subjects reported good/excellent satisfaction, and 84 and 91% of subjects reported spectacle independence, respectively.ConclusionsIn a Korean population, visual performance of the trifocal TFNT00 IOL 3 months postoperatively was < 0.1 logMAR for binocular UCVA at all distances, with high subject satisfaction and spectacle independence.Trial registrationwww.ClinicalTrials.gov (NCT03268746). Registered August 31, 2017.

Femtosecond laser–assisted cataract surgery compared with phacoemulsification cataract surgery: randomized noninferiority trial with 1-year outcomes

To report the 1-year outcomes of a randomized trial comparing femtosecond laser-assisted cataract surgery (FLACS) and phacoemulsification cataract surgery (PCS). Moorfields Eye Hospital, New Cross Hospital, and Sussex Eye Hospital, United Kingdom. Multicenter, randomized controlled noninferiority trial. Patients undergoing cataract surgery were randomized to FLACS or PCS. Postoperative assessments were masked. Outcomes included uncorrected distance visual acuity (UDVA), corrected distance visual acuity (CDVA), complications, corneal endothelial cell count, and patient-reported outcomes measures. The study enrolled 785 participants. A total of 311 of 392 (79%) participants were allocated to FLACS and 292 of 393 (74%) participants were allocated to PCS attended follow-up at 1 year. Mean UDVA was 0.14 (SD = 0.22) for FLACS and 0.17 (0.25) for PCS with difference of -0.03 logarithm of the minimum angle of resolution (logMAR) (95%, -0.06 to 0.01, P = .17). Mean CDVA was 0.003 (0.18) for FLACS and 0.03 (0.23) for PCS with difference of -0.03 logMAR (95% CI, -0.06 to 0.01, P = .11); 75% of both FLACS (230/307) and PCS (218/290) cases were within ±0.5 diopters (D) refractive target, and 292 (95%) of 307 eyes of FLACS and 279 (96%) of 290 eyes of PCS groups were within ±1.0 D. There were no significant differences between arms for all other outcomes with the exception of binocular CDVA mean difference -0.02 (-0.05 to 0.002) logMAR (P = .036) favoring FLACS. Mean cost difference was £167.62 per patient greater for FLACS (95% iterations between -£14.12 and £341.67). PCS is not inferior to FLACS regarding vision, patient-reported health, and safety outcomes after 1-year follow-up. A difference was found for binocular CDVA, which, although statistically significant, was not clinically important. FLACS was not cost-effective.

Comparison of Two Wavefront Autorefractors: Binocular Open-Field versus Monocular Closed-Field.

Purpose To evaluate the agreement and repeatability between a new commercially available binocular open-field wavefront autorefractor, as part of the Eye Refract system, and a monocular closed-field wavefront autorefractor (VX110). Methods A cross-sectional, randomized, and single-masked study was performed. Ninety-nine eyes of 99 healthy participants (37.22 ± 18.04 years, range 8 to 69 years) were randomly analyzed. Three measurements with the Eye Refract and the VX110 were taken on three different days, under noncycloplegic conditions. Mean spherical equivalent (MSE), cylindrical vectors (J0 and J45), and binocular corrected distance visual acuity (BCDVA) were compared between both autorefractors. An intersession repeatability analysis was done considering the values of repeatability (Sr) and its 95% limit (r). Results The VX110 showed more negative values (P < 0.001) in terms of MSE in comparison with the Eye Refract (0.20 D). Regarding cylindrical vectors, J45 showed statistically significant differences (P=0.001) between both wavefront autorefractors, but they were not clinically relevant (<0.05 D). In BCDVA, there were no statistically significant differences (P=0.667) between both wavefront autorefractors. Additionally, the Eye Refract was more repeatable than the VX110 in terms of both MSE (SrEYE REFRACT = 0.21 D, SrVX110 = 0.53 D) and J0 (SrEYE REFRACT = 0.12 D, SrVX110 = 0.35 D). Conclusions The Eye Refract provided enough accuracy and reliability to estimate refractive errors in different age groups, achieving better results than the VX110. Therefore, the Eye Refract proved to be a useful autorefractor to be incorporated into clinical practice.

Clinical outcomes of a novel presbyopia-correcting soft contact lens with a small aperture

PurposeTo investigate the efficacy and safety of a newly developed pinhole soft contact lens (Eyelike Pinhole II; Koryo Eyetech Co. Ltd.) for presbyopia correction. MethodsThis prospective clinical study enrolled 29 patients with presbyopia between October 2018 and December 2018. All participants wore the Eyelike Pinhole II in the non-dominant eye for >3 h/day for a period of 1 week. Binocular and monocular uncorrected near visual acuities, distance-corrected near visual acuity (DCNVA), uncorrected distance visual acuity, and corrected distance visual acuity (CDVA) were measured before and after the intervention. All visual acuities were measured in logarithm of the minimal angle of resolution (logMAR) units. In addition, binocular defocus curves were generated, and contrast sensitivity values were obtained under photopic and mesopic conditions before and after lens wear. ResultsThe mean DCNVA of the treated eye and the mean binocular DCNVA improved from 0.34 ± 0.12 to 0.15 ± 0.14 (P < 0.001) and 0.31 ± 0.13 to 0.11 ± 0.10 (P < 0.001) logMAR, respectively, after pinhole contact lens wear. Although the mean CDVA of the treated eye deteriorated from −0.04 ± 0.05 to 0.02 ± 0.11 logMAR (P = 0.015), there was no significant change in the mean binocular CDVA (P = 0.79). The binocular defocus curve showed a significant improvement from −5.0 dioptres (D) to −1.0 D after pinhole contact lens wear. ConclusionsThe newly developed Eyelike Pinhole II soft contact lens showed safe and effective outcomes; thus, it could be a promising option for the treatment of presbyopia.