Clinical performance of a hybrid presbyopia-correcting intraocular lens in patients undergoing cataract surgery in a multicenter trial.

PURPOSE: To compare the clinical performance of TECNIS Synergy intraocular lens (IOL), model ZFR00V, vs TECNIS IOL, model ZCB00, in cataract patients. SETTING: Multicenter clinical setting. DESIGN: Prospective, randomized, subject/evaluator-masked clinical trial. METHODS: Cataract patients aged ≥22 years were randomly assigned 1:1 to bilateral implantation with ZFR00V or ZCB00. Key end points at 6 months postsurgery included monocular and binocular visual acuities at 4 m, 66 cm, 33 cm, and/or 40 cm, binocular distance-corrected defocus testing, patient-reported outcomes, and safety. RESULTS: 272 patients were implanted with ZFR00V (135) or ZCB00 (137). At 6 months, 83/131 (63.4%) ZFR00V patients demonstrated 20/25 or better combined monocular distance-corrected vision at far, intermediate, or near, compared with 5/130 (3.8%) ZCB00 patients. ZFR00V demonstrated excellent binocular uncorrected vision at intermediate (0.022 logMAR) and distance-corrected vision at 40 cm (0.047 logMAR). Strong ZFR00V performance persisted under mesopic conditions (0.244 logMAR or ∼20/32 Snellen), where improvement over ZCB00 with distance-corrected vision at near was 3.5 lines. ZFR00V provided a broad range of functional vision (20/32 or better) through -3.5 diopters of defocus (29 cm). Most ZFR00V patients reported no spectacle wear overall (93.1%) or at all 4 viewing distances combined (87.8%), and 55.7% qualified as completely spectacle independent. Relatively low proportions of ZFR00V patients reported being very/extremely bothered by halos (13.7%), starbursts (11.5%), or night glare (8.4%). The safety profile was similar between IOL groups. CONCLUSIONS: TECNIS Synergy ZFR00V demonstrated improved intermediate and near vision, increased range of vision, and greater spectacle independence vs TECNIS monofocal ZCB00.

Clinical Evaluation of a Modified Light Transmission Short-Wavelength Filtering Intraocular Lens Compared to a Colorless Control.

INTRODUCTION: The aim of this study was to evaluate the safety and efficacy of a violet-light filtering intraocular lens (IOL) compared to a colorless IOL control. METHODS: This was a prospective, bilateral, randomized, comparative, patient/evaluator-masked multi-center clinical trial at 12 sites in the USA. Patients underwent standard small-incision phacoemulsification cataract extraction. Visual acuity, contrast sensitivity, and color vision were tested 12 months postoperatively. Patient satisfaction and vision-related quality of life were evaluated based on directed patient responses obtained from a binocular subjective questionnaire. RESULTS: A total of 250 subjects were bilaterally implanted with the violet-light filtering TECNIS monofocal ZV9003 (n = 126) and colorless TECNIS monofocal ZA9003 (n = 124). Mean uncorrected distance visual acuity (UDVA) was 0.123 LogMAR for ZV9003 and 0.116 LogMAR for the ZA9003 group. Mean corrected distance visual acuity (CDVA) was 0.00 LogMAR for both groups. No significant difference was found between the groups for 22/25 questionnaire categories, including color perception. A significant difference was found in favor of the ZV9003 group for day driving, night driving, and frustration with vision. Contrast sensitivity mean difference was < 0.05 log units across all lighting conditions and spatial frequencies. CONCLUSION: No difference was found between groups for visual acuity, contrast sensitivity, color testing, and adverse events as well as with the majority of optical/visual symptoms. A statistical difference was noted in driving and frustration with eyesight that may be related to benefits of using a violet-light filtering chromophore. Overall, the violet-light filtering ZV9003 showed excellent visual acuity and contrast sensitivity results with a low incidence of optical/visual symptoms.

The Effectiveness and Safety of Dextenza 0.4 mg for the Treatment of Postoperative Inflammation and Pain in Patients After Photorefractive Keratectomy: The RESTORE Trial.

PURPOSE: To determine patient preference and treatment outcomes with an intracanalicular dexamethasone 0.4 mg insert compared to a standard steroid drop regimen in the contralateral eye following bilateral photorefractive keratectomy (PRK). METHODS: In this randomized, prospective, self-controlled, open-label interventional study, one eye received the dexamethasone insert and the second eye received prednisolone acetate 1% taper following bilateral PRK surgery. Postoperative evaluations were performed on day 3, day 4, month 1, and month 3. Phone call surveys were performed on week 2. The Comparison of Ophthalmic Medications for Tolerability questionnaire was used to determine patient preference between postoperative regimens and postoperative pain. Corneal endpoints included time to epithelialization, presence of corneal haze, sodium fluorescein staining, and modified Standardized Patient Evaluation of Eye Dryness (SPEED) scores. Both corrected distance visual acuity (CDVA) and uncorrected distance visual acuity (UDVA) were assessed. RESULTS: Twenty patients participated in the study. At month 3, 70% of patients preferred the dexamethasone insert, 20% preferred prednisolone acetate, and 10% expressed no preference. Patient surveys did not show a difference in postoperative pain between the study group and control group. No statistical difference was shown in time to epithelialization, 90-day CDVA or UDVA, postoperative corneal haze, corneal staining, or modified SPEED scores. CONCLUSIONS: In patients undergoing PRK, there was preference toward a dexamethasone insert in place of topical prednisolone acetate for the postoperative steroid treatment. There were no statistically or clinically significant differences between the two cohorts in regard to healing time or visual outcomes. [J Refract Surg. 2021;37(9):590-594.].

Overnight Safety Evaluation of a Multi-Pressure Dial in Eyes with Glaucoma: Prospective, Open-Label, Randomized Study.

PURPOSE: To investigate the safety and tolerability of the multi-pressure dial (MPD) worn overnight for seven consecutive days. DESIGN: Prospective, open-label, randomized, single-site study. SUBJECTS: Twenty eyes of 10 subjects with open-angle glaucoma were fitted with an MPD and randomized to negative pressure application of -10 mmHg in one eye (study eye) worn overnight for 7 consecutive days. METHODS: Safety measures included best-corrected visual acuity (BCVA), intraocular pressure (IOP) changes from baseline during and after negative pressure application, slit lamp and dilated fundus exam findings, and rate of adverse events. Subjective assessments were completed daily by the subjects during the 7-day study period and immediately following the study period. RESULTS: Prior to the 7-day testing period, application of 10 mmHg negative pressure reduced mean IOP from 18.2 ± 3.8 mmHg to 14.0 ± 2.1 mmHg (p<0.01), a 22% reduction. After 7 days of consecutive nightly wear, repeat IOP measurements with the application of negative pressure showed a decrease in mean IOP from 16.9 ± 4.3 mmHg to 13.5 ± 3.7 mmHg. The observed IOP reduction was in addition to the subjects' current treatment regimen. There were no statistically significant changes in IOP, BCVA from baseline following the 7-day period of nightly wear with the application of negative pressure. The patient-reported outcomes were favorable. CONCLUSION: The MPD can safely and comfortably be worn overnight. The decrease in IOP of >20% in addition to current therapy is both clinically and statistically significant. The MPD shows promise as a potential new treatment option for nocturnal IOP control.

Extended depth of focus lens implantation after radial keratotomy.

PURPOSE: To identify the visual performance of radial keratotomy (RK) patients that have undergone cataract surgery with implantation of an extended depth of focus (EDOF) intraocular lens (IOL). DESIGN: Retrospective chart review with questionnaire. METHODS: Medical charts of patients with a history of RK that had undergone phacoemulsification with implantation of the Tecnis Symfony IOL (J&J Vision) were reviewed. Data collected included preoperative demographics, number of RK incisions, pupil size, and preoperative visual acuity and manifest refraction. Primary outcome measures of the study included postoperative uncorrected distance visual acuity (UCVA) and manifest refraction spherical equivalent (SE) at each follow-up visit. Secondary outcomes included results from a telephone questionnaire assessing visual performance and satisfaction. RESULTS: Twenty-four eyes of 12 patients were included. UCVA improved from an average Snellen equivalent 20/73 preoperatively to 20/33 at an average final follow-up of 6 months (P=0.0011), while average manifest SE improved from +1.68 D to -0.18 D (P<0.0001). At final follow-up, 15 of 24 eyes (62.5%) were at or within 0.5 D of target refraction, while 20 of 24 eyes (83.3%) were at or within 1.0 D. In total, 79% of eyes (19 of 24) had UCVA of 20/40 or better at distance. In the survey, 78% of patients reported satisfaction with their vision after surgery and 44% of patients reported being spectacle free for all tasks. CONCLUSIONS: An EDOF lens implant can produce good visual outcomes and satisfaction in patients with a history of RK.

Short-Term Safety Evaluation of a Multi-Pressure Dial: A Prospective, Open-label, Non-randomized Study.

INTRODUCTION: Prospective, open-label, non-randomized, single site study to assess the safety and tolerability of a multi-pressure dial. METHODS: 30 healthy subjects received application of negative pressure (-15 mmHg) in one eye for 30 minutes and ambient atmospheric pressure in the contralateral eye. To evaluate safety, the primary outcome measures included best corrected visual acuity (BCVA), intraocular pressure (IOP) changes from baseline, slit-lamp and dilated fundus examination findings, and rate of adverse events. Exploratory analyses included in this study also evaluated changes from baseline measurement in tear break-up time (TBUT) and RNFL thickness measured by OCT. In addition to baseline screening, subjects underwent testing and negative pressure application on day 0 and returned 1 week after the initial visit for clinical testing. The follow-up visit did not include use of the multi-pressure dial (MPD) but repeated baseline testing and evaluated for adverse events. RESULTS: No adverse events were reported in the study. After short-term wear of the MPD on day 0, there was a minimal but statistically significant increase of half a line (LogMAR) in BCDVA for study eyes; this increase was not present at 1 week. There were no observed changes in cup-disk ratio and TBUT 1 week after the initial testing. There was a statistically significant pressure reduction in both study and fellow eyes at 1 week following the study, but clinical significance has yet to be determined. CONCLUSION: The MPD, which consists of a pair of goggles connected to a handheld, programmable pump, was well tolerated by subjects enrolled in the study. Key safety parameters remained stable after short-term exposure. The favorable safety results of this study support the safety profile of the MPD and promote further investigation of the device as a potential treatment of glaucoma. FUNDING: Equinox Ophthalmic, Inc. (Newport Beach, CA).

Precision pulse capsulotomy: Initial clinical experience in simple and challenging cataract surgery cases.

PURPOSE: To evaluate precision pulse capsulotomy (PPC) in simple and challenging cataract surgery cases. SETTING: Clínica Quesada, San Salvador, El Salvador. DESIGN: Prospective case series. METHODS: This single-center prospective study assessed cataract surgeries with anterior capsulotomy performed using a PPC device through a 2.2 mm corneal incision in the presence of an ophthalmic viscosurgical device. This was followed by phacoemulsification and intraocular lens implantation. Outcomes included capsulotomy appearance and diameter, surgical complications, and postoperative visual acuity. RESULTS: The study comprised 38 eyes. All cases resulted in 360-degree complete, round capsulotomies averaging 5.5 mm in diameter with intracapsular IOL fixation. No PPC-related complications were observed intraoperatively or on follow-up at 3 to 8 months. The PPC was useful in challenging cases with corneal opacities that obscured the capsulotomy path or with poorly dilated pupils. Precision pulse capsulotomy occurs instantaneously everywhere along the capsulotomy path, which allowed safe release of subcapsular pressure in intumescent cataracts with consistent creation of a round, appropriately sized capsulotomy. The PPC edge quality was shown in a case with 6 clock hours of zonular dialysis in which iris hooks held the capsulotomy edge for over 45 minutes for removal of a 4+ cataract. CONCLUSIONS: Precision pulse capsulotomy had a short learning curve and was integrated seamlessly into the surgical routine. The combination of suction with ultrafast capsulotomy provided capsulotomy roundness, sizing, safety, and edge quality that significantly facilitated difficult cases. The ease of use, consistency, and efficiency of PPC capsulotomy might support its use under many practice scenarios.

Comparison of Manual, Femtosecond Laser, and Precision Pulse Capsulotomy Edge Tear Strength in Paired Human Cadaver Eyes.

PURPOSE: To compare the anterior lens capsulotomy edge tear strength created by manual continuous curvilinear capsulorhexis (CCC), femtosecond laser capsulotomy (FSLC), and a new automated precision pulse capsulotomy (PPC) device. DESIGN: A 3-arm study in paired human cadaver eyes. PARTICIPANTS: A total of 44 eye specimens from 22 donors in the United States. METHODS: Capsulotomy was performed in all eye specimens using manual CCC, a femtosecond laser (LenSx, Alcon, Fort Worth, TX), or an automated PPC device (Zepto, Mynosys Inc., Fremont, CA). The first study arm consisted of 8 pairs of eyes in which 1 eye received PPC and the fellow eye received FSLC. The second study arm consisted of 8 pairs of eyes, with 1 eye receiving PPC and the fellow eye receiving manual CCC. The third study arm consisted of 6 pairs of eyes, with 1 eye receiving a manual CCC and the fellow eye receiving FSLC. After phacoemulsification, 2 capsulotomy edge retractors attached to force transducers were used to stretch the capsulotomy edge of each eye and to measure the resisting force until the capsulotomy edge was torn. MAIN OUTCOME MEASURES: Capsulotomy edge tear strength in millinewtons. RESULTS: The PPC edge tear strength was greater than that of FSLC for all 8 pairs of eyes by an average factor of 3.1-fold (PPC mean 73.3±24.9 mN vs. femtosecond laser mean 26.1±6.8 mN; P = 0.012, Wilcoxon matched-pairs, signed-ranks test). The PPC tear strength was greater than that of manual CCC for all 8 pairs of eyes by an average factor of 4.1-fold (PPC mean 95±35.2 mN vs. manual CCC mean 29.1±23.1 mN; P = 0.012, Wilcoxon matched-pairs signed-ranks test). There was no significant difference in the tear strength of capsulotomies produced by manual CCC (mean 21.3±4.9 mN) and FSLC (mean 24.5±11.4 mN) (P = 0.75, Wilcoxon matched-pairs signed-ranks test). CONCLUSIONS: The strength of the PPC capsulotomy edge was significantly stronger than that produced by femtosecond laser or manual CCC.

Three-year results of Artisan/Verisyse phakic intraocular lens implantation. Results of the United States Food And Drug Administration clinical trial.

OBJECTIVE: To assess the safety and efficacy of the Artisan/Verisyse phakic intraocular lens (IOL) for the correction of high myopia. DESIGN: Prospective, open-label, noncomparative, multicenter clinical trial. PARTICIPANTS: A total of 684 adults with axial myopia from -4.5 diopters (D) to -22 D were enrolled: 662 in the primary analysis group and 22 under compassionate use protocol expansion. Efficacy data are based on the 662 first eyes implanted. INTERVENTION: Implantation of the Artisan/Verisyse phakic intraocular lens. MAIN OUTCOME MEASURES: Efficacy measures included uncorrected distance visual acuity (UCVA), refractive predictability and stability, patient satisfaction, and contrast sensitivity. Safety measures were best spectacle-corrected visual acuity (BSCVA), intraocular pressure, slit-lamp observations, endothelial cell density (ECD), complications, and adverse events. RESULTS: At 3 years, UCVAs for first eyes were 20/40 or better in 84.0% (194/231) and 20/25 or better in 51.9% (120/231). Of first eyes, 71.7% to 76.7% were within 0.50 D of target refraction and 93.1% to 95.0% were within 1.0 D at 6 months and later. Best spectacle-corrected visual acuity was 20/40 or better for 99% to 100% of first eyes from the 1-month visit through 3 years. At 3 years, 54% of first eyes gained >/=1 lines of BSCVA, and 7.5% lost >/=1 lines of BSCVA. The mean change in ECD from baseline to 3 years was -4.8%+/-7.8%, with a 2.4% loss between 2 and 3 years. One site had a mean cell loss of -5.0% (P = 0.023), and the others combined had a mean cell loss of 1.7%+/-5.4%. For a cohort of 57 eyes with ECD data for all visits, the mean change from baseline was -3.8%+/-9.8% over 3 years. Approximately half (31/59) of the adverse events and preventative repositionings were among the first 10 cases performed by each investigator. CONCLUSIONS: The Artisan/Verisyse phakic IOL provides excellent refractive outcomes; endothelial cell loss within a mean of 5.0% over 3 years, or 1.8% per year; and few complications.