Systane iLux Thermal Pulsation System in the Treatment of Meibomian Gland Dysfunction: A Post-Hoc Analysis of a 12-Month, Randomized, Multicenter Study.

Purpose: This study aimed to demonstrate the effectiveness of Systane iLux, a thermal pulsation device, in patients with MGD, over 12 months post-single treatment. Methods: This is a post-hoc analysis of a previous prospective, assessor-masked, parallel-group, multicenter study (NCT03956225) that compared the effectiveness and safety of iLux with LipiFlow in subjects with MGD. The original study included subjects with meibomian gland score (MGS) ≤12 in lower eyelids, Impact of Dry Eye on Everyday Life-Symptom Bother (IDEEL-SB) module score >16, and non-invasive tear break-up time (NITBUT) <10 seconds. Subjects were randomized (1:1) to receive a single bilateral treatment of iLux or LipiFlow. In this post-hoc analysis, mean changes in MGS, NITBUT (first break-up; seconds), IDEEL-SB module score, and corneal staining, from baseline to 12 months were analyzed post-single treatment with iLux. Results: Data from 119 patients (n=238 eyes) treated with iLux were analyzed. The mean±SD age of the subjects was 58.4±13.4 years, with majority being female (79.0%). MGS (mean±SD) for both eyes improved significantly from baseline to 12 months (OD [baseline: 6.9±3.69; month 12: 22.8±11.31; change: 15.9±11.57, p<0.0001]; OS [baseline: 6.4±3.66; month 12: 23.0±11.33; change: 16.7±11.40, p<0.0001]). Similarly, significant improvements were observed in NITBUT (OD [baseline: 5.2±1.97; month 12: 7.0±3.68; change: 1.9±3.69, p<0.0001]; OS [baseline: 5.6±1.96; month 12: 7.9±4.58; change: 2.3±4.59, p<0.0001]) and IDEEL-SB score (p<0.0001). Corneal staining reduced significantly from baseline to 12 months (OD [baseline: 2.1±2.96; month 12: 0.7±1.56; change: -1.4±2.65, p<0.0001]; OS [baseline: 2.1±2.94; month 12: 0.7±1.44; change: -1.4±2.75, p<0.0001]). Improvements in MGS, NITBUT, IDEEL-SB module score, and corneal staining were seen as early as week 2, and at months 1, 3, 6, and 9 (all p<0.001). Conclusion: A single treatment with iLux significantly improved clinical parameters of MGS, NITBUT, and corneal staining, and patient-reported symptom assessment with IDEEL-SB in patients with MGD over 12 months.

Academy IRIS® Registry Analysis of Incidence of Laser Capsulotomy Due to Posterior Capsule Opacification After Intraocular Lens Implantation.

Purpose: Academy IRIS® (Intelligent Research in Sight) Registry was used to determine the incidence of postoperative neodymium-doped yttrium aluminum garnet laser capsulotomy (Nd:YAG) and time to posterior capsular opacification (PCO) diagnosis based on intraocular lens (IOL) type and brand. Methods: This retrospective analysis included eyes implanted with 1 of 2 IOL brands, with ≥365 days of follow-up available in the IRIS Registry, and ≥2 visits within 180 days of surgery. Analyses included Nd:YAG incidence due to PCO within 1 year after surgery by IOL type and brand, mean time to PCO diagnosis, and mean time to Nd:YAG. Results: Of 89,947 eyes after cataract surgery, 24,834 (28%) had PCO diagnosis within 365 days, and 9262 (10%) underwent Nd:YAG; 4.1% of 57,523 eyes with monofocal and 21.2% of 32,424 eyes with diffractive multifocal (MF) or diffractive extended depth of focus (EDOF) IOLs had Nd:YAG. Nd:YAG was 3.2 times more likely in eyes with diffractive MF or diffractive EDOF IOLs versus monofocal. For monofocal IOLs, 3.2% of eyes with AcrySof® and 8.1% of eyes with Tecnis® had Nd:YAG (P<0.0001). For diffractive MF or diffractive EDOF IOLs, 13.0% of eyes with AcrySof and 21.7% of eyes with Tecnis had Nd:YAG (P<0.0001). Nd:YAG risk was 2.4 times higher in eyes with Tecnis versus AcrySof IOLs. Overall, mean time to PCO diagnosis and Nd:YAG was 150.7 and 180.7 days. Mean time to PCO for monofocal versus diffractive MF or diffractive EDOF IOLs was 165.3 versus 139.7 days (P<0.0001). Mean time to Nd:YAG for monofocal versus diffractive MF or diffractive EDOF IOLs was 196.4 versus 175.3 days (P<0.05). Conclusion: Real-world data for AcrySof and Tecnis IOLs revealed lower Nd:YAG rates and longer time to PCO diagnosis and Nd:YAG after monofocal versus diffractive multifocal or diffractive EDOF implantation. Nd:YAG rates were significantly lower with AcrySof versus Tecnis IOLs.

Comparison of Two Thermal Pulsation Systems in the Treatment of Meibomian Gland Dysfunction: A Randomized, Multicenter Study.

SIGNIFICANCE: Given the significance of meibomian gland dysfunction subjects in evaporative dry eye, its chronic and progressive nature, limited promising treatment options, and novel treatment techniques are important. This randomized clinical study evaluated the noninferiority of SYSTANE iLux with LipiFlow in meibomian gland dysfunction treatment at 12 months. PURPOSE: This study aimed to demonstrate noninferiority of SYSTANE iLux compared with LipiFlow at 12 months after single treatment in meibomian gland dysfunction subjects with evaporative dry eye. METHODS: In this prospective, randomized, multicenter, assessor-masked, parallel-group trial, subjects (N = 236; aged ≥18 years) with meibomian gland score (MGS) of ≤12 in lower eyelids, noninvasive tear breakup time (NITBUT; first breakup) of <10 seconds, and Impact of Dry Eye on Everyday Life-Symptom Bother (IDEEL-SB) module score of >16 were randomized (1:1) to receive SYSTANE iLux (n = 119) or LipiFlow (n = 117). Subjects attended a total of eight visits, including screening, treatment, and follow-up visits at 2 weeks and at 1, 3, 6, 9, and 12 months/exit, to evaluate change from baseline in MGS, NITBUT, IDEEL-SB module score, and safety outcomes. RESULTS: A total of 227 subjects completed the study (mean ± standard deviation age, 57.3 ± 13.8 years). At 12 months, least squares mean change from baseline in MGS was similar between iLux and LipiFlow (17.4 ± 1.97 vs. 17.8 ± 1.98). Noninferiority of SYSTANE iLux compared with LipiFlow in change from baseline in MGS (95% lower confidence limit of least squares mean difference, >-5), NITBUT (>-2.5 seconds), and IDEEL-SB score (95% upper confidence limit, <12) was achieved at all post-treatment visits. No other serious ocular or device-related adverse events were reported. CONCLUSIONS: The treatment outcomes with SYSTANE iLux were noninferior to LipiFlow during the 12-month follow-up in subjects with dry eye-associated meibomian gland dysfunction.

Visual and Patient-Reported Outcomes of a Diffractive Trifocal Intraocular Lens Compared with Those of a Monofocal Intraocular Lens.

PURPOSE: To evaluate the effectiveness and safety of a trifocal intraocular lens (IOL), the TFNT00 (Alcon, Fort Worth, TX), versus a monofocal IOL, the SN60AT (Alcon). DESIGN: Food and Drug Administration-approved, prospective, multicenter, nonrandomized, parallel-group, assessor-masked, confirmatory trial. PARTICIPANTS: Patients enrolled were 22 years of age or older with a diagnosis of bilateral cataract with planned removal by phacoemulsification with a clear corneal incision. METHODS: Consented participants selected their preferred IOL, which was implanted sequentially into each eye of patients meeting eligibility criteria. MAIN OUTCOME MEASURES: The coprimary effectiveness outcomes were mean photopic monocular best-corrected distance visual acuity (BCDVA; 4 m) and distance-corrected near visual acuity (DCNVA; 40 cm) at 6 months after surgery. Secondary effectiveness outcomes included mean monocular distance-corrected intermediate visual acuity (DCIVA; 66 cm) and proportion of participants responding "never" to question 1 of the Intraocular Lens Satisfaction questionnaire (regarding frequency of spectacle use in the past 7 days). Safety outcomes included frequency of "severe" and "most bothersome" visual disturbances. RESULTS: Two hundred forty-three patients underwent cataract surgery with bilateral implantation of the TFNT00 (n = 129) or SN60AT (n = 114) and were followed up for 6 months. Noninferiority of TFNT00 to SN60AT in mean photopic monocular BCDVA (95% upper confidence limit of the difference was <0.1 logarithm of the minimum angle of resolution [logMAR] margin), and superiority in mean photopic monocular DCNVA (difference of 0.42 logMAR; P < 0.001) and DCIVA (difference of 0.26 logMAR; P < 0.001) were demonstrated. The proportion of patients never requiring glasses overall was superior for TFNT00 versus SN60AT (80.5% and 8.2%, respectively). Starbursts, halos, and glare were the most frequently rated severe symptoms with TFNT00; however, less than 5% of patients were very bothered at month 6. CONCLUSIONS: The TFNT00 exhibited superior monocular DCNVA and DCIVA to a spherical monofocal IOL, with comparable monocular BCDVA. Binocular visual acuity was 20/25 or better for distance to near (+0.5 D to -2.5 D), resulting in high levels of spectacle independence. Less than 5% of patients were very bothered by the photic visual disturbances associated with the TFNT00 at 6 months after surgery.

Clinical outcomes with distance-dominant multifocal and monofocal intraocular lenses in post-LASIK cataract surgery planned using an intraoperative aberrometer.

IMPORTANCE: Studies evaluating the clinical benefits of intraoperative aberrometry (IA) in cataract surgery are limited. BACKGROUND: The study was designed to determine whether IA improved clinical outcomes of post-laser in situ keratomileusis (LASIK) cataract surgery with different intraocular lenses (IOLs) implanted. DESIGN: A retrospective chart review of clinical outcomes from one surgeon at one surgical centre was conducted. It included post-LASIK cataract surgeries where IA was used for the confirmation of IOL power, with either a distant-dominant multifocal IOL or a monofocal IOL implanted. PARTICIPANTS: Records for 44 eyes of 31 patients were analysed. METHODS: Differences in visual acuity (VA) and refractions by lens type were compared, and the effects of IA were evaluated. MAIN OUTCOME MEASURES: Uncorrected distance VA and the percentage of eyes with a spherical equivalent refraction within 0.5D of the intended correction were the primary outcome measures. RESULTS: There was no statistically significant difference in the percentage of eyes with uncorrected distance VA of 20/25 or better between IOL groups (P = 0.41). More eyes in the multifocal group had a refraction within 0.50D of intended (P = 0.03). In 39% of cases, the preoperative and IA power calculations suggested the same IOL power. When not equal, the IA results were not significantly more likely to be 'best' (P = 0.08). CONCLUSIONS AND RELEVANCE: Results suggest that a history of previous LASIK is not a contraindication to use of distant-dominant multifocal IOLs. IA did not appear to improve clinical outcomes in post-LASIK eyes, although a positive trend was evident.

Bilateral implantation of +3.0 D multifocal toric intraocular lenses: results of a US Food and Drug Administration clinical trial.

PURPOSE: The purpose of this study was to evaluate the clinical outcomes of apodized diffractive +3.0 D multifocal toric intraocular lens (IOL) implantations in subjects with preoperative corneal astigmatism. PATIENTS AND METHODS: This was a prospective cohort study conducted at 21 US sites. The study population consisted of 574 subjects, aged ≥21 years, with preoperative astigmatism 0.75-2.82 D, and potential postoperative visual acuity (VA) ≥0.2 logMAR, undergoing bilateral cataract removal by phacoemulsification. The intervention was bilateral implantation of aspheric apodized diffractive +3.0 D multifocal toric or spherical multifocal nontoric IOLs. The main outcome measures were monocular uncorrected near and distance VA and safety at 12 months. RESULTS: A total of 373/386 and 182/188 subjects implanted with multifocal toric and nontoric IOLs, respectively, completed 12-month follow-up after the second implantation. Toric IOLs were nonin-ferior in monocular uncorrected distance (4 m) and near (40 cm) VA but had >1 line better binocular uncorrected intermediate VA (50, 60, and 70 cm) than nontoric IOLs. Toric IOLs reduced cylinder to within 0.50 D and 1.0 D of target in 278 (74.5%) and 351 (94.1%) subjects, respectively. Mean ± standard deviation (SD) differences between intended and achieved axis orientation in the first and second implanted eyes were 5.0°±6.1° and 4.7°±4.0°, respectively. Mean ± SD 12-month IOL rotations in the first and second implanted eyes were 2.7°±5.8° and 2.2°±2.7°, respectively. No subject receiving toric IOLs required secondary surgical intervention due to optical lens properties. CONCLUSION: Multifocal toric IOLs were noninferior to multifocal nontoric IOLs in uncorrected distance and near VAs in subjects with preexisting corneal astigmatism and effectively corrected astigmatism of 0.75-2.82 D.

Transzonular vitreous injection vs a single drop compounded topical pharmaceutical regimen after cataract surgery.

PURPOSE: To compare the relative effectiveness of a Tri-Moxi-Vanc intraocular solution injected transzonularly into the vitreous with the topical formulation of Pred-Moxi-Ketor (given for the first week postoperatively) followed by Pred-Ketor (given for weeks 2-4 after surgery). PATIENTS AND METHODS: This was a single-site, single-surgeon, prospective, randomized, subject-masked contralateral eye study with an active comparator and was approved by an appropriate ethics committee. Twenty-five subjects with uncomplicated cataract who were scheduled for cataract surgery were enrolled. If surgery was uneventful, subjects received either an injection in that eye or followed a minimum drop postoperative pharmaceutical regimen. The second eye surgery was performed with the opposite treatment. Subjects were followed for 1 month. Measures of interest were the changes in intraocular pressure (IOP) from baseline and the changes in corneal and macular thickness. Subjects were also asked to evaluate pain perception, visual quality, and overall satisfaction with surgery. They were also asked which regimen they preferred. RESULTS: IOP was not statistically significantly different between the groups (P=0.81); there was also no statistically significant difference in IOP over time (P=0.74). There was no statistically significant difference in central macular thickness at 1 week and 1 month between the groups (P=0.18). The central corneal thickness was significantly greater 1 day postoperatively relative to baseline, but there was no statistically significant difference between the groups at any time point (P=0.92). The difference in reported pain was also not statistically significantly different between the groups (P=0.67). Satisfaction with surgery was similar for both groups, but significantly more subjects preferred the injection for overall experience (P<0.01). CONCLUSION: Cataract surgery completed with the two pharmaceutical regimens was similar in outcome. Significantly more subjects preferred the injection, presumably as a function of the greater convenience with no apparent difference in the therapeutic effect.