A Phase IIa Multicenter, Randomized, Vehicle-Controlled, Dose Escalating Study to Evaluate the Safety, Efficacy, and Pharmacokinetics of CBT-001 Ophthalmic Solution in Patients With Primary or Recurrent Pterygium.

Purpose: To evaluate the safety and efficacy of CBT-001, a multitarget tyrosine kinase inhibitor eyedrop, for pterygia. Design: Phase II clinical trial. Stage 1 was a single center, open-labeled, vehicle-controlled study. Stage 2 was a multicenter, randomized, double-masked, vehicle-controlled trial. Participants: Patients with primary or recurrent pterygia. Main Outcome Measures: The primary efficacy end point was lesion vascularity based on masked grading of photographs by an independent reading center. Other end points included dimensions of pterygia and safety. Methods: In stage 1, 24 eyes of 24 patients received 1 drop of CBT-001 in a dose escalation fashion (0.02%, 0.05%, and 0.2%) to determine the maximally tolerated dose based on adverse events (AEs) and blood drug levels. In stage 2, subjects were randomly assigned to receive the maximally tolerated dose of CBT-001 or vehicle dosed 3 times a day for 4 weeks with a 20-week follow-up. Results: In stage 1, the plasma maximum concentration values for all doses of CBT-001 were at or below the limit of detection (0.01 ng/ml). The most commonly reported AEs were mild foreign body sensation and irritation. CBT-001 0.2% was evaluated in stage 2. Baseline demographic characteristics were similar between patients receiving CBT-001 (n = 25) and vehicle (n = 23). After 4 weeks of dosing, the mean change from baseline in pterygium vascularity scores was -0.8 ± 0.7 (mean ± standard deviation) in subjects receiving CBT-001 0.2% and 0.0 ± 0.5 in subjects receiving vehicle (P < 0.001; 95% confidence interval: -1.12, -0.40). Pterygium vascularity scores remained significantly decreased, after the 4-week dosing period, at weeks 8 and 16, but not at week 24. The mean changes from baseline in the length of the pterygia were also significantly lower in subjects receiving CBT-001 compared with vehicle at weeks 2, 4, and 8 (P ≤ 0.014). The most commonly reported AEs were ocular, mild in severity, resolved after therapy, and did not result in discontinuation. Conclusions: CBT-001 0.2% decreased pterygia vascularity and lesion length after 4 weeks of dosing with a prolonged effect after dosing. The drug was well tolerated with minimal detected systemic drug levels. Financial Disclosures: Proprietary or commercial disclosure may be found in the Footnotes and Disclosures at the end of this article.

A Randomized, Prospective, Observer-Masked Study Comparing Dropless Treatment Regimen Using Intracanalicular Dexamethasone Insert, Intracameral Ketorolac, and Intracameral Moxifloxacin versus Conventional Topical Therapy to Control Postoperative Pain and Inflammation in Cataract Surgery.

Purpose: To evaluate clinical efficacy and patient preference for a dropless treatment regimen compared to conventional topical therapy in patients undergoing cataract surgery. Patients and Methods: In this prospective, contralateral eye study, patients with bilateral cataract were randomized to receive either intracanalicular dexamethasone insert, intracameral phenylephrine 1%/ketorolac 0.3%, and intracameral moxifloxacin (50 µg) (study group) or topical moxifloxacin 0.5%, ketorolac 0.5%, and prednisolone acetate 1.0% QID (control group). The second eye underwent cataract surgery 2 weeks later and was treated with the opposite treatment. All patients were evaluated at Days 1, 7, 14, 28, and 3 months. The primary outcome measure was postoperative ocular pain. Secondary outcomes included summed ocular inflammation score (SOIS; the sum of the mean anterior chamber cells and anterior flare score), the patient preference for medication protocol between the two eyes, and patient out-of-pocket cost of medications. Safety outcome measures included CDVA, intraocular pressure, central retinal thickness (CRT), and the incidence of reported AEs. Results: The proportion of patients with no pain was similar in both groups at all postoperative visits (p>0.05). No statistically significant difference in SOIS score was observed between the two groups at any visit. A strong majority of the patients (94.7%) preferred the study eye's dropless regimen over the control eye's conventional topical therapy regimen. No statistically significant difference in mean intraocular pressure (IOP) was observed at any postoperative visit, except at Week 1. The mean CDVA was also similar in both groups at all postoperative visits (p>0.05). The postoperative mean CRT was comparable between the two groups. Conclusion: A dropless treatment regimen is as effective as topical eyedrop administration. A higher proportion of patients who underwent bilateral cataract surgery preferred the dropless treatment regimen over the patient-administered eye drop regimen.

Radial keratotomy and cataract surgery: A quest for emmetropia.

A 75-year-old man with an ocular history of 8-cut radial keratotomy (RK) in both eyes presented for cataract surgery evaluation. He was previously correctable in spectacles in years prior despite his irregular corneas to 20/25 in the right eye and 20/30 in the left eye. He recently noticed a change in his overall visual function with significant nighttime glare and difficulty reading despite spectacle correction. Of note, he was unable to tolerate contact lenses and was resistant to refitting despite additional encouragement. Cataract surgery was delayed for many years, given he was correctable in spectacles and the concern of uncovering a highly aberrated cornea after removing his cataracts (Figures 1 and 2JOURNAL/jcrs/04.03/02158034-202308000-00021/figure1/v/2023-07-21T030437Z/r/image-tiffJOURNAL/jcrs/04.03/02158034-202308000-00021/figure2/v/2023-07-21T030437Z/r/image-tiff). Of note, the patient was interested in returning to the spectacle independence he enjoyed in the past. Ocular examination revealed a corrected distance visual acuity (CDVA) of 20/30 in the right eye and 20/60 in the left eye, with a manifest refraction of +4.50 -0.50 × 177 in the right eye and +5.75 -1.75 × 14 in the left eye. Glare testing was 20/50 in the right eye and 20/100 in the left eye, with retinal acuity meter testing of 20/25 in each eye. Pupils, confrontation visual fields, and intraocular pressures were normal. Pertinent slitlamp examination revealed corneal findings of 8-cut RK with nasal-gaping arcuate incisions in both eyes and lens findings of 2+ nuclear sclerosis with 2+ cortical changes in the right eye and 3+ nuclear sclerosis with 3+ cortical changes in the left eye. Cup-to-disc ratios of the optic nerves measured 0.5 with temporal sloping in the right eye and 0.6 with temporal sloping in the left eye. The dilated fundus examination was unremarkable. What intraocular lens (IOL) options would you offer this patient and how would you counsel regarding realistic expectations? What additional diagnostic testing would be helpful in your assessment? How would you calculate the IOLs?

Accuracy of the LaserArcs Femtosecond Cataract Surgery Arcuate Incision Nomogram in Patients Undergoing Cataract Surgery and Astigmatism Reduction.

Purpose: The purpose of this study is to evaluate the efficacy and safety of the laserarcs.com nomogram in reducing astigmatism among cataract patients that underwent astigmatism reduction with laser arcuate incisions. Methods: In this retrospective study, 50 patients who underwent uncomplicated cataract surgery with laser arc incisions for the reduction of astigmatism with a single surgeon between the dates of January 23, 2021 and February 10, 2022 were evaluated in a single eye. Preoperative astigmatism was determined on the basis of keratometry from biometry (IOLmaster, Carl Zeiss Meditec or LenStar LS900, Haag-Streit, Bern, Switzerland) and was compared to the postoperative manifest astigmatism. The percent change in the absolute magnitude of astigmatism was calculated along with the percent of patients with various levels of postoperative astigmatism. Results: Mean cylinder was 0.97 ± 0.49 D pre-op and 0.21 ± 0.28 D postop. Mean reduction in cylinder was 81.4 ± 47.7% (P < 0.00001, one-sample t-test compared to a hypothetical 60% reduction in cylinder). Residual cylinder was ≤0.5 D in 90%, 0.25 D in 72%, and 0 D in 58%. Postoperative uncorrected visual acuity was 20/30 or better in 92% and 20/20 or better in 40%. Subgroup analysis showed that residual astigmatism was not affected by patient age, magnitude of preoperative astigmatism, preoperative spherical equivalent, or corneal curvature. No adverse events related to the laser arcuate incisions were noted. Conclusion: Use of the LaserArcs nomogram yielded a significant reduction in preoperative astigmatism. Postoperative uncorrected visual acuity was substantially similar to best-corrected visual acuity, suggesting that many patients undergoing treatment will function without correction for distance tasks.

Phase 2, Randomized, Open-Label Parallel-Group Study of Two Dosing Regimens of Netarsudil for the Treatment of Corneal Edema Due to Fuchs Corneal Dystrophy.

Background: This phase 2 study evaluated the therapeutic potential of netarsudil to reduce corneal edema and to improve vision in patients with Fuchs corneal dystrophy (FCD). Methods: Patients (N = 40) with baseline central corneal thickness (CCT) of ≥600 µm and best-corrected visual acuity (BCVA) of 70-20 letters (20/40-20/400 Snellen equivalent) were randomized 1:1 to receive netarsudil once a day (QD) or twice a day (BID) for 8 weeks. Primary endpoint was mean CCT change from baseline at week 4. Results: Netarsudil QD and BID significantly reduced CCT at week 4 [mean change (standard error of mean), 28.4 (7.99) µm, P = 0.0021; and 20.1 (8.75) µm, P = 0.0335, respectively]. Five (12.5%) patients achieved complete resolution of corneal edema at week 4. BCVA improved by 3.2 (2.76) letters with QD and 1.5 (2.84) letters with BID, and 10 (25%) patients [5 with QD (P = 0.0078) and 5 with BID (P = 0.0096)] gained ≥10 letters at week 4. Improvements in CCT and vision were observed at week 2 and persisted at week 8, without significant differences between the 2 doses at any time point. Netarsudil QD significantly improved visual acuity and glare factor scores on the Visual Function and Corneal Health Status (V-FUCHS) questionnaire at weeks 4 and 8 (mean change, -0.4 to -0.3; P ≤ 0.0200). Netarsudil was well tolerated. Reticular edema developed in one (2.5%) patient with BID, which resolved with treatment discontinuation. Conclusions: Netarsudil QD led to significant reductions in corneal edema as well as improvements in vision and patient-reported symptoms of glare and visual impairment in patients with FCD. Clinical Trial Registration Number: NCT04498169.

The DEPOT Study (Dry Eye Prescription Options for Therapy): Assessing the Efficacy and Safety of OTX-DED (Dexamethasone Ophthalmic Insert 0.3 mg) for Intracanalicular Use Compared with Loteprednol Suspension for the Treatment of Episodic Dry Eye.

Purpose: To compare OTX-DED, an investigational dexamethasone intracanalicular insert, to loteprednol 0.5% suspension applied QID for 28 days as treatments for acute exacerbations of dry eye disease in terms of patient symptoms, corneal staining, tear breakup time (TBUT), and ocular redness. Methods: Fifty patients with an acute exacerbation of dry eye with at least grade 1 corneal staining were randomized to receive treatment and were each evaluated in one eye at baseline, two weeks and four weeks with the standard patient evaluation of eye dryness (SPEED) questionnaire, the Oxford Scale for corneal stain, Schulze Scale for ocular redness, and intraocular pressure (IOP). Results: Forty-four patients completed the study. Significant improvement was noted from baseline to both week 2 and 4 for each treatment in SPEED scores, corneal staining, and TBUT. Ocular redness improved significantly from baseline to week 2 for loteprednol and week 4 for both drugs. No significant difference was noted between treatments in any of these evaluations at any time point. Retention (visibility) of the OTX-DED insert was 95% at week 2 and 90% at week 4. IOP rose significantly from baseline to both week 2 and 4 for eyes receiving loteprednol but not for those receiving OTX-DED. Conclusion: OTX-DED significantly improved on both signs and symptoms of eyes suffering from acute exacerbations of dry eye disease. This improvement was similar to that seen with loteprednol 0.5% suspension, a well-accepted treatment for this condition. IOP did not change significantly in patients with OTX-DED. These findings support the use of this unique intracanalicular insert for the treatment of acute dry eye once this product is approved and available for use.

Reduction of Artificial Tears and Use of Adjunctive Dry Eye Therapies After Lifitegrast Treatment: Evidence from Clinical and Real-World Studies.

Purpose: To assess the frequency of patients reducing the use of artificial tears (ATs) among patients with dry eye disease (DED) following lifitegrast treatment. Patients and Methods: Two independent analyses were performed using the data from the 1-year, randomized, multicenter, Phase 3 SONATA trial and a noninterventional, real-world evidence (RWE) study conducted in patients with DED who were treated with lifitegrast in the United States and Canada. In SONATA, patients who had used ATs in the lifitegrast and placebo groups were included. The RWE study reviewed patients' electronic medical records, prescribing patterns, and practices of physicians throughout the survey. These data were then used to compare the proportion of patients using ATs in the 6-month pre-index period versus the 12-month post-index period. Results: Of 293 patients (lifitegrast, n=195; placebo, n=98) from SONATA, 107 (lifitegrast, n=64; placebo, n=43) used ATs during the on-therapy period while 186 (lifitegrast, n=131; placebo, n=55) did not. Of those not using ATs, the proportion of patients in the lifitegrast group at any time was higher (~67% [n=131]) versus placebo (~56% [n=55]); this was the case at all study time-points (Days 90, 180, 270, and 360). The RWE study included 600 patient charts (US, n=550; Canada, n=50); 75.5% (n=453) reported AT use. There was ~40% decrease in the proportion of patients using ATs as adjunct DED therapy to lifitegrast in the post-index period (n=273) versus those in the pre-index period (n=453). Conclusion: The findings show that the reliance on AT use can be gradually reduced with lifitegrast treatment, eventually leading to a reduction in disease burden.

Intracameral dexamethasone 9% vs prednisolone acetate 1% in controlling postoperative pain and inflammation in patients undergoing cataract surgery.

PURPOSE: To compare patient preferences of postoperative cataract surgery topical medication use between a 1-drop and a 3-drop regimen. SETTING: Two private cataract surgery centers. DESIGN: Open-label randomized self-controlled prospective study. METHODS: This study included 30 patients (60 eyes) undergoing routine cataract surgery in both eyes. In this contralateral eye study, 1 eye of each patient was randomized to the 1-drop regimen of intracameral delivery of moxifloxacin and dexamethasone suspension and topical bromfenac for 30 days. The other eye, randomized to the 3-drop regimen, received topical moxifloxacin 0.5% 4 times a day for 7 days and bromfenac 0.07% daily for 30 days postoperatively, along with prednisolone acetate 1% 4 times a day for 30 days. Patients reported their preferred regimen 2 weeks after the second surgery with a validated questionnaire. Secondary outcomes included subjective ocular pain, inflammation score, and out-of-pocket cost. Intraocular pressure (IOP) and macular thickness were also measured. RESULTS: Of the 29 patients, 28 (96.6%) significantly more preferred the eye treated with a 1-drop regimen. Self-reported pain, activity interference, and out-of-pocket cost were significantly less in the 1-drop group. Inflammation and 1-day uncorrected distance visual acuity were also significantly better in the 1-drop group. Macular thickness and mean IOP were similar between groups. CONCLUSIONS: Intracameral delivery of steroid and antibiotics was preferred by most of the patients undergoing cataract surgery. These eyes had significantly less pain, inflammation, activity interference, and out-of-pocket cost and significantly better uncorrected distance visual acuity at 1 day postoperatively. IOP and macular thickness were similar between groups.

The Vivity Extended Range of Vision IOL vs the PanOptix Trifocal, ReStor 2.5 Active Focus and ReStor 3.0 Multifocal Lenses: A Comparison of Patient Satisfaction, Visual Disturbances, and Spectacle Independence.

PURPOSE: To compare patient-reported outcomes (PROs) after intraocular lens (IOL) implantation with the AcrySof IQ Vivity IOL or Vivity Toric IOL to those achieved with other multifocal IOLs. PATIENTS AND METHODS: Prospective, open-label, multicenter analysis of PROs, including spectacle independence, dysphotopsia, and overall satisfaction among patients who underwent cataract surgery at least 1 month previously with bilateral Vivity or Vivity Toric lenses (n=60). Results were compared to outcomes from two similar prospective studies of bilateral AcrySof IQ PanOptix or PanOptix Toric trifocal IOLs (n = 59), blended AcrySof ReSTOR 2.5/3.0 IOLs (n=72) or bilateral ReSTOR ActiveFocus 2.5 D IOLs with a mini-monovision target [n = 95]). RESULTS: Patients in the Vivity cohort were significantly less likely to notice glare and halo in dim light (85% "none" or "just a little") compared to PanOptix (69%, p<0.03), 2.5 mini-monovision (75%, p< 0.05) or 2.5/3.0 (71%, p< 0.05) patients. Complete spectacle independence for all visual activities combined (never need glasses) with Vivity was comparable to the mini-monovision and 2.5/3.0 groups (33%, 36%, and 31%, respectively) but significantly lower than in the PanOptix cohort (83%, p < 0.0001). Satisfaction was high across all groups. There were no statistically significant differences in best-corrected visual acuity, and no new safety concerns were reported. CONCLUSION: The AcrySof IQ Vivity extended depth of focus IOL offers an expanded range of vision and better spectacle independence than has typically been achieved with traditional monofocal IOLs, with high rates of satisfaction and a favorable dysphotopsia profile compared to diffractive multifocal IOLs.

Effect of Cyclosporine 0.09% Treatment on Accuracy of Preoperative Biometry and Higher Order Aberrations in Dry Eye Patients Undergoing Cataract Surgery.

PURPOSE: To determine the effect of topical cyclosporine 0.09% on ocular surface regularity and the predictive accuracy of preoperative corneal power measurements in patients undergoing cataract surgery. SETTING: Private practice. DESIGN: Open-label, multicenter, prospective study. METHODS: Seventy-five patients (75 eyes) who presented for cataract surgery evaluation with signs of dry eye disease were prescribed topical cyclosporine 0.09% for 28 days BID. Corneal curvature measurements, slit lamp exam, and Standardized Patient Evaluation of Eye Dryness (SPEED) questionnaire were evaluated at the initial and follow-up visits. Cataract surgery occurred 1 to 3 weeks after the second biometry visit. Refraction and corrected distance visual acuity measurements were performed 1-month post-surgery. The primary outcome was the difference in absolute prediction error of 1-month spherical equivalent refractive outcome before and after cyclosporine treatment. Secondary outcomes included the effect of topical cyclosporine 0.09% on ocular surface irregularity. RESULTS: Sixty-four patients completed the study. The absolute prediction error of 1-month spherical equivalent refractive outcome was 0.39 ± 0.30 D vs 0.33 ± 0.25 D (P < 0.03) before and after treatment, respectively. The proportion of eyes that achieved the target refraction was greater based on measurements after topical cyclosporine 0.09% than would have occurred using pre-treatment measurements. CONCLUSION: Cataract surgery patients with dry eye who are prescribed topical cyclosporine 0.09% BID for 28 days pre-surgery showed a statistically significant improvement in the prediction error of the spherical equivalent outcome of surgery. Other measures of dry eye severity showed significant improvements after treatment.

Comparison of Preoperative Measurements with Intraoperative Aberrometry in Predicting Need for Correction in Eyes with Low Astigmatism Undergoing Cataract Surgery.

PURPOSE: To determine whether intraoperative aberrometry during cataract surgery measures higher levels of absolute astigmatism than preoperative biometry readings and which method yields a lower, final level of astigmatism if the two do not agree. PATIENTS AND METHODS: Retrospective record review of all patients who underwent uncomplicated cataract surgery from February 2015 to May 2019 with planned intraoperative aberrometry. Data analysis included preoperative keratometry, total astigmatism as measured by intraoperative aberrometry, intraocular lens model and power used, and postoperative manifest refraction ≥1 month after surgery. The primary outcome measure was the proportion of patients requiring astigmatism correction (≥0.5 D) when measured by preoperative keratometry vs intraoperative aberrometry. Secondary outcomes included postoperative residual astigmatism, where adjusted preoperative astigmatism fell below the 0.5 D threshold for treatment but the intraoperative measurement was ≥0.5 D or ≥1.0 D. RESULTS: A total of 451 patient records were evaluated. Intraoperative aberrometry measured statistically higher levels of mean astigmatism than keratometry (0.86 D vs 0.79 D, respectively; P < 0.0001) and significantly greater astigmatism among patients with 0.5-1.5 D of adjusted preoperative astigmatism (P < 0.0001). Significantly more patients qualified for with-the-rule astigmatism correction when measured by intraoperative aberrometry (n=339; 75%) than by preoperative keratometry alone (n=314; 70%); P < 0.03. This difference did not hold for against-the-rule or oblique astigmatism. For patients whose preoperative biometry astigmatism differed from intraoperative biometry, final postoperative astigmatism was lower when corrected if the adjusted preoperative and intraoperative measurements had a vector difference of <0.5 D, but there was no additional benefit in final astigmatism reduction when the vector difference was ≥0.5 D. CONCLUSION: Using intraoperative biometry readings can produce lower postoperative astigmatism than using preoperative biometry readings, but caution should be used when interpreting intraoperative readings that disagree with preoperative measurements with a vector magnitude of >0.5 D.

The PanOptix Trifocal IOL vs the ReSTOR 2.5 Active Focus and ReSTOR 3.0-Add Multifocal Lenses: A Study of Patient Satisfaction, Visual Disturbances, and Uncorrected Visual Performance.

PURPOSE: To compare spectacle independence, patient-reported outcomes (PROs), and dysphotopsia after multifocal intraocular lens (IOL) implantation with the AcrySof PanOptix trifocal or the ReSTOR +2.5/3.0 D or ReSTOR +2.5 D mini-monovision multifocal IOL. PATIENTS AND METHODS: Prospective, open-label, multicenter analysis of PROs, spectacle independence, and satisfaction among patients undergoing cataract surgery who had been implanted at least 1 month previously with AcrySof IQ PanOptix or PanOptix Toric trifocal (n = 59) IOLs bilaterally. Results were compared to outcomes from a similar study with the AcrySof ReSTOR 2.5/3.0 or the ReSTOR ActiveFocus 2.5 mini-monovision lens [n = 191]). RESULTS: Spectacle independence was significantly higher in the PanOptix cohort, with 83% of patients "never" needing glasses for any activity versus 36% in the ReSTOR 2.5 mini-monovision and 34% in the ReSTOR 2.5/3.0 cohorts. No significant differences in patient satisfaction rates were reported between the three cohorts. Glare and halo were rated "extremely" noticeable more with the PanOptix (10%) than with the ReSTOR 2.5 mini-monovision (1%) or ReSTOR 2.5/3.0 (3%). BCVA differences were not statistically significant, and no new safety concerns were reported. CONCLUSION: The AcrySof PanOptix trifocal provides significantly greater spectacle independence across all measured activities than the AcrySof ReSTOR multifocal IOLs.

Real-World Experience with Lifitegrast Ophthalmic Solution (Xiidra®) in the US and Canada: Retrospective Study of Patient Characteristics, Treatment Patterns, and Clinical Effectiveness in 600 Patients with Dry Eye Disease.

PURPOSE: This study evaluated real-world treatment of dry eye disease (DED) with lifitegrast. PATIENTS AND METHODS: Ophthalmologists and optometrists treating patients with DED were invited to participate through a healthcare provider (HCP)-based panel. HCPs completed a provider survey and contributed data toward a chart review for up to five qualifying patients with DED who initiated lifitegrast ophthalmic solution (index date) between 01/01/2017 (US) or 01/01/2018 (Canada) and 06/30/2019. Patient demographics, treatments, clinical characteristics, and outcomes (ie, severity, signs, symptoms) were collected for the 6-month pre-index period and up to 12-months post-index. RESULTS: For this study, 517 HCPs contributed 600 patient charts. Among 554 and 281 patients with follow-up at 6 and 12-months post-index, 512 (92.4%) and 238 (84.7%) patients had ongoing lifitegrast treatment, respectively. Other DED-related treatments were less frequently used post-index with lifitegrast vs pre-index: over-the-counter artificial tear use (45.2% vs 75.5%), topical corticosteroids (3.8% vs 18.8%), any cyclosporine (3.0% vs 20.5%). At 3-months (n=571) and 12-months (n=320) post-index vs pre-index, fewer patients had eye dryness (47 [8.2%] and 16 [5.0%] vs 525 [87.5%]), blurred vision (28 [4.9%] and 11 [3.4%] vs 346 [57.7%]), ocular burning/stinging (25 [4.4%] and 8 [2.5%] vs 336 [56.0%]), depression (8 [1.4%] and 9 [2.8%] vs 55 [9.2%]), fatigue (4 [0.7%] and 1 [0.3%] vs 82 [13.7%]), and headache (1 [0.2%] and 0 vs 19 [3.2%]). At 3 and 12-months post-index vs pre-index, average corneal staining score was numerically lower (2.7 and 2.0 vs 6.5), and average Schirmer score (10.6 and 10 vs 6.3) and tear film break-up time (7.3 and 8.0 vs 4.8) higher. CONCLUSION: The majority of patients had ongoing lifitegrast treatment 6-months post-index with reduction in overall treatment burden. Improvement in DED signs and symptoms, including QoL impacts, was evident at 3 months and up to 12 months after lifitegrast initiation.

Pterygium Surgery Utilizing Limbal Conjunctival Autograft and Subconjunctival Amniotic Membrane Graft in High-Risk Populations.

OBJECTIVE: To measure the outcomes of primary pterygium excision with a limbal conjunctival autograft when combined with the adjunctive use of a prophylactic subconjunctival graft of amniotic membrane to decrease the recurrence rate after surgery in an ethnically diverse population with a statistically higher risk for recurrence (African American, Asian, Caribbean, Asian, Latin). DESIGN: This is a retrospective, non-comparative study of post-operative outcomes. PARTICIPANTS: A total of 355 patients, totaling 493 eyes, with clinically significant, primary pterygia. PATIENTS AND METHODS: Patients were enrolled into the study based on the need for pterygium surgery and if they underwent primary pterygium excision with conjunctival autograft with subconjunctival amniotic membrane placement. Patients with recurrent pterygium or those with pseudopterygium were excluded from this study. All surgeries took place at the Florida Eye Microsurgical Institute (Boynton Beach, FL) between June 2006 and October 2013 by a single surgeon (BAS). Patients were seen on post-operative day 1, 7, 30, 90, 180 and 365 to evaluate for pterygium recurrence. Pterygium recurrence is defined in this study as growth greater than 1 mm past the corneal limbus at or after 6 months. RESULTS: There were six cases of recurrent pterygium for a recurrence rate of 1.22% ± 0.97% (n=493, p=0.05). Follow-up ranged from 6 months to 6 years (mean 28 months). CONCLUSION: Primary pterygium excision with a limbal conjunctival autograft and placement of a subconjunctival amniotic membrane graft has a low recurrence rate consistent with previously published data.

Patient-Reported Outcomes/Satisfaction and Spectacle Independence with Blended or Bilateral Multifocal Intraocular Lenses in Cataract Surgery.

PURPOSE: To compare patient-reported outcomes (PROs) and satisfaction results after multifocal intraocular lens (IOL) implantation in three groups: two receiving bilateral implantation of the same IOL and another undergoing blended vision with two different multifocal IOLs. PATIENTS AND METHODS: A questionnaire was administered to patients who had undergone uncomplicated cataract surgery and 2 months of follow-up: the first group underwent bilateral implantation with Alcon's AcrySof ReSTOR 3.0 lens ("3.0/3.0," n=78); the second group underwent implantation with the ReSTOR ActiveFocus 2.5 or the ReSTOR ActiveFocus 2.5 toric lens ("2.5 mini-monovision," n=102); and the third group underwent implantation with the ReSTOR 2.5 lens in the dominant eye and the ReSTOR 3.0 lens in the non-dominant eye ("2.5/3.0," n=89). RESULTS: Overall PROs and satisfaction was similar among the groups. Refractive outcomes and accuracy were similar among the groups, but the 2.5 mini-monovision group reported better intermediate vision. Refractive outcome differences were not meaningful among the groups and were not a differentiating factor in PROs. Substantially fewer patients in the 2.5 mini-monovision group noticed glare and halo compared with the 3.0/3.0 group (P<0.0001, chi-square test). No new safety concerns were reported. CONCLUSION: The 2.5 mini-monovision results in a higher percentage of patients being satisfied with intermediate vision than bilateral ReSTOR 3.0 or blended vision with ReSTOR 2.5/3.0 implants, but overall PRO differences were not statistically significant.

Safety and tolerability of lifitegrast ophthalmic solution 5.0%: Pooled analysis of five randomized controlled trials in dry eye disease.

PURPOSE: Characterize the safety and tolerability of lifitegrast ophthalmic solution 5.0% for the treatment of dry eye disease. METHODS: Pooled data from five randomized controlled trials were analyzed. Key inclusion criteria were adults with dry eye disease (Schirmer tear test score ⩾1 and ⩽10 mm, eye dryness score ⩾40 (visual analog scale 0-100), corneal staining score ⩾2.0 (0-4 scale)). Participants were randomized to lifitegrast ophthalmic solution 5.0% or placebo twice daily for 84 or 360 days. Treatment-emergent adverse events and drop comfort scores were assessed. RESULTS: Overall, 2464 participants (lifitegrast, n = 1287; placebo, n = 1177) were included. Ocular treatment-emergent adverse events occurring in >5% in either group were instillation site irritation (lifitegrast, 15.2%; placebo, 2.8%), instillation site reaction (lifitegrast, 12.3%; placebo, 2.3%), and instillation site pain (lifitegrast, 9.8%; placebo, 2.1%); the most common (> 5%) nonocular treatment-emergent adverse event was dysgeusia (lifitegrast, 14.5%; placebo, 0.3%). The majority of treatment-emergent adverse events were mild to moderate in severity. Discontinuation due to treatment-emergent adverse events occurred in 7.0% (lifitegrast) versus 2.6% (placebo) of participants (ocular: 5.5% vs 1.5%; nonocular: 1.9% vs 1.1%). Drop comfort scores with lifitegrast improved within 3 min of instillation and the score at 3 min improved across visits (12-week trials (both eyes, day 84 vs 0): 2.0 vs 3.3; SONATA (day 360 vs 0): right eye, 1.2 vs 1.7; left eye, 1.2 vs 1.8). CONCLUSION: Lifitegrast ophthalmic solution 5.0% appeared to be safe and well tolerated for the treatment of dry eye disease. Drop comfort with lifitegrast improved within 3 min of instillation.

Patient-reported outcomes of multifocal and accommodating intraocular lenses: analysis of 117 patients 2-10 years after surgery.

PURPOSE: The purpose of this study was to determine the satisfaction levels of patients at least 2 years after cataract surgery implantation with bilateral accommodating or bilateral multifocal intraocular lenses (IOLs) and to determine the relative rate of spectacle independence and adverse symptoms in that same time frame. DESIGN: Patient questionnaire administered in a single-center private practice at least 2 years after cataract surgery with presbyopia-correcting IOL implantation. METHODS: Patients who had undergone uncomplicated cataract surgery with an accommodating or multifocal IOL implant were eligible for inclusion. Patients with visually significant non-IOL-related postoperative morbidity were excluded. Patients with astigmatism or residual refractive error were not excluded. The main outcome measure was patient satisfaction at least 2 years after IOL implantation. RESULTS: Sixty-eight patients who received accommodating lenses and 49 patients who received multifocal lenses completed the questionnaire. The mean age of all patients was 75.7 years at the time of survey; the mean number of years since cataract surgery was 5.4 years. Overall, there were no significant differences between the two groups or within each group between the different lenses used. About 90% of patients in each group were "very satisfied" or "somewhat satisfied" with their vision at least 2 years after the initial surgery. Conversely, only one in eleven patients found his vision to be worse than expected. CONCLUSIONS: The majority of patients who received either accommodating or multifocal IOLs remain satisfied with their lens of choice more than 5 years after the original surgery. Glare and halos remain more noticeable in patients who received multifocal lenses.

Surgical techniques and adjuvants for the management of primary and recurrent pterygia.

The removal and rate of recurrence of pterygium have been discussed for years. The disorder is highly associated with environmental factors, and recurrence rates can be unacceptably high and cannot be successfully predicted. New techniques and graft preparations and postoperative management strategies are helping to reduce the recurrence rates and provide an ocular surface that is near ideal for future cataract or refractive surgery. This review discusses the advantages and disadvantages of various treatment strategies.

Pterygium excision with conjunctival autograft and subconjunctival amniotic membrane as antirecurrence agents.

OBJECTIVE: To determine the outcome of pterygium excision with a conjunctival autograft when the adjunctive use of a subconjunctival graft of amniotic membrane is employed to reduce fibrosis and recurrence after surgery. DESIGN: This is a retrospective, noncomparative study of postoperative outcomes. PARTICIPANTS: Eighty-four patients totalling 101 eyes with clinically significant pterygia that warranted surgical excision. METHODS: Surgeries were performed at South Orange County Outpatient Surgery Center (San Clemente, Calif.) between June 6, 2006, and October 23, 2013, by a single surgeon (J.A.H.). Patients were included in the study according to the need for pterygium surgery and the type of surgery performed. Exclusion criteria included patients with recurrent pterygium, those with pseudopterygium, and those whose treatment plan included prophylactic mitomycin during or after surgery. Initial pterygia measurements and postoperative findings were taken through standard slit-lamp examinations. RESULTS: Pterygium recurrence was defined as growth greater than 1 mm onto the corneal limbus at or after 6 months. There was 1 case of pterygium recurrence for a recurrence rate of 0.99% ± 1.93% (n = 101, p = 0.05). The mean extent of preoperative horizontal encroachment of pterygium on the cornea was 2.4 ± 0.87 mm. CONCLUSIONS: Pterygium excision with a conjunctival autograft and prophylactic placement of a subconjunctival amniotic membrane graft has a low recurrence rate with minimal added surgical time and minimal added risk to the patient and has merit as a surgical technique.