Purpose:To assess the effect of oral re-esterified omega-3 fatty acids on tear osmolarity, matrix metalloproteinase-9 (MMP-9), tear break-up time (TBUT), Ocular Surface Disease Index (OSDI), fluorescein corneal staining, Schirmer score, meibomian gland dysfunction (MGD) stage and omega-3 index in subjects with dry eyes and confirmed MGD.Methods:This was a multicenter, prospective, interventional, placebo-controlled, double-masked study. Subjects were randomized to receive 4 softgels containing a total of 1680 mg of eicosapentaenoic acid/560 mg of docosahexaenoic acid or a control of 3136 mg of linoleic acid, daily for 12 weeks. Subjects were measured at baseline, week 6, and week 12 for tear osmolarity, TBUT, OSDI, fluorescein corneal staining, and Schirmer test with anesthesia. MMP-9 testing and omega-3 index were done at baseline and at 12 weeks.Results:One hundred five subjects completed the study. They were randomized to omega-3 (n = 54) and control group (n = 51). Statistically significant reduction in tear osmolarity was observed in the omega-3 group versus control group at week 6 (−16.8 ± 2.6 vs. −9.0 ± 2.7 mOsm/L, P = 0.042) and week 12 (−19.4 ± 2.7 vs. −8.3 ± 2.8 mOsm/L, P = 0.004). At 12 weeks, a statistically significant increase in omega-3 index levels (P < 0.001) and TBUT (3.5 ± 0.5 s vs. 1.2 ± 0.5 s, P = 0.002) was also observed. Omega-3 group experienced a significant reduction in MMP-9 positivity versus control group (67.9% vs. 35.0%, P = 0.024) and OSDI scores decreased significantly in omega-3 (−17.0 ± 2.6) versus control group (−5.0 ± 2.7, P = 0.002).Conclusions:Oral consumption of re-esterified omega-3 fatty acids is associated with statistically significant improvement in tear osmolarity, omega-3 index levels, TBUT, MMP-9, and OSDI symptom scores.
Drs. Epitropoulos, Matossian, Berdy, and Malhotra received compensation from Tearlab for participating in the study. No author has a financial or proprietary interest in any material or method mentioned.
PurposeThe aim of this study was to evaluate the efficacy of a lipid containing emollient eye drop, Soothe XP, which was reformulated in 2014 with a more stable preservative and buffer system, compared to a control, non-emollient, eye drop (Systane Ultra) in improving lipid layer thickness (LLT) in subjects with dry eye due to meibomian gland dysfunction (MGD).Patients and methodsThis prospective single-center, open-label, cross-over, examiner masked-study enrolled subjects aged 30–75 years with lipid-deficient dry eye and a clinical diagnosis of MGD as determined by a slit lamp examination, an evaluation of meibomian gland drop out with meibography, and a standard patient evaluation of eye dryness questionnaire of >5. Eligibility was then determined by a LLT of <75 nm at baseline and the inability to increase LLT ≥15 nm with three blinks, as determined by interferometric methods. Subjects were randomized to receive a single emollient or non-emollient eye drop at Visit 1 and were crossed over for the alternate treatment at Visit 2. At each visit, LLT was measured prior to and 15 minutes following the instillation of the assigned eye drop. The primary endpoint was the change in LLT from baseline.ResultsSubjects (n=40) were enrolled and 35 completed the two study arms. Mean (±SD) patient age was 55.7 years (10.9) and 69% were female. Mean (±SD) LLT at baseline was 49.5 nm (9.2). Instillation of Soothe XP resulted in an increase in LLT to 77.5 nm (29.3) 15 minutes following drop instillation, which is an increase of 28.0 nm (27.4) (P<0.001). In contrast, LLT 15 minutes after the instillation of Systane Ultra was 50.8 nm (14.1), which was not statistically significant when compared to the baseline LLT.ConclusionIn this study of subjects with MGD, the emollient, or lipid containing eye drop, increased the LLT of tears when measured 15 minutes after instilling a single eye drop.
Purpose To determine the effect of lifitegrast ophthalmic solution 5% on improving the tear film, biometry/keratometry, and refractive accuracy for dry eye patients scheduled for cataract surgery. Patients and Methods Multicenter, prospective, open-label study of 100 eyes of 100 patients undergoing cataract surgery who had a confirmed diagnosis of dry eye. Patients underwent biometry at baseline and again after a 28-day course of lifitegrast 5% BID. Primary outcome was an improvement in the accuracy of preoperative anterior corneal power measurements at predicting postoperative spherical equivalent (SE) pre- and post-lifitegrast treatment. Secondary outcomes included changes in dry eye symptoms and corneal staining. Results The accuracy of the biometry readings for the achieved refractive SE: within 0.25 D in 47% and 50% of eyes before and after the initial lifitegrast treatment, respectively; within 0.5 D in 71% and 79% of eyes before and after the initial lifitegrast treatment; and within 0.75 D in 81% and 91% of eyes before and after the initial lifitegrast treatment (p < 0.04). Conclusion Lifitegrast 5% significantly improved preoperative corneal surface measurement accuracy in patients with confirmed dry eye who were scheduled for cataract surgery.
Purpose To investigate the efficacy of a micro-emulsion (ME) lipid layer artificial tear in improving tolerance of immunomodulator eye drops for the treatment of dry eye disease. Patients and Methods A total of 33 patients with previously diagnosed dry eye disease were given the micro-emulsion lipid layer artificial tear in conjunction with either lifitegrast or cyclosporine. Patients were queried on their tolerance of the regimen by reporting VAS scores before starting the adjunctive eye drop, immediately after starting, and 2–3 weeks later. Tolerance was statistically compared over time and with respect to previous medication compliance, timing of the adjunctive eye drop, age, gender, and ethnicity. Results Across all patients, the VAS pre-treatment score (6.8 ± 0.6) was significantly higher than both the VAS 1-day post ME lipid tear instillation time point (3.0 ± 0.7) (post hoc Bonferroni, p < 0.001) and the VAS 2–3-week post instillation time point (1.7 ± 0.7) (post hoc Bonferroni, p < 0.001), with the mean VAS score improving over time (post hoc Bonferroni, p < 0.028). Average VAS scores did not vary with respect to specific medical therapy or the timing of instillation of this artificial tear. Both the “at-risk” and “conversion” groups independently had significant improvements at both 1-day and 2–3-week time points compared to baseline. Conclusion The micro-emulsion lipid layer artificial tear was effective as an adjunctive eye drop to improve tolerance of lifitegrast and cyclosporine for patients with dry eye disease who were at risk of failing or had previously failed immunomodulatory therapy.
PurposeTo measure the effects from a single vectored thermal pulsation treatment of the meibomian glands on dry eye signs and symptoms in patients who tested positively versus negatively for novel Sjögren’s syndrome (SS) biomarkers.MethodsThe retrospective study included the deidentified data of 102 eyes of 59 patients with dry eye and meibomian gland dysfunction (MGD), who were also tested for novel biomarkers for SS and underwent a single 12-minute LipiFlow thermal pulsation procedure. All patients were already being treated with individualized dry eye therapy but remained symptomatic. Meibomian gland secretion (MGS) scores, Standard Patient Evaluation of Eye Dryness (SPEED) questionnaire scores and tear breakup times (TBUTs) before and 8 weeks after thermal pulsation treatment were analyzed.ResultsTwenty-three patients tested positive for novel biomarkers of SS and 36 patients tested negative. At baseline, MGS, SPEED and TBUT of both SS-positive and SS-negative patients were equivalent. At 8 weeks’ post-treatment, mean MGS score, SPEED and TBUT were 13.0±7.8, 12.5±6.8 and 9.6±4.6, respectively, in SS-positive patients and 15.9±7.9, 10.0±6.3 and 8.3±4.6, respectively, in SS-negative patients (P<0.001). While the post-treatment MGS was significantly better in SS-negative patients than SS-positive (P=0.021), no significant difference between post-treatment SPEED and TBUT was observed between the two groups (P>0.05).ConclusionLipiFlow treatment in MGD patients who were SS-positive for novel biomarkers of SS demonstrated improvement in signs and symptoms of dry eye. While improvement in MGS scores in SS-negative patients was higher than that observed in SS-positive patients, SPEED and TBUT were equivalent between these two groups.
PurposeTo compare the ability of two optical biometers to acquire the axial length (AL) measurement in cataractous eyes.MethodsThis prospective, comparative, single-center study comprised 105 eyes (63 patients). AL was acquired by the composite mean value of 20 measurements (composite-20 IM) and five measurements (composite-5 IM) (IOLMaster® 500 version 7.1 software), and the standard mean value of the first five measurements (standard-5 LS, Lenstar LS 900®). Anterior chamber depth (ACD) and average keratometry (K) readings were acquired.ResultsAL was acquired in 83.8%, 92.4%, and 84.8% of eyes for the composite-5 IM, composite-20 IM, and standard-5 LS, respectively. Standard-5 LS AL measurements were significantly shorter (P<0.001). IOLMaster® 500-acquired ACD (corneal epithelium to lens) measurements were significantly shorter (P<0.001). IOLMaster® 500 average K measurements were significantly steeper (P<0.001).ConclusionThe composite-20 IM had the highest AL acquisition success rate of the three versions evaluated. AL, ACD, and average Ks were statistically different between the two biometers, although the differences were clinically insignificant.
A new controlled point source LED glare tester demonstrated the adverse effect on visual acuity due to glare in patients with cataract, accurately simulated night driving glare issues for patients with cataracts, and was rated as easy to use and useful by investigators.
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