Clinical Outcomes of Lifitegrast 5% Ophthalmic Solution in the Treatment of Dry Eye Disease.

PURPOSE: To evaluate the clinical characteristics, outcomes, and adverse reactions after the use of lifitegrast 5% ophthalmic solution for the treatment of patients with dry eye disease (DED). METHODS: Retrospective chart review was performed in 121 patients seen at the Duke Eye Center with DED who were prescribed lifitegrast 5% and seen for follow-up after treatment initiation. Charts were reviewed for meibomian gland dysfunction (MGD) grading, conjunctival and corneal staining scores, and tear breakup time (TBUT), as well as matrix metalloproteinase-9 (MMP-9) levels. Ocular Surface Disease Index (OSDI) questionnaire scores and self-reported adverse reactions were also assessed. RESULTS: The average patient age was 60.5 years (range, 22-88 years); 87.6% were female, and 20.7% had a previous autoimmune disease diagnosis. Of the 54 eyes with an initial positive MMP-9, 21 eyes (38.9%) normalized after treatment. The ocular symptoms OSDI subscore demonstrated an improvement of -2.43±6.85 (P=0.011) after treatment. Corneal staining scores showed an average change of -0.15 (P=0.007). The average change in TBUT was 1.9 sec (P<0.001). Self-reported adverse reactions were noted in 31.4% of patients. There was no statistically significant change in MGD grading. Patients with moderate-severe DED showed statistically significant improvements in conjunctival and corneal staining scores and TBUT (-0.17±0.66, P=0.0442; -0.54±0.65, P<0.001; +2.02±2.63, P=0.004, respectively). CONCLUSION: Lifitegrast 5% is a useful therapeutic option for DED with a moderate proportion of self-reported adverse reactions, all of which were related to ocular discomfort. Treatment with lifitegrast was associated with statistically significant improvements in MMP-9 levels, ocular symptoms, corneal staining, and TBUT.

Wound closure and tissue adhesives in clear corneal incision cataract surgery.

PURPOSE OF REVIEW: Achieving secure wound closure in clear corneal incision cataract surgery remains highly desired for its role in reducing infection risk and leak-related complications, including hypotony, corneal edema, and lens dislocation. Although classic techniques of stromal hydration or wound suturing represent traditional approaches, the introduction of newer and more effective ocular surface adhesives has increased the options that are available. This review aims to provide an update on the peer-reviewed literature regarding wound closure and the currently available and investigational tissue adhesives used to seal clear corneal incisions in cataract surgery. RECENT FINDINGS: Stromal hydration and sutured closure of clear corneal incisions remain viable options for wound closure. Wound sealants, particularly polyethylene glycol (PEG)-based hydrogels, have been found to provide watertight wound seal with less foreign-body sensation and surgically induced astigmatism compared with sutures, and less adverse effects and greater ease of use compared with cyanoacrylate and fibrin glues. SUMMARY: Stromal hydration, sutured closure, and use of a corneal adhesive are all wound closure options for clear corneal incisions. Of the currently available tissue adhesives, PEG hydrogel sealants have become the most widely accepted, with an improved side-effect and biocompatibility profile.

Assessment of retinal nerve fiber layer thickness in healthy, full-term neonates.

PURPOSE: To measure average retinal nerve fiber layer (RNFL) thicknesses in healthy, full-term neonates. DESIGN: Descriptive research to develop normative data. METHODS: Healthy infants born between 37 and 42 weeks postmenstrual age were imaged with hand-held spectral-domain optical coherence tomography. A custom script segmented the RNFL; the fovea and optic nerve center were manually selected. A second script measured the average RNFL thickness along the papillomacular bundle, defined as the arc from -15 degrees to +15 degrees on the axis from the optic nerve to fovea, with radii of 1.1, 1.3, 1.5, and 1.7 mm from the center of the optic disc. Shapiro-Wilk W tests assessed these measurements for normality to determine the age-appropriate radial distance for subsequent analyses. Average RNFL thicknesses for four temporal 45-degree sectors (superior temporal, temporal superior, temporal inferior, and inferior temporal) and the temporal quadrant were calculated and compared to demographic parameters for all infants. RESULTS: Fifty full-term infants were adequately imaged for RNFL analysis. RNFL thicknesses at 1.5 mm radial distance from the optic nerve were the most normally distributed. While there was a trend toward greater mean superior temporal RNFL thickness for both black and Hispanic vs white infants (128 ± 27 µm, 124 ± 30 µm, and 100 ± 19 µm, respectively, P = .04 for both comparisons), there were no other significant differences noted in RNFL thicknesses by race, sex, gestational age, or birth weight. CONCLUSIONS: We present RNFL thickness measurements for healthy, full-term infants that may serve as normative data for future analyses.

Poorer neurodevelopmental outcomes associated with cystoid macular edema identified in preterm infants in the intensive care nursery.

PURPOSE: To evaluate the association between cystoid macular edema (CME) observed in very preterm infants and developmental outcomes at 18 to 24 months corrected age. DESIGN: Cohort study. PARTICIPANTS: Infants born at or less than 1500 g or at or less than 30 weeks postmenstrual age who underwent screening for retinopathy of prematurity (ROP) in an intensive care nursery. METHODS: Bedside handheld spectral-domain optical coherence tomography (SD OCT; Envisu, Bioptigen, Inc, Research Triangle Park, NC) imaging was obtained from preterm infants who were being screened for ROP and graded for presence of CME, central foveal thickness (CFT), inner nuclear layer thickness, and foveal-to-parafoveal thickness ratio. At 18 to 24 months corrected age, the children were assessed with the Bayley Scales of Infant and Toddler Development, Third Edition. MAIN OUTCOME MEASURES: Scores on the Bayley cognitive, language, and motor subscales. RESULTS: Among 77 children with SD OCT imaging, 53 were evaluated with the Bayley Scales. Compared with children who did not have CME as infants (n=22), the mean score for children who had CME (n=31) was 7.3 points (95% confidence interval [CI], -15.5 to 0.9; P=0.08) lower on the cognitive subscale, 14.1 points (95% CI, -22.7 to -5.5; P=0.002) lower for the language subscale, and 11.5 points (95% CI, -21.6 to -1.3; P=0.03) lower for the motor subscale. Differences were maintained after adjusting for gestational age and birth weight. Severity of CME, as assessed by foveal-to-parafoveal thickness ratio, within the CME group correlated with poorer cognitive (R2=0.16, P=0.03) and motor (R2=0.15, P=0.03) development. CONCLUSIONS: Cystoid macular edema observed on SD OCT in very preterm infants screened for ROP is associated with poorer language and motor skills at 18 to 24 months corrected age. Evaluation of the retina with SD-OCT may serve as an indicator of neurodevelopmental health for very preterm infants in the intensive care nursery.

Evaluation of optic nerve development in preterm and term infants using handheld spectral-domain optical coherence tomography.

PURPOSE: To evaluate effects of prematurity on early optic nerve (ON) development and the usefulness of ON parameters as indicators of central nervous system (CNS) development and pathology. DESIGN: Prospective, cross-sectional, longitudinal study. PARTICIPANTS: Forty-four preterm infants undergoing retinopathy of prematurity (ROP) screening and 52 term infants. METHODS: We analyzed ON from portable handheld spectral-domain optical coherence tomography (SD-OCT) images (Bioptigen, Inc, Research Triangle Park, NC) of 44 preterm and 52 term infants. The highest-quality ON scan from either eye was selected for quantitative analysis. Longitudinal analysis was performed at 31-36 weeks and 37-42 weeks postmenstrual age (PMA). Preterm ON parameters also were assessed for correlation with indicators of cognitive, language, and motor development and CNS pathology. MAIN OUTCOME MEASURES: Vertical cup diameter (vCD), vertical disc diameter (vDD), vertical cup-to-disc ratio (vCDR), cup depth, and indicators of neurocognitive development and CNS pathology. RESULTS: At 37-42 weeks PMA, preterm infants had larger vCD and vCDR than term infants (908 vs. 700 µm [P<0.001] and 0.68 vs. 0.53 µm [P<0.001], respectively), whereas cup depth and vDD were not significantly different. Longitudinal changes (n = 26 preterm eyes; mean interval, 4.7 weeks) in vDD and in vCDR were an increase of 74 µm (P = 0.008) and decrease of 0.05 (P = 0.015), respectively. In preterm infants (n = 44), periventricular leukomalacia was associated with larger vCD (1084 vs. 828 µm; P = 0.005) and vCDR (0.85 vs. 0.63; P<0.001), posthemorrhagic hydrocephalus was associated with shallower cup (331 vs. 456 µm; P = 0.030), and clinical magnetic resonance imaging was associated with larger vCDR (0.73 vs. 0.64; P = 0.023). In 23 preterm infants with Bayley Scales of Infant Development scores, larger vCDR was associated with lower cognitive scores (P = 0.049). CONCLUSIONS: This is the first analysis of ON parameters in premature infants using SD-OCT. It demonstrated that by age of term birth, vCD and vCDR are larger in preterm infants who were screened for ROP than in term infants. In this prospective pilot study, ON parameters in these preterm infants associate weakly with CNS pathology and future cognitive development. Future prospective studies with larger numbers are necessary before further conclusions can be made.

Spectral domain optical coherence tomography characterization of pediatric epiretinal membranes.

PURPOSE: To compare the macular morphology of pediatric versus adult eyes with epiretinal membrane (ERM) using spectral domain optical coherence tomography and identify characteristics associated with postoperative visual acuity. METHODS: This retrospective study analyzed spectral domain optical coherence tomography from pediatric subjects and a randomly selected cohort of adult subjects with ERM. Morphologic retinal and ERM features were graded by two masked spectral domain optical coherence tomography readers and compared with a postoperative change in visual acuity. RESULTS: Pediatric ERMs (age, 0.3-16.5 years) were more confluently attached to the retina than adult ERMs (age, 40-88 years; P = 0.009) and had less fibrillary appearance of the inner retina when separation was present (P = 0.044). Pediatric ERMs were associated with more vessel dragging (P = 0.019) and less external limiting membrane (P = 0.001) and inner segment band visibility (P = 0.010), with a trend toward foveal sparing by ERM (P = 0.051) and "taco" retinal folds (P = 0.052) compared with adult eyes. Visual acuity improvement was associated with intact (P = 0.048) and smooth (P = 0.055, trend) inner segment band in children and with smooth inner segment band (P = 0.083, trend) and visible external limiting membrane (P = 0.098, trend) in adults. CONCLUSION: We identified morphologic differences between pediatric and adult ERM on spectral domain optical coherence tomography. Similar to adults, photoreceptor integrity with pediatric ERM seems to predict better visual acuity changes after surgical ERM removal.

Three-dimensional assessment of vascular and perivascular characteristics in subjects with retinopathy of prematurity.

PURPOSE: To study vascular features detected with spectral domain optical coherence tomography (SD-OCT) in subjects undergoing retinopathy of prematurity (ROP) screening. DESIGN: Cross-sectional study. PARTICIPANTS AND CONTROLS: Fifty-seven premature neonates, 10 with plus disease in at least 1 eye and 47 without plus disease. METHODS: Bedside noncontact SD-OCT imaging was performed after obtaining parental consent on 97 consecutive infants between January 2009 and September 2012. Fifty-seven subjects (31-49 weeks' post-menstrual age) who had an SD-OCT scan in at least 1 eye showing the edge of the optic nerve and at least 1 major retinal vascular arcade were included. One eye per subject was randomly selected for analysis. Two masked graders evaluated scans for (1) retinal vessel elevation, (2) scalloped retinal layers, (3) hyporeflective vessels, and (4) retinal spaces. To coalesce the weight of these features, a Vascular Abnormality Score by OCT (VASO) was created. For quantitative assessment of vessel elevation, retinal surface maps were created. MAIN OUTCOME MEASURES: Prevalence of SD-OCT vascular abnormalities, the VASO, intergrader agreement, and presence of elevation on surface maps. RESULTS: From among 67 SD-OCT characteristics that were recorded, the most common characteristics found were vessel elevation (44%), hyporeflective vessels (40%), scalloped layers (22%), and retinal spaces (11%). Features significantly associated with plus disease were vessel elevation (P = 0.01), hyporeflective vessels (P = 0.04), and scalloped retinal layers (P = 0.006). Intragrader agreement was between 74% and 90% for all features. The VASO was significantly higher in subjects with plus disease (P = 0.0013). On 3-dimensional SD-OCT volumes, eyes with plus disease had greater retinal surface elevation that more often matched en face retinal vascular patterns. CONCLUSIONS: We present a novel 3-dimensional analysis of vascular and perivascular abnormalities identified in SD-OCT images of eyes with ROP. The SD-OCT characteristics that are more common in eyes with plus disease provide the first in vivo demonstration of the effects of vascular dilation and tortuosity on perivascular tissue. The VASO and surface maps also delineate the severity of vascular pathology in plus disease. Further studies evaluating these findings in eyes with pre-plus versus normal posterior pole vessels may determine the usefulness of SD-OCT in the early detection of vascular abnormalities in ROP.