Donor Diabetes Mellitus Severity and Corneal Transplant Suitability in a US Eye Bank Donor Population Purpose: To determine whether donor diabetes mellitus (DM) severity is associated with differences in endothelial cell density (ECD) and surgically unsuitable tissue. Methods: Raw data were obtained from Saving Sight Eye Bank (Kansas City, MO) including 10,454 donated eyes from 5346 eligible donors from July 2014 through May 2017. Donors were grouped into 5 categories by their insulin use and the presence of microvascular end-organ complications. The categories were non-DM (NDM), noninsulin-dependent DM without complications (NIDDMnc), noninsulin-dependent DM with complication (NIDDMc), insulin-dependent DM without complications, and insulin-dependent DM with complication. Outcome variables included ECD and tissue transplant suitability. Mixed effects models were used to adjust for the random effect of repeated measures and fixed effects of donor age, race, lens status, and death to refrigeration and death to preservation times. Interaction effects of DM severity group and donor age and DM severity group and lens status were included in the models. Results: One thousand six hundred eighty-four (32.1%) donors had a diagnosis of DM. Six hundred fifty-eight donors were in the NIDDMnc group, 225 in the NIDDMc group, 404 in the insulin-dependent DM without complication group, and 397 in the insulin-dependent DM with complication group. Compared with non-DM, donors with DM were older (P < 0.001) and more likely to be pseudophakic (P < 0.001). DM severity groups did not affect adjusted ECD at mean donor age. There was no statistically significant ECD interaction between DM severity group and lens status. There was a statistically significant ECD crossover interaction with NIDDMnc and donor age (P < 0.001). In phakic eyes, NIDDMc was associated with a statistically significantly lower odds of transplant suitability (odds ratio 0.62, P = 0.006). Conclusions: DM severity does not affect lowering adjusted ECD at mean donor age. DM severity and pseudophakia were not associated with lower adjusted ECD. NIDDMnc was associated with an attenuation of the age-dependent decrease in ECD. NIDDMc was associated with decreased transplant suitability in phakic eyes. Future studies should include age, lens status, and interaction effects in their models of ECD and transplant suitability.

A Simple 60-Second Swelling Technique for More Consistent Ultrathin DSAEK Graft Preparation Purpose: The purpose of this study is to describe a simple but novel 60-second swelling technique for ultrathin Descemet stripping automated endothelial keratoplasty (DSAEK) graft preparation. In addition, we aim to demonstrate the effectiveness of this technique in obtaining thinner DSAEK grafts more consistently without compromising graft quality. Methods: We performed a retrospective case–control study comparing standard DSAEK preparation using an ML7 Microkeratome Donor Cornea System (Med-Logics Inc, Athens, TX) with an additional 60 seconds of stromal swelling with a balanced salt solution after the removal of the epithelium but before the microkeratome pass. Thirty cases using this novel swelling technique were compared with controls matched by age, sex, and precut corneal thickness. Donor characteristics and both precut and postcut graft characteristics were analyzed. Results: DSAEK grafts prepared with our simple swelling method were approximately 13 μm thinner on average than those prepared with our conventional ultrathin DSAEK preparation technique (P = 0.001). The frequency of grafts less than 100 μm was much greater with swelling (93.3% vs. 63.3% with conventional technique, P = 0.0052). There were no significant differences in postcut cell counts or decrease in cell counts between the groups. Conclusions: A simple 60-second swelling technique can yield significantly thinner DSAEK tissue in a more consistent range without a significant impact on the endothelial cell count.

Spatial Analysis of Corneal Densitometry, Thickness Profile, and Volume Distribution After Uneventful Descemet Membrane Endothelial Keratoplasty Purpose: To present normative corneal densitometry (CD), thickness (CT), and volume (CV) after uneventful Descemet membrane endothelial keratoplasty (DMEK). Methods: Medical records of 212 consecutive surgeries were reviewed. One hundred cases without intraoperative and postoperative complications were included (group 1). Scheimpflug CD of the optically relevant 0- to 2-mm zone and 2- to 6-mm annulus, CT at the 2-, 4-, and 6-mm rings, and CV at the 3-, 5-, and 7-mm zones were evaluated preoperatively and at 3, 6, 12, and 24 months postoperatively. The 24-month results were compared with an age-matched group of uncomplicated pseudophakic eyes (group 2; n = 20) and a group of healthy, young subjects (group 3; n = 30). Results: Total CD at 0 to 2 mm was 33.9 ± 10.7 grayscale units preoperatively and decreased to 20.3 ± 4.7 at 24 months (P < 0.001), being significantly higher compared with both control groups (P ≤ 0.026). Total CD at 2 to 6 mm was 27.9 ± 8.1 preoperatively and decreased to 20.2 ± 4.6 at 24 months (P < 0.001), showing no statistically significant difference compared with group 2 (P = 0.061). At 24 months, group 1 showed a similar central CT, CT at the 2-mm and 4-mm rings compared with group 2 (P ≥ 0.440); however, CT at 6 mm increased significantly (P = 0.008). CV at 3, 5, and 7 m decreased significantly at 24 months (P < 0.001), showing no significant differences compared with both control groups (P ≥ 0.122). Conclusions: Twenty four months after uneventful DMEK, CT within the central 4-mm zone and CV at the 3-, 5-, and 7-mm zones were similar to uncomplicated pseudophakic eyes. The total CD at the 0- to 2-mm zone and midperipheral CT at the 6-mm ring were higher compared with the pseudophakic controls.

Clinical Properties and Risk Factors for Descemet Membrane Folds After Deep Anterior Lamellar Keratoplasty in Patients With Keratoconus Purpose: To report the clinical properties and risk factors for corneal Descemet membrane (DM) folds after deep anterior lamellar keratoplasty (DALK) in patients with keratoconus. Methods: This is a retrospective case–control study. Study participants—experimental group: 44 eyes with DM folds after DALK; control group: 135 eyes without DM folds after DALK. Results: Forty eyes with DM folds were displayed as 1 or 2 translucent lines in the DM layer. Three eyes appeared as several arcuate shape lines, and 1 eye presented as a radial shape. DM folds impaired corrected visual acuity after DALK (P = 0.018). Age older than 20.5 years at surgery and disease duration longer than 5.5 years were independent risk factors for DM fold formation after DALK surgery (odds ratio 5.39, 95% confidence interval: 2.11–13.73, P < 0.001; 6.60, 95% confidence interval: 2.92–14.94, P < 0.001). Preoperative Kmean, Kmax, central corneal thickness, anterior chamber depth, sex, history of rigid gas permeable contact lens wearing, Vogt striae, stromal scar, and intraoperative microperforation had no influence on the occurrence of DM folds (P1 = 0.775, P2 = 0.896, P3 = 0.555, P4 = 0.182, P5 = 0.656, P6 = 0.237, P7 = 1.000, P8 = 0.587, and P9 = 0.798). Conclusions: DM folds impaired postoperative corrected visual acuity. The risk factors for DM folds included age older than 20.5 years and disease duration longer than 5.5 years.

Clinical Outcomes of a New Asymmetric Intracorneal Ring Segment for the Treatment of Keratoconus Purpose: To report visual, refractive, and corneal aberrations after implantation of a new asymmetric intracorneal ring segment (ICRS). Methods: This was a prospective, multicenter clinical study including 30 eyes of 26 patients with keratoconus. All cases were implanted with an ICRS, named the VISUMRING (VR), which had an arc length of 353 degrees and 2 asymmetric sections that can be customized in base width, length, and thickness. Ophthalmic evaluation included uncorrected distance visual acuity (UDVA), corrected distance visual acuity (CDVA), refraction, topography, and anterior corneal aberrations using the Sirius System (CSO, Firenze, Italy). Mean follow-up period was 14.7 ± 7.9 months. Results: Significant improvement of both UDVA and CDVA was observed after 1 year. UDVA improved from 0.08 ± 0.22 to 0.22 ± 0.16 and CDVA from 0.24 ± 0.29 to 0.43 ± 0.18 (P = 0.01). A significant reduction of more than 7 D in the spherical equivalent from −12.38 ± 3.77 D to −5.00 ± 3.26 D (P < 0.05) was noted 1 year after the procedure. In terms of higher-order aberrations, a slight reduction that was not statistically significant in the higher-order and coma-like aberrations was noted at 1 year from 4.32 and 3.82, to 4.12 and 3.55, respectively. Regarding complications, 5 of the 30 cases needed to have the VR explanted throughout the follow-up period due to severe corneal melting. Conclusions: VR ICRS improves vision and refraction and induces major corneal flattening in patients with keratoconus. Further design enhancement is needed to increase the reduction of the asymmetric corneal aberrations and reduce the extrusion rate.

Combined Phototherapeutic Keratectomy, Intracorneal Ring Segment Implantation, and Corneal Collagen Cross-Linking in Keratoconus Management Purpose: To evaluate the efficacy, predictability, and safety of combined corneal collagen cross-linking (CXL), intracorneal ring segment (ICRS) implantation, and superficial phototherapeutic keratectomy (PTK) in patients with keratoconus. Methods: Fifty-five eyes received ICRS implantation, followed by CXL and PTK combination treatment. Patients were followed up for 6 months. Primary outcomes included Logarithm of the Minimum Angle of Resolution (LogMAR) uncorrected distance VA (UDVA) and corrected distance VA (CDVA), sphere, cylinder, mean spherical equivalent, index of surface variance, index of vertical asymmetry, keratoconus index, central keratoconus index, index of height asymmetry, and index of height decentration. Secondary outcomes were higher-order aberrations (HOAs), including HOA total, coma, spherical, secondary astigmatism, and trefoil. Results: At 6 months, there was a statistically significant improvement in UDVA, CDVA, sphere, and cylinder compared with baseline (P < 0.001). UDVA improved in 14% of the eyes to 20/25 and 96% had at least 20/40 or better spectacle corrected vision; 30.9% of the eyes were within ±0.5 diopter (D), 45.5% of the eyes were within ±1.0 D, and 74.5% of the eyes were within ±2.0 D. For CDVA, 1 eye (2%) lost 3 lines (but gained UDVA), 11% lost 1 line, 38% showed no change, and 49% gained between 1 and 8 lines of vision. Eighty-eight United Arab Emiratespercent of the eyes had at least 1 line of UDVA visual improvement, 79% improved by ≥2 lines, and 69% improved by ≥3 lines. HOA total, coma, spherical aberration, and secondary astigmatism showed improvements of −0.87 (P < 0.001), −0.84 (P < 0.001), −0.10 (P = 0.002), and −0.15 (P = 0.035), respectively. Conclusions: A combined procedure of ICRS implantation, CXL, and PTK is effective, predictable, and apparently safe for patients diagnosed with moderate keratoconus.

Interferon Alpha-2b Eye Drops Prevent Recurrence of Pterygium After the Bare Sclera Technique: A Single-Center, Sequential, and Controlled Study Purpose: To investigate the efficacy and safety of interferon (IFN) alpha-2b eye drops in preventing pterygium recurrence after the bare sclera technique. Methods: Sixty eyes in 53 patients who underwent treatment for primary pterygium (the length of corneal invasion ranged from 2 to 4 mm) were enrolled in this prospective study. All patients were divided in chronological sequence into 2 groups. The control group included the first 30 eyes, whereas the treatment group included the next 30 eyes. After treatment with the bare sclera technique, levofloxacin and 0.1% fluorometholone eye drops were used 4 times a day for 3 months after surgical excision in both groups. In addition, IFN alpha-2b eye drops were applied in the treatment group 4 times a day for 3 months. Throughout an 18-month follow-up period, all patients in both groups were examined 1 day, 10 days, 1 month, 3 months, 6 months, 12 months, and 18 months after surgery. The main outcome measures were pterygium recurrence, conjunctival redness and thickness, and neovascularization and complications (ie, delayed conjunctival healing, persistent corneal epithelial defection, conjunctival granuloma, and scleral melting and necrosis). Results: The recurrence rates in the control group and the treatment group at the end of the sixth month were 29.2% and 3.7%, respectively, and the rates were significantly different between the 2 groups (P = 0.019). Up to 12 months after surgeries, the recurrence rate was 33.3% in the control group and 7.4% in the treatment group, and the difference between the 2 groups was statistically significant (P = 0.048). The rates at the end of 18 months were the same. During the follow-up period, no complications were observed except for 1 conjunctival granuloma (in the treatment group) and 2 corneal epithelial defects (one in the control group and the other in the treatment group). Conclusions: Administration of IFN alpha-2b eye drops after the bare sclera technique appear safe and effective in reducing the recurrence of pterygium.

Direct Visualization of Continuous Meibum Secretion From the Orifices of Meibomian Glands to the Tear Film Purpose: To present a new method to directly visualize meibum secretion on the tear film from meibomian gland orifices and show that meibum is continuously secreted between blinking. Methods: Eighteen patients with dry eye syndrome and 17 healthy subjects were included in the study. We used the Lipiscanner to evaluate the tear film lipid layer. The lipid layer was classified into thick, normal, and thin lipid layer. The lipid layer on the lower tear meniscus of the right eye was observed after a drop of saline solution was applied to the eye. We recorded continuous meibum secretion onto the tear meniscus surface. We calculated the rate of continuous meibum secretion by analyzing videos. Noncontact meibography was performed for meibomian glands in the lower eyelid. The quality of meibum from the 5 orifices at the same area was then scored. Results: The mean continuous meibum secretion rate was 2.7 pL/s in the healthy group and 8.0 pL/s in the dry eye group. The rates were 1.3, 6.7, and 9.4 pL/s in the thin, normal, and thick tear film lipid layer group, respectively. They were 3.4, 3.4, 10.7, and 18.1 pL/s in grade 0, 1, 2, and 3 meibomian gland dropout groups, respectively. The rates were 0.00, 4.7, 10.1, 2.0, and 0.7 pL/s in the normal meibum, yellow without increased viscosity, yellow with increased viscosity, toothpaste, and no meibum groups, respectively. Conclusions: We showed how to visualize meibum being secreted into the tear film from the meibomian gland orifices, and we were able to observe the continuous secretion of meibum between blinks.

Corneal Subbasal Nerve Analysis Using In Vivo Confocal Microscopy in Patients With Dry Eye: Analysis and Clinical Correlations Purpose: This study aimed to observe corneal subbasal nerves and Langerhans cells (LCs) using in vivo confocal microscopy (IVCM) in patients with dry eye, a tool for the evaluation of disease stage and severity and for treatment monitoring at the microstructural level. Methods: A total of 107 eyes from 62 patients were included. The Ocular Surface Disease Index (OSDI) questionnaire and other examinations were used to assess dry eye symptoms and signs. IVCM was performed to observe subbasal corneal nerves and LCs. Corneal nerves were graded using both objective and subjective methods. The correlations between dry eye symptoms and corneal nerve parameters, corneal nerve grading, and LC number were analyzed. Results: Corneal nerve length was negatively correlated with sensitivity to light [correlation coefficient (CC)= −0.24, P < 0.05]; nerve width was positively correlated with the OSDI score, painful eyes, and blurred vision (CC = 0.41, 0.23, and 0.46, respectively, all P < 0.05); and nerve tortuosity was positively correlated with sensitivity to light (CC = 0.23, P < 0.05). Moreover, both total objective and subjective grading scores were positively correlated with OSDI scores (CC = 0.48 and 0.27, respectively, both P < 0.05). LC number was found not to be significantly correlated with dry eye symptoms (P > 0.05). Conclusions: IVCM is a useful tool to evaluate corneal subbasal nerve changes in patients with dry eye. Detailed nerve grading could help to understand and evaluate the pathophysiologic conditions of the disease and could be used for further treatment follow-up in the future.

Effect of OTX-101, a Novel Nanomicellar Formulation of Cyclosporine A, on Corneal Staining in Patients With Keratoconjunctivitis Sicca: A Pooled Analysis of Phase 2b/3 and Phase 3 Studies Background: Keratoconjunctivitis sicca affects 5% to 33% of the population and is often accompanied by symptoms such as burning and dryness. This pooled analysis evaluated total and central corneal fluorescein staining (CFS) in patients receiving OTX-101 0.09% or vehicle in phase 2b/3 and 3 studies and whether improvements in corneal staining correlated with improved visual acuity. Methods: In these randomized, vehicle-controlled studies, patients received 1 drop of OTX-101 or vehicle in both eyes twice daily. Corneal staining was performed at baseline and days 28, 56, and 84. CFS was evaluated in each zone (0-to-4 scale); total corneal staining (0-to-20 scale per eye) was averaged over both eyes. Pooled safety assessments included adverse event monitoring. Results: Mean baseline CFS total scores (SD) were 4.2 (2.5) and 4.3 (2.6) for the OTX-101 (n = 523) and vehicle (n = 525) groups, respectively. For total corneal staining, least squares mean changes from baseline (standard error) were −0.9 (0.08) versus −0.5 (0.08) for OTX-101 and vehicle, respectively (P = 0.0008), on day 28 and −1.4 (0.09) versus −0.9 (0.09) on day 84 (P = 0.0002). There was a significantly high correlation (P = 0.0117) between reduced central corneal staining and improved visual acuity on day 84. Treatment-related adverse events were mostly mild, with instillation site pain reported by 21.8% and 4.0% of patients receiving OTX-101 and vehicle, respectively. Conclusions: Treatment with OTX-101 led to greater improvements versus vehicle in corneal surface staining as early as 4 weeks, and further improvements were seen up to 12 weeks. OTX-101 was well tolerated in patients with keratoconjunctivitis sicca.