Purpose To evaluate whether levels of corneal subbasal nerve fiber length (SNFL) in dry eye disease (DED) could prognosticate the level of improvement in signs and symptoms after treatment. Design Phase IV, double-masked, randomized clinical trial. Participants Sixty patients with meibomian gland dysfunction-associated DED and 27 age-matched controls. Methods Patients with DED were randomized to receive topical artificial tears, loteprednol etabonate 0.5%, or loteprednol etabonate 0.5%/tobramycin 0.3% twice daily for 4 weeks. At baseline, in vivo confocal microscopy of central cornea was performed in both eyes. Patients with DED were divided into 2 subgroups, those with low baseline SNFL and those with near-normal baseline SNFL (the cut-off point: mean SNFL in controls minus 2 standard deviations). Clinical signs and symptoms at baseline and after 4 weeks of treatment were compared between the subgroups with low and near-normal SNFL for all therapeutic groups. Main Outcome Measures Symptom questionnaires, corneal fluorescein staining (CFS), conjunctival staining with lissamine green, tear break-up time, Schirmer’s test, and SNFL. Results In patients with DED, baseline SNFL (17.06 ± 5.78 mm/mm2) was significantly lower than in controls (23.68 ± 3.42, P=0.001). In the artificial tear and loteprednol groups, although no significant improvement in any sign or symptom was noted in patients with low baseline SNFL (<16.84 mm/mm2), subjects with near-normal baseline SNFL (≥16.84 mm/mm2) showed significant improvement in both symptoms and corneal fluorescein staining (CFS) score (all P<0.05). In the loteprednol/tobramycin group, no significant change was evident for any sign or symptom in either subgroup of low or near-normal baseline SNFL. Conclusions Significant improvements in CFS and patient symptomatology after DED treatment were evident only in the subgroup with near-normal corneal SNFL. Consideration of SNFL may thus assist in explaining the variability of patients’ response to DED therapy.

No author has a financial or proprietary interest in any material or method mentioned.

Objective To study the factors affecting the time to onset of ocular GVHD in patients undergoing allogeneic hematopoietic stem cell transplantation (allo-HSCT). Methods A retrospective chart review of 200 patients with ocular GVHD was performed to evaluate the association between various donor-recipient characteristics on the time to onset of ocular GVHD after allo-HSCT. Results The median time to onset of chronic ocular GVHD after allo-HSCT was 293 days (range 26 to 2308). Patients receiving fully HLA-matched transplants had a delayed onset of ocular GVHD (median 294 days) compared to mismatched transplants (219 days; P=0.029). HLA-matched transplants from related donors had delayed onset of ocular GVHD (307 days) compared to HLA-matched (286 days; P=0.168) and HLA-mismatched (231 days; P=0.015) transplants from unrelated donors. Ocular GVHD followed systemic GVHD in 76% of patients but preceded systemic disease in 7%, occurred concurrently in 15%, and was not associated with systemic GVHD in 2% of patients. The time elapsed between the occurrence of systemic and ocular GVHD was significantly longer in matched-related transplants (250 days) than in matched-unrelated transplants (120 days; P=0.004). Conclusion The onset of ocular GVHD after allogeneic hematopoietic stem cell transplantation is variable and is influenced by the donor-recipient matching characteristics. In the majority of patients with GVHD ocular involvement follows the occurrence of systemic manifestations; however, importantly, it can also precede or develop independently of systemic disease in a minority. Regular ophthalmic follow-up is recommended after allo-HSCT regardless the concurrent systemic GVHD status.

Importance-The immunopathogenic mechanisms of dry eye disease (DED), one of the most common ophthalmic conditions, is incompletely understood. Data from this prospective, doublemasked, randomized trial demonstrate that targeting interleukin 1 (IL-1) by topical application of an IL-1 antagonist is efficacious in significantly reducing DED-related patient symptoms and corneal epitheliopathy.Objective-To evaluate the safety and efficacy of treatment with the topical IL-1 receptor antagonist anakinra (Kineret; Amgen Inc) in patients having DED associated with meibomian gland dysfunction.Design and Setting-Prospective phase 1/2, randomized, double-masked, vehicle-controlled clinical trial.Participants-Seventy-five patients with refractory DED.

Purpose The aim of this study was to compare patient reported symptoms of dry eye disease (DED) as assessed by the Ocular Surface Disease Index (OSDI©), a 12-item symptom frequency-based questionnaire, and the Symptom Assessment iN Dry Eye (SANDE), a 2-item frequency- and severity-based visual analog scale. Design Clinic-based evaluation of diagnostic test. Participants One hundred fourteen patients with dry eye disease. Methods Patients were administered the OSDI and SANDE questionnaires at baseline and follow-up visits to evaluate dry eye disease-related symptoms. The correlations between both questionnaires’ scores were evaluated using the Spearman coefficient and their clinical differences were assessed using the Bland-Altman analysis. Main Outcome Measures Baseline and follow-up visit OSDI and SANDE dry eye symptom scores. Results At the baseline visit, the OSDI and SANDE questionnaire scores significantly correlated (R = 0.64; P <0.001). Moreover, a significant correlation was found between changes in the OSDI and SANDE scores from baseline to follow-up visits (R = 0.47; P <0.001). A Bland-Altman analysis, after score normalization, revealed a difference (bias) of less than two centesimal units between the scores of the two questionnaires. Conclusions Data collected from the SANDE questionnaire showed a significant correlation and negligible score differences with those from the OSDI, suggesting that the SANDE visual analog scale-based questionnaire has the potential to provide clinicians with a short, quick and reliable measure for DED symptoms.

No author has a financial or proprietary interest in any material or method mentioned.

Objective To assess the vision-related quality of life in a cohort of patients with ocular graft-versus-host disease (GVHD). Design Prospective study. Participants Eighty-four patients diagnosed with chronic ocular GVHD Methods We assessed the vision-related quality of life with the 25-item National Eye Institute Visual Function Questionnaire (NEI-VFQ-25). The symptoms of ocular GVHD were assessed using the Ocular Surface Disease Index (OSDI) and Symptom Assessment in Dry Eye (SANDE) questionnaires. Main outcome measures We assessed vision-related quality of life with NEI-VFQ-25 and compared the scores obtained from patients with ocular GVHD to those from a healthy population. In the ocular GVHD population, we also evaluated the associations between the NEI-VFQ-25 and dry eye symptoms measured by OSDI and SANDE questionnaires, age, duration of disease, best-corrected visual acuity, corneal fluorescein staining, tear break-up time, and Schirmer test. Results The mean composite NEI-VFQ-25 score in patients with ocular GVHD was 76.5 ± 17. Compared to healthy subjects, ocular GVHD patients reported reduced scores on all NEI-VFQ-25 subscales (each P < 0.001) with exception of color vision (P = 0.11). The NEI-VFQ-25 composite scores significantly correlated with OSDI (R = −0.81, P < 0.001), SANDE (R = −0.56, P < 0.001), corneal fluorescein staining (R = −0.36, P = 0.001) and best-corrected visual acuity (R = −0.30, P = 0.004). Conclusion Patients with ocular GVHD experience measurable impairment of vision-related quality of life. This study highlights the impact of ocular GVHD on the vision-related quality of life, and hence the importance of comprehensive diagnosis and treatment of this condition.

Purpose To examine the effect of topical ranibizumab on clinically stable corneal neovascularization (NV). Methods This was a prospective, open-label, monocentric, uncontrolled, non-comparative study. Ten eyes of 9 patients with corneal NV received topical ranibizumab (1%) 4 times a day for 3 weeks with a follow-up of 16 weeks. The main corneal neovascularization outcome measures were: neovascular area (NA), the area occupied by the corneal neovessels; vessel caliber (VC), the mean diameter of the corneal neovessels; and invasion area (IA), the fraction of the total cornea area covered by the vessels. This study was conducted at the Massachusetts Eye and Ear Infirmary, Boston, MA, USA. Results Statistically significant decreases in NA (55.3%, P<0.001), which lasted through 16 weeks, and VC (59%, P<0.001), which continued to improve up to week 16, were observed after treatment. No significant decrease was observed in IA (12.3%, P=0.49). There was no statistically significant change in visual acuity or intraocular pressure. No adverse events ascribed to the treatment were noted. Conclusions Topical application of ranibizumab is effective in reducing the severity of corneal NV in the context of established corneal NV, mostly through decrease in VC rather than IA.