Topical tacrolimus 0.03% as sole therapy in vernal keratoconjunctivitis: a randomized double-masked study.

OBJECTIVE: This study sought to evaluate the efficacy of the isolated use of tacrolimus compared with the combined use of tacrolimus and olopatadine for the treatment of severe vernal keratoconjunctivitis (VKC). METHODS: Twenty-one patients with severe VKC were randomized into two groups: one treated with 0.03% tacrolimus ointment combined with 1% olopatadine ophthalmic solution and the other with 0.03% tacrolimus ointment combined with placebo eye drops. The clinical signs and symptoms were graded from 0 to 3, and the efficacy of treatment was determined by the difference between the score at the beginning of treatment and after 30 days. The clinical impression of improvement as perceived by the evaluator and the self-assessment provided by the patient were scored at day 30 of treatment and compared between the groups. RESULTS: The scores for symptoms decreased between the assessments in both groups (-1.7±3.9 in the experimental group; -0.6±1.6 in the control group), with no significant difference between groups (P=0.205). The scores for clinical signs decreased between the assessments in the experimental group (-1.1±2.7) and increased in the control group (0.3±0.9) but with no significant differences (P=0.205). There was no significant difference between the groups regarding the self-assessment (P=0.659) and the clinical impression of the evaluator (P=0.387). CONCLUSIONS: The isolated use of tacrolimus and the combined use of tacrolimus and olopatadine seems to have the same efficacy, although controlled studies with larger samples are required to confirm this hypothesis.

Corneal Collagen Cross-Linking in Young Patients for Progressive Keratoconus.

PURPOSE: The goal of this study was to compare the effect of early corneal collagen cross-linking (CXL) intervention (before 17 years of age) with that of late intervention (after 17 years of age) on the characteristics and progression of keratoconus. PATIENTS AND METHODS: One hundred five eyes of 94 patients with keratoconus undergoing treatment with CXL were included. The patients were divided into 2 groups by age: group 1 (mean age of 13.8 yrs; range 10-16) and group 2 (mean age of 21.5 yrs; range 17-36). Eyes were evaluated regarding best-corrected visual acuity (BCVA), refractive error, corneal endothelial cell density, and central corneal thickness, as well as using slit-lamp biomicroscopy, Goldmann tonometry, and the keratometry (Kmax, Ksteep, and Kflat parameters) test before CXL and at 1, 3, 6, and 12 months thereafter. RESULTS: The mean (SD) BCVA of group 1 was 0.45 (±0.25) before CXL and 0.56 (±0.29) 1 year after CXL (P = 0.030); mean (SD) Kmax, Ksteep, and Kflat were 58.47 (±7.2), 52.93 (±5.4), 47.22 (±4.2) before CXL respectively, and 58.21 (±7.7), 52.25 (±5.5), and 46.56 (±4.6) 1 year after CXL, respectively (P = 0.897, 0.481, and 0.491). The mean (SD) BCVA of group 2 was 0.50 (±0.30) before CXL and 0.56 (±0.32) 1 year thereafter (P = 0.346); mean (SD) Kmax, Ksteep, and Kflat were, respectively, 57.64 (±7.1), 54.02 (±6.2), and 48.60 (±4.1) before CXL and 56.46 (±8.0), 52.46 (±5.8), and 47.85 (±4.9) 1 year after CXL, respectively (P = 0.553, 0.258, and 0.640). CONCLUSIONS: The study showed no statistical differences between younger and older patients. These findings support the indication of CXL treatment in pediatric patients for early stabilization of the disease and better progress regarding BCVA and keratometry parameters.

Long-term use of topical tacrolimus ointment: a safe and effective option for the treatment of vernal keratoconjunctivitis.

PURPOSE: To assess the compliance, efficacy, and safety of the long-term use of topical tacrolimus for the clinical management of vernal keratoconjunctivitis. METHODS: The medical records of patients with vernal keratoconjunctivitis undergoing long-term treatment with 0.03% topical tacrolimus were retrospectively reviewed. The duration of tacrolimus use and the causes for drug discontinuation were used to assess treatment compliance. To assess drug efficacy, the need for and the number of times that topical corticosteroids were used to control symptoms were registered. Side effects related to tacrolimus use were monitored to determine drug safety. RESULTS: The study cohort consisted of 21 patients who met the eligibility criteria. The mean duration of tacrolimus use was 41.3 ± 18.5 months. Fourteen patients (66.7%) continuously used tacrolimus, and three (14.3%) discontinued treatment following complete remission. Four patients (19%) did not use tacrolimus as prescribed or interrupted tacrolimus use on their own: two (9.5%) because of discomfort upon application and two (9.5%) because of the lack of improvement. Ten patients (47.6%) maintained disease control without the use of corticosteroids, whereas 11 (52.4%) required an average of 2.70 ± 1.35 corticosteroid cycles to control symptoms. The only reported side effect was discomfort upon application. CONCLUSIONS: Despite the small sample size and study design limitations, these results support the long-term use of topical tacrolimus as an effective and safe option for the treatment of vernal keratoconjunctivitis, with good compliance of patients to the treatment.

Macular phototoxicity after corneal cross-linking.

PURPOSE: To assess potential vascular, structural, and functional changes to the macula in patients with keratoconus that underwent ultraviolet A (UVA)-riboflavin-mediated corneal collagen cross-linking (CXL) therapy. PATIENTS AND METHODS: Seventeen eyes from 17 patients of age 16 years or older with keratoconus undergoing CXL treatment were studied. The same eye served as its own control (before CXL vs after CXL). Eyes were evaluated in terms of best-corrected visual acuity (BCVA), refractive error, intraocular pressure, Amsler grid, retinography, fluorescein angiography, autofluorescence, and spectral domain optical coherence tomography (SD-OCT) prior to CXL and 7 and 30 days after treatment. Multifocal electroretinography (mfERG) was recorded prior to and 7 days after CXL. RESULTS: Mean (SD) BCVA by logMAR chart was 0.47 (±0.12) pre-CXL, 0.55 (±0.15) 7 days post-CXL (P=0.57), and 0.46 (±0.10) 30 days post-CXL (P=0.87). Mean (SD) SD-OCT central macular thickness (µm) was 253.62 (±20.9) pre-CXL, 260.5 (±18.7) 7 days post-CXL (P=0.48), and 256.44 (±21.6) 30 days post-CXL (P=0.69). In 12 eyes, mfERG revealed a statistically significant increase (P=0.0353) in P1 latency (ms) of ring four from the pre-CXL period (39.45±2.05) to 7 days post-CXL (41.04±1.28) period. Regression analysis showed that the increase in P1 latency was correlated with the increase in central macular thickness (P=0.027). Furthermore, nine patients experienced a significant decrease in P1 amplitudes of rings 1 (P=0.0014), 2 (P=0.0029), 3 (P=0.0037), 4 (P=0.0014), and 5 (P=0.0012) from pre-CXL to 7 days post-CXL. Conclusion: In this pilot study, most of the patients exhibited slight changes in their mfERG parameters and OCT thickness, despite a lack of vascular abnormalities observed on fluorescein angiography/autofluorescence imaging, no alteration in BCVA, and no reports of symptoms. These changes could, therefore, be categorized as a mild subclinical effect of the corneal cross-linking procedure.

[Penetrating keratoplasty indications in "Hospital das Clínicas-UNICAMP"]. / Indicações para ceratoplastia penetrante no Hospital das Clínicas-UNICAMP.

PURPOSE: To determine the main causes of penetrating keratoplasty indications at "Hospital das Clínicas-UNICAMP" (January, 1999 to December, 2003). METHODS: A non-comparative, retrospective series of case studies. The authors reviewed the files of 857 patients who underwent penetrating keratoplasty at "Hospital das Clínicas-UNICAMP" between 1999-2003 and classified them into different categories according to diagnostic indication for surgery. RESULTS: The age range was between 0-88 years (average 44 years +/-1.2). The main causes of penetrating keratoplasty were: keratoconus in 427 cases (49.82%); 152 cases (17.74%) of corneal ulceration (perforated or not); corneal graft failure in 87 cases (10.15%); bullous keratopathy, 72 cases (8.40%); Fuchs dystrophy in 59 cases (6.88%); trachoma complications in 28 cases (3.27%); other causes, 32 (3.74%). In children under 10 years of age, the main cause of penetrating keratoplasty indications was infectious ulcer (77.78%) and between 11-50 years of age, keratoconus was the main cause (71.65%). CONCLUSION: This study was composed of a young population, and the main causes of penetrating keratoplasty were keratoconus and therapeutic keratoplasty.

Distribution of Ocular Component Measures and Refraction in Brazilian School Children.

PURPOSE: To describe ocular component values and refraction in 6-17-year-old school children in Campinas, Brazil. METHODS: To obtain a representative sample, a total of 1100 6-17-year-old public school students in Campinas, Brazil, were randomly selected and divided into groups according to median ages 6 years (range 5-7 years), 10 years (range 9-11 years), 14 years (range 13-15 years), and 17 years (range 16-18 years). Cycloplegic autorefraction and ocular biometry were performed on each child. RESULTS: Parental consent for participation was obtained for 778 of the 1100 students (70.7%). Of these, 440 (56.6%) were female and 330 (44.4%) male. Sex distributions were similar for each median age group. Median age groups 6, 10, 14, and 17 years displayed significant trends of decreasing mean spherical equivalent refraction (SER; 0.96, 0.89, 0.57, and 0.23 diopters, D, respectively), mean lens thickness (3.50, 3.42, 3.41, and 3.45 mm, respectively), and mean lens power (23.6, 22.7, 21.8, and 21.2D, respectively), but significant trends of increasing mean anterior chamber depth (ACD; 3.00, 3.12, 3.16, and 3.15 mm, respectively), mean vitreous chamber depth (VCD; 16.0, 16.4, 16.6, and 16.8 mm, respectively), and mean axial length (22.5, 23.0, 23.2, 23.4 mm, respectively; all p for trend <0.001). CONCLUSIONS: Significant trends towards lower refractive power, increased prevalence of myopia, increased ACD, VCD, and axial length, and decreased lens power were associated with increasing age in these children. There were no significant changes in corneal thickness or corneal curvature.

Dexamethasone/Povidone Eye Drops versus Artificial Tears for Treatment of Presumed Viral Conjunctivitis: A Randomized Clinical Trial.

PURPOSE: To determine whether topical dexamethasone 0.1%/povidone-iodine 0.4% reduces the duration of presumed viral conjunctivitis better than artificial tears and whether the treatment relieves the symptoms of this disease. METHODS: Randomized, masked and controlled trial. One-hundred twenty-two patients with a clinical diagnosis of presumed viral conjunctivitis were randomized to either the treatment group or the control group. Physicians and patients were masked to the treatment. Swabs were taken from the conjunctival fornix for adenovirus PCR analyses. Patients in the treatment group received topical dexamethasone 0.1%/povidone-iodine 0.4% eye drops four times daily, and patients in the placebo group received artificial tears four times daily, both for seven days. Symptoms were recorded on the day of recruitment and at the time of a follow-up examination 5, 10 and 30 d later. The main outcome was duration of the disease. The others outcomes were overall discomfort, itching, foreign body sensation, tearing, redness, eyelid swelling, side effects of the eye drops, intraocular pressure and the incidence of subepithelial corneal infiltrates. RESULTS: There was no statistically significant difference between the treatment group and the control group in terms of the patients' symptoms, intraocular pressure and incidence of subepithelial cornea infiltrates during the entire follow-up period. Patients of the treatment group reported more stinging (p < 0.001) and a shorter conjunctivitis duration (9.4 ± 4.6 d in the dexamethasone 0.1%/povidone-iodine 0.4% group versus 11.8 ± 4.9 d in the artificial tears group, p = 0.009). CONCLUSIONS: The use of topical dexamethasone 0.1%/povidone-iodine 0.4% eye drops four times daily appears to reduce the duration of conjunctivitis, although it causes more stinging than artificial tears.