Ophthalmology and Therapy最新文献

Introduction: Dry eye disease (DED) is a frequently observed condition characterized by ocular discomfort and visual disturbance. It is highly prevalent and impairs patients' quality of life (QoL). This study assessed the benefit of a preservative-free bioprotectant eye drop formulation containing sodium hyaluronate and trehalose (SH-trehalose) with regards to DED, as well as patient satisfaction, through a large-scale real-life survey.

Methods: In a multi-center, international, prospective observational study, subjects with DED received SH-trehalose for 84 days. Ocular Surface Disease Index (OSDI), Dry Eye Questionnaire-5 items (DEQ-5), and patient satisfaction were assessed at baseline, day 28, and day 84, and clinical evaluations included ocular surface staining, Schirmer test, tear film break-up time (TBUT), and conjunctival hyperemia at baseline and day 84.

Results: A total of 312 patients were evaluated, of whom 82.4% were women. The mean age was 57.9 ± 15.2 years. The mean OSDI score at baseline was 41.7 ± 20.6. After 84 days, the mean OSDI score was 27.3 ± 19.8 (p < 0.001). The percentage of patients with a severe OSDI score decreased from 60.3 to 34.5%. The DEQ-5 score significantly (p < 0.001) improved after 28 and 84 days, as did patient satisfaction. Ocular surface staining, Schirmer test, TBUT, and conjunctival hyperemia scores improved significantly (all p < 0.001) for both eyes with SH-trehalose between baseline and day 84. Tolerance of SH-trehalose was good.

Conclusions: SH-trehalose significantly improved the clinical signs and symptoms of DED after 84 days. Moreover, it significantly increased patient satisfaction and was well tolerated.

Trial registration: NCT04803240.

Introduction: Dry eye disease (DED) is a multifactorial condition of the ocular surface (OS) characterized by loss of tear film homeostasis, ocular discomfort, and vision disturbances. Most available ocular lubricants target the aqueous deficiency of the tear, restoring only this layer, leaving the tear lipid stratum deficient, as occurs in most patients with evaporative DED. An innovative propylene glycol-hydroxypropyl guar enriched with a phospholipid nanoemulsion (PG-HPG-PH-N) is indicated to restore deficiencies in both the lipid and aqueous layers of the tear film, and its composition was designed to increase lubricant retention on the OS. The purpose of this study was to evaluate, through the Ocular Surface Disease Index (OSDI) and clinical assessment, the treatment of patients who had DED due to aqueous deficiency arising from mixed or evaporative DED subtypes with a PG-HPG-PH-N ocular lubricant at a reduced frequency of twice a day, in a prospective, multicenter, and single-arm study.

Methods: Patients were screened from days - 7 to 0, and from day 1 (baseline and first day of treatment) to day 28 of treatment with this lubricant. After visit 1 (screening visit, days - 7 to 0), designed as pre-treatment OS assessment, patients returned to their research center on days 14 and 28 of treatment for a complete assessment, including anamnesis, the OSDI, corrected visual acuity, tear breakup time (TFBUT), OS staining evaluation, tolerability index, and environmental exposure questionnaire.

Results: Seventy patients were enrolled in this study (60 women, 10 men), with a mean age of 45 (range 27-64) years. TFBUT results showed an improvement in tear film stability as vital dyes sodium fluorescein and lysamine green showed a decrease in corneal staining after 14 and 28 days of treatment. No significant adverse events were reported, demonstrating the good tolerability of the lubricant.

Conclusions: The PG-HPG-PH-N nanoemulsion can be considered to be a safe and effective ocular lubricant for treating DED due to aqueous deficiency, both mixed and evaporative subtypes.

Trial registration: Brazilian National Research Ethics Commission (ReBEC registration number 16055).

Introduction: Our aim in this work was to investigate the macular choroidal thickness (ChT) changes in 6-12-year-old Danish children with myopia during 2 years of low-dose atropine treatment and 1-year wash-out vs. placebo in an investigator-initiated, placebo-controlled, double-blind randomized clinical trial.

Methods: Ninety-seven participants were randomized to either 0.01% for 2 years, 0.1% loading dose for 6 months followed by 0.01% for 18 months, or placebo, then a 1-year wash-out. The primary outcome was ChT in the sub-foveal and inner and outer superior, nasal, inferior, and temporal sectors. The secondary outcome was axial length (AL). Outcomes were measured at baseline and 6, 12, 24, and 36 months. One-way analysis of variance was used to detect baseline ChT differences between AL-stratified groups (< 24 mm, 24-25 mm, or > 25 mm). To determine the longitudinal changes in ChT and its effect on AL, all eyes were included in linear mixed modeling with individual eyes nested in the study ID as a random effect.

Results: Longer eyes had significantly thinner ChT in all choroidal sectors (adj-P < 0.01) at baseline. There was no statistically significant change in any ChT sector after 3 years in the placebo group. Sub-foveal and nasal ChT in the 0.1% loading dose and 0.01% group were not significantly different from placebo after 2-year treatment. In the placebo group, a 1-mm increase in AL was significantly associated with a 47-µm thinner nasal ChT after 3 years (95% confidence interval (CI): - 55; - 38, adj-P < 0.001). A 10-µm thicker nasal choroid at baseline was associated with 0.13 mm (95% CI: 0.009; 0.017, adj-P < 0.001) less 3-year axial elongation.

Conclusions: The ChT in Danish children with myopia remained stable over the 3-year follow-up. A thinner choroid at myopia onset might predispose to increased axial elongation. Treatment with 0.01% atropine did not change the ChT. We speculate that low-dose atropine does not primarily reduce myopia progression via a choroidal mechanism.

Trial registration: ClinicalTrials.gov identifier, NCT03911271.

Introduction: The study aimed to compare postoperative pain between alcohol-assisted and transepithelial photorefractive keratectomy in patients who received the novel analgesic preoperative nepafenac treatment 2 days preoperatively and 3 days postoperatively. Pain, stinging, tearing, light sensitivity, and stress levels were evaluated.

Methods: The study included a retrospective analysis of 55 patients divided into two groups: bilateral alcohol-assisted photorefractive keratectomy (aa-PRK) and transepithelial photorefractive keratectomy (transepithelial-PRK). Nepafenac was administered for pain control for all patients, with patients receiving four drops for 2 days before the surgery and 3 days postoperatively per clinical instructions. Patients completed questionnaires on the day of the surgery and for the first 5 days postoperatively. Statistical analysis was performed using XLSTAT (version 2023.1.2). t-Test was used to analyze and compare pain and symptom levels and Fisher's exact test for categorical data. p-Values less than 0.05 were considered statistically significant.

Results: The study examined 55 patients (49% female) with a mean age of 25.11 ± 6.81 years who had undergone bilateral surface refractive surgery to correct myopic errors. The mean baseline standard error (SE) was -3.16 ± 2.20 D. Among these patients, 27 patients underwent aa-PRK and 28 patients underwent transepithelial-PRK. Higher levels of pain were significant in the aa-PRK group (p = 0.003). However, there was no significant difference between the groups in the average levels of stinging, tearing, or light sensation. Additionally, stress levels decreased over time in both groups, with levels becoming almost equal after 5 days, and there was no significant difference in the average stress levels between the two groups.

Conclusions: The study found that patients who underwent the transepithelial-PRK procedure had significantly lower pain levels compared with those who underwent aa-PRK after being treated with nepafenac per protocol. However, there was no significant difference between the two groups in terms of stinging, tearing, light sensation, and stress levels.

Introduction: The aim of this study was to assess the knowledge, attitude, and practices (KAP) of parents or guardians regarding the prevention and management of childhood myopia.

Methods: This cross-sectional study was conducted at the Department of Ophthalmology in the First Affiliated Hospital of Soochow University (Suzhou, China) between August 2023 and November 2023. Parents or guardians who willingly volunteered to take part in the study were surveyed using a self-designed questionnaire.

Results: A total of 571 participants returned valid questionnaires, among whom 288 respondents (50.44%) fell within the 31- to 40-year age group and 474 respondents (83.01%) were identified as myopic. The mean KAP scores for the knowledge, attitude and practices dimensions were 23.34 ± 3.05 (possible range: 0-26), 46.47 ± 4.02 (possible range: 12-60), and 40.52 ± 7.07 (possible range: 11-54), respectively. Structural equation modeling analysis indicated that education had a direct effect on knowledge (estimate = 0.41, P = 0.038), while knowledge directly influenced both attitude (estimate = 0.40, P < 0.001) and practices (estimate = 0.36, P < 0.001). Also, attitude was found to have a direct impact on practices (estimate = 0.45, P < 0.001).

Conclusions: Parents or guardians had adequate knowledge, a positive attitude, and proactive practices towards the prevention and management of childhood myopia, which might be affected by their educational level. This comprehensive understanding of parental perspectives highlights the potential for targeted interventions in clinical settings to further enhance pediatric eye care.

Introduction: In congenital aniridia caused by mutations in paired box 6 (PAX6), PAX6 influences the migration and differentiation of limbal epithelial cells (LECs), thereby playing a pivotal role in aniridia-associated keratopathy. The antidepressants ritanserin and duloxetine affect PAX6 expression in LECs. Limbal stromal cells, which support limbal epithelial stem cells, are crucial in the limbal stem cell niche. This study explores how ritanserin and duloxetine influence gene expression in primary human limbal stromal cells from subjects with congenital aniridia and from healthy subjects, in vitro.

Methods: Primary human limbal stromal cells from corneas affected by aniridia (AN-LSCs) (n = 8) and from healthy corneas (LSCs) (n = 8) were isolated and cultured in either low-glucose serum-free (LGSF) or normal-glucose serum-containing (NGSC) media. Cells were treated with 4 µM ritanserin or duloxetine for 24 h. Quantitative PCR (qPCR) and western blot were used to assess the expression of PAX6, FOSL2, TGF-β1, ACTA2A1, LUM, COL1A1, COL5A1, DSG1, FABP5 and ADH7.

Results: In AN-LSCs with LGSF-medium, ritanserin increased PAX6 messenger RNA (mRNA) (p = 0.007) and decreased TGF-β1 and FOSL2 mRNA levels (P = 0.005, P = 0.038). In addition, TGF-β1 protein levels decreased with both treatments (P = 0.02, P = 0.007), and FABP5 protein level increased, using ritanserin (P = 0.019). In LSCs with LGSF-medium, ACTA2A1 mRNA levels decreased using ritanserin and duloxetine (P = 0.028; P = 0.031), while FABP5 mRNA levels increased with ritanserin treatment (P = 0.003). Also, duloxetine use reduced α-SMA protein (P = 0.013) and increased FABP5 protein levels (P = 0.029). In LSCs with NGSC-medium, ritanserin elevated LUM, FABP5 and ADH7 mRNA and protein levels (P = 0.025, P = 0.003, P = 0.047, P = 0.024, P = 0.013, P = 0.039).

Conclusions: The results of our study confirmed that the antipsychotropic drugs ritanserin and duloxetine alter PAX6 and TGF-β1 gene expression in AN-LSCs cultured in LGSF-medium. These drugs were found to have an impact on retinoic acid signaling pathways and keratocyte characteristic markers both in LSCs and AN-LSCs, using different culture media.

Introduction: The aim of this study was to investigate the predictive factors for persistent disease activity following anti-vascular endothelial growth factors (anti-VEGF) and their long-term effects in patients to be treated for neovascular age-related macular degeneration (nAMD) under real-world conditions.

Methods: Retrospective data analysis of the PROOF study, a multi-center real-world retrospective chart review conducted across Korea in patients with nAMD included treatment-naive patients with nAMD who received first anti-VEGF (ranibizumab, bevacizumab, or aflibercept) between January 2017 and March 2019 was performed. All 600 patients (cohort 1) had a minimum follow-up of 12 months of which 453 patients (cohort 2) were followed-up for 24 months from baseline.

Results: At month 12 after anti-VEGF therapy, 58.10% (95% confidence interval [CI]: 54.09, 62.12) of patients and at month 24, 66.02% of patients continued to have persistent retinal fluid. At both months 12 and 24, predictive factors for persistent disease activity were fibrovascular pigment epithelial detachments (PED) (P = 0.0494) and retinal fluid at month 3 after loading phase (P = 0.0082). The mean changes in visual acuity were + 6.2, + 10.1, and + 13.3 letters and in the central subfield thickness were - 79.1 µm, - 96.3 µm, and - 134.4 µm at 12 months from baseline, in the bevacizumab, aflibercept, and ranibizumab groups, respectively.

Conclusions: The presence of retinal fluid after loading phase and fibrovascular PED were predictors of persistent disease activity after at least 1 year of anti-VEGF treatment.

Introduction: This study assessed the efficacy, durability, and safety of faricimab in patients with neovascular age-related macular degeneration (nAMD), previously treated with aflibercept or ranibizumab with unsatisfactory results.

Methods: This was a single-center, prospective cohort study of all consecutive patients with nAMD switched to intravitreally administered faricimab from traditional anti-vascular endothelial growth factor (anti-VEGF) treatments between September 2022 and April 2023 because of unsatisfactory response (maximal fluid-free interval ≤ 8 weeks). Faricimab was administered with a loading dose of four 4-weekly injections, followed by a treat-and-extend regimen. The primary outcome measures were maximum fluid-free interval after the switch and last assigned treatment interval. Secondary outcome measures included best-corrected visual acuity (BCVA) and structural optical coherence tomography parameters.

Results: Thirty-three eyes of 33 patients were included. Patients were followed for a median of 72 weeks [interquartile range 61, 76]. Median maximum fluid-free treatment interval after switch to faricimab and the last assigned interval were significantly longer than before the switch (7 vs. 4 weeks, p < 0.001 and 8 vs. 5 weeks, p < 0.001, respectively). Significant improvements in central subfield thickness (353 vs. 281 µm), macular volume (2.46 vs. 2.16 mm³), and pigment epithelial detachment height (198 vs. 150 µm) were observed (all p < 0.001). BCVA remained stable at 0.4 versus 0.3 logMAR before switch (p = 0.190). One eye (3%) developed intraocular inflammation and one eye (3%) developed a retinal pigment epithelium tear.

Conclusions: Faricimab improved anatomical outcomes and allowed longer treatment intervals in patients with nAMD previously treated with other anti-VEGF therapies with unsatisfactory response, reducing treatment burden. A favorable safety profile was observed.