Clinical ophthalmology (Auckland, N.Z.)最新文献

Objective: This study aimed to compare efficacy, safety, and immunogenicity of the biosimilar ranibizumab in comparison with the Innovator Ranibizumab in treatment-naive patients with neovascular (wet) age-related macular degeneration (nAMD or wAMD).

Materials and methods: This comparative, double blind, multicentre, Phase III clinical study randomized eligible patients in a 3:1 ratio to receive either OPTIMAB^® (Alkem Laboratories Ltd./ Enzene Biosciences Ltd.) or Innovator Ranibizumab. Intravitreal injections of Innovator Ranibizumab (0.5 mg in 0.05 mL) and OPTIMAB^® (0.5 mg in 0.05 mL) were administered every four weeks for 12 weeks (three doses). Primary efficacy endpoints included loss of <15 letters from baseline, gain of ≥15 letters from baseline in visual acuity, mean change in best corrected visual acuity (BCVA) from baseline, and change in central subfoveal thickness (CSFT) from baseline at week 12. Safety was assessed through monitoring of adverse events (AEs) and serious adverse events (SAEs) throughout the study.

Results: Overall, of the 152 patients randomized, 141 (92.8%) patients (mean age, 66.6 ± 9.37 years) completed the study. Percentage of patients who lost < 15 letters in BCVA at week 12 from baseline was comparable in both the groups (100.0%, each). On secondary end point analysis, the two groups had comparable mean changes in BCVA (OPTIMAB^®, 11.8 ± 9.18; innovator ranibizumab, 12.9 ± 10.29; P = 0.5509); proportion of patients who gained ≥ 15 letters in visual acuity (OPTIMAB^®, 32.18%; innovator ranibizumab, 25.74%; P = 0.4785) and mean change in CSFT (OPTIMAB^®, -76.6 ± 89.03; Innovator ranibizumab, -73.1 ± 92.23 μm; P = 0.8422) at week 12 as compared to baseline. OPTIMAB^® and innovator ranibizumab demonstrated comparable safety over the 12-week treatment period and no patient expressed anti-ranibizumab antibody in either group patient.

Conclusion: Biosimilar ranibizumab (OPTIMAB^®) was non-inferior to innovator ranibizumab in terms of efficacy, safety, and immunogenicity in the patients of nAMD.

Purpose: To examine response to faricimab in neovascular age-related macular degeneration (nARMD) refractory to traditional anti-vascular endothelial growth factor (anti-VEGF) agents.

Patients and methods: Retrospective chart review was conducted on eyes with nARMD with persistent subretinal and/or intraretinal fluid despite previously receiving ≥15 injections with ≥2 different anti-VEGF agents. Best corrected visual acuity (BCVA) and optical coherence tomography (OCT) parameters were collected at baseline, initial post-injection visit, and most recent visit with OCT following last faricimab.

Results: Nineteen eyes were included. Average logMAR BCVA was 0.47 ± 0.60 at baseline, 0.42 ± 0.47 at initial follow-up (p=0.38), and 0.51 ± 0.63 at final visit (p = 0.50). Average central subfield thickness (CST) was 310 ± 92 μm at baseline, 279 ± 88 μm at initial follow-up (p = 0.001), and 274 ± 100 μm at last visit (p < 0.001). 9 eyes (47%) achieved resolution of fluid at both initial and final follow-up visits.

Conclusion: Faricimab mildly decreased CST and reduced fluid in some nARMD eyes refractory to traditional anti-VEGF agents but had minimal effect on BCVA.

Objective: To investigate the visual outcomes and patient satisfaction following trifocal intraocular lens (IOL) implantation after radial keratotomy (RK).

Methods: This was a retrospective chart review wherein we studied 14 eyes from 7 patients who had undergone cataract surgery and had trifocal intraocular lens (IOL) implanted in the Eastern Province of Saudi Arabia's King Fahd University Hospital and Kahhal private centre. Data such as demographic characteristics, the time between RK and cataract removal, intraoperative and postoperative complications, preoperative and postoperative uncorrected distance visual acuity (UDVA), corrected distance visual acuity (CDVA), and refraction were evaluated. In addition, visual complaints and satisfaction were assessed through a questionnaire.

Results: All eyes included had 8 RK sections. The mean spherical equivalent was +1.81 ± 4.27 D preoperatively and was -0.41 ± 1.2 D at the last follow-up. The mean uncorrected distance visual acuity (UDVA) increased from 0.32 ± 0.2 prior to surgery to 0.64 ± 0.2 following surgery. The mean efficacy index was 1.01 and a safety index was 1.26. In the last follow-up, 29% reported having 0.5 spherical equivalents, while 86% were within 1D. Improvement in cylindrical correction was noticed in the last follow-up with 36% not more than 0.5 D and 43% within 1D. In total, 80% of patients had a distance-corrected near visual acuity (DCNVA) of better than 20/40. The survey response rate was 100%, and two patients reported a lower degree of satisfaction. Glare and difficulty seeing at night were the most often reported complaints, with a mean of 2.86 ± 1.95 and 22 ± 1.9, respectively.

Conclusion: Our results suggest that implantation of a trifocal IOL is safe and effective in patients with previous RK. However, several factors, including the patient's preoperative expectations, glare testing, refractive error, number of cuts, optical zone size, and visual phenomena related to RK, should be considered before implantation.

Purpose: Cosmetic products applied to the periocular area can cause skin sensitivity reactions, and manufacturers routinely test the safety and tolerability of products in development. This research was sponsored by Bausch + Lomb to evaluate three Lumify Eye Illuminations products: a lash and brow serum, a hydra-gel eye cream, and a micellar water eye makeup remover.

Methods: A cumulative irritation test (CIT) study and a repeated insult patch test (RIPT) study enrolled adult males or females with no known sensitivities to cosmetic products. Three clinical safety studies enrolled adult females with self-reported characteristics targeted by each product, which was applied in a manner consistent with expected use for 8 or 12 weeks.

Results: In CIT (n=34) and RIPT (n=201) studies, faint/minimal erythema reactions were observed in 0% to 2.9% of participants; there were no moderate or severe reactions. No safety signals were observed in participants who completed clinical safety studies for lash and brow serum (n=66 enrolled, n=55 completed [83%]), eye cream (n=61 enrolled, n=52 completed [85%]), or eye makeup remover (n=80 enrolled, n=68 completed [85%]). No clinically relevant changes in visual acuity or ophthalmologic slit-lamp examination findings were noted. No participants reported ocular sensations of burning/stinging, foreign-body sensation, or soreness. At the final clinical safety study assessment, mild cutaneous erythema (as graded by the investigator) was reported for one participant (eye cream study); no other prespecified signs of cutaneous irritation (eg, edema, dryness) were observed. A treatment-related adverse event that led to study discontinuation was experienced by one participant in the eye makeup remover study (bilateral periorbital swelling).

Conclusion: Findings from rigorously conducted irritation testing and clinical safety studies indicated that these products were safe and well tolerated. Increased availability of data regarding ocular and cutaneous safety of cosmetic products can inform consumer decision-making and eye care provider recommendations.

Purpose: The purpose of this study was to evaluate retinal and choroidal vascularization parameters in patients with type 2 diabetes mellitus (DM), without diabetic retinopathy (DR), and to compare them to healthy controls.

Patients and methods: Seventy-four eyes from 74 patients (40 eyes in the DM group and 34 eyes in the control group) were included in the study. Optical coherence tomography angiography RTVue XR Avanti was used to obtain 3×3mm scans of the macula. The choroidal vascularity index (CVI), superficial and deep capillary plexus vascular densities (SCP and DCP, respectively), and choroidal thickness (CT) were measured.

Results: In the diabetic group, SCP was lower in the superior and nasal segments (48.68 vs 50.62, p=0.02; 45.50 vs 48.82, p=0.02, respectively). The DCP did not differ between the groups. CVI was significantly lower in the study group in all measured segments, including central and parafoveal (31.73 vs 48.86 and 50.32 vs 59.58, p<0.001, respectively). CT was larger in the study group only at the center of the macula (281.89µm vs 268.37µm p<0.001) and in the inferior segment (337.47µm vs 329.40µm, p<0.001). In the multivariate regression, clinical and vascularization parameters affecting CVI and CT were analyzed after adjusting for age and sex. Decreased central CVI was associated with the presence of DM, lower central SCP, and bigger foveal avascular zone area (b=-0.68, b=0.47, b=-0.21). Parafoveal CVI was also negatively affected by DM (b= -0.46) and positively by parafoveal SCP (b= 0.44). Increased central CT was found to be positively associated with higher central SCP (b=0.48) and male sex (b=0.20).

Conclusion: The results of our study confirmed a reduction of SCP and CVI in diabetic patients without DR. DM and SCP are age and sex independent parameters affecting CVI. Central CT is affected by SCP and sex, rather than the presence of diabetes.

[This corrects the article DOI: 10.2147/OPTH.S455984.].

Purpose: We compared the corneal endothelial cell loss between trabeculectomy (Trab) and Ex-Press^® surgery (EXP) for low-intraocular pressure (IOP) glaucoma patients.

Patients and methods: This was a single-facility retrospective study. We analyzed the cases of patients with primary open-angle glaucoma (POAG) and pre-operative IOP ≤ 21 mmHg who had undergone Trab or EXP surgery and were followed for >3 years. Noncontact specular microscopy was used to determine the corneal endothelial cell density (CED) before and after Trab or EXP surgery. We measured the CED at 12, 24, and 36 months post-surgery. We compared the CED values and CED survival ratio after both surgeries using paired t-tests.

Results: We included 39 eyes that underwent Trab and 36 eyes that underwent EXP surgery. In the Trab group, the mean CED value had decreased from 2333 ± 399 at baseline to 2066 ± 587 cells/mm2 after 3 years. In the EXP group, the mean CED value had decreased from 2320 ± 393 at baseline to 2229 ± 460 cells/mm² after 3 years. The survival ratio of CED at >3 years was 89.3 ± 14.2% (Trab group) and 95.6 ± 11.1% (EXP group); compared to the Trab surgery, the EXP surgery thus significantly decreased the CED loss (p = 0.037). No case resulted in bullous keratopathy.

Conclusion: Compared to trabeculectomy, Ex-Press^® surgery appears to be a safer surgical method with regard to the endothelial cell loss risk.

Objective: To explore the research hotspots in acupuncture treatment for myopia from 2014 to 2023.

Methods: A comprehensive search was conducted in the Science Citation Index-Expanded (SCI-E) within the Web of Science Core Collection (WOSCC). We used CiteSpace 6.2.R6 to perform an in-depth analysis of the annual publication trends, prolific authors, institutions, keyword co-occurrences, and citation bursts. The study followed the PICO framework: the population (P) includes studies on patients with myopia, the intervention (I) is acupuncture treatment, no direct comparison (C) is applied, and the primary outcome (O) focuses on the identification of research trends and hotspots. Major outcome assessments included the analysis of publication trends over time, author productivity, influential journals, and the detection of emerging research topics through citation burst analysis. This bibliometric analysis was conducted on November 15, 2023.

Results: A total of 281 articles were included in the analysis. The trend line of annual publications over the past decade showed a modest increase, with a significant decline in 2019 and a surge in 2021. China and its affiliated academic institutions led globally in publication volume, with Ma Xiaopeng being the most prolific author and Fudan University the most influential institution. Ophthalmology emerged as the journal with the highest citation frequency. The most frequently occurring keywords were related to adolescent myopia and its complications. The developmental trajectory of the field is distinct, characterized by the integration of a single discipline.

Conclusion: Acupuncture shows promise as a complementary and alternative therapy for treating myopia, with growing interest in its clinical efficacy and mechanisms of action. Future research is likely to focus on optimizing treatment protocols and understanding the underlying biological mechanisms of acupuncture in myopia management.

Purpose: This prospective comparative study aimed to assess the effects on contact lens comfort, dryness, and wear time when symptomatic daily disposable (DD) contact lens (CL) wearers were refit with delefilcon A (DT1) lenses.

Patients and methods: Thirty five symptomatic DD CL wearers with dry eye disease as determined according to the TFOS DEWS 2 guidelines, were enrolled and completed the study. Participants wore their habitual DD CLs during an initial assessment and were subsequently refit with DT1 for 1 month. Participants were masked to the study lens type. Subjective ratings of end-of-day comfort and dryness, average wear time, and comfortable wear time were evaluated as primary endpoints.

Results: Of the 35 participants, two participants were classified as aqueous deficient dry eye, while the remaining participants exhibited symptoms primarily due to evaporative causes. The median CLDEQ-8 score for dryness significantly improved from 17 (fair) with habitual lenses to 13 (good) with DT1 lenses (p < 0.01). Participants reported significantly better end-of-day comfort (p = 0.01) and less end-of-day dryness (p = 0.01) with DT1 compared to their habitual DD lenses. The comfortable wear time was significantly longer with DT1 (8.5 ± 4.1 hours) compared to habitual DD lenses (6.7 ± 3.2 hours) (p = 0.04). No significant differences were observed in vision ratings (p = 0.07).

Conclusion: Refitting symptomatic DD CL wearers with DT1 resulted in improved end-of-day comfort, reduced end-of-day dryness, and extended comfortable wear time compared to their habitual lenses. These findings suggest that DT1 may offer benefits for symptomatic DD wearers with dry eye disease.

Purpose: To evaluate patient-reported outcomes of cataract surgery using the Clareon Panoptix and Panoptix Toric trifocal lenses and to compare these to the data collected previously for the AcrySof Panoptix and Panoptix Toric.

Patients and methods: Prospective, open-label, multicenter analysis of satisfaction, spectacle independence, presence of unwanted side effects, and best-corrected visual acuity among patients undergoing cataract surgery who had been implanted at least 1 month previously with the Clareon PanOptix or PanOptix Toric trifocal IOL bilaterally. Results were compared to outcomes measured two years ago from a similar study with the AcrySof version of the same lens.

Results: No significant differences in patient satisfaction rates were reported between the two cohorts. Spectacle independence was similar with 88% of Clareon Panoptix and 83% of AcrySof Panoptix patients having no need for any corrective lenses. Quality of vision was not statistically different with 7% of Clareon vs 15% of AcrySof patients reporting "very much" or more of glare/halo severity. Significantly more AcrySof (66%) than Clareon (42%) patients achieved a spherical equivalent outcome within 0.25 D of target. Best corrected distance visual acuity differences were not statistically significant, and no safety concerns were reported.

Conclusion: The Clareon PanOptix trifocal lens provides similar satisfaction and spectacle independence and has a similar side effect profile and BCVA outcome to the identical lens made of the predecessor AcrySof lens.