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Shunsuke Nakakura,1 Minamai Yamamoto,1 Etsuko Terao,1 Nozomi Nagatomi,1 Naoko Matsuo,1 Yausko Fujisawa,1 Yuki Fujio,1 Hitoshi Tabuchi,1 Yoshiaki Kiuchi2 1Department of Ophthalmology, Saneikai Tsukazaki Hospital, Himeji, Japan; 2Department of Ophthalmology and Visual Sciences, Graduate School of Biomedical Sciences, Hiroshima University, Hiroshima, Japan Purpose: We investigated the incidence of prostaglandin-associated periorbitopathy (PAP) in subjects with glaucoma treated with latanoprost ophthalmic solution.Subjects and methods: One eye and the forehead in 22 subjects were evaluated. All patients had used latanoprost for more than 1 year (range, 12 to 45 months; mean, 26.0 months) and were prostaglandin F2α analogue treatment-naïve. Digital photographs of the subjects obtained before latanoprost therapy and at the last examination were compared retrospectively. Four signs of PAP (deepening of the upper eyelid sulcus (DUES), upper eyelid ptosis, flattening of the lower eyelid bags, and inferior scleral show) and supplemental side effects around the eyelids (eyelash growth, poliosis, and eyelid pigmentation) were judged to be negative or positive by three independent observers. If the observers unanimously rated a sign as positive, the result was defined as positive.Results: Twelve subjects (54.5%) had no apparent signs. Three subjects were judged to have DUES (13.6%), and two subjects each were judged to have flattening of the lower eyelid bags and eyelid pigmentation (9.0%). The other signs were judged as positive in only one subject each, respectively (4.5%). A univariate logistic regression analysis showed no significant associations between any of the signs and age, sex, or the duration of therapy.Conclusion: Latanoprost induced DUES, upper eyelid ptosis, flattening of the lower eyelid bags, inferior scleral show, and supplemental side effects around the eyelids; however, the rates of such occurrence might be relatively low. Keywords: glaucoma, prostaglandin F2α, deepening of the upper eyelid sulcus

BACKGROUND: Nutritional status likely plays an important role in determining the outcome of protozoan infections. Despite the evidence of Plasmodium sensitivity to oxidative stress, the potential role of vitamin E, a free radical scavenger, on the outcome of cerebral malaria (CM) has yet to be elucidated. OBJECTIVE: To determine the influence of vitamin E on Plasmodium parasite development and murine CM outcome, alpha-tocopherol transfer protein (alpha-TTP), a regulator of vitamin E in the host circulation, was abrogated. DESIGN: alpha-TTP knockout mice were infected with Plasmodium berghei ANKA, and survival rate, parasitemia, brain histologic alterations, and brain barrier permeability were assessed. In addition, mRNA expression of the cytokines and adhesion molecules involved in this neurologic pathology were monitored. RESULTS: alpha-TTP knockout mice infected with P. berghei ANKA did not exhibit any clinical or pathologic signs of CM, and a histologic analysis of the brain tissues in these animals showed no alteration of blood-brain barrier integrity compared with that in control mice. Interestingly, protection of the blood-brain barrier in these infected alpha-TTP knockout mice was lost when dietary supplementation with vitamin E was added to their diet. Moreover, interleukins and adhesion molecule transcripts in the brain of control mice were significantly up-regulated compared with those in the alpha-TTP knockout mice. CONCLUSION: It appears that a deficiency of alpha-tocopherol in the circulation prevents CM and suggests that alpha-TTP is a putative target for the early prevention of CM. [ABSTRACT FROM AUTHOR]

Background This study aimed to evaluate postoperative changes in ocular biometry following initial PreserFlo MicroShunt implantation and trabeculectomy. Methodology This prospective, observational study analyzed 27 cases of PreserFlo MicroShunt implantation and 29 cases of trabeculectomy performed by a single surgeon. Visual acuity, intraocular pressure, corneal curvature, central corneal thickness, anterior chamber depth, and axial length were assessed at baseline and postoperatively at one day, one week, two weeks, one month, two months, three months, and six months. Patients requiring additional surgery and those with missing data were excluded. Consecutive data were compared with the baseline values using multiple comparisons. Results In both groups, intraocular pressure was significantly decreased from baseline at all postoperative time points (all p < 0.01). Visual acuity decreased in both groups at one day and one week postoperatively. Corneal curvature remained unchanged in both groups throughout the six-month follow-up. Central corneal thickness increased at one day and one week postoperatively in the PreserFlo group, but not in the trabeculectomy group. Anterior chamber depth exhibited a significant decrease at one week postoperatively in both groups. Axial length significantly decreased postoperatively until three months in the PreserFlo group and at all postoperative time points in the trabeculectomy group. Conclusions Ocular biometry following PreserFlo and trabeculectomy had a similar tendency postoperatively., Competing Interests: The authors have declared that no competing interests exist., (Copyright © 2024, Nakakura et al.)

An international collaborative study was jointly organised by the World Health Organization (WHO) and the European Directorate for the Quality of Medicines & HealthCare (EDQM) to establish the WHO 3 rd International Standard (IS) for Prekallikrein activator (PKA) and European Pharmacopoeia (Ph. Eur.) PKA in albumin Biological Reference Preparation (BRP) batch 7. Twenty-six laboratories took part in the study to calibrate these replacement batches, as well as an additional reserve batch for the WHO IS, against the current WHO 2 nd IS for PKA (02/168). Ph. Eur. PKA in albumin BRP batch 6 was also included to evaluate the continuity of the consecutive batches of BRP. The centrally calculated overall Huber's means based on the results from laboratories with at least two valid assays were 29.6 and 29.6 IU/ampoule for the candidate WHO 3 rd IS (Sample A) and reserve batch (Sample B), and were 38.4 and 37.0 IU/vial for the current BRP batch 6 (Sample C) and the candidate BRP batch 7 (Sample D). The intra-laboratory variation expressed as coefficient of variation (CV) ranged between 1.4 and 16.6 %. The inter-laboratory variation expressed as CV based on Huber's means ranged between 4.4 and 5.4 %. The Huber's mean activity of Sample D against Sample C was 36.6 IU/vial with a CV of 1.7 %. These results confirm the good continuity of the consecutive batches of BRP. Based on the results of this study, it is recommended to establish Sample A as the WHO 3 rd IS for PKA with an assigned potency of 30 IU/ampoule and Sample D as the Ph. Eur. PKA in albumin BRP batch 7 with an assigned potency of 37 IU/vial. Sample B is intended to be kept as a future reserve replacement WHO IS., (© Council of Europe 2024.)

Secondary epiretinal membranes (ERMs) can develop from various causes, including those associated with glaucoma treatments such as trabeculectomy (TLE) and EX-PRESS (EXP) insertion surgery. This study aimed to investigate the occurrence of new ERMs and changes in preexisting ERMs following TLE or EXP insertion. Between April 2018 and March 2019, 102 and 74 eyes that underwent primary and standalone TLE and EXP insertion, respectively, were evaluated. Of these, 48 eyes were included in the TLE group and 32 eyes were included in the EXP group. Optical coherence tomography (OCT) was used to assess preoperative and postoperative ERMs. In the TLE group, postoperative ERMs were observed in one (case 1) (3%) out of 34 eyes without preexisting ERMs and in one (case 2) (7%) out of 14 eyes with preexisting ERMs, showing an increase in ERM stage. In the EXP group, postoperative ERMs were observed in one (case 3) (5%) out of 22 eyes without preexisting ERMs and in one (case 4) (10%) out of 10 eyes with preexisting ERMs, showing a decrease in the ERM stage. Case 1 was a 58-year-old man with primary open-angle glaucoma (POAG) in the left eye who underwent TLE. Although no preoperative ERMs were observed, postoperative ERM was noted at the three-month follow-up. Case 2 was a 49-year-old man with POAG in the right eye who underwent TLE. Although ERM was observed preoperatively, ERM progressed at six months postoperatively. Case 3 was a 59-year-old woman with POAG in the right eye who underwent EXP insertion. No preoperative ERMs were observed, but an ERM was noted at the 15-month follow-up. Case 4 was a 72-year-old woman with steroid-induced glaucoma in the right eye who underwent EXP insertion surgery. A preoperative ERM was present, and the foveal pit was absent; however, the foveal pit was observed at the 12-month follow-up. Despite the low incidence of ERMs, filtration surgery may be associated with ERM development and the progression or regression of preexisting ERMs., Competing Interests: The authors have declared that no competing interests exist., (Copyright © 2023, Aoki et al.)

Objective: To evaluate the intraocular pressure (IOP)-lowering effect based on the number of ingredients and survival rate due to adverse reactions of brinzolamide (1%)/brimonidine (0.1%) fixed combination (BBFC)., Methods and Analysis: Among 424 patients newly administered BBFC from June 2020 to May 2021, 406 were retrospectively evaluated for adverse reactions and 299 were evaluated for the IOP-lowering effect of BBFC. Among those evaluated for IOP, group A (n=86) included patients whose treatment was changed to BBFC from other two ingredients, Group B (n=90) included patients who added one ingredient by switching to BBFC, and group C (n=123) included patients who added BBFC in addition to other drugs., Results: The mean IOP (mm Hg) at BBFC initiation and at 3, 6 and 12 months after BBFC initiation was 14.1, 14.0, 14.3 and 13.8 in group A, 15.9, 14.4, 13.8 and 14.5 in group B and 17.2, 14.0, 14.1 and 14.9 in group C, respectively. Group A showed no significant difference in mean IOP from baseline to any time point after BBFC initiation, whereas groups B and C showed significant IOP reductions at all time points. Seventy-three (18%) patients discontinued treatment due to adverse reactions. The survival rate was 72% at 12 months after the start of BBFC when discontinuation due to adverse reactions was defined as failure., Conclusion: Using BBFC, sustained IOP or decreasing IOP were observed depending on the number of ingredients. Drop-outs due to the adverse reactions should also be given attention., Competing Interests: Competing interests: None declared., (© Author(s) (or their employer(s)) 2022. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.)

Background/objectives: Co-existing idiopathic epiretinal membrane (ERM) and glaucoma complicate the estimation of glaucoma severity via optical coherence tomography (OCT). We investigated the effect of ERM and a new associated parameter, SUKIMA (space between the ERM and retinal surface), on ganglion cell complex (GCC) thickness in eyes with glaucoma, based on a matched comparison of visual field defects., Subjects/methods: We retrospectively recruited 41 eyes from 34 glaucoma patients with idiopathic ERM and 41 eyes from 41 glaucoma patients without ERM as controls (matched by age, axial length, and mean visual field deviation). The thicknesses of GCC layers [retinal nerve fiber layer (RNFL), ganglion cell layer + inner plexiform layer (GCIPL), and GCC (RNFL + GCIPL)] were measured with swept-source OCT. We investigated the presence of SUKIMA and its effect on GCC measurements., Results: RNFL, GCIPL, and GCC were thicker in ERM (+) eyes than in control eyes (31.0 ± 12.3 μm vs. 22.7 ± 10.8 μm, 62.6 ± 12.2 μm vs. 53.8 ± 5.9 μm, and 91.8 ± 16.6 μm vs. 76.8 ± 13.3 μm, respectively; P < 0.01). Eyes in the ERM-associated SUKIMA (+) group had thicker GCIPL and GCC than those in the ERM-associated SUKIMA (-) and control groups ( P < 0.01)., Conclusion: ERM-associated SUKIMA affects GCC thickness and can result in underestimations of glaucoma severity. We should check for the presence of ERM using a B mode scan as well as check for the SKIMA sign., Competing Interests: The authors declare that the research was conducted in the absence of any commercial or financial relationships that could be construed as a potential conflict of interest., (Copyright © 2022 Nakakura, Asaoka, Oogi, Aoki, Terao, Ueda and Kiuchi.)

The control of somatropin products according to the monographs of the European Pharmacopoeia (Ph. Eur.) requires a system suitability preparation for the test for related proteins by liquid chromatography. A preparation consisting in a mixture of somatropin and desamidosomatropin, such as the Ph. Eur. Somatropin/desamidosomatropin resolution mixture Chemical Reference Substance (CRS), is to be used to ascertain adequate resolution of the chromatographic setup. Due to low stocks, the Biological Standardisation Programme (BSP) of the Council of Europe and the European Union ran a study to establish a new batch of this system suitability CRS. A freeze-dried candidate batch (cCRS2) was produced and tested at the European Directorate for the Quality of Medicines and HealthCare (EDQM, Council of Europe). The resolution between the peaks due to somatropin and desamidosomatropin was 1.7 and the symmetry factor for the somatropin peak was 1.2. The mean percentage area of the desamidosomatropin peak was 14.6 %. These results showed that cCRS2 is suitable for its intended purpose. Based on these data, in May 2020 the Ph. Eur. Commission established the candidate batch as Ph. Eur. Soma-tropin/desamidosomatropin resolution mixture CRS batch 2., (© Council of Europe, 2022.)

Background: This study investigated the agreement between a new rebound tonometer, IC200, and IcarePRO and Goldmann applanation tonometry (GAT)., Methods: This was a prospective cross-sectional study. We measured the intraocular pressure (IOP) in 145 eyes of 145 glaucoma patients in the sitting position using GAT, IcarePRO, and IC200. IcarePRO and IC200 measurements were also obtained in the supine position. IC200 measurement was performed using two modes: single six (IC200-single) and automatic (IC200-continuous) six-measurements mode., Results: All tonometers provided high reproducibility in both positions (all intraclass correlation coefficients > 0.90), although it was highest with GAT, followed by IC200-continuous and IC200-single and then IcarePRO. In the sitting position, the mean (± SD) IOPs of GAT, IcarePRO, IC200-single, and IC200-continuous were 14.5 ± 2.9 mmHg, 13.3 ± 3.2 mmHg, 11.6 ± 3.2 mmHg, and 11.5 ± 3.2 mmHg, respectively. IOPs measured with IcarePRO or IC200 were significantly lower than those with GAT, particularly in patients with low IOP. IOPs measured with all tonometers were significantly elevated in the supine position as compared with the sitting position, but this difference was significantly greater with IC200-single and IC200-continuous compared with IcarePRO. IOP elevation was significant in eyes without bleb versus those with bleb, but this finding was not observed when IOP was measured with IcarePRO. The IOPs of the single and continuous modes of IC200 were interchangeable in both positions., Conclusions: GAT, IcarePRO, and IC200 had sufficiently high reproducibility, but measurements with IcarePRO may not be accurate in the supine position. Elevation of IOP in the supine position, especially in eyes with bleb, was more sensitively captured with IC200 than with IcarePRO., Trial Registration: Japan Clinical Trials Register, No. UMIN000039982 .

An international collaborative study was organised under the aegis of the Biological Standardisation Programme (BSP) of the Council of Europe and the European Union to calibrate a replacement batch for the European Pharmacopoeia (Ph. Eur.) Heparin sodium Biological Reference Preparation (BRP). Seventeen laboratories contributed data to value assign a candidate batch (cBRP4) in International Units (IU) against the WHO 6th International Standard for Unfractionated Heparin using chromogenic and sheep plasma clotting assays according to Ph. Eur. texts 2.7.5. on unfractionated heparin and 0878 on human antithrombin III. The continuity of consecutive batches of BRP was evaluated by including BRP3 in the set of test samples. The central analysis of the study data showed good precision and reproducibility of both chromo-genic and clotting assays among laboratories. Based on the study data, the Ph. Eur. Commission adopted cBRP4 as Ph. Eur. Heparin sodium BRP4 with assigned activities of 985 IU/mL for anti-IIa assays, 995 IU/mL for anti-Xa assays and 1035 IU/mL for sheep clotting assays., (© Council of Europe, 2021.)