Japanese Journal of Ophthalmology最新文献

Purpose: To evaluate changes in cataract and refractive surgery practice patterns among members of the Japanese Society of Cataract and Refractive Surgery (JSCRS) over the past 20 years.

Study design: Questionnaire survey study.

Subjects and methods: Clinical surveys were conducted annually between February and April from 2004 to 2023. Survey questions covered various areas, including cataract surgical techniques, anesthesia, endophthalmitis prophylaxis, toric and presbyopia-correcting intraocular lenses (IOLs), complications, and refractive surgery.

Results: The highest (n=554 [36.8%]) and lowest (n=316 [19.1%]) numbers of responses were collected in 2012 and 2016, respectively. In perioperative management, the intraoperative use of polyvinyl alcohol-iodine solution and topical antibiotic prescription 3 days before surgery has increased. The use of intracameral injection at the end of surgery has also significantly increased, although it has not been established as common practice. In anesthesia, there is a clear polarization between the use of topical drops and tenon injection. The use of toric IOLs and presbyopia-correcting IOLs has significantly increased from 2010 to 2023. In the latter, the use of trifocal IOLs has particularly increased. Regarding IOL power calculations, the Barrett True K and the Barrett Universal II formulas are rapidly gaining popularity for application with and without post-laser vision correction, respectively. In refractive surgery, phakic IOLs and corneal refractive therapy have attracted considerable interest, followed by laser in situ keratomileusis.

Conclusions: Evaluation of annual clinical survey data over the past two decades provided valuable insights into the shifting practice patterns and clinical opinions among JSCRS members.

Purpose: To objectively assess visual function in Leber's Hereditary Optic Neuropathy (LHON) patients; this study evaluated pre- and post-idebenone treatment changes in primary visual cortical (V1) responses using functional magnetic resonance imaging (fMRI), given the challenges in subjective testing due to central retinal ganglion cell damage.

Study design: A descriptive study involving four confirmed LHON patients.

Methods: Four patients received 900 mg/day of oral idebenone for 24 weeks. Baseline and post-treatment visual acuity, visual fields, and BOLD fMRI responses while passively viewed drifting contrast pattern visual stimuli were compared with self-reported symptoms.

Results: Post-idebenone, one patient showed positive trends across subjective tests, reported symptoms, and fMRI. Two patients had stable symptoms and fMRI responses; one improved on subjective tests, and another worsened slightly. Another patient improved in visual field tests despite worsening symptoms and fMRI trends.

Conclusion: fMRI may offer a valuable objective measure of visual functions in LHON and appears to be more relevant in assessing symptoms. Further research with more participants is needed to ascertain fMRI's role in developing objective visual assessments and treatment evaluation.

Purpose: To compare surgical results between ab-externo microshunt surgery and trabeculectomy, focusing on postoperative corneal astigmatism.

Study design: Retrospective study.

Methods: Subjects were patients with glaucoma who underwent either standalone ab-externo microshunt surgery or trabeculectomy. Data on ophthalmic examinations obtained preoperatively and 1, 3, and 5 months postoperatively were analyzed. To assess corneal astigmatism, two separate data sets measured by anterior segment optical coherence tomography and autorefractometer were evaluated. Multivariate linear mixed model analyses were conducted to identify factors associated with the astigmatism changes.

Results: Sixty eyes were examined: 13 eyes underwent microshunt surgery, and 47 eyes underwent trabeculectomy. The total corneal astigmatism measurements by anterior segment optical coherence tomography (AS-OCT) were: - 1.15 ± 0.85 D and - 1.17 ± 0.81 D for the microshunt and trabeculectomy groups, respectively, preoperatively. At five months postoperatively they were - 0.92 ± 0.47 D and - 1.61 ± 0.83 D, respectively (P = 0.807 for the microshunt group and P = 0.005 for the trabeculectomy group: Wilcoxon signed-rank test). AS-OCT also indicated similar results for posterior corneal astigmatism. Autorefractometry also found the total corneal astigmatism was significantly changed only in the trabeculectomy group. The linear mixed model analysis revealed that trabeculectomy (P = 0.001), older age (P = 0.004), and longer postoperative period (P = 0.015) were correlated with greater astigmatism changes. The intraocular pressures significantly decreased following both surgical treatments.

Conclusions: Standalone ab-externo microshunt surgery has less effect on corneal astigmatism during a 5 month period than trabeculectomy. Both surgical procedures significantly reduced intraocular pressure.

Purpose: To reveal the penetration of epinastine, an anti-allergic ophthalmic agent, into the eyelid and its distribution to the conjunctiva after administration of a cream formulation on rabbit eyelid skin.

Study design: Experimental study.

Methods: Rabbits were treated with 0.5% epinastine cream on hair-shaved eyelids, followed by preparation of eyelid tissue slices to determine spatial tissue distribution of epinastine by liquid chromatography-tandem mass spectrometry (LC-MS/MS) quantification using laser-microdissected tissues and desorption electrospray ionization mass spectrometry imaging (DESI-MSI). In addition, following either eyelid application of 0.5% epinastine cream or ocular instillation of 0.1% epinastine eye drops, concentration-time profiles of epinastine in the palpebral conjunctiva and bulbar conjunctiva were determined using LC-MS/MS.

Results: Laser microdissection coupled with LC-MS/MS analysis detected high concentrations of epinastine around the outermost layer of the eyelid at 0.5 h post-administration that gradually diffused deeper into the eyelid and was distributed in the conjunctival layer at 8 and 24 h post-administration. Similar time-dependent drug distribution was observed in high-spatial-resolution images obtained using DESI-MSI. Epinastine concentrations in the conjunctival tissues peaked at 4-8 h after administration of 0.5% epinastine cream and then decreased slowly over 72 h post-administration. In contrast, epinastine concentrations peaked quickly and decreased sharply after epinastine eye drop administration.

Conclusion: After the application of epinastine cream to the eyelid skin, epinastine gradually permeated the eyelid. The compound was retained in the conjunctiva for 8-24 h post-administration, indicating that epinastine cream is a promising long-acting formulation for treating allergic conjunctivitis.

Purpose: To assess the safety and efficacy of ripasudil for retinopathy of prematurity (ROP).

Study design: Phase 1/2, multicenter, open-label, single-arm, 12-week clinical trial.

Methods: Infants born with gestational age (GA) of ≤ 32 weeks or weight of ≤ 1500 g with zone I or II, ≥ stage 1, ROP in both eyes were enrolled. Ripasudil eye drops were administered to patients in both eyes. Phase 1 was a dose-escalation study (once daily for 1 week, then twice daily for 2 weeks); an additional dosing up to 9 weeks was allowed if no safety issues occurred. In phase 2, ripasudil was administered twice daily for up to 12 weeks. Adverse events were assessed. The proportion of patients with type 1 ROP progression, number of days for type 1 ROP progression, and progression to the most advanced ROP stage were estimated.

Results: Twenty-four infants were enrolled (phase 1, n = 3; phase 2, n = 21). Nineteen and four patients experienced systemic and ocular adverse events, respectively. Efficacy endpoints were not different between the ripasudil and historical control groups. However, in the GA ≤ 27 weeks subgroup, fewer patients progressed to type 1 ROP in the ripasudil than in the historical control group (P = 0.09). In the GA ≤ 27 weeks subgroups, the 25th percentile for the number of days for type 1 ROP progression was 22 days in the historical control group and 44 days in the ripasudil group.

Conclusion: Ripasudil was safe and inhibited/delayed type 1 ROP progression, especially in infants with short GA.

Purpose: To investigate the surgical outcomes of intrascleral intraocular lens (IOL) fixation using a modified extraocular forceps-guided technique.

Study design: Retrospective case series.

Methods: Overall, 81 eyes of 78 patients who underwent intrascleral IOL fixation using the modified extraocular forceps-guided technique were included. The procedure entailed creating 2 scleral half-layer T-shaped incisions perpendicular to the main incision and forming a scleral tunnel. A 25-gauge trocar was inserted at the lower end of the T-shaped incision to perform vitrectomy. A 27-gauge needle was inserted from the left-hand port, and the leading haptic was inserted into the needle lumen. After removal of the right-hand trocar, a 90°-curved intrascleral fixation forceps was inserted into the eye, exposing the tip at the main incision, thus allowing the tip of the extraocular trailing haptic to be gripped and both haptics to be pulled out. The left-hand trocar was removed, and the haptics were buried in the scleral tunnel. The surgical outcomes of this technique were retrospectively evaluated on the basis of the medical records.

Results: The induction of haptics was successful in all cases. The preoperative best-corrected visual acuity improved from 0.35±0.68 to 0.12±0.36 logMAR postoperatively (P<0.01). The refractive error was -0.27±0.87 D; IOL decentration, 0.39±0.18 mm; IOL tilt, 5.97±2.65°; IOL astigmatism, 0.35±0.36 D; and corneal endothelial cell loss, 10.3±12.7%. There were no serious complications related to the surgical technique.

Conclusion: The modified extraocular forceps-guided technique allows for safe and straightforward induction of the trailing haptics and enables the performance of intrascleral IOL fixation with minimal scleral incisions.

Purpose: To evaluate the 2-year efficacy, durability, and safety of faricimab in patients with diabetic macular edema (DME) in the YOSEMITE Japan subgroup.

Study design: YOSEMITE/RHINE (NCT03622580/NCT03622593) subgroup analysis: global, multicenter, randomized, double-masked, active-comparator-controlled, phase 3 faricimab trials.

Methods: Patients were randomized 1:1:1 to intravitreal faricimab 6.0 mg every 8 weeks (Q8W) and per treat-and-extend (T&E) dosing, or aflibercept 2.0 mg Q8W. Outcomes were assessed through year 2 for the YOSEMITE Japan subgroup (N = 60) and the pooled YOSEMITE/RHINE global cohort (N = 1891).

Results: In the YOSEMITE Japan subgroup, 21, 19, and 20 patients were randomized to faricimab Q8W, faricimab T&E, and aflibercept Q8W, respectively (632, 632, and 627 patients in the pooled YOSEMITE/RHINE cohort). Vision gains and anatomic improvements with faricimab at year 1 were maintained over 2 years and were generally consistent between groups. Mean best-corrected visual acuity changes from baseline at year 2 (weeks 92-100 average) for the YOSEMITE Japan subgroup were +12.5, +9.0, and +5.0 letters in the faricimab Q8W, faricimab T&E and aflibercept Q8W arms, respectively (+10.8, +10.4, and +10.3 letters in the pooled YOSEMITE/RHINE cohort). At week 96, 61.1% of the YOSEMITE Japan subgroup and 78.1% of the pooled YOSEMITE/RHINE cohort were on ≥ Q12W dosing. Faricimab was well-tolerated with a safety profile comparable with aflibercept.

Conclusion: Faricimab up to Q16W offered durable vision gains and anatomic improvements up to 2 years in patients with DME in the YOSEMITE Japan subgroup. Outcomes were generally consistent with the pooled YOSEMITE/RHINE cohort.

Purpose: To assess the effectiveness of switching from the concomitant use of brinzolamide 1% (BZM) and brimonidine 0.1% (BMD) to a BZM/BMD fixed-dose combination (BBFC) for the reduction of corneal epithelial damage.

Study design: Retrospective cohort study.

Methods: This study involved 52 eyes of 52 glaucoma patients (26 women, 26 men; mean age: 67.0 ± 14.0 years) followed for more than 3 months after being switched from concomitant BZM and BMD to BBFC. Superficial punctate keratitis (SPK) was assessed by fluorescein staining according to the National Eye Institute classification, with the cornea divided into 5 areas: center, superior, nasal, temporal, and inferior. SPK density was graded as 0 (no SPK), 1 (separate SPK), 2 (moderately dense SPK), and 3 (high SPK with overlapping lesions). SPK scores and intraocular pressure (IOP) at pre switching to BBFC (pre-BBFC) and at 3-months post switching to BBFC (post-BBFC) were then compared using the Wilcoxon signed-rank test.

Results: At pre-BBFC and post-BBFC, respectively, mean IOP was 12.4 ± 2.5 and 12.4 ± 2.7 mmHg, thus illustrating no significant difference in IOP between pre and post switch (p = 0.924), and the mean SPK score for center, superior, nasal, temporal, and inferior was 0.06 ± 0.24, 0.04 ± 0.19, 0.52 ± 0.67, 0.15 ± 0.36, and 0.92 ± 0.74, and 0.04 ± 0.19, 0.02 ± 0.14, 0.37 ± 0.56, 0.04 ± 0.19, and 0.75 ± 0.62, thus clearly showing a significant reduction in SPK scores for the nasal, temporal, and inferior areas at post-BBFC compared to those at pre-BBFC (p < 0.05).

Conclusion: Our findings reveal that compared with the concomitant use of BZM and BMD, BBFC is effective in reducing corneal epithelial damage.

Purpose: To investigate the efficacy of our wearable night-vision aid in patients with concentric peripheral visual field loss.

Study design: Prospective, single blind, three-group, and three-period crossover clinical study.

Methods: The study included patients with concentric peripheral visual field loss, a best-corrected visual acuity (decimal visual acuity) of 0.1 or higher in the better eye, and the presence of a central visual field. HOYA MW10 HiKARI® (HOYA Corporation), our original wearable night-vision aid, was used as the test device with three types of camera lenses (standard-, middle-, and wide-angle lenses). Under both bright and dark conditions, the angle of the horizontal visual field was measured using each of the three lens types for each group. The baseline angle was measured when each participant wore the night-vision aid (powered off).

Results: The study included 21 participants. Under bright condition, the perceived horizontal visual field was significantly wider than the baseline setup when using the standard-angle lens ("the standard lens"); the middle-angle lens ("the middle lens") was significantly wider than both the baseline setup and the standard lens; and the wide-angle lens ("the wide lens") was significantly wider than the other lenses. Under dark condition, the perceived horizontal visual field was again significantly wider when using the middle lens than the baseline setup and the standard lens, and when using the wide lens, the perceived horizontal visual field was again wider than when using the other lenses. The control in the bright condition was significantly wider (p < 0.001) than when used in the dark condition, while the standard-angle lens in the dark condition was significantly wider (p = 0.05) than when used in the bright condition. In regards to the middle and wide lenses, there was no statistically significant result emerging from either of the illumination conditions.

Conclusion: Our wearable night-vision aid with a middle-angle or wide-angle lens appears to provide wider visual field images in patients with concentric peripheral visual field loss, regardless of whether the illumination conditions are bright or dark.

Accurate interpretation of sequence variants in inherited retinal dystrophy (IRD) is vital given the significant genetic heterogeneity observed in this disorder. To achieve consistent and accurate diagnoses, establishment of standardized guidelines for variant interpretation is essential. The American College of Medical Genetics and Genomics/Association for Molecular Pathology (ACMG/AMP) guidelines for variant interpretation serve as the global "cross-disease" standard for classifying variants in Mendelian hereditary disorders. These guidelines propose a systematic approach for categorizing variants into 5 classes based on various types of evidence, such as population data, computational data, functional data, and segregation data. However, for clinical genetic diagnosis and to ensure standardized diagnosis and treatment criteria, additional specifications based on features associated with each disorder are necessary. In this context, we present a comprehensive framework outlining the newly specified ACMG/AMP rules tailored explicitly to IRD in the Japanese population on behalf of the Research Group on Rare and Intractable Diseases (Ministry of Health, Labour and Welfare of Japan). These guidelines consider disease frequencies, allele frequencies, and both the phenotypic and the genotypic characteristics unique to IRD in the Japanese population. Adjustments and modifications have been incorporated to reflect the specific requirements of the population. By incorporating these IRD-specific factors and refining the existing ACMG/AMP guidelines, we aim to enhance the accuracy and consistency of variant interpretation in IRD cases, particularly in the Japanese population. These guidelines serve as a valuable resource for ophthalmologists and clinical geneticists involved in the diagnosis and treatment of IRD, providing them with a standardized framework to assess and classify genetic variants.