Removable regulating sutures during trabeculectomy for a safer and more effective intraocular pressure control.

PURPOSE: Comparing the effect of standard trabeculectomy with direct sutures versus trabeculectomy with compression and everting sutures. METHODS: Mono-centric randomized prospective comparative study on 38 glaucomatous eyes undergoing trabeculectomy: 19 with standard fixed sutures (group A) and 19 withremovable regulating sutures (group B). Preoperatively and at day-7, 1-month, 2-months, 3-months and 6-months after surgery, we recorded best-corrected visual acuity (BCVA), intraocular pressure (IOP) and possible complications. Complete, partial success and failure rates were recorded at the end of the study. RESULTS: In group B, we pulled everting sutures with the "horse bridle" technique at the 14th day, and successively removed all sutures between the 14th-30th post-operative day. At month-1, we recorded a significant IOP reduction in both groups (mean reduction of 11.5 mmHg for group A and of 14.4 mmHg for Group B, p = 0.001 and p < 0.0001, respectively). Furthermore, group B showed a significantly lower IOP than group A (-4.2 mmHg, 95% confidence interval [CI] -7.0 to -0.5 mmHg for group B, p = 0.01). At 2, 3 and 6-months, no significant IOP differences were reported between the two groups (all p > 0.05), but failure rate was higher for group A (21%) than for group B (11%). No differences in visual outcomes at any timepoints were noted. CONCLUSIONS: Trabeculectomy with removable regulating sutures showed a good safety profile, comparable to standard trabeculectomy. Moreover, we reported a lower IOP one month postoperatively, suggesting this technique may optimize early management of trabeculectomy.

SING IMT in pseudophakic eyes: Results of the first experiences.

Purpose: To evaluate the feasibility and outcomes of implanting the Smaller-Incision New-Generation Implantable Miniature Telescope (SING IMT) in pseudophakic patients affected by late-stage dry AMD. Subjects: Five pseudophakic patients' eyes with stable dry AMD were suitable for SING IMT implantation. Four eyes were excluded because of previous YAG laser capsulotomy. Patients underwent preoperative assessments, including visual acuity measurements and OCT scans. Methods: Surgical procedures were performed under peribulbar anesthesia, with careful IOL removal and SING IMT implantation. Postoperative follow-up was conducted at regular intervals to monitor visual acuity, device positioning and complications. Results: Postoperative outcomes demonstrated improvements in visual acuity for most patients with an average gain in CDVA (Corrected Distance Visual Acuity) and CNVA (Corrected Near Visual Acuity) of 16,8 ± 10,2 and 13,8 ± 7,4 ETDRS letters, respectively. Limited complications have been observed. In one case, we observed dislocation of the device into the vitreous chamber, which we managed through vitrectomy and scleral fixation of the SING IMT using GoreTex suture. Conclusions: Despite being traditionally contraindicated for pseudophakic patients, SING IMT implantation in selected cases yielded favorable outcomes, indicating potential benefits for this population. Further research with larger sample sizes and longer follow-up periods is warranted to refine patient selection criteria and optimize surgical techniques.

Safety Results for Geographic Atrophy Associated with Age-Related Macular Degeneration Using Subretinal Cord Blood Platelet-Rich Plasma.

Purpose: To evaluate the safety of subretinal injection of cord blood platelet-rich plasma (CB-PRP) and its possible effect in eyes affected by geographic atrophy (GA) associated with dry age-related macular degeneration (d-AMD). Design: Interventional, open-label study started in January 2021 with follow-up at 12 months (the Si.Cord Study). This study was a single-center, nonrandomized, sequential-assigned clinical trial conducted in Rome, Italy, at Fondazione Policlinico Universitario Agostino Gemelli IRCCS (ClinicalTrials.gov NCT04636853). Participants: Thirteen patients (26 eyes) with bilateral d-AMD-related GA were enrolled. One eye from each patient (with more advanced GA) underwent CB-PRP treatment, and the fellow eye was considered the control. All patients participated in follow-up at 12 months. Intervention: All 13 eyes received 23-gauge (G) vitrectomy and subretinal injection of CB-PRP using a 41-gauge needle. Main Outcomes and Measures: Best-corrected visual acuity (BCVA) with ETDRS letters, central macular thickness using OCT, and atrophic area measured on en face OCT images were assessed at baseline, 1, 3, 6, and 12 months. Results: The BCVA in the treated group was 34.46 ± 20.8 ETDRS at baseline, 40.84 ± 20.52 at 1 month, 40.07 ± 20.34 at 3 months, 39.38 ± 19.84 at 6 months, and 35.84 ± 18.38 at 12 months. In the untreated group, the BCVA was 53 ± 21.1 ETDRS letters at baseline, 51.54 ± 20.99 at 1 month, 46.62 ± 19.47 at 3 months, 46.85 ± 18.58 at 6 months, and 43.92 ± 17.97 at 12 months (2-way analysis of variance: interaction of treatment by eye or time, P = 0.084). Central macular thickness did not show a significant intereye difference at 12 months (P = 0.97). The atrophic geographic areas tended to increase in both treated and fellow eyes at 12 months (P < 0.0001). No inflammatory reaction, endophthalmitis, retinal detachment, uveitis, or other complications due to the subretinal injection of CB-PRP were observed during the follow-up. Conclusions: Subretinal injection of CB-PRP could be safely used for d-AMD in its GA form. Despite its safety, a larger cohort of patients, and probably a new way of administration, will be needed to understand whether the CB-PRP could have a role in the GA treatment. Financial Disclosures: Proprietary or commercial disclosure may be found in the Footnotes and Disclosures at the end of this article.

Management of Perifoveal Exudative Vascular Anomalous Complex.

PURPOSE: To report a case of a patient with perifoveal exudative vascular anomalous complex (PEVAC) and to analyze morphological and vascular changes by OCT and OCTA before and after treatment. MATERIALS AND METHODS: In this case we reported a case which received multiple treatment for unresponsive effect to Repeated Aflibercept intravitreal injections, subthreshold micropulse laser therapy (SMPL) duty cycle 5%. At last the focal fully dose yellow laser was performed. RESULTS: A 57-year-old male patient presented with best corrected visual acuity (BCVA) of 20/50 in his right eye (RE) The fundoscopic evaluation, structural optical coherence tomography (OCT) and OCT angiography (OCTA) deposed for a diagnosis of PEVAC. The patient underwent three Aflibercept intravitreal injections in the RE. Since no changes were detected, we opted for multiple sessions of yellow subthreshold micropulse laser therapy (SMPL) duty cycle 5%, however no signs of regression were registered. Only after a fully dose yellow laser, signs of edema regression were observed. Stuctural OCT B-scan showed complete restitutio of retinal profile, in absence of any intraretinal or subretinal fluid and PEVAC lesion, while the OCTA showed a slight flow deficit at the previous lesion site. CONCLUSIONS: and Importance: The PEVAC treatment is still unknown. In our experience, we reported a case of multiple treatments for unresponsive effect to: Aflibercept intravitreal injections, subthreshold micropulse laser therapy (SMPL) duty cycle 5%. At list the focal fully dose yellow laser was the only effective in our patient. We proposed our management to share the heterogeneous response at PEVAC entity.

Reproducibility of SIMPLE classification for diabetic retinopathy screening and its comparison to current Italian guidelines.

PURPOSE: To evaluate the reproducibility of SIMPLE (Single field Image Multi Parameters defined Lesions Extent), a new Diabetic Retinopathy (DR) classification for screening of 45° single field fundus pictures of patients with diabetes (PwDM), assessing DR, Diabetic Maculopathy (DMac) and referral rate agreement and comparing it to current Italian Guidelines (IG). MATERIALS AND METHODS: We conducted a retrospective, observational, multicentre study, collecting 1000 retinal 45° single field images of PwDM obtained during routine visits in two diabetes clinics. Three ophthalmologists evaluated each image, determining the presence and number of specific DR lesions and then assigning a stage according to the current IG for screening. SIMPLE staging was performed automatically via Excel software, based on the pre-specified DR characteristics observed by the graders. We analysed intra-centre, inter-centre and total inter-grader agreement for DR and DMac stage and referral rate of the two classifications. RESULTS: Agreement amongst the three graders was consistently higher when using SIMPLE classification than when using current IG classification. For DR, kappa (k) was 0.86 with IG and 0.95 with SIMPLE classification; for DMac, k-IG was 0.78, while k-SIMPLE was 0.96; concordance on the referral rate was 0.91 with IG and 0.99 with SIMPLE. Similar results were obtained in sub-analyses for the evaluation of intra-centre and inter-centre concordance. CONCLUSIONS: Our results suggest that the new SIMPLE classification has an excellent reproducibility amongst graders, comparable or superior to the current IG for DR screening proposed in 2015, improving the standardisation of the decision on referability.

Extensive macular atrophy with pseudodrusen-like appearance: comprehensive review of the literature.

PURPOSE: This review focuses on extensive macular atrophy with pseudodrusen-like appearance (EMAP), a recently described maculopathy presenting with pseudodrusen-like lesions and chorioretinal atrophy more pronounced in the vertical axis. METHODS: Narrative review of the literature published until May 2024. RESULTS: The early onset age of EMAP (50-55 years) and its distinctive natural history, which includes night blindness followed by severe vision loss, differentiate it from atrophic age-related macular degeneration (AMD). A clear pathogenesis has not been determined, but risk factors include female gender and complement system abnormalities (altered levels of C3 and CH50). Moreover, lifelong exposure to pesticides has been suggested as risk factor for direct neuronal degeneration involving rods and cones. In the early phase of the disease, reticular pseudodrusen-like lesions appear in the superior perifovea and tend to coalescence horizontally into a flat, continuous, reflective material localized between the retinal pigmented epithelium and Bruch's membrane. Over time, EMAP causes profound RPE and outer retinal atrophy in the macular area, with a recent classification reporting a 3-stages evolution pattern. Blue autofluorescence showed rapidly evolving atrophy with either hyperautofluorescent or isoautofluorescent borders. Significant similarities between the diffuse-trickling phenotype of geographic atrophy and EMAP have been reported. Macular neovascularization is a possible complication. CONCLUSION: EMAP is specific form of early-onset atrophic macular degeneration with rapid evolution and no treatment. Further studies are needed to assess the best management.

Exploring the contribution of carotid artery disease to the onset of non-arteritic ischemic optic neuropathies: A systematic review.

PURPOSE: The role of carotid artery disease (CAD) in the development of various types of ocular arterial occlusive disorders has often been reported. This systematic review aims to evaluate and review the current evidence regarding the role of CAD and the subsequent carotid artery hemodynamic alterations in the development of non-arteritic anterior (NA-AION) and posterior (NA-PION) ischemic optic neuropathy. METHODS: We systematically reviewed studies following Preferred Reporting Items for Systematic Reviews and Meta-Analysis guidelines. We systematically searched PubMed, Embase, and Scopus databases for relevant studies that clearly assessed the role of CAD and the subsequent carotid artery hemodynamic alterations in the development of NA-AION and NA-PION. All studies that examined the associations between CAD and the development of NA-AION and NA-PION in adults aged 18 years or older were synthesized. Quality assessment using the Newcastle-Ottawa Scale (NOS), and Joanna Briggs Institute (JBI) Critical Appraisal Checklist for Case Reports and Case-Series were also conducted. RESULTS: Our search identified 1933 manuscripts published in the English language. The number of participants with non-arteritic ischemic optic neuropathy (NA-ION) ranged from 1 to 191, with a total of 478 patients experiencing either NA-AION (410 out of 478), NA-PION (13 out of 478), or a combination of thereof (1 out of 478). The number of participants with NA-ION due to atherosclerosis ranged from 1 to 191, with a total of 376 patients. CONCLUSIONS: Although carotid artery disease may rarely contribute to the development of NA-ION, it should be considered as a possible cause of NA-ION.

Chorio-retinal vessel density in women affected by functional hypothalamic amenorrhea: a monocentric observational cross-sectional study to evaluate the impact of hypoestrogenism on chorio-retinal vascularization.

PURPOSE: Functional hypothalamic amenorrhea (FHA) is characterized by an estrogen deficiency which in turn can cause vascular dysfunction. The aim of this study is to evaluate any changes in the chorio-retinal circulation in patients affected by FHA. 24 patients with FHA and 24 age-matched controls underwent a gynecological evaluation and an OCT angiography (OCTA) to study chorio-retinal vascularization. RESULTS: OCTA in FHA patients showed an increase in vessel density in the choriocapillaris (CC) layer (both in the fovea area, at 5% p value = 0.037 and in the whole area, at 5% p value = 0.028) and an increase in vascular density in the deep fovea (DVP) (at 10% p value = 0.096) in the whole district compared to controls. Simple linear regressions show a significant negative association between CC vessel density and insulin (p = 0.0002) and glucose values (p = 0.0335) for the fovea district and a negative association between DVP vessel density and endometrial thickness (at 10%, p value: 0.095) in the whole district. CONCLUSION: Our study shows that CC vessel density is increased in women affected by FHA. This could represent a compensation effort to supply the vascular dysfunction caused by estrogen deficiency. We also found an increasing trend in vascular density in DVP associated with the decrease of endometrial thickness, an indirect sign of estrogenization. Considering that these changes occur in absence of visual defects, they could be used as a biomarker to estimate hypoestrogenism-induced microcirculation changes before clinical appearance.

Effects of a human amniotic membrane extract on ARPE-19 cells.

BACKGROUND: Human Amniotic Membrane (hAM) is endowed with several biological activities and might be considered an optimal tool in surgical treatment for different ophthalmic pathologies. We pioneered the surgical use of hAM to treat retinal pathologies such as macular holes, tears, and retinal detachments, and to overcome photoreceptor damage in age-related macular degeneration. Although hAM contributed to improved outcomes, the mechanisms of its effects are not yet fully understood. The characterization and explanation of the effects of hAM would allow the adoption of this new natural product in different retinal pathologies, operative contexts, and hAM formulations. At this end, we studied the properties of a hAM extract (hAME) on the ARPE-19 cells. METHODS AND RESULTS: A non-denaturing sonication-based technique was developed to obtain a suitable hAME. Viability, proliferation, apoptosis, oxidative stress, and epithelial-mesenchymal transition (EMT) were studied in hAME-treated ARPE-19 cells. The hAME was able to increase ARPE-19 cell viability even in the presence of oxidative stress (H2O2, TBHP). Moreover, hAME prevented the expression of EMT features, such as EMT-related proteins, fibrotic foci formation, and migration induced by different cytokines. CONCLUSIONS: Our results demonstrate that the hAME retains most of the properties observed in the whole tissue by others. The hAME, other than providing a manageable research tool, could represent a cost-effective and abundant drug to treat retinal pathologies in the future.

Optical Coherence Tomography Advanced Parameters in Patients With Multiple Sclerosis: Ophthalmological and Neurological Assessments.

PURPOSE: To evaluate ophthalmological, neurological, radiological, and laboratory data in patients with multiple sclerosis (MS) and to identify new ophthalmological factors that could be helpful as biomarkers of the disease, potentially leading to an earlier prediction of disease course and disability progression. DESIGN: Retrospective, cross-sectional-study. METHODS: Best-corrected visual acuity (BCVA), ophthalmological biomicroscopy of the anterior segment and fundus, structural optical coherence tomography (OCT) with retinal nerve fiber layer (RNFL) and ganglion cell complex (GCC), and OCT angiography (OCTA) with vascular density (VD) were performed. The following clinical and neuro-radiological features were assessed: MS phenotype, disease duration, clinical severity, type of treatment, and T2-weighted lesion and T1-weighted Gd+ enhancing lesion number on the brain and spinal cord MRI. RESULTS: One hundred and six patients (212 eyes) were analyzed. Sixty-six of them (62.2%) had MS and 40 (37.8%) were matched healthy controls (HCs). patients with MS showed lower RNFL, GCC, and VD in the radial peripapillary capillary plexus than controls in both eyes (P < .05). By Performing a logistic regression with a distinct MS outcome for both eyes, we were able to demonstrate that the value that was most predictive of MS was the average GCC thickness (P = .009). Regression analysis demonstrated that patients with a higher T2-weighted lesions showed a lower RNFL thickness value and reduced GCC and VD values than those with a low lesion load (P < .01 and P < .05, respectively). Similarly, relapsing MS patients showed lower RNFL values (P < .05). CONCLUSIONS: Several OCT and OCTA-optic nerve parameters could be useful prognostic biomarkers for the MS disease course in clinical practice. However, it is necessary to do additional research with larger sample sizes in order to validate these findings.

OCT analysis of preoperative foveal microstructure in recent-onset macula-off rhegmatogenous retinal detachment: visual acuity prognostic factors.

BACKGROUND: To evaluate, in patients undergoing macula-off rhegmatogenous retinal detachment surgery (RRD), the correlation between preoperative optical coherence tomography (OCT) morphological features and postoperative visual acuity. METHODS: Retrospective interventional non-randomised clinical trial on 89 eyes of 89 patients undergoing pars plana vitrectomy for macula-off primary RRD at Policlinico Universitario Agostino Gemelli from 2020 to 2023. Preoperative 6×6 mm OCT B scans with Nidek Mirante (Nidek, Gamagori, Japan) were performed, collecting the following features: foveal involvement (fovea-on vs fovea-off), subretinal hyper-reflective points (HRPs), outer retinal corrugations (ORCs) and intraretinal cystic spaces (ICS) in the outer nuclear layer. The patients were followed in a 6-month follow-up to evaluate best-corrected visual acuity (BCVA) outcomes. RESULTS: Preoperative mean BCVA was 0.15±0.22 and improved to 0.29±0.3 decimals at 6 months (p<0.001). The presence of subretinal HRPs showed a significant negative impact on BCVA improvement in the univariate regression analysis (r=-0.264, p=0.024), as well as the presence of foveal detachment (r=-0.355, p=0.012). The other OCT features did not show a significant correlation with BCVA improvement: ORCs (r=0.072, p=0.257) and ICS (r=-0.020, p=0.734). In the multivariate regression analysis, the negative impact of foveal detachment was confirmed (r=-0.199, p=0.05) while the statistical significance of subretinal HRPs was lost (r=-0.135, p=0.105). CONCLUSIONS: The negative impact of foveal involvement in a macula-off RRD was confirmed. Moreover, the presence of subretinal HRPs, as a possible indirect marker of inflammatory response extent, may act as a negative predictor for postoperative visual recover. TRIAL REGISTRATION NUMBER: NCT05747144.

3D Heads-up digital filters for cataract surgery and corneal transplantation.

PURPOSE: To describe the advantages of Ngenuity 3D digital filters for enhancing visualization during cataract and corneal transplant surgery. METHODS: All surgeries were performed by the same experienced surgeon (L.M.) using the Ngenuity 3D heads-up visualization system connected to a microscope. Images were simultaneously captured with and without the filter in each of the following phases: endothelial evaluation, capsulorhexis, capsule rupture, vitreous leak, cortex removal, visco removal, corneal suture, descemetorhexis, DMEK graft preparation and insertion. RESULTS: In cataract surgery, green and monochrome filters facilitate capsulorhexis in difficult situations by highlighting the anterior capsule and can improve visualization of a posterior capsular tear. The enhanced contrast of the monochrome filter is also useful for cortex and viscoelastic removal. In corneal surgery, the green filter highlights the rim of the DMEK graft during tissue preparation, the yellow filter enhances the contrast of the stained DMEK graft in the anterior chamber, the monochrome filter simplifies descemetorhexis by improving visualization of the Descemet/endothelial layer and allows a better view in red saturated images while performing sutures. CONCLUSIONS: Ngenuity digital filters have the potential to enhance tissue visualization during cataract and corneal surgeries, especially in poor visibility conditions.

Large language models as assistance for glaucoma surgical cases: a ChatGPT vs. Google Gemini comparison.

PURPOSE: The aim of this study was to define the capability of ChatGPT-4 and Google Gemini in analyzing detailed glaucoma case descriptions and suggesting an accurate surgical plan. METHODS: Retrospective analysis of 60 medical records of surgical glaucoma was divided into "ordinary" (n = 40) and "challenging" (n = 20) scenarios. Case descriptions were entered into ChatGPT and Bard's interfaces with the question "What kind of surgery would you perform?" and repeated three times to analyze the answers' consistency. After collecting the answers, we assessed the level of agreement with the unified opinion of three glaucoma surgeons. Moreover, we graded the quality of the responses with scores from 1 (poor quality) to 5 (excellent quality), according to the Global Quality Score (GQS) and compared the results. RESULTS: ChatGPT surgical choice was consistent with those of glaucoma specialists in 35/60 cases (58%), compared to 19/60 (32%) of Gemini (p = 0.0001). Gemini was not able to complete the task in 16 cases (27%). Trabeculectomy was the most frequent choice for both chatbots (53% and 50% for ChatGPT and Gemini, respectively). In "challenging" cases, ChatGPT agreed with specialists in 9/20 choices (45%), outperforming Google Gemini performances (4/20, 20%). Overall, GQS scores were 3.5 ± 1.2 and 2.1 ± 1.5 for ChatGPT and Gemini (p = 0.002). This difference was even more marked if focusing only on "challenging" cases (1.5 ± 1.4 vs. 3.0 ± 1.5, p = 0.001). CONCLUSION: ChatGPT-4 showed a good analysis performance for glaucoma surgical cases, either ordinary or challenging. On the other side, Google Gemini showed strong limitations in this setting, presenting high rates of unprecise or missed answers.

A novel homozygous splice site variant in ARL2BP causes a syndromic autosomal recessive rod-cone dystrophy with situs inversus, asthenozoospermia, unilateral renal agenesis and microcysts.

BACKGROUND: This report presents a clinical case of syndromic rod-cone dystrophy due to a splice site variant in the ARL2BP gene causing situs inversus, asthenozoospermia, unilateral renal agenesis and microcysts. The presence of renal agenesis and cryptorchidism expands the clinical manifestations due to ARL2BP variants. The detailed, long-term follow-up contributes valuable insights into disease progression, aiding clinical diagnosis and patient management. CASE PRESENTATION: The male patient complained of photophobia as the first symptom when he was 20 years old followed by nyctalopia, loss of central visual acuity and peripheral visual field ten years later. Genetic analysis identified a likely pathogenic homozygous variant (c.294-1G > C) involving the splicing acceptor site of intron 4. Reported symptoms together with full-field stimulus threshold testing, electroretinogram and advanced multimodal imaging allowed us to recognize the typical characteristics of a mixed retinal dystrophy. Despite the end-stage retinal disease, this patient still retained a useful residual vision at 63 years and had a slow disease progression during the last 5 years of evaluation. DISCUSSION AND CONCLUSIONS: Our findings underscore the variable clinical presentation of ARL2BP variants, emphasizing the importance of a nuanced approach in diagnosing and managing patients. The presence of renal cysts warrants consideration of a differential diagnosis, particularly with Senior-Loken (SLS), Bardet-Biedl (BBS) and Joubert syndromes (JS) but also with Short Rib Thoracic Dysplasia 9, highlighting the need for careful phenotypic evaluation in these cases.

Exploring AI-chatbots' capability to suggest surgical planning in ophthalmology: ChatGPT versus Google Gemini analysis of retinal detachment cases.

BACKGROUND: We aimed to define the capability of three different publicly available large language models, Chat Generative Pretrained Transformer (ChatGPT-3.5), ChatGPT-4 and Google Gemini in analysing retinal detachment cases and suggesting the best possible surgical planning. METHODS: Analysis of 54 retinal detachments records entered into ChatGPT and Gemini's interfaces. After asking 'Specify what kind of surgical planning you would suggest and the eventual intraocular tamponade.' and collecting the given answers, we assessed the level of agreement with the common opinion of three expert vitreoretinal surgeons. Moreover, ChatGPT and Gemini answers were graded 1-5 (from poor to excellent quality), according to the Global Quality Score (GQS). RESULTS: After excluding 4 controversial cases, 50 cases were included. Overall, ChatGPT-3.5, ChatGPT-4 and Google Gemini surgical choices agreed with those of vitreoretinal surgeons in 40/50 (80%), 42/50 (84%) and 35/50 (70%) of cases. Google Gemini was not able to respond in five cases. Contingency analysis showed significant differences between ChatGPT-4 and Gemini (p=0.03). ChatGPT's GQS were 3.9±0.8 and 4.2±0.7 for versions 3.5 and 4, while Gemini scored 3.5±1.1. There was no statistical difference between the two ChatGPTs (p=0.22), while both outperformed Gemini scores (p=0.03 and p=0.002, respectively). The main source of error was endotamponade choice (14% for ChatGPT-3.5 and 4, and 12% for Google Gemini). Only ChatGPT-4 was able to suggest a combined phacovitrectomy approach. CONCLUSION: In conclusion, Google Gemini and ChatGPT evaluated vitreoretinal patients' records in a coherent manner, showing a good level of agreement with expert surgeons. According to the GQS, ChatGPT's recommendations were much more accurate and precise.

Ranibizumab Port Delivery System in Neovascular Age-Related Macular Degeneration: Where Do We Stand? Overview of Pharmacokinetics, Clinical Results, and Future Directions.

The ranibizumab (RBZ) port delivery system (PDS) is a device designed to continuously deliver RBZ in the vitreous chamber for the treatment of neovascular age-related macular degeneration (nAMD). It is implanted during a surgical procedure and can provide sustained release of the medication for several months. This review, updated to January 2024, focuses on past clinical studies as well as current and forthcoming trials looking into a PDS with RBZ. In the phase 2 LADDER trial, the mean time to first refill of a PDS with RBZ 100 mg/mL was 15.8 months, with the pharmacokinetic (PK) profile showing a sustained concentration of RBZ in the blood and aqueous humor. More recently, a PDS with RBZ (100 mg/mL) refilled every 24 weeks was shown to be non-inferior to a monthly intravitreal injection (IVI) with RBZ (0.5 mg) over 40 and 92 weeks in the phase 3 ARCHWAY trial. The refill every 24 weeks allowed for a RBZ vitreous exposure within the concentration range of monthly intravitreal injections (IVIs), and the expected half-life (106 days) was comparable with the in vitro results. Nonetheless, vitreous hemorrhage and endophthalmitis were more common side effects in PDS patients. In conclusion, a PDS continuously delivering RBZ has a clinical effectiveness level comparable with IVI treatment. However, a greater frequency of unfavorable occurrences highlights the need for procedure optimization for a wider adoption. Ongoing trials and possible future approaches need to be addressed.

High-Fluence Epithelium-off Accelerated Pulsed Corneal Cross-linking (15 mW/cm2; 7.2 J/cm2) for Pediatric Keratoconus: A 3-Year Retrospective Analysis.

PURPOSE: To assess the safety and efficacy of treatment and secondarily determine the topographic changes, visual outcomes, and demarcation line depth after high-fluence pulsed light accelerated cross-linking (ACXL) in pediatric patients (younger than 18 years) with progressive keratoconus. METHODS: This retrospective analysis included 32 eyes (25 children, aged 11 to 18 years), with progressive keratoconus treated with high-energy epithelium-off pulsed light ACXL (7.2 J/cm2, 15 mW/cm2, 12 minutes, 2 seconds on/1 second off). Corrected distance visual acuity (CDVA), Scheimpflug tomography, and anterior optical coherence tomography measurements were recorded preoperatively and 1, 2, and 3 years postoperatively. RESULTS: A total of 32 eyes were included. Significant CDVA improvement, pachymetry, and maximum keratometry reduction were found at all follow-up visits. Mean keratometric values remained stable, and astigmatism showed a mild worsening (< 0.25 D) with statistical significance at 1 and 3 years. Total aberration showed discordant results and coma aberration had a slight improvement without statistical significance. The demarcation line depth was 265 ± 26 µm. Three patients developed mild haze without visual acuity loss. None of the patients underwent a second CXL procedure. CONCLUSIONS: In pediatric patients, high-fluence epithelium-off pulsed light ACXL appears to be a safe and effective procedure to halt the progression of keratoconus, slightly improving the CDVA and keratometric values. [J Refract Surg. 2024;40(3):e148-e155.].

Scleral fixation of the Smaller-Incision New-Generation Implantable Miniature Telescope (SING IMT ™) using GoreTex suture.

PURPOSE: In this case report we describe a surgical technique for scleral fixation of the Smaller-Incision New-Generation Implantable Miniature Telescope (SING-IMT). Using this surgical technique, patient's eye which receive surgery for the SING-IMT, could still have a safe SING IMT implant despite the anatomical conditions of the capsular bag or in cases of intraoperative complications. METHODS: The surgery was performed at Policlinico A. Gemelli, Rome, Italy. The patient's eye underwent a first surgery for artificial intraocular lens (IOL) explant and SING-IMT implant at the same time. We observed SING IMT dislocation into the vitreous chamber 90 days after surgery. We therefore carried out a 23-gauge vitrectomy and after SING IMT recovery from the vitreous chamber, we fixed one of its haptic to the sclera using a 8.0 GoreTex suture. CONCLUSION: Scleral fixation of SING-IMT haptics might be useful in eyes with dislocated or not stable SING IMT. We believe that reporting our experience can help surgeons to fix SING IMT in complicated cases where a capsular bag rupture o disinsertion (like our case) can cause SING IMT decentration or worse its drop into the vitreous chamber. We speculate that GoreTex suture could assure firm fixation of the SING IMT and could reduce the risk of recurrent dislocations.

Ocular Involvement in Systemic Sclerosis: Updated Review and New Insights on Microvascular Impairment.

Systemic sclerosis (SSc) is a chronic multisystemic disease characterized by immunological activation, diffuse vasculopathy, and generalized fibrosis exhibiting a variety of symptoms. A recognized precursor of SSc is Raynaud's phenomenon, which is part of the very early disease of systemic sclerosis (VEDOSS) in combination with nailfold videocapillaroscopy (NVC) impairment. The pathophysiology of ocular involvement, alterations in internal organs, and body integumentary system involvement in SSc patients are complicated and poorly understood, with multiple mechanisms presumptively working together. The most prevalent ocular symptoms of SSc are abnormalities of the eyelids and conjunctiva as well as dry eye syndrome, due to fibroblasts' dysfunction and inflammation of the ocular surface. In particular, lagophthalmos, blepharophimosis limitation of eyelid motion, eyelid telangiectasia, and rigidity or tightening of the lids may affect up to two-third of the patients. In addition, reduction in central corneal thickness, iris defects and higher rates of glaucoma were reported. In the first reports based on retinography or fluorescein angiography, about 50% of SSc patients showed signs of vascular disease: peripheral artery occlusion, thinning of retinal pigment epithelium and choroidal capillaries, ischemic areas surrounded by intraretinal extravasation and microaneurysms, and peripheral capillary non-perfusion. Successively, thanks to the advent of optical coherence tomography angiography (OCTA), several studies highlighted significant impairment of either the choriocapillaris and retinal vascular plexuses, also correlating with NVC involvement and skin disease, even in VEDOSS disease. Given the sensitivity of this technique, ocular micro-vasculopathy may act as a tool for early SSc identification and discriminate between disease stages.

Taser-Related Ocular Injuries: A Review of the Literature and Medico-Legal Implications.

PURPOSE: Electric weapons have dangers associated with their use, such as burns and trauma related with the impacts of uncontrolled falls, even though they often minimize morbidity and mortality. The exact visual outcome of the damage inflicted is unknown, even though numerous studies have been documented in the literature about the ocular damage induced by the use of these tools. METHODS: We present a narrative review of types of eye damage associated with the use of the Taser. The following search terms were used to identify eligible articles through the PubMed database: "TASER", "Conducted Electric Weapons", "CEWs". RESULTS: A total of 15 articles were included with information about 38 patients with eye damage associated with the use of taser. The majority of patients were males. In most cases the mechanism of injury was the penetration of the probe inside the eye. Clinical manifestations of ocular damage were present in only 18 out of 38 cases and varied according to the type of damage mechanism. Indeed, the cases in which the probe had penetrated the eye showed more severe clinical manifestations with a poor visual outcome. CONCLUSION: In conclusion, the introduction of taser use for law enforcement requires serious consideration and adequate training for officers.