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Journal of Pharmaceutical Health Care... Jan 2024Bevacizumab is a monoclonal antibody against vascular endothelial growth factor. It has a wide range of clinical applications in various cancers and retinal diseases....
OBJECTIVE
Bevacizumab is a monoclonal antibody against vascular endothelial growth factor. It has a wide range of clinical applications in various cancers and retinal diseases. The drugs entered the Chinese market by a large margin in 2017, and the user population changed to some extent. This study reevaluated the safety of bevacizumab through an analysis of the World Pharmacovigilance database (Food and Drug Administration Open Vigil 2.1) in conjunction with a comprehensive meta-analysis of RCTs.
METHODS
Real-world pharmacovigilance data originating from case reports were mined using Open Vigil and coded at the preferred term (PT) level using the Standardized MedDRA Query. Proportional reporting ratios (PRR) and reporting odds ratios (ROR) were used to detect safety signals. Eligible items were screened by searching PubMed, Wanfang, and Web of Science, and data were extracted for systematic review and meta-analysis using RevMan 5.4 software.
RESULTS
Analysis of the drug pharmacovigilance database revealed that the most significant PRRs were limb decortication syndrome (PRR = 2926), stomal varices (PRR = 549), anastomotic (PRR = 457) and ureteral fistula (PRR = 406). Most safety signals at the PT level emerged as various types of injuries, toxicities, operational complications, systemic diseases, various reactions at the administration site, hematological and lymphatic disorders, and gastrointestinal disorders. Adverse reactions such as nasal septal perforation (PRR = 47.502), necrotizing fasciitis (PRR = 20.261), and hypertensive encephalopathy (PRR = 18.288) listed as rare in drug specifications should not be ignored with a high signal in the real world. A total of 8 randomized controlled trials (RCTs) were included in the meta-analysis, and the overall risk of adverse reactions following bevacizumab administration was relatively low, indicating a good safety profile (HR = 1.19, 95% CI:0.85 ~ 1.65, p = 0.32).
CONCLUSION
The frequent adverse reactions of bevacizumab occurring in the real world are consistent with the data provided in RCTs and drug specifications. However, adverse reactions such as nasal septum perforation, necrotizing fasciitis, hypertensive encephalopathy and so on, listed as rare in drug specifications, may have a high signal of correlation in the real world, which all requires active monitoring and timely adjustment of bevacizumab posology during its clinical use.
PubMed: 38167326
DOI: 10.1186/s40780-023-00314-w -
Photodiagnosis and Photodynamic Therapy Feb 2024Full-thickness macular hole (FTMH) is a debilitating retinal disorder, particularly in its advanced forms, necessitating surgical intervention for vision restoration....
Full-thickness macular hole (FTMH) is a debilitating retinal disorder, particularly in its advanced forms, necessitating surgical intervention for vision restoration. This case report details the successful closure of a large FTMH using the inverted flap technique, highlighting the essential role of multimodal imaging, and particularly macular pigment optical density (MPOD) assessment, in preoperative and postoperative evaluation. A 55-year-old patient presented with severe vision loss in one eye due to a large FTMH. Surgery was performed by an expert vitreoretinal surgeon, resulting in significant postoperative improvements in visual acuity and retinal architecture. Multimodal imaging, including MPOD assessment, played a pivotal role in preoperative evaluation and postoperative monitoring. The notable increase in MPOD following successful surgery suggests its potential role as a valuable adjunctive biomarker associated with a good visual prognosis following this type of macular hole surgical interventions.
Topics: Humans; Middle Aged; Retinal Perforations; Macular Pigment; Photochemotherapy; Photosensitizing Agents; Retinal Diseases
PubMed: 38145775
DOI: 10.1016/j.pdpdt.2023.103950 -
International Journal of Molecular... Dec 2023Müller cells play a critical role in the closure of macular holes, and their proliferation and migration are facilitated by the internal limiting membrane (ILM)....
MicroRNA-152-3p and MicroRNA-196a-5p Are Downregulated When Müller Cells Are Promoted by Components of the Internal Limiting Membrane: Implications for Macular Hole Healing.
Müller cells play a critical role in the closure of macular holes, and their proliferation and migration are facilitated by the internal limiting membrane (ILM). Despite the importance of this process, the underlying molecular mechanism remains underexplored. This study investigated the effects of ILM components on the microRNA (miRNA) profile of Müller cells. Rat Müller cells (rMC-1) were cultured with a culture insert and varying concentrations of ILM component coatings, namely, collagen IV, laminin, and fibronectin, and cell migration was assessed by measuring cell-free areas in successive photographs following insert removal. MiRNAs were then extracted from these cells and analyzed. Mimics and inhibitors of miRNA candidates were transfected into Müller cells, and a cell migration assay and additional cell viability assays were performed. The results revealed that the ILM components promoted Müller cell migration ( < 0.01). Among the miRNA candidates, miR-194-3p was upregulated, whereas miR-125b-1-3p, miR-132-3p, miR-146b-5p, miR-152-3p, miR-196a-5p, miR-542-5p, miR-871-3p, miR-1839-5p, and miR-3573-3p were significantly downregulated ( < 0.05; fold change > 1.5). Moreover, miR-152-3p and miR-196a-5p reduced cell migration ( < 0.05) and proliferation ( < 0.001), and their suppressive effects were reversed by their respective inhibitors. In conclusion, miRNAs were regulated in ILM component-activated Müller cells, with miR-152-3p and miR-196a-5p regulating Müller cell migration and proliferation. These results serve as a basis for understanding the molecular healing process of macular holes and identifying potential new target genes in future research.
Topics: Animals; Rats; Collagen Type IV; Ependymoglial Cells; Membranes; MicroRNAs; Retinal Perforations
PubMed: 38139016
DOI: 10.3390/ijms242417188 -
Indian Journal of Ophthalmology Jan 2024
Topics: Humans; Retinal Perforations; Tomography, Optical Coherence; Vitrectomy
PubMed: 38131588
DOI: 10.4103/IJO.IJO_1763_23 -
Indian Journal of Ophthalmology Jan 2024To analyze the surgical outcomes of petalloid multilayered inverted internal limiting flap using perfluorocarbon liquid (PFCL) in extra-large macular holes (MHs)...
PURPOSE
To analyze the surgical outcomes of petalloid multilayered inverted internal limiting flap using perfluorocarbon liquid (PFCL) in extra-large macular holes (MHs) (minimum linear diameter >550 µm and basal diameter [BD] >1000 µm).
METHODS
This was a prospective interventional series of 103 eyes of 99 patients with extra-large MHs which were treated with 25-gauge pars plana vitrectomy, petalloid multilayered inverted internal limiting membrane flaps under PFCL and 15% perfluoropropane (C3F8) gas tamponade. Intraoperative optical coherence tomography (i-OCT) was used to confirm correct positioning of flaps. Follow-up was at 1 week, 1 month, and 3 months postoperatively.
RESULTS
Mean age of patients was 58.282 ± 16.3 years. Mean preoperative best corrected visual acuity (BCVA) was logarithm of minimum angle of resolution (logMAR) 1.206 ± 0.384, and the value at the third month was logMAR 0.793 ± 0.337. Mean minimum linear diameter (MLD) was 711.96 ± 270.744 µm. MLD ranged from 557µm (minimum MLD) to 2657 µm (maximum MLD). Mean BD was 1301.165 ± 425.914 µm. Type 1 closure was seen in 92.2% eyes, 5.8% eyes had type 2 closure, and 1.9% eyes had type 3 closure. Eyes with both type 1 closure (P = 0.001) and type 2 closure (P = 0.009) showed a significant improvement in BCVA postoperatively at 3 months.
CONCLUSION
Petalloid multilayered inverted internal limiting membrane flap under PFCL technique with adjunctive use of i-OCT showed improved morphological and functional outcomes in the treatment of extra-large MHs. We present here a large series of extra-large MHs, in which a novel technique of petalloid multilayered inverted ILM flaps was used.
Topics: Humans; Adult; Middle Aged; Aged; Retinal Perforations; Prospective Studies; Basement Membrane; Visual Acuity; Retrospective Studies; Vitrectomy; Tomography, Optical Coherence; Treatment Outcome
PubMed: 38131559
DOI: 10.4103/IJO.IJO_761_23 -
Indian Journal of Ophthalmology Jan 2024To examine the retinal displacement and change in mean superficial foveal avascular zone (FAZ) after successful closure of macular hole (MH) with vitrectomy with...
PURPOSE
To examine the retinal displacement and change in mean superficial foveal avascular zone (FAZ) after successful closure of macular hole (MH) with vitrectomy with internal limiting membrane peeling (ILM) and gas tamponade.
METHODS
A total of 45 patients with idiopathic MH who underwent 23G pars plana vitrectomy with ILM peeling and tamponade with 20% SF6/14% C3F8 were included. Follow-up visits were performed at 2, 4, and 8 weeks. OCT and OCT-A scans were performed along with detailed ocular examination. Distance between optic disc and an easily identifiable vascular bifurcation nasal and temporal to fovea, FAZ, was noted. Chi-square test (categorical data) and Mann-Whitney U test and t tests for other parameters were performed for statistical analysis.
RESULTS
The mean displacement (µm) of an easily identifiable vascular bifurcation in the nasal quadrant was 96.58 ± 36.55 at 8 weeks and in the temporal quadrant was 273.07 ± 85.51 at 8 weeks. The change was statistically significant in the temporal quadrant (P = <0.001). The mean BCVA changed from a minimum of 0.08 at the preoperative timepoint to a maximum of 0.23 at 8 weeks (P = <0.001). The mean FAZ area (mm²) decreased from a maximum of 0.37 at the preoperative timepoint to a minimum of 0.19 at 8 weeks (p = <0.001).
CONCLUSION
The retina in the temporal quadrant is displaced significantly more than nasal quadrant after successful closure of macular hole. The mean superficial FAZ also decreases suggesting a centripetal movement of the foveal tissue postoperatively.
Topics: Humans; Retinal Perforations; Cross-Sectional Studies; Tomography, Optical Coherence; Retina; Retinal Diseases; Vitrectomy; Basement Membrane; Retrospective Studies
PubMed: 38131556
DOI: 10.4103/IJO.IJO_2707_22 -
Indian Journal of Ophthalmology Jan 2024To evaluate the retinal microvascular differences after successful macular hole surgery by using the superior and temporal inverted flap technique.
PURPOSE
To evaluate the retinal microvascular differences after successful macular hole surgery by using the superior and temporal inverted flap technique.
METHODS
In this retrospective study, patients with idiopathic macular holes with a horizontal diameter of 250-400 μm at the narrowest point, and who have a follow-up of 6 months were included in the study. Group 1 included 14 patients' 14 eyes that have been treated using the superior inverted flap technique. Group 2 included 15 patients' 15 eyes that have been treated using the temporal inverted flap technique. The vessel density (VD) ratios in the superficial capillary plexus (SCP) and the deep capillary plexus (DCP) at the central area and the four parafoveal quadrants were compared between the groups at baseline and postoperative month 6.
RESULTS
The mean baseline BCVA improved significantly in both groups at postoperative month 6 (1.21 to 0.50 and 1.32 to 0.52 logMAR, respectively; P < 0.05). There was no significant difference in mean BCVA between the two groups at postoperative month 6 (P < 0.05). The mean VD in SCP in the center area increased significantly in both groups at month 6 postoperatively (P = 0.011 and 0.020, respectively); however, the mean VD in DCP in the center area did not significantly change in both groups (P = 0.079 and 0.078, respectively). The mean VD ratios in SCP and DCP at the four parafoveal quadrants did not change significantly in both groups at month 6 (P < 0.05 for both).
CONCLUSIONS
Both techniques are safe for retinal microvasculature at postoperative month 6.
Topics: Humans; Retinal Perforations; Retrospective Studies; Retinal Vessels; Fluorescein Angiography; Retina
PubMed: 38131547
DOI: 10.4103/IJO.IJO_1678_23 -
Indian Journal of Ophthalmology Jan 2024To analyze the outcomes following conventional internal limiting membrane (ILM) peeling versus perfluoro octane-assisted inverted flap technique for large macular holes... (Comparative Study)
Comparative Study Randomized Controlled Trial
Closure rate and recovery of subfoveal microstructures following conventional internal limiting membrane peeling versus per fluoro octane-assisted inverted flap for large macular holes - A randomized controlled trial (InFlap Study).
PURPOSE
To analyze the outcomes following conventional internal limiting membrane (ILM) peeling versus perfluoro octane-assisted inverted flap technique for large macular holes (MH).
METHODS
A consecutive 99 eyes of 99 patients were enrolled {45 - conventional group and 54 - inverted flap (InFlap) group}. The primary outcome was a difference in closure rate. Secondary outcomes were differences in best-corrected visual acuity (BCVA), restoration of external limiting membrane (ELM) and ellipsoid zone (EZ) between groups at 3 (primary endpoint), 6 and 12 (secondary endpoints) months. Additionally, the effect of different gas tamponades on closure rates, ILM flap disintegration in InFlap group, and subfoveal thickness (SFT) between groups in closed.
RESULTS
At 3 months, there was no difference in the closure rate and BCVA between groups. At six months, closure rate was significantly better in the InFlap group. However, this difference was not maintained at 12 months. There was no difference in BCVA between groups at any visit. The ELM recovery was significantly higher in the conventional group at three months; however, there was no difference in ELM/EZ recovery between groups at other visits. The closure rate in the InFlap group was the same irrespective of gas tamponade. The ILM flap was identifiable in one-third of patients at 12 months. In closed MH, SFT was significantly more in InFlap group.
CONCLUSION
The closure rate and visual outcomes remained similar in both groups in the immediate and long term. Conventional ILM peeling technique seems to have early ELM recovery when compared to inverted flap technique.
Topics: Humans; Basement Membrane; Octanes; Retinal Perforations; Retrospective Studies; Tomography, Optical Coherence; Visual Acuity; Vitrectomy
PubMed: 38131546
DOI: 10.4103/IJO.IJO_484_23 -
Indian Journal of Ophthalmology Jan 2024Clinically, hemorrhages at the vitreoretinal interface have been termed as 'pre-retinal' in location. However, there is a careful distinction to be made between...
Clinically, hemorrhages at the vitreoretinal interface have been termed as 'pre-retinal' in location. However, there is a careful distinction to be made between sub-hyaloid and sub-internal limiting membrane (ILM) planes of blood collection. In the past half-century, a body of literature has accrued on sub-internal limiting membrane hemorrhage. We characterize the etiopathological, clinical, anatomical, and imaging characteristics of this entity (often misconstrued as sub-hyaloid hemorrhage). Management decisions are briefly described, and a unifying term of sub-internal limiting membrane macular hemorrhage is proposed to aid in further research.
Topics: Humans; Retinal Hemorrhage; Vitrectomy; Retina; Basement Membrane; Visual Acuity; Epiretinal Membrane; Retinal Perforations
PubMed: 38131534
DOI: 10.4103/IJO.IJO_266_23 -
BMC Ophthalmology Dec 2023To assess the safety and effectiveness of the exclusive use of 27-gauge instruments for all vitreoretinal diseases requiring vitrectomy.
BACKGROUND
To assess the safety and effectiveness of the exclusive use of 27-gauge instruments for all vitreoretinal diseases requiring vitrectomy.
METHODS
In this retrospective study, 1020 consecutive surgeries were performed on 958 eyes of 848 patients using 27-gauge instruments from March 2017 to June 2021. Patients with a minimum follow-up of 3 months were included. Surgical case-mix, best-corrected visual acuity (BCVA), intraocular pressure (IOP), intra- and post-operative complications, and surgery times were recorded.
RESULTS
The study patients were followed up for averagely 11 months. Of the 1020 vitrectomies, 958 were primary procedures. Of the 148 retinal detachment (RD) cases, 138 (93%) required a single vitrectomy. Primary macular hole closure was achieved in 143 of 145 (99%) cases. The average surgical times were 55 and 38 min for RD surgeries and for all other indications, respectively. BCVA improved significantly at the final visit (20/49) compared with the pre-operative visit (20/78) (p < 0.01). IOP was similar at the pre-operative (14.8mmHg) and final (14.3mmHg) visits. Complications recorded include transient hypotony in 39 eyes, iatrogenic retinal breaks in 2 eyes, and a vitreous bleed in 1 other eye.
CONCLUSION
This study revealed that 27-gauge vitrectomy instruments can be used for a wide range of indications, with exclusive use in certain settings. The outcomes were similar to other gauges, including for rhegmatogenous retinal detachment, with minimal complications.
Topics: Humans; Retinal Detachment; Vitrectomy; Retrospective Studies; Visual Acuity; Retinal Perforations; Eye Diseases; Treatment Outcome; Follow-Up Studies
PubMed: 38129776
DOI: 10.1186/s12886-023-03265-w