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AIM: Routine alcohol testing of practicing physicians remains controversial since there are no uniform guidelines or legal regulations in the medical field. Our aim was to quantitatively study the acute and next-morning effects of breath alcohol concentration (BAC)-adjusted alcohol intake on overall simulated surgical performance and microtremor among senior vitreoretinal surgeons. METHODS: This prospective cohort study included 11 vitreoretinal surgeons (>10 years practice). Surgical performance was first assessed using the Eyesi surgical simulator following same-day alcohol consumption producing a BAC reading of 0.06%-0.10% (low-dose), followed by 0.11%-0.15% (high-dose). Dexterity was then evaluated after a 'night out' producing a high-dose BAC combined with a night's sleep. Changes in the total score (0-700, worst-best) and tremor (0-100, best-worst) were measured. RESULTS: Surgeon performance declined after high-dose alcohol compared with low-dose alcohol (-8.60±10.77 vs -1.21±7.71, p=0.04, respectively). The performance during hangover was similar to low-dose alcohol (-1.76±14.47 vs -1.21±7.71, p=1.00, respectively). The performance during hangover tended to be better than after high-dose alcohol (-1.76±14.47 vs -8.60±10.77, p=0.09, respectively). Tremor increased during hangover compared with low-dose alcohol (7.33±21.65 vs -10.31±10.73, p=0.03, respectively). A trend toward greater tremor during hangover occurred compared with high-dose alcohol (7.33±21.65 vs -4.12±17.17, p=0.08, respectively). CONCLUSION: Alcohol-related decline in simulated surgical dexterity among senior vitreoretinal surgeons was dose-dependent. Dexterity improved the following morning but remained comparable to after low-dose alcohol ingestion. Tremor increased during hangover compared with same-day intoxication. Further studies are needed to investigate extrapolations of these data to a real surgical environment regarding patient safety and surgeon performance.
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BACKGROUND: Age-related macular degeneration (AMD) is a leading cause of vision loss. Photobiomodulation (PBM) offers a controversial approach for managing dry AMD, aiming to halt or reverse progression through mitochondrial activity modulation. However, the efficacy and clinical relevance of PBM as a potential approach for managing dry AMD remain debated. METHODS: We systematically searched PubMed, Embase, and Cochrane databases for randomized controlled trials (RCTs) comparing PBM versus a sham in patients with dry AMD. We performed trial sequential analysis (TSA) and minimal clinically important difference (MCID) calculations to assess statistical and clinical significance applying a random-effects model with 95% confidence intervals (CI). RESULTS: We included three RCTs comprising 247 eyes. The pooled analysis showed that PBM significant improved BCVA (MD 1.76 letters; 95% CI: 0.04 to 3.48) and drusen volume (MD -0.12 mm³; 95% CI: -0.22 to -0.02) as compared with a sham control. However, the TSA indicated that the current sample sizes were insufficient for reliable conclusions. No significant differences were observed in GA area. The MCID analysis suggested that the statistically significant results did not translate into clinically significant benefits. In the quality assessment, all studies were deemed to have a high risk of bias. CONCLUSION: This meta-analysis points limitations in the current evidence base for PBM in dry AMD treatment, with issues around small sample sizes. Statistically significant improvements do not translate into clinical benefits. The research underscores need for larger RCTs to validate PBM's therapeutic potential for dry AMD.
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Purpose: To assess ocular pain in patients undergoing multiple intravitreal injections of anti-vascular endothelial growth factor (anti-VEGF) who have previous factors that may influence pain sensitivity. Methodology: This is a prospective, observational, case series study involving patients who underwent multiple (≥3) pro re nata intravitreal injections of ranibizumab or aflibercept to treat any cause of chorioretinal vascular disease. Ocular pain was assessed by the numerical analog scale during intravitreal injection. For this study, the main variable was ocular pain and the secondary variables included age, sex, previous history of glaucoma, primary retinal vascular disease, severe dry eye history, trigeminal pain, scleral buckle surgery, collagen diseases, fibromyalgia, severe migraine history, pars plana vitrectomy, scleral thickness measurements, and type of anti-VEGF. Results: In a total of 894 patients, 948 eyes (4822 intravitreal injections), 793 patients (88.6%) had ocular pain sensitivity between no pain to mild pain, 80 patients (8.9%) had moderate ocular pain, 15 patients (1.6%) had severe ocular pain, and 6 patients (0.7%) had extremely severe ocular pain. Patients with severe dry eye (p = 0.01) and previous history of scleral buckle surgery (p = 0.01) showed a significant correlation with ocular pain during intravitreal injection. Pars plana scleral thickness (>550 um) and diabetic neuropathy were associated with ocular pain but did not meet the criteria for statistical significance (p = 0.09 and p = 0.06, respectively). Conclusion: Dry eye and prior scleral buckle surgery may contribute to pain associated with intravitreal injection. These issues should be taken into consideration in patients undergoing multiple intravitreal injections.
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BACKGROUND: Describe complications and clinical outcomes of heavy silicone oil (HSO) Oxane HD® use as an alternative to overcome the challenges of performing vitrectomy to treat tractional and rhegmatogenous retinal detachments with proliferative vitreoretinopathy (PVR). METHODS: A retrospective, observational study was performed on patients from one center from August 2014 to Aug 2023. It was included patients who underwent surgery using HSO Oxane HD® to treat rhegmatogenous retinal detachment with PVR or mixed tractional and rhegmatogenous diabetic retinal detachment. Severely ill patients who could not attend to follow up were excluded. The primary outcome was successful retinal attachment at first postoperative month. A descriptive analysis was performed. RESULTS: Among the 31 patients, 29 (93.5%) underwent surgeries due to rhegmatogenous retinal detachment and two (6.5%) for diabetic retinal detachment. The primary anatomic success was achieved in 27 (87.1%) patients. At the final visit, 17 (56.6%) had vision better than 20/400 (range, 20/30 to light perception). The vision was stable or improved in 22 (76.8%) patients at the end of follow-up. Nineteen (61.3%) patients required hypotensive eye drops after HSO use and twelve (38.7%) still required hypotensive eye drops at the final follow-up; three (9.7%) patients required additional glaucoma surgeries. CONCLUSIONS: HSO is safe and useful for complex retinal detachments cases specially with inferior tears and PVR. Ocular hypertension is frequent and usually clinically controlled with hypotensive eyedrops. Close postoperatively follow-up is advised due to the ocular complications, particularly elevated intraocular pressure and emulsification.
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Background: Measuring pharmacodynamic biomarkers near the therapeutic site of action presents considerable challenges for sites with limited matrix volume or difficult access. Bioanalytical method qualification requires the use of numerous matrix samples, which is problematic for rare matrices. The aim of this study was to design and implement a streamlined, fit-for-purpose strategy for qualification of biomarker assays in rare matrices. Materials & methods: A multiplexed biomarker immunoassay was developed in human aqueous humor. Results: Our strategy was successfully implemented, providing characterization of assay performance while reducing number of samples in assay qualification. Our assay was used in clinical trial support for an ophthalmic drug candidate. Conclusion: Our results indicate this approach can be applied to other early stage drug development programs facing similar challenges.
Bioanalytical assay development and qualification requires the use of numerous matrix samples, which is problematic for rare matrices. We designed and successfully implemented a streamlined strategy for qualification of biomarker assays in rare matrices.
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Humor Aquoso , Biomarcadores , Humor Aquoso/química , Humor Aquoso/metabolismo , Humanos , Biomarcadores/análise , Biomarcadores/metabolismo , Imunoensaio/métodosRESUMO
PURPOSE: To evaluate novice and senior vitreoretinal surgeons after various exposures. Multiple comparisons ranked the importance of these exposures for surgical dexterity based on experience. METHODS: This prospective cohort study included 15 novice and 11 senior vitreoretinal surgeons (<2 and >10 years' practice, respectively). Eyesi-simulator tasks were performed after each exposure. Day 1, placebo, 2.5 mg/kg caffeine, and 5.0 mg/kg caffeine; day 2, placebo, 0.2 mg/kg propranolol, and 0.6 mg/kg propranolol; day 3, baseline simulation, breathalyzer readings of 0.06% to 0.10% and 0.11% to 0.15% blood alcohol concentrations; day 4, baseline simulation, push-up sets with 50% and 85% repetitions maximum; and day 5, 3-hour sleep deprivation. Eyesi-generated score (0-700, worst-best), out-of-tolerance tremor (0-100, best-worst), task completion time (minutes), and intraocular pathway (in millimeters) were measured. RESULTS: Novice surgeons performed worse after caffeine (-29.53, 95% confidence interval [CI]: -57.80 to -1.27, P = 0.041) and alcohol (-51.33, 95% CI: -80.49 to -22.16, P = 0.001) consumption. Alcohol caused longer intraocular instrument movement pathways (212.84 mm, 95% CI: 34.03-391.65 mm, P = 0.02) and greater tremor (7.72, 95% CI: 0.74-14.70, P = 0.003) among novices. Sleep deprivation negatively affected novice performance time (2.57 minutes, 95% CI: 1.09-4.05 minutes, P = 0.001) and tremor (8.62, 95% CI: 0.80-16.45, P = 0.03); however, their speed increased after propranolol (-1.43 minutes, 95% CI: -2.71 to -0.15 minutes, P = 0.029). Senior surgeons' scores deteriorated only following alcohol consumption (-47.36, 95% CI: -80.37 to -14.36, P = 0.005). CONCLUSION: Alcohol compromised all participants despite their expertise level. Experience negated the effects of caffeine, propranolol, exercise, and sleep deprivation on surgical skills.
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Competência Clínica , Destreza Motora , Oftalmologistas , Cirurgia Vitreorretiniana , Estudos Prospectivos , Estudos de Coortes , Simulação por Computador , Cafeína/efeitos adversos , Privação do Sono , Consumo de Bebidas Alcoólicas/efeitos adversos , Oftalmologistas/estatística & dados numéricos , Cirurgia Vitreorretiniana/estatística & dados numéricos , Destreza Motora/efeitos dos fármacos , Destreza Motora/fisiologia , Exposição Ambiental/efeitos adversos , Propranolol/efeitos adversos , Exercício Físico , Humanos , Masculino , Feminino , Adulto , Pessoa de Meia-IdadeRESUMO
This study aimed to evaluate the image quality assessment (IQA) and quality criteria employed in publicly available datasets for diabetic retinopathy (DR). A literature search strategy was used to identify relevant datasets, and 20 datasets were included in the analysis. Out of these, 12 datasets mentioned performing IQA, but only eight specified the quality criteria used. The reported quality criteria varied widely across datasets, and accessing the information was often challenging. The findings highlight the importance of IQA for AI model development while emphasizing the need for clear and accessible reporting of IQA information. The study suggests that automated quality assessments can be a valid alternative to manual labeling and emphasizes the importance of establishing quality standards based on population characteristics, clinical use, and research purposes. In conclusion, image quality assessment is important for AI model development; however, strict data quality standards must not limit data sharing. Given the importance of IQA for developing, validating, and implementing deep learning (DL) algorithms, it's recommended that this information be reported in a clear, specific, and accessible way whenever possible. Automated quality assessments are a valid alternative to the traditional manual labeling process, and quality standards should be determined according to population characteristics, clinical use, and research purpose.
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Diabetes Mellitus , Retinopatia Diabética , Humanos , Retinopatia Diabética/diagnóstico por imagem , Fundo de Olho , Algoritmos , Aprendizado de Máquina , Confiabilidade dos DadosRESUMO
Purpose: The COVID-19 pandemic affected medical practice worldwide due to interventions to prevent spreading. Its effect on ophthalmology practices in Latin America has not yet been explored. We aimed to assess the perceptions about the pandemic from countries' ophthalmological national and subspecialty retina societies affiliated to the Pan-American Association of Ophthalmology (PAAO). Patients and Methods: A survey-based study of leaders of national ophthalmological and retinal societies was conducted. The survey was sent by email to 30 societies, from which 20 responded (12 countries, 66.6% response rate). It included closed- and open-ended questions about (1) operational capacity and precautions, (2) telemedicine and virtual care, (3) procedures, and (4) post-pandemic considerations. Results: There was a marked decline in ophthalmology patient visits (80-95%) and elective surgeries (90%) during 2020 compared to before the pandemic. Precautions like temperature checks, mask usage, and social distancing were widely implemented while personal protective equipment (PPE) availability varied. Telemedicine use was limited due to lack of experience with it. Reopening plans focused on maintaining precautions and gradually resuming activities. Economic and security concerns were raised, and adherence to guidelines was emphasized. Respondents acknowledged the need to adapt to a "new normal". Long duration drugs, fewer imaging studies, and shorter wait times were preferred; however, availability of long duration drugs was limited. Conclusion: The pandemic impacted ophthalmology in Latin America, with reduced patient visits, procedures, and surgeries. Delayed treatment and complications were likely the result of the pandemic.
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The main drawback for the use of heavy silicone oil (HSO) Oxane HD is the difficulties it presents during removal. It differs from conventional silicone oil removal because it progressively concentrates in the posterior pole during the removal because of its heavier than water density. We describe a technique to facilitate proper HSO Oxane HD removal and minimize residual posterior bubbles and intraoperative complications. We describe our pearls for removing HSO to obtain the optimal results. A concern associated with HSO is the difficulty it presents when it is removed. However, this can be overcome by appropriate modification of surgical techniques during removal to limit intraoperative complications.
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BACKGROUND: To describe the incidence of endophthalmitis and the treatment outcomes of acute bacterial endophthalmitis following intravitreal anti-vascular endothelial growth factor (anti-VEGF) injections in a Brazilian hospital. The analysis was based on the timing of infection after intravitreal injection, culture results, visual acuity, and the presence of epiretinal membrane after a 1-year follow-up period, spanning nine years. METHODS: This retrospective case series, conducted over a 9-year period, aimed to evaluate the treatment outcomes of acute endophthalmitis following intravitreal Bevacizumab injections. The inclusion criteria involved a chart review of 25 patients who presented clinical signs of acute endophthalmitis out of a total of 12,441 injections administered between January 2011 and December 2019. Negative culture results of vitreous samples or incomplete data were excluded. Ultimately, 23 patients were enrolled in the study. Eight patients were treated with intravitreal antibiotic injections (IVAI) using vancomycin 1.0 mg/0.05mL and ceftazidime 2.25 mg/0.05mL, while 15 patients underwent pars plana vitrectomy (PPV) followed by intravitreal antibiotic injections at the end of surgery (IVAIES). The main outcome measures were the efficacy of controlling the infection with IVAI as a standalone therapy compared to early PPV followed by IVAIES. Data collected included pre-infection and one-year post-treatment best corrected visual acuity (BCVA), optical coherence tomography (OCT) abnormalities, and enucleation/evisceration rates. To compare groups, Mann-Whitney and ANOVA tests were employed for statistical analysis. RESULTS: The incidence rate of bacterial endophthalmitis was 0.185% (1/541 anti-VEGF injections), with the highest infection rates observed in 2014 and 2017. Patients presented clinical symptoms between 2 and 7 days after injection. The most common isolated organisms were coagulase-negative Staphylococci and Streptococci spp. Treatment outcomes showed that both IVAI and PPV + IVAIES effectively controlled the infection and prevented globe atrophy. After one year, the PPV group with BCVA better than Light Perception had a significantly better BCVA compared to the IVAI group (p 0.003). However, PPV group had higher incidence of epiretinal membranes formation compared to the IVAI group. (P 0.035) CONCLUSION: Anti-VEGF injections carry a risk of developing acute bacterial endophthalmitis. Isolated antibiotic therapy could be an effective treatment to control the infection, but performing PPV + IVAIES as a primary treatment showed promising results in terms of improving BCVA after one year, despite a higher rate of epiretinal membrane formation. Further studies are needed to confirm these findings.
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PURPOSE: To compare accuracy, precision, and residual volume of commonly used syringes for intravitreal injections (IVIs) and to assess the intraocular pressure (IOP) rise by variations in volumes delivered. DESIGN: Experimental laboratory study. SUBJECTS: No subjects were involved in this study. METHODS: We tested 8 syringe models with 2 different needle setups, with 2 different solutions (distilled water or glycerin) and target volumes (50 and 70 µL). To obtain the delivered and residual volumes, we weighed the syringe-needle setups with scale before liquid withdrawal, with liquid, and after liquid release. We also created an experimental eye model to determine the transient rise in IOP following stepwise 10-µL increases in injection volumes. MAIN OUTCOME MEASURES: Delivered and residual volumes, IOP rise. RESULTS: We tested a total of 600 syringe-needle setups. Becton Dickinson (BD) Ultra-Fine (0.34 ± 0.28 µL), Zero Residual (1.53 ± 1.15 µL), and Zero Residual Silicone Oil-free (1.40 ± 1.16 µL) syringes showed the lowest residual volume (P < 0.001) in comparison with the others (range: 24.86 ± 1.78 µL for Injekt-F to 51.97 ± 3.37 µL for Omnifix-F). The most accurate setups were (percentage deviation from target volume): Zero Residual Silicone Oil-free (+ 0.70%), Zero Residual 0.3 ml (+ 4.49%), BD Ultra-Fine (+ 7.83%), Injekt-F (9.42%), Norm-Ject (+ 15.88%), Omnifix-F (+ 16.96%), BD Plastipak Brazil (+17.96%), and BD Plastipak Spain syringes (+ 19.41%). There was a statistically significant difference between the Zero Residual Silicone Oil-free syringe and all other syringes (P < 0.0001), except for the Zero Residual 0.3-ml syringe (P = 0.029). The coefficient of variation was low for all syringes. The modeled IOP rise ranged from 32.3 (standard deviation [SD], 1.4) mmHg for 20-µL injection volume to 76.5 (SD, 1.0) mmHg for 80-µL injection volume. For the standard 50-µL injection volume, the peak pressure was 50.7 (SD, 0.1) mmHg, and the pressure rise duration was 28 (SD, 2) minutes. CONCLUSIONS: There were significant differences in accuracy and residual volume between syringes, whereas they showed a high precision. Volume excess results in a considerable increase in IOP rise after injection. These findings may provide a relevant overview to clinicians and to both device and drug manufacturers regarding pharmacoeconomic, safety, and efficacy issues. FINANCIAL DISCLOSURE(S): Proprietary or commercial disclosure may be found in the Footnotes and Disclosures at the end of this article.
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Oftalmopatias , Seringas , Humanos , Injeções Intravítreas , Volume Residual , Pressão Intraocular , Óleos de SiliconeRESUMO
The port delivery system with ranibizumab (PDS) is designed to continuously deliver ranibizumab to maintain therapeutic drug concentrations in the vitreous of the eye for an extended duration. The PDS has been evaluated for the treatment of neovascular age-related macular degeneration in the Ladder (PDS 10, 40, and 100 mg/mL, with refill exchanges as needed, versus monthly intravitreal ranibizumab 0.5 mg), Archway (PDS 100 mg/mL with 24-week refill exchanges, versus monthly intravitreal ranibizumab 0.5 mg), and ongoing Portal (PDS 100 mg/mL with 24-week refill exchanges) clinical trials. Data from Ladder, Archway, and Portal were used to develop a population pharmacokinetics (PK) model to estimate the ranibizumab release rate from the PDS implant, describe ranibizumab PK in serum and aqueous humor, and predict the concentration in vitreous humor. A model was developed to adequately describe the serum and aqueous humor PK data, as suggested by goodness-of-fit plots as well as visual predictive checks. In the final model, the first-order implant release rate was estimated to be 0.00654 (1/day), corresponding to a half-life of 106 days, consistent with the implant release rate determined in vitro. The model-predicted vitreous concentrations achieved with PDS 100 mg/mL given every 24 weeks were below the intravitreal peak concentration and above the intravitreal trough concentration of ranibizumab over the entire 24-week refill interval. The results demonstrate a durable release of ranibizumab from the PDS with a half-life of 106 days, providing vitreous exposure to ranibizumab for at least 24 weeks that is within the range of exposure for monthly intravitreal treatment.
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Degeneração Macular , Ranibizumab , Humanos , Ranibizumab/uso terapêutico , Inibidores da Angiogênese/farmacocinética , Inibidores da Angiogênese/uso terapêutico , Anticorpos Monoclonais Humanizados/farmacocinética , Injeções Intravítreas , Degeneração Macular/tratamento farmacológicoRESUMO
PURPOSE: To assess the impact of a 3-hour polysomnography (PSG)-recorded night of sleep deprivation on next-morning simulated microsurgical skills among vitreoretinal (VR) surgeons with different levels of surgical experience and associate the sleep parameters obtained by PSG with Eyesi-generated performance. DESIGN: Self-controlled cohort study. PARTICIPANTS: Eleven junior VR surgery fellows with < 2 years of surgical experience and 11 senior surgeons with > 10 years of surgical practice. METHODS: Surgical performance was assessed at 7am after a 3-hour sleep-deprived night using the Eyesi simulator and compared with each subject's baseline performance. MAIN OUTCOME MEASURES: Changes in Eyesi-generated score (0-700, worst to best), time for task completion (minutes), tremor-specific score (0-100, worst to best), and out-of-tolerance tremor percentage. Polysomnography was recorded during sleep deprivation. RESULTS: Novice surgeons had worse simulated surgical performance after sleep deprivation compared with self-controlled baseline dexterity in the total score (559.1 ± 39.3 vs. 593.8 ± 31.7; P = 0.041), time for task completion (13.59 ± 3.87 minutes vs. 10.96 ± 1.95 minutes; P = 0.027), tremor-specific score (53.8 ± 19.7 vs. 70.0 ± 15.3; P = 0.031), and out-of-tolerance tremor (37.7% ± 11.9% vs. 28.0% ± 9.2%; P = 0.031), whereas no performance differences were detected in those parameters among the senior surgeons before and after sleep deprivation (P ≥ 0.05). Time for task completion increased by 26% (P = 0.048) in the post-sleep deprivation simulation sessions for all participants with a high apnea-hypopnea index (AHI) and by 37% (P = 0.008) among surgeons with fragmented sleep compared with those with normal AHI and < 10 arousals per hour, respectively. Fragmented sleep was the only polysomnographic parameter associated with a worse Eyesi-generated score, with a 10% (P = 0.005) decrease the following morning. CONCLUSIONS: This study detected impaired simulated surgical dexterity among novice surgeons after acute sleep deprivation, whereas senior surgeons maintained their surgical performance, suggesting that the impact of poor sleep quality on surgical skills is offset by increased experience. When considering the 2 study groups together, sleep fragmentation and AHI were associated with jeopardized surgical performance after sleep deprivation. FINANCIAL DISCLOSURE(S): The authors have no proprietary or commercial interest in any materials discussed in this article.
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Cirurgiões , Cirurgia Vitreorretiniana , Humanos , Privação do Sono , Estudos de Coortes , TremorRESUMO
BACKGROUND/OBJECTIVES: Tremor and expertise are potentially influenced variables in vitreoretinal surgery. We investigated whether surgeon experience impacts the association of microsurgical performance with caffeine and ß-blockers weight-adjusted intake. SUBJECTS/METHODS: Novice and senior surgeons (<2 and >10 practice years, respectively) were recruited in this self-controlled, cross-sectional study. A simulator's task sequence was repeated over 2 days, 30 min after the following exposures: day 1, placebo, 2.5 mg/kg caffeine, 5.0 mg/kg caffeine, and 0.6 mg/kg propranolol; and day 2, placebo, 0.2 mg/kg propranolol, 0.6 mg/kg propranolol, and 5.0 mg/kg caffeine. Outcomes were total score (0-700, worst-best), simulation time (minutes), intraocular trajectory (centimeters), and tremor-specific score (0-100, worst-best). RESULTS: We recruited 15 novices (9 men [60%], 1.33 ± 0.49 practice years) and 11 seniors (8 men [72.7%], 16.00 ± 4.24 practice years). Novices performed worse after 2.5 mg/kg caffeine and improved following 0.2 mg/kg propranolol in total score (557 vs. 617, p = 0.009), trajectory (229.86 vs. 208.07, p = 0.048), time (14.9 vs. 12.7, p = 0.048), and tremor-score (55 vs. 75, p = 0.009). Surgical performance improved with propranolol post-caffeine but remained worse than 0.2 mg/kg propranolol in total score (570 vs. 617, p = 0.014), trajectory (226.59 vs. 208.07, p = 0.033), and tremor-score (50 vs. 75, p = 0.029). Seniors' tremor-score was lower after 2.5 mg/kg caffeine compared to 0.2 mg/kg propranolol (8 vs. 37, p = 0.015). Tremor-score following propranolol post-caffeine remained inferior to 0.6 mg/kg propranolol alone (17 vs. 38, p = 0.012). CONCLUSION: While caffeine and propranolol were associated with performance changes among novices, only tremor was affected in seniors, without dexterity changes. The pharmacologic exposure impact on surgical dexterity seems to be offset by increased experience.
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Cafeína , Cirurgiões , Humanos , Masculino , Antagonistas Adrenérgicos beta/farmacologia , Antagonistas Adrenérgicos beta/uso terapêutico , Cafeína/farmacologia , Estudos Transversais , Método Duplo-Cego , Propranolol/farmacologia , Propranolol/uso terapêutico , Retina , Tremor/tratamento farmacológicoRESUMO
PURPOSE: To determine the long-term anatomic outcomes and surgical complications of pars plana vitrectomy (PPV) and 4-point Gore-Tex-sutured Akreos AO60 intraocular lens (IOL) scleral fixation. DESIGN: Retrospective, multicenter, multisurgeon case series. PARTICIPANTS: Ninety-seven patients in tertiary eye care centers. METHODS: The patients underwent PPV and intraocular fixation of the Akreos AO60 IOL using Gore-Tex CV-8 sutures between January 2015 and April 2020. The inclusion criteria were aphakia, no capsular support, and a minimal 1 year of follow-up. MAIN OUTCOME MEASURES: Uncorrected visual acuity (VA), complication rates or types, and refraction. RESULTS: Data from 101 eyes of the 97 patients were analyzed (mean follow-up duration, 33.4 months; range, 12-62 months). The mean ± standard deviation uncorrected logarithm of the minimum angle of resolution VA improved from 1.04 ± 0.73 (20/200 Snellen equivalent) before surgery to 0.66 ± 0.65 (20/80) at 6 months after surgery (P < 0.001). The most prevalent complications included hypotony (12.9%), ocular hypertension (12.9%), corneal edema (8.9%), cystoid macular edema (6.9%), and vitreous hemorrhage (5.9%). Refraction was measured between 3 and 6 months after surgery, and 61.8% of the patients had spherical equivalent of ± 2.0 diopters. Most complications occurred in the first postoperative month and resolved spontaneously or with medical treatment. CONCLUSIONS: The results demonstrated that this surgical technique is well tolerated by the eyes, with a low complication rate in the long term. The rates of IOL opacification were infrequent for up to 62 months of follow-up.
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Implante de Lente Intraocular , Lentes Intraoculares , Humanos , Implante de Lente Intraocular/métodos , Vitrectomia/métodos , Estudos Retrospectivos , PolitetrafluoretilenoRESUMO
PURPOSE: To assess the safety of injecting human embryonic stem cell retinal pigment epithelial cell dose to treat Stargardt disease. METHODS: In this prospective, Phase I clinical trial, human embryonic stem cell retinal pigment epithelial cells in suspension were injected into the subretinal space in eyes with the worse best-corrected visual acuity (BCVA). After vitrectomy/posterior hyaloid removal, a partial retinal detachment was created and the human embryonic stem cell retinal pigment epithelial cells were administered. Phacoemulsification with intraocular lens implantation was performed in eyes with lens opacity. All procedures were optical coherence tomography-guided. The 12-month follow-up included retinal imaging, optical coherence tomography, visual field/electrophysiologic testing, and systemic evaluation. The main outcome was the absence of ocular/systemic inflammation or rejection, tumor formation, or toxicity during follow-up. RESULTS: The mean baseline BCVAs in the phacoemulsification and no phacoemulsification groups were similar (1.950 ± 0.446 and 1.575 ± 0.303, respectively). One year postoperatively, treated eyes showed a nonsignificant increase in BCVA. No adverse effects occurred during follow-up. Intraoperative optical coherence tomography was important for guiding all procedures. CONCLUSION: This surgical procedure was feasible and safe without cellular migration, rejection, inflammation, or development of ocular or systemic tumors during follow-up.