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Importance: Fluoroquinolone use has been associated with increased risk of uveitis and retinal detachment in noninterventional studies, but the findings have been conflicting and causality is unclear. Objective: To estimate the association of systemic fluoroquinolone use with acute uveitis or retinal detachment, using multiple analyses and multiple databases to increase the robustness of results. Design, Setting, and Participants: This cohort study used data from the Clinical Practice Research Datalink Aurum and GOLD UK primary care records databases, which were linked to hospital admissions data. Adults prescribed a fluoroquinolone or a comparator antibiotic, cephalosporin, between April 1997 and December 2019 were included. Adults with uveitis or retinal detachment were analyzed in a separate self-controlled case series. Data analysis was performed from May 2022 to May 2023. Exposures: Systemic fluoroquinolone or comparator antibiotic. Main Outcomes and Measures: The primary outcome was a diagnosis of acute uveitis or retinal detachment. Hazard ratios (HRs) were estimated in the cohort study for the association of fluoroquinolone prescription with either uveitis or retinal detachment, using stabilized inverse probability of treatment weighted Cox regression. Rate ratios (RRs) were estimated in the self-controlled case series, using conditional Poisson regression. Estimates were pooled across databases using fixed-effects meta-analysis. Results: In total, 3â¯001â¯256 individuals in Aurum (1â¯893â¯561 women [63.1%]; median [IQR] age, 51 [35-68] years) and 434â¯754 in GOLD (276â¯259 women [63.5%]; median [IQR] age, 53 [37-70] years) were included in the cohort study. For uveitis, the pooled adjusted HRs (aHRs) for use of fluoroquinolone vs cephalosporin were 0.91 (95% CI, 0.72-1.14) at first treatment episode and 1.07 (95% CI, 0.92-1.25) over all treatment episodes. For retinal detachment, the pooled aHRs were 1.37 (95% CI, 0.80-2.36) at first treatment episode and 1.18 (95% CI, 0.84-1.65) over all treatment episodes. In the self-controlled case series, for uveitis, the pooled adjusted RRs (aRRs) for fluoroquinolone use vs nonuse were 1.13 (95% CI, 0.97-1.31) for 1 to 29 days of exposure, 1.16 (95% CI, 1.00-1.34) for 30 to 59 days, and 0.98 (95% CI, 0.74-1.31) for 60 days for longer. For retinal detachment, pooled aRRs for fluoroquinolone use vs nonuse were 1.15 (95% CI, 0.86-1.54) for 1 to 29 days of exposure, 0.94 (95% CI, 0.69-1.30) for 30 to 59 days, and 1.03 (95% CI, 0.59-1.78) for 60 days or longer. Conclusions and Relevance: These findings do not support an association of systemic fluoroquinolone use with substantively increased risk of uveitis or retinal detachment. Although an association cannot be completely ruled out, these findings indicate that any absolute increase in risk would be small and, hence, of limited clinical importance.
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Antibacterianos , Fluoroquinolonas , Desprendimiento de Retina , Uveítis , Humanos , Fluoroquinolonas/efectos adversos , Desprendimiento de Retina/inducido químicamente , Desprendimiento de Retina/diagnóstico , Desprendimiento de Retina/epidemiología , Femenino , Masculino , Persona de Mediana Edad , Uveítis/inducido químicamente , Uveítis/tratamiento farmacológico , Uveítis/diagnóstico , Antibacterianos/efectos adversos , Adulto , Factores de Riesgo , Anciano , Estudios Retrospectivos , Reino Unido/epidemiología , Bases de Datos Factuales , IncidenciaRESUMEN
BACKGROUND: Idiopathic full-thickness macular hole (iFTMH) closure rates following conventional vitrectomy, gas tamponade and internal limiting membrane (ILM) peeling decrease when the minimum linear diameter (MLD) ≥ 500 microns. ILM flap creation has been proposed to improve closure in larger holes. This study evaluated the anatomical and functional impact of ILM flap introduction to routine practice in iFTMH ≥500 microns. METHODS: Retrospective, interventional analysis of prospectively collected data of 191 eyes from consecutive surgeries for primary iFTMH ≥500 microns performed by two surgeons between June 2018 and June 2022, during which both surgeons replaced ILM peeling with ILM flap creation. Post-operative best-corrected visual acuity (BCVA) and anatomical closure were compared between Group 1 (ILM peel) and Group 2 (ILM flap) in an intention-to-treat analysis. RESULTS: Rates of iFTMH closure were greater in the ILM flap group (77/80; 96.3%) than the ILM peel group (94/110; 85.5%) (OR = 4.37, 95% CI = 1.23-15.55, p = 0.023). A non-significant increase in post-operative BCVA improvement was observed in the ILM flap group (p = 0.084). There was no statistically significant difference in final BCVA (p = 0.83). Multivariate logistic regression found only MLD (OR = 0.993, 95% CI = 0.989-0.997, p = 0.001) and ILM flap group (OR = 5.795, 95% CI = 1.313-25.570, p = 0.020) predicted primary closure. CONCLUSION: ILM flap creation improves closure rates in larger holes and should be considered routinely in iFTMH ≥500 microns. Whether ILM flaps affect post-operative visual function remains uncertain.
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Membrana Basal , Endotaponamiento , Perforaciones de la Retina , Colgajos Quirúrgicos , Tomografía de Coherencia Óptica , Agudeza Visual , Vitrectomía , Humanos , Perforaciones de la Retina/cirugía , Perforaciones de la Retina/fisiopatología , Agudeza Visual/fisiología , Estudios Retrospectivos , Femenino , Masculino , Membrana Basal/cirugía , Vitrectomía/métodos , Anciano , Endotaponamiento/métodos , Persona de Mediana Edad , Resultado del Tratamiento , Membrana Epirretinal/cirugía , Membrana Epirretinal/fisiopatologíaRESUMEN
PURPOSE: To establish whether Densiron 68, a heavier-than-water endotamponade agent, is an effective alternative to conventional light silicone oil in primary rhegmatogenous retinal detachment (RD) surgery for eyes with inferior breaks in the detached retina and severe proliferative vitreoretinopathy (PVR). DESIGN: Cohort study of routinely collected data from the European Society of Retina Specialists and British and Eire Association of Vitreoretinal Surgeons vitreoretinal database between 2015 and 2022. PARTICIPANTS: All consecutive eyes that underwent primary rhegmatogenous RD surgery using Densiron 68 or light silicone oil as an internal tamponade agent. METHODS: To minimize confounding bias, we undertook 2:1 nearest-neighbor matching on inferior breaks, large inferior rhegmatogenous RDs, PVR, and, for visual analyses, baseline visual acuity (VA) between treatment groups. We fit regression models including prognostically relevant covariates, treatment-covariate interactions, and matching weights. We used g-computation with cluster-robust methods to estimate marginal effects. For nonlinear models, we calculated confidence intervals (CIs) using bias-corrected cluster bootstrapping with 9999 replications. MAIN OUTCOME MEASURES: Presence of a fully attached retina and VA at least 2 months after oil removal. RESULTS: Of 1061 eyes enrolled, 426 and 239 were included in our matched samples for anatomic and visual outcome analyses, respectively. The primary success rate was higher in the Densiron 68 group (113 of 142; 80%) compared with the light silicone oil group (180 of 284; 63%), with an adjusted odds ratio of 1.90 (95% CI, 1.63-2.23, P < 0.001). We also observed a significant improvement favoring Densiron 68 of -0.26 logarithm of the minimum angle of resolution (logMAR) in postoperative VA between the 2 groups (95% CI, -0.43 to -0.10, P = 0.002). The anatomic benefit of using Densiron 68 in eyes with inferior retinal breaks and large detachments was more pronounced among eyes with PVR grade C. We found no evidence of visual effect moderation by anatomic outcome or foveal attachment. CONCLUSIONS: Densiron achieved higher anatomic success rates and improved visual outcomes compared with conventional light silicone oil in eyes with inferior retinal pathology and severe PVR. 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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Endotaponamiento , Desprendimiento de Retina , Aceites de Silicona , Agudeza Visual , Vitrectomía , Humanos , Desprendimiento de Retina/cirugía , Desprendimiento de Retina/fisiopatología , Aceites de Silicona/administración & dosificación , Agudeza Visual/fisiología , Femenino , Masculino , Persona de Mediana Edad , Vitrectomía/métodos , Anciano , Estudios Retrospectivos , Resultado del Tratamiento , Vitreorretinopatía Proliferativa/cirugía , Vitreorretinopatía Proliferativa/fisiopatología , Estudios de Cohortes , Estudios de SeguimientoRESUMEN
INTRODUCTION: To identify variables associated with primary anatomical outcome following vitrectomy and internal tamponade for rhegmatogenous retinal detachment (RD). METHODS: A retrospective analysis of prospectively collected data, using a database of RD treated with vitrectomy and internal tamponade. Collected data complied with the RCOphth Retinal Detachment Dataset. The main outcome measure was anatomical failure within six months of surgery. RESULTS: There were 6377 vitrectomies. 869 eyes were excluded, either because no outcome was recorded, or inadequate follow up, leaving 5508 operations for analysis. 63.9% of patients were male, and the median age was 62. Primary anatomical failure occurred in 13.9%. On multivariate analysis, the following were associated with increased risk of failure: age <45, or >79, inferior retinal breaks, total detachment, one quadrant or greater inferior detachment, low density silicone oil, and presence of proliferative vitreoretinopathy. C2F6 tamponade, cryotherapy, and 25 G vitrectomy, were associated with reduced risk of failure. The area under the receiver operator curve was 71.7%. According to this model, 54.3% of RD are at low risk (<10%), 35.6% are at moderate risk (10-25%), and 10.1% are at high risk (>25%) of failure. CONCLUSIONS: Previous attempts to identify high risk RD have been limited by small numbers, the inclusion of both scleral buckling and vitrectomy, or by excluding some types of RD. This study examined outcomes in unselected RD, treated by vitrectomy. Identification of the variables associated with anatomical outcome after RD surgery enables accurate risk stratification, which is valuable for patient counselling and selection, and for future clinical trials.
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Desprendimiento de Retina , Humanos , Masculino , Persona de Mediana Edad , Femenino , Desprendimiento de Retina/etiología , Vitrectomía/efectos adversos , Estudios de Cohortes , Estudios Retrospectivos , Curvatura de la Esclerótica/efectos adversos , Aceites de Silicona , Reino Unido/epidemiología , Resultado del TratamientoRESUMEN
BACKGROUND: To assess the effect of sex and laterality on clinical features of primary rhegmatogenous retinal detachment (RRD). METHOD: This study is a retrospective analysis of data prospectively collected. We extracted data from two online datasets over a 7-year period of patients older than 16 years who had undergone surgery for primary RRD. Data on baseline characteristics were analyzed to compare males versus females, and right versus left eyes. RESULTS: Of 8133 eyes analyzed, 4342 (53.4%) were right. The overall male predominance (63.7%) was more marked in the age range 50-69 years. Men were more commonly pseudophakic and presented more frequently with baseline posterior vitreous detachment (PVD). Female sex was significantly associated with baseline myopia, retinal holes as causative retinal break, and isolated inferior RD. Men had more frequent foveal involvement, greater RRD extent, greater numbers and larger sized retinal tears including dialysis and giant retinal tears. Regarding laterality, foveal involvement, larger retinal breaks, isolated temporal RD and temporal retinal breaks were more common in right eyes, whereas left eyes were more myopic at baseline and presented more frequently with isolated nasal RD and nasal retinal breaks. CONCLUSIONS: This study confirmed the predominance of male sex and right laterality in RRD. Sex and laterality were associated with multiple presenting features of RRD including extent, break distribution, number, size and type, as well as RD distribution.
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Miopía , Desprendimiento de Retina , Perforaciones de la Retina , Humanos , Masculino , Femenino , Persona de Mediana Edad , Anciano , Desprendimiento de Retina/cirugía , Desprendimiento de Retina/etiología , Perforaciones de la Retina/cirugía , Estudios Retrospectivos , Miopía/cirugía , Vitrectomía/efectos adversos , Fóvea Central , FenotipoRESUMEN
PURPOSE: To develop and evaluate an automated deep learning model to predict the anatomical outcome of rhegmatogenous retinal detachment (RRD) surgery. METHODS: Six thousand six hundred and sixty-one digital images of RRD treated by vitrectomy and internal tamponade were collected from the British and Eire Association of Vitreoretinal Surgeons database. Each image was classified as a primary surgical success or a primary surgical failure. The synthetic minority over-sampling technique was used to address class imbalance. We adopted the state-of-the-art deep convolutional neural network architecture Inception v3 to train, validate, and test deep learning models to predict the anatomical outcome of RRD surgery. The area under the curve (AUC), sensitivity, and specificity for predicting the outcome of RRD surgery was calculated for the best predictive deep learning model. RESULTS: The deep learning model was able to predict the anatomical outcome of RRD surgery with an AUC of 0.94, with a corresponding sensitivity of 73.3% and a specificity of 96%. CONCLUSION: A deep learning model is capable of accurately predicting the anatomical outcome of RRD surgery. This fully automated model has potential application in surgical care of patients with RRD.
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Aprendizaje Profundo , Desprendimiento de Retina , Humanos , Desprendimiento de Retina/diagnóstico , Desprendimiento de Retina/cirugía , Proyectos Piloto , Inteligencia Artificial , Agudeza Visual , Estudios Retrospectivos , Vitrectomía/métodos , Resultado del TratamientoRESUMEN
BACKGROUND: The Scottish RD Survey reported an incidence of 12.05/100,000/yr in 2009. Data published from Denmark recently confirmed a 50% increase in RD presentations over the last 16 years. We set out to repeat the Scottish RD survey to determine if a similar trend has been observed in Scotland. METHODS: All 16 Scottish VR surgeons, who make up the collaboration of Scottish VR Surgeons (SCVRs) were asked to prospectively record all primary RDs presenting from 12th August 2019 to 11th August 2020. For consistency, the case definitions were the same as for the 2009 Scottish RD Survey. Basic demographic and clinical features were recorded. Age specific incidence was calculated from mid-year population estimates for 2019 obtained from the National Records of Scotland. RESULTS: There were 875 RRDs recorded, which gives an updated incidence of 16.02/100,000/year in Scotland. 62.8% occurred in males and the greatest increases were seen in males aged 50-59 (p = 0.0094), 60-69 (p = 0.0395) and females aged 40-49 (p = 0.0312) and 50-59 (p = 0.0024). The proportion of pseudophakic RRDs in this study is 29.4% (253/860). Compared to the 21.6% in the 2010 study, this represents a 28% increase (χ2 = 11.03, p = 0.0009). The proportion of macula-off RRDs remained generally stable at 58%. CONCLUSION: Our study confirms that RRD is becoming more common in the UK, reflecting almost identical findings from Denmark. This trend is in part due to increasing myopia, increasing pseudophakia, and possibly other factors. This should be considered when planning VR services and allocating resources in the future.
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Miopía , Desprendimiento de Retina , Masculino , Femenino , Humanos , Desprendimiento de Retina/cirugía , Incidencia , Seudofaquia , Miopía/epidemiología , Escocia/epidemiologíaRESUMEN
BACKGROUND: To evaluate the influence of age on the clinical characteristics of primary rhegmatogenous retinal detachments (RRD). METHODS: We conducted a retrospective review of a prospectively collected dataset. Data regarding adult patients (aged 16-100 years) who had undergone primary RRD repair, were extracted from two online databases. Baseline demographics, preoperative clinical characteristics and surgical management details were collected. Age-based groups (16-30, 30-39, 40-49, 50-59, 60-69, 70-79, ≥80) were compared using univariate analysis, with multivariate testing for interaction of age with sex, laterality and pseudophakia. RESULTS: In total, 8,133 eyes were analysed, of which the majority (59%) were in the 50-69 age-range peaking at 60, with a male predominance (64%). Myopia was significantly more frequent in patients aged <50 years. The presence of posterior vitreous detachment increased up to 50 years, then remained >95%. Foveal involvement, grade C proliferative vitreoretinopathy, total RD and greater RD extent were more common and progressively increased after 60 years, with worsening visual acuity. Isolated superior RRDs became more prevalent with age reaching a plateau in the age-range 50-69, before reducing again; conversely, isolated inferior RRDs were commoner in those <30, with a minimum in the 70-79 age-range. The incidence of fellow-eye RRD decreased linearly with age. CONCLUSIONS: Age appeared a key variable in RRD phenotype influencing a wide range of RRD characteristics. The higher incidence of myopia, PVD absent and bilateral RRD in patients <40 years and the significant phenotypical differences in the under 40 and over 50 age-groups highlight that there are several discrete forms of RRD.
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Miopía , Desprendimiento de Retina , Masculino , Femenino , Humanos , Desprendimiento de Retina/epidemiología , Desprendimiento de Retina/cirugía , Desprendimiento de Retina/etiología , Ojo , Miopía/cirugía , Agudeza Visual , Seudofaquia/cirugía , Estudios Retrospectivos , Vitrectomía/efectos adversosRESUMEN
PURPOSE: To investigate changes in subjective and objective distortion in the first 6 months after macula-involving retinal detachment repair. METHODS: Post hoc analysis of the PostRD trial: a prospective, multicentered randomized controlled trial. Two hundred and sixty-two patients with macula-involving retinal detachments undergoing repair with vitrectomy and gas tamponade were asked to complete a distortion questionnaire and objective distortion assessment (D chart) 2 and 6 months postoperatively. Visual acuity, retinal displacement (measured with fundus autofluorescence imaging), and quality of life were also recorded. RESULTS: Two months postoperatively 75.5% of patients reported subjective distortion, and this fell to 61.1% at 6 months. Over that period, distortion persisted in 56.5% of patients, resolved in 19.2%, and developed in 5.6%. Approximately one in four had resolution of their distortion by 6 months. The median overall and weighted D chart distortion scores fell between 2 and 6 months but 29% of patients had a worsening of D chart distortion score. D chart distortion scores were more closely correlated with amplitude of postoperative retinal displacement and quality-of-life scores in comparison with subjective distortion. CONCLUSION: Subjective distortion and objective distortion are common after macula-involving retinal detachment, but can improve over time. Objective measures of distortion were more closely correlated with quality of life and retinal displacement in comparison with subjective distortion.
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Mácula Lútea , Desprendimiento de Retina , Humanos , Vitrectomía , Desprendimiento de Retina/diagnóstico , Desprendimiento de Retina/cirugía , Estudios Prospectivos , Calidad de Vida , Estudios RetrospectivosRESUMEN
OBJECTIVE: To identify risk factors affecting visual outcomes in successfully re-attached macula-off rhegmatogenous retinal detachment (RD) surgery. DESIGN: A prospective study, using online databases, of visual outcomes for 2074 macula-off retinal detachments that were successfully re-attached by vitrectomy and internal tamponade. The database included detailed retinal diagrams of each detachment. MAIN OUTCOME MEASURE: The probability of achieving a post-operative visual acuity (VA) of ≤0.30 LogMAR (Snellen 6/12 or better). RESULTS: Male patients accounted for 64.9% of the sample and the median age was 63 years old. The median pre-operative VA was counting fingers (LogMAR 1.98); this improved to 0.41 LogMAR post-operatively. A post-operative VA of ≤0.30 LogMAR was achieved for 1012 (48.8%) eyes and the factors affecting this were the patient age and gender, pre-operative VA, duration of central vision loss, PVR grade, lens status, total RD and the presence of any ocular co-pathology where the model area under the receiver operator curve was 71.6%. CONCLUSIONS: From the identified risk factors that decrease the probability of achieving a post-operative visual acuity of ≤0.30 LogMAR, the most important modifiable risk factor was the duration of central vision loss. Recent macula-off retinal detachments should be repaired within 72 h of the loss of central vision.
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Desprendimiento de Retina , Estudios de Cohortes , Humanos , Masculino , Persona de Mediana Edad , Estudios Prospectivos , Desprendimiento de Retina/cirugía , Estudios Retrospectivos , Curvatura de la Esclerótica , Factores de Tiempo , Resultado del Tratamiento , Reino Unido/epidemiología , VitrectomíaRESUMEN
PURPOSE: To analyze the outcomes of revision surgery for idiopathic full-thickness macular holes that have failed to close after primary surgery, and also to assess factors predicting success and to review the relative effect of adjunctive surgical techniques. METHODS: A multicenter retrospective study. Anatomical closure rates and visual acuity change between pre and postrevision surgery were assessed. Hole size, age, symptom duration, surgical interval, and reduced hole size were analyzed as predictive factors for success. Effectiveness of adjunctive surgical techniques was reviewed. RESULTS: Seventy-seven eyes were included in the study. Anatomical closure was achieved in 71% (55/77) cases. There was a median gain of 11 Early Treatment of Diabetic Retinopathy Score letters in all holes and 14 letters in closed holes. Full-thickness macular holes that increased in size by more than 10% following primary surgery had a closure rate of 50% compared with 80% in holes that reduced by 10% or stayed the same (P = 0.015). Increasing hole size is associated with a modest reduction in odds of closure (odds ratio = 0.99; P = 0.04). Surgical interval <2 months is not associated with better outcomes compared with >2 months (P = 0.14). CONCLUSION: Revision surgery for full-thickness macular holes that have failed to close after primary surgery is associated with high closure rates and significant visual gains.
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Mácula Lútea/diagnóstico por imagen , Perforaciones de la Retina/rehabilitación , Agudeza Visual , Vitrectomía/métodos , Adulto , Anciano , Anciano de 80 o más Años , Femenino , Estudios de Seguimiento , Humanos , Masculino , Persona de Mediana Edad , Reoperación/métodos , Perforaciones de la Retina/diagnóstico , Perforaciones de la Retina/cirugía , Estudios Retrospectivos , Resultado del TratamientoRESUMEN
PURPOSE: To compare phakic and pseudophakic primary rhegmatogenous retinal detachments (RD) and, within phakic RD, eyes with and without cataract. DESIGN: Retrospective comparative clinical study. METHODS: Setting: Online database of prospectively collected data. StudyPopulation: Patients aged ≥50 years who had undergone RD repair. PROCEDURE: Data included baseline demographic and clinical features, surgical details, and anatomical and functional outcomes. Univariate analysis was performed to compare pseudophakic with phakic RD, and phakic RD with and without cataract. Age and sex dependency of variables was analyzed and the association of preoperative variables with final visual acuity was assessed using multivariate analysis. MainOutcomeMeasures: Preoperative features, intraoperative management, postoperative outcomes, association of preoperative features with postoperative outcomes. RESULTS: Of 4,231 eyes, 1,212 were pseudophakic and 3,019 phakic, among which 310 had cataract. Pseudophakic RD showed significant differences compared with phakic RD, including older age, higher prevalence of male sex, foveal detachment, grade C proliferative vitreoretinopathy (PVR), inferior retinal breaks, inferior retinal involvement, and greater RD extent. Despite the more advanced features of pseudophakic RD, pseudophakia was a positive factor for visual outcome. Contralateral RD was more frequent in pseudophakic than phakic RD eyes (P < .0001). Within phakic RD, phakic RD with cataract exhibited several similarities with pseudophakic RD, including greater age, more frequent foveal detachment, PVR, and greater RD extent. CONCLUSIONS: The presenting features differed significantly between pseudophakic and phakic RD, with greater occurrence of inferior retinal breaks and inferior retinal involvement in particular. Phakic RD with cataract shared several features in common with pseudophakic RD.
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Extracción de Catarata/efectos adversos , Catarata/complicaciones , Seudofaquia/complicaciones , Desprendimiento de Retina/cirugía , Agudeza Visual , Anciano , Femenino , Humanos , Masculino , Persona de Mediana Edad , Fenotipo , Desprendimiento de Retina/etiología , Estudios RetrospectivosRESUMEN
Importance: The value of facedown positioning following surgery for large full-thickness macular holes is unknown. Objective: To determine whether advice to position facedown postoperatively improves the outcome for large macular holes. Design, Setting, and Participants: This randomized, parallel group superiority trial with 1:1 randomization stratified by site with 3 months' follow-up was conducted at 9 sites across the United Kingdom and included participants with an idiopathic full-thickness macular hole of at least 400 µm minimum linear diameter and a duration of fewer than 12 months. All participants had vitrectomy surgery with peeling of the internal limiting membrane and injection of perfluoropropane (14%) gas, with or without simultaneous surgery for cataract. Interventions: Following surgery, participants were randomly advised to position either facedown or face forward for 8 hours daily for 5 days. Main Outcomes and Measures: The primary outcome was closure of the macular hole determined 3 months following surgery by masked optical coherence tomography evaluation. Secondary outcome measures at 3 months were visual acuity, participant-reported experience of positioning, and quality of life measured by the National Eye Institute Visual Function Questionnaire 25. Results: A total of 185 participants (45 men [24.3%]; 156 white [84.3%]; 9 black [4.9%]; 10 Asian [5.4%]; median age, 69 years [interquartile range, 64-73 years]) were randomized. Macular hole closure was observed in 90 (85.6%) who were advised to position face forward and 88 (95.5%) advised to position facedown (adjusted odds ratio, 3.15; 95% CI, 0.87-11.41; P = .08). The mean (SD) improvement in best-corrected visual acuity at 3 months was 0.34 (0.69) logMAR (equivalent to 1 Snellen line) in the face-forward group and 0.57 (0.42) logMAR (equivalent to 3 Snellen lines) in the facedown group (adjusted mean difference, 0.22 [95 % CI, 0.05-0.38]; equivalent to 2 Snellen lines); 95% CI, 0.05-0.38; P = .01). The median National Eye Institute Visual Function Questionnaire 25 score was 89 (interquartile range, 76-94) in the facedown group and 87 (interquartile range, 73-93) in the face-forward group (mean [SD] change on a logistic scale, 0.08 [0.26] face forward and 0.11 [0.25] facedown; adjusted mean [SD] difference on a logistic scale, 0.02; 95% CI, -0.03 to 0.07; P = .41). Conclusions and Relevance: The results do not prove that facedown positioning following surgery is more likely to close large macular holes compared with facing forward but do support the possibility that visual acuity outcomes may be superior. Trial Registration: Isrctn.org Identifier: 12410596.
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Mácula Lútea/patología , Cuidados Posoperatorios/métodos , Posición Prona , Calidad de Vida , Perforaciones de la Retina/cirugía , Agudeza Visual , Vitrectomía/métodos , Anciano , Femenino , Humanos , Masculino , Persona de Mediana Edad , Perforaciones de la Retina/diagnóstico , Tomografía de Coherencia Óptica , Resultado del TratamientoRESUMEN
Importance: A lack of consensus exists with regard to the optimal positioning regimen for patients after macula-involving retinal detachment (RD) repair. Objective: To evaluate the effect of face-down positioning vs support-the-break positioning on retinal displacement and distortion after macula-involving RD repair. Design, Setting, and Participants: A prospective 6-month single-masked randomized clinical trial was conducted at a multicenter tertiary referral setting from May 16, 2016, to May 1, 2018. Inclusion criteria were fovea-involving rhegmatogenous RD; central visual loss within 14 days; patients undergoing primary vitrectomy and gas surgery, under local anesthetic; patients able to give written informed consent; and 18 years old and older. Analysis was conducted following a modified intention-to-treat principle, with patients experiencing a redetachment or failure to attach the macula being excluded from analysis. Interventions: Participants were randomized 1:1 to receive face-down positioning or support-the-break positioning for a 24-hour period postoperatively. Positioning compliance was not monitored. Main Outcomes and Measures: The proportion of patients with retinal displacement on autofluorescence imaging at 6 months postoperatively. Secondary outcomes included proportion of patients with displacement at 2 months; amplitude of displacement at 2 and 6 months; corrected Early Treatment Diabetic Retinopathy Study visual acuity; objective Distortion Scores; and quality of life questionnaire scores at 6 months. Results: Of the 262 randomized patients, 239 were analyzed (171 male [71.5%]; mean [SD] age, 60.8 [9.8] years). At 6 months, retinal displacement was detected in 42 of 100 (42%) in the face-down positioning group vs 58 of 103 (56%) in the support-the-break positioning group (odds ratio, 1.77; 95%CI, 1.01-3.11; P = .04). The degree of displacement was lower in the face-down group. Groups were similar in corrected visual acuity (face-down, 74 letters vs support-the-break, 75 letters), objective D Chart Distortion Scores (range: 0, no distortion to 41.6, severe distortion; with face-down at 4.5 vs support-the-break at 4.2), and quality of life scores (face-down 89.3 vs support-the-break 89.0) at 2 and 6 months. Retinal redetachment rate was similar in both groups (face-down group, 12.2% and support-the-break group, 13.7%). Retinal folds were less common in the face-down positioning group vs the support-the-break positioning group (5.3% vs 13.5%, respectively; odds ratio, 2.8; 95% CI, 1.2-7.4; P = .03). Binocular diplopia was more common in the support-the-break group compared with the face-down positioning group (7.6% vs 1.5%, respectively; odds ratio, 5.3; 95% CI, 1.3-24.6; P = .03). Amplitude of displacement was associated with worse visual acuity (r = -0.5; P < .001) and distortion (r = 0.28; P = .008). Conclusions and Relevance: In this study, findings suggest that face-down positioning was associated with a reduction in the rate and amplitude of postoperative retinal displacement after macula-involving RD repair and with a reduction in binocular diplopia. No association was found with visual acuity or postoperative distortion. Trial Registration: ClinicalTrials.gov Identifier: NCT02748538.