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Advances in Therapy Dec 2023A systematic literature review (SLR) and network meta-analysis (NMA) were conducted to evaluate the comparative efficacy, durability and safety of faricimab, used in a... (Meta-Analysis)
Meta-Analysis
INTRODUCTION
A systematic literature review (SLR) and network meta-analysis (NMA) were conducted to evaluate the comparative efficacy, durability and safety of faricimab, used in a Treat & Extend (T&E) regime with intervals up to every 16 weeks (Q16W), relative to other therapies currently in use for treatment of diabetic macular oedema (DME). Of particular interest were anti-vascular endothelial growth factor (VEGF) therapies applied in flexible dosing regimens such as Pro re nata (PRN) and T&E, which are the mainstay in clinical practice.
METHODS
An SLR identifying randomised controlled trials (RCTs) published before August 2021 was conducted, followed by a Bayesian NMA comparing faricimab T&E treatment to aflibercept, ranibizumab, bevacizumab, dexamethasone and laser therapy. Outcomes included in the analysis were change in best-corrected visual acuity (BCVA), change in central subfield thickness (CST), injection frequency, ocular adverse events (AE) and all-cause discontinuation, all of which were evaluated at 12 months. Subgroup analyses including patients' naïve to anti-VEGF were conducted where feasible.
RESULTS
Twenty-six studies identified in the SLR were included in the NMA. Most importantly for decision making in clinical practise, faricimab T&E was associated with a statistically greater (95% credible intervals exclude zero) and clinically meaningful decrease in retinal thickness compared to all other flexible dosing regimens (greater retinal drying by 55-125 microns). Anatomical outcomes determine treatment efficacy and retreatment of patients. The NMA also showed a statistically greater increase in mean change in BCVA for faricimab T&E vs. flexible regimens using ranibizumab and bevacizumab (increase of 4.4-4.8 letters) as well as a numerical improvement vs. aflibercept PRN (two letters, 95% credible intervals including zero). Accordingly, the injection frequency was numerically lower versus other treatments using flexible dosing regimens (decrease by 0.92-1.43 injections). The analyses also indicated that the safety profile of faricimab T&E was comparable to those of ranibizumab and aflibercept, which have well-established safety profiles, with similar results for the number of all-cause discontinuations.
CONCLUSION
Faricimab provides a new treatment option in DME with dual-pathway inhibition of VEGF and angiopoeitin-2 (Ang-2). To the authors' knowledge, this is the first indirect comparison of faricimab T&E in DME. The analyses indicate that faricimab T&E is associated with superior retinal drying along with numerically fewer injections compared to all other treatments given in flexible dosing regimens. It also showed superior visual acuity outcomes compared to ranibizumab and bevacizumab.
Topics: Humans; Angiogenesis Inhibitors; Bevacizumab; Diabetic Retinopathy; Intravitreal Injections; Macular Edema; Network Meta-Analysis; Ranibizumab; Vascular Endothelial Growth Factor A
PubMed: 37751021
DOI: 10.1007/s12325-023-02675-y -
The Cochrane Database of Systematic... Jun 2023Diabetic retinopathy (DR) remains a major cause of sight loss worldwide, despite new therapies and improvements in the metabolic control of people living with diabetes.... (Review)
Review
BACKGROUND
Diabetic retinopathy (DR) remains a major cause of sight loss worldwide, despite new therapies and improvements in the metabolic control of people living with diabetes. Therefore, DR creates a physical and psychological burden for people, and an economic burden for society. Preventing the development and progression of DR, or avoiding the occurrence of its sight-threatening complications is essential, and must be pursued to save sight. Fenofibrate may be a useful strategy to achieve this goal, by reversing diabetes' effects and reducing inflammation in the retina, as well as improving dyslipidaemia and hypertriglyceridaemia. OBJECTIVES: To investigate the benefits and harms of fenofibrate for preventing the development and progression of diabetic retinopathy in people with type 1 (T1D) or type 2 diabetes (T2D), compared with placebo or observation.
SEARCH METHODS
We searched CENTRAL, MEDLINE, Embase, and three trials registers (February 2022).
SELECTION CRITERIA
We included randomised controlled trials (RCTs) that included people with T1D or T2D, when these compared fenofibrate with placebo or with observation, and assessed the effect of fenofibrate on the development or progression of DR (or both).
DATA COLLECTION AND ANALYSIS
We used standard Cochrane methods for data extraction and analysis. Our primary outcome was progression of DR, a composite outcome of 1) incidence of overt retinopathy for participants who did not have DR at baseline, or 2) advancing two or more steps on the Early Treatment Diabetic Retinopathy Study (ETDRS) severity scale for participants who had any DR at baseline (or both), based on the evaluation of stereoscopic or non-stereoscopic fundus photographs, during the follow-up period. Overt retinopathy was defined as the presence of any DR observed on stereoscopic or non-stereoscopic colour fundus photographs. Secondary outcomes included the incidence of overt retinopathy, reduction in visual acuity of participants with a reduction in visual acuity of 10 ETDRS letters or more, proliferative diabetic retinopathy, and diabetic macular oedema; mean vision-related quality of life, and serious adverse events of fenofibrate. We used GRADE to assess the certainty of evidence.
MAIN RESULTS
We included two studies and their eye sub-studies (15,313 participants) in people with T2D. The studies were conducted in the US, Canada, Australia, Finland, and New Zealand; follow-up period was four to five years. One was funded by the government, the other by industry. Compared to placebo or observation, fenofibrate likely results in little to no difference in progression of DR (risk ratio (RR) 0.86; 95% confidence interval (CI) 0.60 to 1.25; 1 study, 1012 participants; moderate-certainty evidence) in a population with and without overt retinopathy at baseline. Those without overt retinopathy at baseline showed little or no progression (RR 1.00, 95% CI 0.68 to 1.47; 1 study, 804 participants); those with overt retinopathy at baseline found that their DR progressed slowly (RR 0.21, 95% CI 0.06 to 0.71; 1 study, 208 people; test for interaction P = 0.02). Compared to placebo or observation, fenofibrate likely resulted in little to no difference in either the incidence of overt retinopathy (RR 0.91; 95% CI 0.76 to 1.09; 2 studies, 1631 participants; moderate-certainty evidence); or the incidence of diabetic macular oedema (RR 0.39; 95% CI 0.12 to 1.24; 1 study, 1012 participants; moderate-certainty evidence). The use of fenofibrate increased severe adverse effects (RR 1.55; 95% CI 1.05 to 2.27; 2 studies, 15,313 participants; high-certainty evidence). The studies did not report on incidence of a reduction in visual acuity of 10 ETDRS letters or more, incidence of proliferative diabetic retinopathy, or mean vision-related quality of life.
AUTHORS' CONCLUSIONS
Current, moderate-certainty evidence suggests that in a mixed group of people with and without overt retinopathy, who live with T2D, fenofibrate likely results in little to no difference in progression of diabetic retinopathy. However, in people with overt retinopathy who live with T2D, fenofibrate likely reduces the progression. Serious adverse events were rare, but the risk of their occurrence was increased by the use of fenofibrate. There is no evidence on the effect of fenofibrate in people with T1D. More studies, with larger sample sizes, and participants with T1D are needed. They should measure outcomes that are important to people with diabetes, e.g. change in vision, reduction in visual acuity of 10 ETDRS letters or more, developing proliferative diabetic retinopathy; and evaluating the requirement of other treatments, e.g. injections of anti-vascular endothelial growth factor therapies, steroids.
Topics: Humans; Diabetic Retinopathy; Fenofibrate; Macular Edema; Diabetes Mellitus, Type 1; Retinal Diseases; Diabetes Mellitus, Type 2
PubMed: 37310870
DOI: 10.1002/14651858.CD013318.pub2 -
Scientific Reports Nov 2023To conduct a systematic review and meta-analysis of the association between children and adolescents with attention deficit hyperactivity disorder (ADHD) or autism... (Meta-Analysis)
Meta-Analysis
To conduct a systematic review and meta-analysis of the association between children and adolescents with attention deficit hyperactivity disorder (ADHD) or autism spectrum disorder (ASD) and ocular characteristics. Systematic review with meta-analysis. Six databases (PubMed, Scopus, APA PsycInfo, Embase, EBSCOhost, and Cochrane library) were selected for a systematic literature search from database inception to July 2022. The observational studies assessing and reporting at least one outcome regarding ocular characteristics in children and adolescents with ADHD or ASD aged 6-17 were included. Studies in languages other than English, studies of adult or elderly human populations, and animal studies were excluded. The results were analyzed following the PRISMA guideline 2020. The findings of 15 studies, including 433 participants with ADHD, 253 participants with ASD, and 514 participants with typical development (TD), revealed that there were no significant differences in retinal nerve fiber layer, ganglion cell complex, and macular thickness between the ADHD group and the TD group. In subgroup analysis, significant differences in inferior ganglion cell (MD = - 3.19; 95% CI = [- 6.06, - 0.31], p = 0.03) and nasal macular thickness (MD = 5.88; 95% CI = [- 0.01, 11.76], p = 0.05) were detected between the ADHD group and the TD group. A significant difference in pupillary light reflex (PLR) was also observed between the ASD group and the TD group (MD = 29.7; 95% CI = [18.79, 40.63], p < 0.001). Existing evidence suggests a possible association between children and adolescents with ADHD or ASD and ocular characteristics. Given the limited number of studies, further research on a larger cohort is necessary to claim a possible diagnosis of ADHD or ASD through ocular characteristics.
Topics: Adult; Animals; Aged; Adolescent; Child; Humans; Autism Spectrum Disorder; Face; Retina; Nose; Neurodevelopmental Disorders
PubMed: 37938638
DOI: 10.1038/s41598-023-46206-9 -
BMJ Open Ophthalmology Jan 2023To facilitate the integration of eye care into universal health coverage, the WHO is developing a Package of Eye Care Interventions (PECI). Development of the PECI... (Review)
Review
To facilitate the integration of eye care into universal health coverage, the WHO is developing a Package of Eye Care Interventions (PECI). Development of the PECI involves the identification of evidence-based interventions from relevant clinical practice guidelines (CPGs) for uveitis.A systematic review of CPGs published on uveitis between 2010 and March 2020 was conducted. CPGs passing title and abstract and full-text screening were evaluated using the Appraisal of Guidelines for Research and Evaluation II (AGREE II) tool and data on recommended interventions extracted using a standard data extraction sheet.Of 56 CPGs identified as potentially relevant from the systematic literature search, 3 CPGs underwent data extraction following the screening stages and appraisal with the AGREE II tool. These CPGs covered screening for, monitoring and treating juvenile idiopathic arthritis (JIA)-associated uveitis, the use of adalimumab and dexamethasone in treating non-infectious uveitis, and a top-level summary of assessment, differential diagnosis and referral recommendations for uveitis, aimed at primary care practitioners. Many of the recommendations were based on expert opinion, though some incorporated clinical study and randomised controlled trial data.There is currently sparse coverage of the spectrum of disease caused by uveitis within CPGs. This may partially be due to the large number of conditions with diverse causes and clinical presentations covered by the umbrella term uveitis, which makes numerous sets of guidelines necessary. The limited pool of CPGs to select from has implications for clinicians seeking guidance on clinical care strategies for uveitis.
Topics: Humans; Uveitis; Adalimumab; Arthritis, Juvenile
PubMed: 37278434
DOI: 10.1136/bmjophth-2022-001091 -
Molecular Psychiatry Jan 2023To conduct the first systematic review and meta-analysis assessing whether attention-deficit/hyperactivity disorder (ADHD) is associated with disorders of the eye,... (Meta-Analysis)
Meta-Analysis
AIM
To conduct the first systematic review and meta-analysis assessing whether attention-deficit/hyperactivity disorder (ADHD) is associated with disorders of the eye, and/or altered measures of visual function.
METHOD
Based on a pre-registered protocol (PROSPERO: CRD42021256352), we searched PubMed, Web of Knowledge/Science, Ovid Medline, Embase and APA PsycINFO up to 16th November 2021, with no language/type of document restrictions. We included observational studies reporting at least one measure of vision in people of any age meeting DSM/ICD criteria for ADHD and in people without ADHD; or the prevalence of ADHD in people with and without vision disorders. Study quality was assessed with the Appraisal tool for Cross-Sectional Studies (AXIS). Random effects meta-analyses were used for data synthesis.
RESULTS
We included 42 studies in the narrative synthesis and 35 studies in the meta-analyses (3,250,905 participants). We found meta-analytic evidence of increased risk of astigmatism (OR = 1.79 [CI: 1.50, 2.14]), hyperopia and hypermetropia (OR = 1.79 [CI: 1.66, 1.94]), strabismus (OR = 1.93 [CI: 1.75, 2.12]), unspecified vision problems (OR = 1.94 [CI: 1.38, 2.73]) and reduced near point of convergence (OR = 5.02 [CI: 1.78, 14.11]); increased lag (Hedge's g = 0.63 [CI: 0.30, 0.96]) and variability (Hedge's g = 0.40 [CI: 0.17, 0.64]) of the accommodative response; and increased self-reported vision problems (Hedge's g = 0.63 [CI: 0.44, 0.82]) in people with ADHD compared to those without ADHD (with no significant heterogeneity). We also found meta-analytic evidence of no differences between people with and without ADHD on retinal nerve fiber layer thickness (Hedge's g = -0.19 [CI: -0.41, 0.02]) and refractive error (Hedge's g = 0.08 [CI: -0.26, 0.42]) (with no significant heterogeneity).
DISCUSSION
ADHD is associated with some self-reported and objectively ascertained functional vision problems, but not with structural alterations of the eye. Further studies should clarify the causal relationship, if any, between ADHD and problems of vision.
TRIAL REGISTRATION
PROSPERO registration: CRD42021256352.
Topics: Humans; Attention Deficit Disorder with Hyperactivity; Cross-Sectional Studies; Prevalence; Eye Diseases
PubMed: 35931758
DOI: 10.1038/s41380-022-01699-0 -
The Cochrane Database of Systematic... Feb 2020Glaucoma is a multi-factorial optic neuropathy characterized by an acquired loss of retinal ganglion cells at levels beyond normal age-related loss and corresponding... (Meta-Analysis)
Meta-Analysis
BACKGROUND
Glaucoma is a multi-factorial optic neuropathy characterized by an acquired loss of retinal ganglion cells at levels beyond normal age-related loss and corresponding atrophy of the optic nerve. Although many treatments are available to manage glaucoma, patients may seek complementary or alternative medicine approaches such as acupuncture to supplement their regular treatment. The underlying plausibility of acupuncture is that disorders related to the flow of Chi (traditional Chinese concept of vital force or energy) can be managed by stimulating relevant points on the body surface.
OBJECTIVES
To assess the effectiveness and safety of acupuncture compared with other treatments, no treatment, or placebo in patients with glaucoma.
SEARCH METHODS
We searched the Cochrane Central Register of Controlled Trials (CENTRAL), which contains the Cochrane Eyes and Vision Trials Register (2018, Issue 11); Ovid MEDLINE; Embase.com; the Cumulative Index to Nursing and Allied Health Literature (CINAHL); the Allied and Complementary Medicine Database (AMED); PubMed; Latin American and Caribbean Literature on Health Sciences (LILACS); ZETOC; the metaRegister of Controlled Trials (mRCT); ClinicalTrials.gov; the World Health Organization (WHO) International Clinical Trials Registry Platform (ICTRP); and the National Center for Complementary and Alternative Medicine (NCCAM) website. We did not use any language or date restrictions in the search for trials. We last searched electronic databases on November 16, 2018, with the exception of NCCAM, which we last searched on July 14, 2010, and the metaRegister of Controlled Trials (mRCT), which we last searched on January 8, 2013. We handsearched Chinese medical journals at Peking Union Medical College Library in April 2007. We searched the Chinese Acupuncture Trials Register, the Traditional Chinese Medical Literature Analysis and Retrieval System (TCMLARS), the Chinese Biological Database (CBM), and the China National Knowledge Infrastructure (CNKI). We last searched Chinese electronic databases on November 19, 2018.
SELECTION CRITERIA
We included randomized controlled trials (RCTs) in which one arm involved acupuncture treatment.
DATA COLLECTION AND ANALYSIS
Two review authors independently screened results, then extracted the data and assessed risk of bias for eligible trials.
MAIN RESULTS
We included three completed trials and one ongoing trial in the 2019 update of this review. The three completed trials, conducted in Taiwan and the United States, included participants with glaucoma or intraocular hypertension. The interventions investigated varied across trials. One trial compared auricular acupressure-a non-standard acupuncture technique-with the sham procedure in 33 patients. Another trial compared transcutaneous electrical nerve stimulation (TENS) with a sham procedure in 82 patients. The third trial compared 12 sessions of acupuncture on eye-points versus on non-eye-points in 22 patients. All three trials were rated at high risk of bias for at least one domain. The certainty of evidence across all outcomes was very low due to high risk of bias in at least one contributing study; substantial clinical heterogeneity and methodological heterogeneity; and imprecision of results. One trial reported change in the visual field from baseline without any between-group comparison. Because of the quantity of missing data (50%), we did not calculate a between-group comparison, as the quantitative results are difficult to interpret. All three trials reported data for estimation of reduction of intraocular pressure (IOP). However, time points of IOP measurement varied. For the trial comparing acupressure to a sham procedure, the difference in IOP reduction (measured in mm Hg) is estimated to be -3.70 (95% confidence interval [CI] -7.11 to -0.29) for the right eye and -4.90 (95% CI -8.08 to -1.72) for the left eye at four weeks, and -1.30 mm Hg (95% CI -4.78 to 2.18) for the right eye and -2.30 mm Hg (95% CI -5.73 to 1.13) for the left eye at eight weeks. For the trial comparing TENS to sham treatment, the difference reduction is estimated to be -2.81 (95% CI -3.8 to -1.84) for the right eye and -2.58 (95% CI -3.36 to -1.80) for the left eye immediately after treatment, -2.93 (95% CI -3.72 to -2.13) for the right eye and -3.56 (95% CI -4.35 to 2.78) for the left eye 30 minutes after treatment, and finally -3.61 (95% CI -4.47 to -2.75) for the right eye and -3.61 (95% -4.47 to -2.74) for the left eye. For the trial that compared acupuncture on eye-points versus non-eye-points, 11 out of 22 (50%) participants did not complete the treatment. One trial reported data for estimation of visual acuity. When acupressure is compared to sham treatment, the difference in uncorrected visual acuity (UCVA, measured in logMAR) is estimated to be -0.01 (95% CI -0.24 to 0.22) for the right eye and -0.04 (95% CI -0.27 to 0.19) for the left eye at four months, and -0.03 logMAR (95% CI -0.27 to 0.21) for the right eye and -0.16 logMAR (95% CI -0.43 to 0.11) for the left eye at eight months. The difference in best corrected visual acuity (BCVA) is estimated to be 0.10 (95% CI -0.06 to 0.26) for the right eye and 0 (95% CI -0.14 to 0.14) for the left eye at four months, and -0.04 logMAR (95% CI -0.09 to 0.17) for the right eye and -0.04 logMAR (95% CI -0.18 to 0.10) for the left eye at eight months. One trial reported progression of optic disc damage or nerve fiber layer loss without any between-group comparison. Because of the quantity of missing data (50%), we did not calculate a between-group comparison, as the quantitative results are difficult to interpret. One trial reported adverse events in two patients (out of 22) who experienced needle sensitivity. However, the study did not report between-group comparisons. Because of the quantity of missing data (50%), we did not calculate a between-group comparison, as the quantitative results are difficult to interpret.
AUTHORS' CONCLUSIONS
At this time, it is impossible to draw reliable conclusions from available data to support the use of acupuncture for treatment of patients with glaucoma. Because of ethical considerations, RCTs comparing acupuncture alone with standard glaucoma treatment or placebo are unlikely to be justified in countries where the standard of care has already been established.
Topics: Acupuncture Therapy; Glaucoma; Humans; Randomized Controlled Trials as Topic; Treatment Outcome; Visual Acuity
PubMed: 32032457
DOI: 10.1002/14651858.CD006030.pub4 -
Indian Journal of Ophthalmology May 2021The incidence of leishmaniasis is reported to be up to 1 million per year. To date, there has been no comprehensive review describing the diversity of clinical... (Review)
Review
The incidence of leishmaniasis is reported to be up to 1 million per year. To date, there has been no comprehensive review describing the diversity of clinical presentations of ocular leishmaniasis (OL) and its treatment. This systematic review aims to address this knowledge gap and provide a summary of the clinical presentation, natural course, and treatment options for OL. Our study identified a total of 57 published articles as describing cases of OL involving: adnexa (n = 26), orbit (n = 1), retina (n = 7), uvea (n = 18) and cornea (n = 6). Though well described and easily treated, palpebral leishmaniasis is often misdiagnosed and may lead to chronic issues if untreated. The retinal manifestations of Leishmaniasis consist of self-resolving hemorrhages secondary to thrombocytopenia. Two main uveitis etiologies have been identified: uveitis in the context of active Leishmanial infection (associated with immunosuppression) and uveitis occurring as an immune reconstitution syndrome. Corneal involvement in most geographic areas generally follows an aggressive course, most often ending in corneal perforation if left untreated. In the Americas, a chronic indolent interstitial keratitis may also occur. Topical steroids are of little use in keratitis (systemic antileishmanials being the cornerstone of treatment). However, these are essential in cases of uveitis, with or without concomitant systemic antileishmanial therapy. In conclusion, though ocular involvement in Leishmaniasis is rare, severe sight-threatening consequences follow if left untreated. Early diagnosis, enthusiastic follow-up and aggressive treatment are essential for good outcomes.
Topics: Cornea; Corneal Perforation; Humans; Keratitis; Leishmaniasis; Uveitis
PubMed: 33913831
DOI: 10.4103/ijo.IJO_2232_20 -
BMJ Open Ophthalmology Jun 2023This systematic review and meta-analysis provides a summary of the efficacy and safety of ranibizumab biosimilars relative to reference ranibizumab anti-vascular... (Meta-Analysis)
Meta-Analysis
TOPIC
This systematic review and meta-analysis provides a summary of the efficacy and safety of ranibizumab biosimilars relative to reference ranibizumab anti-vascular endothelial growth factor (VEGF) therapy for the treatment of neovascular age-related macular degeneration (nAMD).
METHODS
We conducted systematic searches from January 2003 to August 2022 on Ovid MEDLINE, EMBASE and the Cochrane Controlled Register of Trials. We included studies reporting changes in early treatment diabetic retinopathy study-measured best-corrected visual acuity (BCVA), number of patients who lost or gained more than 15 letters in BCVA from baseline, changes in retinal thickness and adverse events between treatment arms. The following studies were excluded: studies that did not report visual outcomes following biosimilar and reference ranibizumab intravitreal injections, study arms combining anti-VEGF agents with laser or steroid injections, sham injections as a control comparator, studies without English full texts and non-comparative, observational study design.
RESULTS
Five studies reported on four randomised controlled trials (RCTs) and 1544 eyes at baseline were included in this systematic review and meta-analysis. The studies in our systematic review found no significant differences between reference ranibizumab and ranibizumab biosimilar medications (FYB201, SB11, RanizuRel and Lupin's ranibizumab) for visual and anatomical outcomes. No significant differences were detected between biosimilar and reference ranibizumab for treatment emergent adverse events (risk ratio, RR 1.06, 95% CI (0.91 to 1.23), p=0.45, I=52%) or IOP-related adverse events with significant heterogeneity (RR 2.59, 95% CI (0.11 to 62.25), p=0.56, I=76%).
CONCLUSION
This systematic review of four RCTs demonstrated no significant difference in visual outcomes, retinal thickness outcomes, as well as meta-analysis of adverse events between biosimilar and reference ranibizumab therapies for nAMD treatment.
Topics: Humans; Ranibizumab; Biosimilar Pharmaceuticals; Angiogenesis Inhibitors; Bevacizumab; Vascular Endothelial Growth Factor A; Receptors, Vascular Endothelial Growth Factor; Vascular Endothelial Growth Factors; Observational Studies as Topic
PubMed: 37493655
DOI: 10.1136/bmjophth-2022-001205 -
Stem Cell Research & Therapy Oct 2023Stem cell therapy is a promising therapeutic approach for inherited retinal diseases (IRDs). This study aims to quantitatively examine the effectiveness and safety of... (Meta-Analysis)
Meta-Analysis Review
PURPOSE
Stem cell therapy is a promising therapeutic approach for inherited retinal diseases (IRDs). This study aims to quantitatively examine the effectiveness and safety of stem cell therapy for patients with IRDs, including retinitis pigmentosa and Stargardt disease (STGD).
METHODS
We searched PubMed, EMBASE, Web of Science, Cochrane Library databases, and the ClinicalTrials.gov website. The latest retrieval time was August 20, 2023. The primary outcomes were rates and mean difference (MD) of best-corrected visual acuity (BCVA) improvement. Subgroup analyses were conducted according to administration routes and stem cell types. This study was registered with PROSPERO (CRD42022349271).
RESULTS
Twenty-one prospective studies, involving 496 eyes (404 RP and 92 STGD) of 382 patients (306 RP and 76 STGD), were included in this study. For RP, the rate of BCVA improvement was 49% and 30% at 6 months and 12 months, respectively, and the BCVA was significantly improved in the operative eyes at 6 months post-treatment (MD = - 0.12 logMAR, 95% CI .17 to - 0.06 logMAR; P < 0.001), while there was no significant difference at 12 months post-treatment (MD = -0.06 logMAR; 95% CI - 0.13 to 0.01 logMAR; P = 0.10). For STGD, the rate of BCVA improvement was 60% and 55% at 6 months and 12 months, respectively, and the BCVA was significantly improved in the operative eyes at 6 months (MD = - 0.14 logMAR, 95% CI - 0.22 to - 0.07 logMAR; P = 0.0002) and 12 months (MD = - 0.17 logMAR, 95% CI - 0.29 to - 0.04 logMAR; P = 0.01). Subgroup analyses showed suprachoroidal space injection of stem cells may be more efficient for RP. Eleven treated-related ocular adverse events from three studies and no related systemic adverse events were reported.
CONCLUSIONS
This study suggests stem cell therapy may be effective and safe for patients with RP or STGD. The long-term vision improvement may be limited for RP patients. Suprachoroidal space injection of stem cells may be a promising administration route for RP patients. Limited by the low grade of evidence, large sample size randomized clinical trials are required in the future.
Topics: Humans; Prospective Studies; Visual Acuity; Retinitis Pigmentosa; Choroidal Effusions; Cell- and Tissue-Based Therapy
PubMed: 37798796
DOI: 10.1186/s13287-023-03526-x -
Ophthalmology. Retina Jun 2023To characterize the presentation, management, and outcomes of suprachoroidal hemorrhage (SCH). (Meta-Analysis)
Meta-Analysis Review
TOPIC
To characterize the presentation, management, and outcomes of suprachoroidal hemorrhage (SCH).
CLINICAL RELEVANCE
Suprachoroidal hemorrhage is a potentially devastating condition but there is no high-quality evidence for the prognosis or management of SCH.
METHODS
We performed a systematic review and meta-analysis of peer-reviewed studies of SCH published in PubMed, EMBASE, Web of Science, or Google Scholar between January 1, 1990, and September 1, 2022. The protocol was prospectively registered on the Open Science Framework (https://osf.io/69v3q/). Random-effects models were used to calculate the pooled estimate and 95% confidence intervals (CIs) for visual acuity (VA) and anatomic outcomes. Univariable and multivariable random-effects meta-regressions were performed to determine factors associated with VA outcomes and anatomic success, defined as the retina attached at the last follow-up.
RESULTS
Sixty-eight studies comprising 1246 eyes of 1245 patients were included, with mean (standard deviation [SD]) follow-up of 14.0 (9.4) months. The pooled estimate (95% CI) for mean change in logarithm of the minimum angle of resolution (logMAR) VA from baseline to the last follow-up was -0.98 (-1.22 to -0.74) (I = 88.4%), with 72.0% (63.5%-80.5%) (I = 74.3%) achieving VA improvement of ≥ 0.3 logMAR (3-line improvement in ETDRS VA), 39.6% (32.5%-46.7%) (I = 83.2%) achieving final VA of 1.0 logMAR (Snellen equivalent 20/200) or better, and 75.5% (68.4%-82.7%) (I = 74.7%) achieving anatomic success. Studies with predominantly nonspontaneous SCH and greater percent of eyes receiving systemic steroids were associated with greater improvement in logMAR VA, a greater proportion of eyes with VA improvement ≥ 0.3 logMAR, and greater proportion of eyes achieving anatomic success (all P < 0.05 univariable meta-regression). Studies with greater percent of eyes treated surgically were associated with greater proportion of eyes with VA improvement of ≥ 0.3 logMAR in (P < 0.05, univariable and multivariable analysis). The mean (SD) quality score across studies was 13.9 (2.3) out of 24, and outcomes were of very low certainty of evidence.
CONCLUSION
Although limited by heterogeneous observational studies, published reports of SCH indicate that most eyes with SCH experience some degree of VA improvement and anatomic success. However, final VA outcomes remain poor, with most cases resulting in severe visual impairment or blindness.
FINANCIAL DISCLOSURE(S)
Proprietary or commercial disclosure may be found after the references.
Topics: Humans; Retina; Prognosis; Hemorrhage
PubMed: 36858317
DOI: 10.1016/j.oret.2023.02.011