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Frontiers in Immunology 2020The term ocular microbiota refers to all types of commensal and pathogenic microorganisms present on or in the eye. The ocular surface is continuously exposed to the...
The term ocular microbiota refers to all types of commensal and pathogenic microorganisms present on or in the eye. The ocular surface is continuously exposed to the environment and harbors various commensals. Commensal microbes have been demonstrated to regulate host metabolism, development of immune system, and host defense against pathogen invasion. An unbalanced microbiota could lead to pathogenic microbial overgrowth and cause local or systemic inflammation. The specific antigens that irritate the deleterious immune responses in various inflammatory eye diseases remain obscure, while recent evidence implies a microbial etiology of these illnesses. The purpose of this review is to provide an overview of the literature on ocular microbiota and the role of commensal microbes in several eye diseases. In addition, this review will also discuss the interaction between microbial pathogens and host factors involved in intraocular inflammation, and evaluate therapeutic potential of targeting ocular microbiota to treat intraocular inflammation.
Topics: Animals; Eye; Eye Diseases; Humans; Immune System; Immunity; Inflammation; Microbiota
PubMed: 33424865
DOI: 10.3389/fimmu.2020.609765 -
Nutrition & Diabetes Mar 2017Diabetes mellitus is associated with extensive morbidity and mortality in any human community. It is well understood that the burden of diabetes is attributed to chronic... (Review)
Review
Diabetes mellitus is associated with extensive morbidity and mortality in any human community. It is well understood that the burden of diabetes is attributed to chronic progressive damage in major end-organs, but it is underappreciated that the most superficial and transparent organ affected by diabetes is the cornea. Different corneal components (epithelium, nerves, immune cells and endothelium) underpin specific systemic complications of diabetes. Just as diabetic retinopathy is a marker of more generalized microvascular disease, corneal nerve changes can predict peripheral and autonomic neuropathy, providing a window of opportunity for early treatment. In addition, alterations of immune cells in corneas suggest an inflammatory component in diabetic complications. Furthermore, impaired corneal epithelial wound healing may also imply more widespread disease. The non-invasiveness and improvement in imaging technology facilitates the emergence of new screening tools. Systemic control of diabetes can improve ocular surface health, possibly aided by anti-inflammatory and vasoprotective agents.
Topics: Corneal Diseases; Diabetes Mellitus, Type 1; Diabetes Mellitus, Type 2; Epithelium, Corneal; Humans
PubMed: 28319106
DOI: 10.1038/nutd.2017.4 -
The Cochrane Database of Systematic... Feb 2016A pterygium is a fleshy, wing-shaped growth from the conjunctiva, crossing over the limbus onto the cornea. Prevalence ranges widely around the world. Evidence suggests... (Meta-Analysis)
Meta-Analysis Review
BACKGROUND
A pterygium is a fleshy, wing-shaped growth from the conjunctiva, crossing over the limbus onto the cornea. Prevalence ranges widely around the world. Evidence suggests that ultraviolet light is a major contributor in the formation of pterygia. Pterygia impair vision, limit eye movements, and can cause eye irritation, foreign body sensation, and dryness. In some susceptible patients, the pterygium can grow over the entire corneal surface, blocking the visual axis.Surgery is the only effective treatment for pterygium, though recurrences are common. With simple excision techniques (that is, excising the pterygium and leaving bare sclera), the risk of recurrence has been reported to be upwards of 80%. Pterygium excision combined with a tissue graft has a lower risk of recurrence. In conjunctival autograft surgery, conjunctival tissue from another part of the person's eye along with limbal tissue is resected in one piece and used to cover the area from which the pterygium was excised. Another type of tissue graft surgery for pterygium is amniotic membrane graft, whereby a piece of donor amniotic membrane is fixed to the remaining limbus and bare sclera area after the pterygium has been excised.
OBJECTIVES
The objective of this review was to assess the safety and effectiveness of conjunctival autograft (with or without adjunctive therapy) compared with amniotic membrane graft (with or without adjunctive therapy) for pterygium. We also planned to determine whether use of MMC yielded better surgical results and to assess the direct and indirect comparative costs of these procedures.
SEARCH METHODS
We searched CENTRAL (which contains the Cochrane Eyes and Vision Trials Register) (Issue 10, 2015), Ovid MEDLINE, Ovid MEDLINE In-Process and Other Non-Indexed Citations, Ovid MEDLINE Daily, Ovid OLDMEDLINE (January 1946 to November 2015), EMBASE (January 1980 to November 2015), PubMed (1948 to November 2015), Latin American and Caribbean Health Sciences Literature Database (LILACS) (1982 to November 2015), the metaRegister of Controlled Trials (mRCT) (www.controlled-trials.com) (last searched 21 November 2014), ClinicalTrials.gov (www.clinicaltrials.gov) and the World Health Organization (WHO) International Clinical Trials Registry Platform (ICTRP) (www.who.int/ictrp/search/en). We did not use any date or language restrictions in the electronic search for trials. We last searched the electronic databases on 23 November 2015.
SELECTION CRITERIA
We included in this review randomized controlled trials that had compared conjunctival autograft surgery (with or without adjunctive therapy) with amniotic membrane graft surgery (with or without adjunctive therapy) in people with primary or recurrent pterygium.
DATA COLLECTION AND ANALYSIS
Two review authors independently screened search results and assessed full-text reports from among the potentially eligible trials. Two review authors independently extracted data from the included trials and assessed the trial characteristics and risk of bias. The primary outcome was the risk of recurrence of pterygium at 3 months and 6 months after surgery. We combined results from individual studies in meta-analyses using random-effects models. Risk of recurrence of pterygium was reported using risk ratios to compare conjunctival autograft with amniotic membrane transplant.
MAIN RESULTS
We identified 20 studies that had analyzed a total of 1947 eyes of 1866 participants (individual studies ranged from 8 to 346 participants who were randomized). The studies were conducted in eight different countries: one in Brazil, three in China, three in Cuba, one in Egypt, two in Iran, two in Thailand, seven in Turkey, and one in Venezuela. Overall risk of bias was unclear, as many studies did not provide information on randomization methods or masking to prevent performance and detection bias.The risk ratio for recurrence of pterygium using conjunctival autograft versus amniotic membrane transplant was 0.87 (95% confidence interval (CI) 0.43 to 1.77) and 0.53 (95% CI 0.33 to 0.85) at 3 months and 6 months, respectively. These estimates include participants with primary and recurrent pterygia. We performed a subgroup analysis to compare participants with primary pterygia with participants with recurrent pterygia. For participants with primary pterygia, the risk ratio was 0.92 (95% CI 0.37 to 2.30) and 0.58 (95% CI 0.27 to 1.27) at 3 months and 6 months, respectively. We were only able to estimate the recurrence of pterygia at 6 months for participants with recurrent pterygia, and the risk ratio comparing conjunctival autograft with amniotic membrane transplant was 0.45 (95% CI 0.21 to 0.99). One included study was a doctoral thesis and did not use allocation concealment. When this study was excluded in a sensitivity analysis, the risk ratio for pterygium recurrence at 6 months' follow-up was 0.43 (95% CI 0.30 to 0.62) for participants with primary and recurrent pterygium. One of the secondary outcomes, the proportion of participants with clinical improvement, was analyzed in only one study. This study reported clinical outcome as the risk of non-recurrence, which was seen in 93.8% of participants in the conjunctival limbal autograft group and 93.3% in the amniotic membrane transplant group at 3 months after surgery.We did not analyze data on the need for repeat surgery, vision-related quality of life, and direct and indirect costs of surgery due to an insufficient number of studies reporting these outcomes.Thirteen studies reported adverse events associated with conjunctival autograft surgery and amniotic membrane transplant surgery. Adverse events that occurred in more than one study were granuloma and pyogenic granuloma and increased intraocular pressure. None of the included studies reported that participants had developed induced astigmatism.
AUTHORS' CONCLUSIONS
In association with pterygium excision, conjunctival autograft is associated with a lower risk of recurrence at six months' after surgery than amniotic membrane transplant. Participants with recurrent pterygia in particular have a lower risk of recurrence when they receive conjunctival autograft surgery compared with amniotic membrane transplant. There are few studies comparing the two techniques with respect to visual acuity outcomes, and we identified no studies that reported on vision-related quality of life or direct or indirect costs. Comparison of these two procedures in such outcome measures bears further investigation. There were an insufficient number of studies that used adjunctive mitomycin C to estimate the effects on pterygium recurrence following conjunctival autograft or amniotic membrane transplant.
Topics: Amnion; Autografts; Conjunctiva; Humans; Pterygium; Randomized Controlled Trials as Topic; Recurrence; Time Factors
PubMed: 26867004
DOI: 10.1002/14651858.CD011349.pub2 -
BMC Ophthalmology Nov 2023Refractive errors are one of the most common ocular conditions among children and adolescents, with myopia showing an increasing prevalence and early onset in this... (Meta-Analysis)
Meta-Analysis
BACKGROUND
Refractive errors are one of the most common ocular conditions among children and adolescents, with myopia showing an increasing prevalence and early onset in this population. Recent studies have identified a correlation between refractive errors and ocular biometric parameters.
METHODS
A systematic search was conducted in electronic databases including PubMed, EMBASE, Cochrane Library, Web of Science, and Medline from January 1, 2012, to May 1, 2023. Various ocular biometric parameters were summarized under different refractive states, including axial length (AL), central corneal thickness (CCT), anterior chamber depth (ACD), lens thickness (LT), corneal curvature (CC), Corneal curvature radius (CR),axial length-to-corneal radius ratio (AL/CR ratio), choroidal thickness (ChT), retinal thickness (RT), retinal nerve fiber layer thickness (RNFL), and retinal blood density (VD). The differences in these parameters among different refractive states were analyzed using Stata software with fixed or random-effects models, taking into account the assessed heterogeneity level.
RESULTS
This meta-analysis included a total of 69 studies involving 128,178 eyes, including 48,795 emmetropic eyes, 60,691 myopic eyes, 13,983 hyperopic eyes, 2,040 low myopic eyes, 1,201 moderate myopic eyes, and 1,468 high myopic eyes. The results of our study demonstrated that, compared to the control group (emmetropic group), the myopic group and low, moderate, and high myopic groups showed significant increases in AL, AL/CR ratio, and ACD, while the hyperopic group exhibited significant decreases. Compared to the control group, the myopic group had a significantly increase for CC, while CR, CCT, perifoveal RT, subfoveal ChT, foveal ChT, parafoveal ChT, perifoveal (except nasal) ChT, and pRNFL (except temporal) significantly decreased. Compared to the control group, the hyperopic group had a significantly increase for subfoveal ChT, foveal ChT, parafoveal ChT, perifoveal ChT, and nasal pRNFL. Compared to the control group, the low and moderate myopic groups had a significantly decreases for the CCT, parafoveal RT (except nasal), perifoveal RT (except nasal), and pRNFL (except superior and temporal). Compared to the control group, the high myopic group had a significantly increase for CR, while LT, perifoveal ChT (except nasal), parafoveal RT, perifoveal RT, and pRNFL (except temporal) had significant decreased.
CONCLUSION
The changes of ocular biometric parameters in children and adolescents are closely related to refractive errors. Ocular biometric parameters devices, as effective non-invasive techniques, provide objective biological markers for monitoring refractive errors such as myopia.
Topics: Humans; Child; Adolescent; Tomography, Optical Coherence; Refractive Errors; Myopia; Retina; Refraction, Ocular; Hyperopia; Biometry
PubMed: 37990308
DOI: 10.1186/s12886-023-03222-7 -
PloS One 2016Chronic glaucoma is a multifactorial disease among which oxidative stress may play a major pathophysiological role. We conducted a systematic review and meta-analysis to... (Meta-Analysis)
Meta-Analysis Review
Chronic glaucoma is a multifactorial disease among which oxidative stress may play a major pathophysiological role. We conducted a systematic review and meta-analysis to evaluate the levels of oxidative and antioxidative stress markers in chronic glaucoma compared with a control group. The PubMed, Cochrane Library, Embase and Science Direct databases were searched for studies reporting oxidative and antioxidative stress markers in chronic glaucoma and in healthy controls using the following keywords: "oxidative stress" or "oxidant stress" or "nitrative stress" or "oxidative damage" or "nitrative damage" or "antioxidative stress" or "antioxidant stress" or "antinitrative stress" and "glaucoma". We stratified our meta-analysis on the type of biomarkers, the type of glaucoma, and the origin of the sample (serum or aqueous humor). We included 22 case-control studies with a total of 2913 patients: 1614 with glaucoma and 1319 healthy controls. We included 12 studies in the meta-analysis on oxidative stress markers and 19 on antioxidative stress markers. We demonstrated an overall increase in oxidative stress markers in glaucoma (effect size = 1.64; 95%CI 1.20-2.09), ranging from an effect size of 1.29 in serum (95%CI 0.84-1.74) to 2.62 in aqueous humor (95%CI 1.60-3.65). Despite a decrease in antioxidative stress marker in serum (effect size = -0.41; 95%CI -0.72 to -0.11), some increased in aqueous humor (superoxide dismutase, effect size = 3.53; 95%CI 1.20-5.85 and glutathione peroxidase, effect size = 6.60; 95%CI 3.88-9.31). The differences in the serum levels of oxidative stress markers between glaucoma patients and controls were significantly higher in primary open angle glaucoma vs primary angle closed glaucoma (effect size = 12.7; 95%CI 8.78-16.6, P < 0.001), and higher in pseudo-exfoliative glaucoma vs primary angle closed glaucoma (effect size = 12.2; 95%CI 8.96-15.5, P < 0.001). In conclusion, oxidative stress increased in glaucoma, both in serum and aqueous humor. Malonyldialdehyde seemed the best biomarkers of oxidative stress in serum. The increase of some antioxidant markers could be a protective response of the eye against oxidative stress.
Topics: Aged; Aqueous Humor; Biomarkers; Case-Control Studies; Chronic Disease; Female; Glaucoma, Angle-Closure; Glaucoma, Open-Angle; Glutathione Peroxidase; Humans; Male; Malondialdehyde; Middle Aged; Oxidative Stress; Superoxide Dismutase
PubMed: 27907028
DOI: 10.1371/journal.pone.0166915 -
The Cochrane Database of Systematic... Jan 2015Primary congenital glaucoma (PCG) manifests within the first few years of a child's life and is not associated with any other systemic or ocular abnormalities. PCG... (Review)
Review
BACKGROUND
Primary congenital glaucoma (PCG) manifests within the first few years of a child's life and is not associated with any other systemic or ocular abnormalities. PCG results in considerable morbidity even in developed countries. Several surgical techniques for treating this condition, and lowering the intraocular pressure (IOP) associated with it, have been described.
OBJECTIVES
To compare the effectiveness and safety of different surgical techniques for PCG.
SEARCH METHODS
We searched CENTRAL (which contains the Cochrane Eyes and Vision Group Trials Register) (The Cochrane Library 2014, Issue 6), Ovid MEDLINE, Ovid MEDLINE In-Process and Other Non-Indexed Citations, Ovid MEDLINE Daily, Ovid OLDMEDLINE (January 1946 to June 2014), EMBASE (January 1980 to June 2014), (January 1982 to June 2014), PubMed (January 1946 to June 2014), the metaRegister of Controlled Trials (mRCT) (www.controlled-trials.com), ClinicalTrials.gov (www.clinicaltrials.gov), the WHO International Clinical Trials Registry Platform (ICTRP) (www.who.int/ictrp/search/en). We did not use any date or language restrictions in the electronic searches for trials. We last searched the electronic databases on 23 June 2014.
SELECTION CRITERIA
We included all randomized and quasi-randomized trials in which different types of surgical interventions were compared in children under five years of age with PCG.
DATA COLLECTION AND ANALYSIS
We used standard methodological procedures specified by The Cochrane Collaboration.
MAIN RESULTS
We included a total of six trials (four randomized and two quasi-randomized) with 102 eyes in 61 children. Two trials were conducted in the USA and one trial each in Egypt, Israel, Lebanon and Saudi Arabia. All trials included children aged younger than one year when diagnosed with PCG, and followed them for periods ranging from six months to five years.No two trials compared the same pair of surgical interventions, so we did not perform any meta-analysis. One trial compared trabeculotomy versus goniotomy; a second trial compared combined trabeculectomy-trabeculotomy with mitomycin C versus trabeculectomy-trabeculotomy with mitomycin C and deep sclerectomy; a third trial compared combined trabeculotomy-trabeculectomy versus trabeculotomy; a fourth trial compared one goniotomy versus two goniotomies; a fifth trial compared trabeculotomy versus viscocanalostomy; and the sixth trial compared surgical goniotomy versus neodymium-YAG laser goniotomy. For IOP change and surgical success (defined by IOP achieved), none of the trials reported a difference between pairs of surgical techniques. However, due to the limited sample sizes for all trials (average of 10 children per trial), the evidence as to whether a particular surgical technique is effective and which surgical technique is better still remains uncertain. Adverse events, such as choroidal detachment, shallow anterior chamber and hyphema, were reported from four trials. None of the trials reported quality of life or economic data.These trials were neither designed nor reported well overall. Two trials were quasi-randomized trials and judged to have high risk of selection bias; four trials were at unclear or high risk for performance bias and detection bias; and we judged one trial to have high risk of attrition bias due to high proportions of losses to follow-up. Due to poor study design and reporting, the reliability and applicability of evidence remain unclear.
AUTHORS' CONCLUSIONS
No conclusions could be drawn from the trials included in this review due to paucity of data. More research is needed to determine which of the many surgeries performed for PCG are effective.
Topics: Child, Preschool; Glaucoma; Glaucoma Drainage Implants; Humans; Infant; Infant, Newborn; Mitomycin; Postoperative Complications; Randomized Controlled Trials as Topic; Sclera; Trabecular Meshwork; Trabeculectomy
PubMed: 25636153
DOI: 10.1002/14651858.CD008213.pub2 -
The Cochrane Database of Systematic... Feb 2013This is an update of a Cochrane review first published in The Cochrane Library in Issue 1, 2010.Ménière's disease is characterised by three major symptoms: vertigo,... (Meta-Analysis)
Meta-Analysis Review
BACKGROUND
This is an update of a Cochrane review first published in The Cochrane Library in Issue 1, 2010.Ménière's disease is characterised by three major symptoms: vertigo, deafness, and tinnitus or aural fullness, all of which are discontinuous and variable in intensity. A number of surgical modalities, of varying levels of invasiveness, have been developed to reduce the symptoms of Ménière's disease, but it is not clear whether or not these are effective.
OBJECTIVES
To assess the effectiveness of surgical options for the treatment of Ménière's disease. All surgical interventions used in the treatment of Ménière's disease, either to alter the natural history of the disease or to abolish vestibular function, were considered for this review.
SEARCH METHODS
We searched the Cochrane Ear, Nose and Throat Disorders Group Trials Register; the Cochrane Central Register of Controlled Trials (CENTRAL); PubMed; EMBASE; CINAHL; Web of Science; BIOSIS Previews; Cambridge Scientific Abstracts; ICTRP and additional sources for published and unpublished trials. The date of the most recent search was 7 November 2012.
SELECTION CRITERIA
Randomised or quasi-randomised controlled studies of a surgical modality versus a placebo therapy in Ménière's disease.
DATA COLLECTION AND ANALYSIS
Two authors independently assessed trial quality and extracted data. We contacted study authors for further information.
MAIN RESULTS
The only surgical intervention which has been evaluated in randomised controlled trials and met the inclusion criteria was endolymphatic sac surgery. We identified two randomised trials, involving a total of 59 patients; one comparing endolymphatic sac surgery with ventilation tubes and one with simple mastoidectomy. Neither study reported any beneficial effect of surgery either in comparison to placebo surgery or grommet insertion.
AUTHORS' CONCLUSIONS
The two trials included in this review provide insufficient evidence of the beneficial effect of endolymphatic sac surgery in Ménière's disease.
Topics: Endolymphatic Sac; Humans; Mastoid; Meniere Disease; Middle Ear Ventilation; Randomized Controlled Trials as Topic
PubMed: 23450562
DOI: 10.1002/14651858.CD005395.pub3 -
PloS One 2022Previous studies proposed possible applications of spectral-domain optical coherence tomography (SD-OCT) measurements in prognosticating pathologies observed in... (Meta-Analysis)
Meta-Analysis
BACKGROUND
Previous studies proposed possible applications of spectral-domain optical coherence tomography (SD-OCT) measurements in prognosticating pathologies observed in overweight/obesity, including ocular, vascular, and neurologic consequences. Therefore, we conducted a systematic review and meta-analysis to investigate the changes in the in SD-OCT measurements of the patients with higher body mass index (BMI) compared to normal weight individuals.
MATERIALS AND METHODS
We conducted a systematic search on PubMed, Scopus, and Embase. The search results underwent two-phase title/abstract and full-text screenings. We then analyzed SD-OCT measurements differences in patients with high BMI and controls, and performed meta-regression, sub-group analysis, quality assessment, and publication bias assessment. The measurements included macular thickness, cup to disc ratio, ganglion cell-inner plexiform layer (GC-IPL) and its sub-sectors, RNFL and peripapillary RNFL (pRNFL) and their sub-layers, and choroidal thickness and its sub-sectors.
RESULTS
19 studies were included in this meta-analysis accounting for 1813 individuals, 989 cases and 824 controls. There was an overall trend towards decreased thickness in high BMI patients, but only two measurements reached statistical significance: temporal retinal nerve fiber layer (RNFL) (Standardized mean difference (SMD): -0.33, 95% confidence interval (CI): -0.53 to -0.14, p<0.01) and the choroidal region 1.0 mm nasal to fovea (SMD: -0.38, 95% CI: -0.60 to -0.16, p<0.01).
CONCLUSION
Some ocular layers are thinner in patients with higher BMI than the controls. These SD-OCT measurements might correlate with adverse events related to increased body weight and have prognostic abilities. As SD-OCT is a robust, rapid and non-invasive tool, future guidelines and studies are needed to evaluate the possibility of their integration into care of the patients with obesity.
Topics: Cross-Sectional Studies; Humans; Nerve Fibers; Obesity; Retinal Ganglion Cells; Tomography, Optical Coherence
PubMed: 35476846
DOI: 10.1371/journal.pone.0267495 -
The Indian Journal of Medical Research Jul 2021In the current scenario, with availability of different surgical procedures for limbal stem cell deficiency (LSCD), there exists no common consensus as to the... (Review)
Review
BACKGROUND & OBJECTIVES
In the current scenario, with availability of different surgical procedures for limbal stem cell deficiency (LSCD), there exists no common consensus as to the standardization of the management protocol for the same. In addition, there also exists diversity in the views about the clinical diagnosis, ancillary investigations and clinical parameters. The objective of the present study was to evaluate the reported outcomes of surgical interventions for the management of LSCD.
METHODS
A systematic review of published literature on limbal stem cell transplantation (LSCT) was performed using Ovid Medline, Embase and PubMed for a duration of 2009 to 2019. Original studies including prospective, retrospective case series and randomized controlled trials, articles in English language, articles with access to full text and studies with more than or at least 10 patients were included in this review. Data related to clinical and visual outcomes were evaluated, and pool estimates of different surgeries were calculated using random-effects model and individually using Pearson's Chi-square test.
RESULTS
A total of 1133 abstracts were evaluated. Finally, 17 studies were included for the analysis. Among these 17 studies, direct limbal lenticule transplantation was performed in five studies, of which autologous tissue from the fellow eye [conjunctival limbal autograft (CLAU)], allograft from a cadaver/live donor [keratolimbal allograft (KLAL)/conjunctival limbal allograft (CLAL)] and combination of CLAU plus KLAL were done in one, three and one studies, respectively. The ex vivo expanded cultivated limbal epithelial transplantation (CLET) was reported in six studies and simple limbal epithelial transplantation (SLET) in four studies. Two were comparative studies comparing CLET and CLAL (living-related CLAL) with cadaveric KLAL, respectively. Outcome analysis of the included studies showed significant heterogeneity. Calculated pool rate for various types of surgeries was calculated. The pool estimate for CLAL was 67.56 per cent [95% confidence interval (CI), 41.75-93.36; I=83.5%, P=0.002]. For KLAL, this value was 63.65 per cent (95% CI, 31.38-95.91; I=92.4%, P=0.000). Pool estimate for CLET was 78.90 per cent (95% CI, 70.51-87.28; I=73.6%, P=0.001). Corresponding values for SLET were 79.08 per cent (95% CI, 74.10-84.07; I=0.0%, P=0.619). CLAU and combination of CLAU plus KLAL were done in one study each; hence, statistical analysis could not be done. The functional outcome in terms of gain in visual acuity post-operatively was better in KLAL (P<0.005) and SLET group as compared to CLET group.
INTERPRETATION & CONCLUSIONS
The present analysis suggests that though the anatomical success rates were almost identical between SLET, CLET, CLAL, and KLAL procedures, the functional success rates were better following KLAL and SLET procedures as compared to CLET. Decision for LSCT for cases of ocular burns based on either clinical judgement of the surgeon or individual diagnosis remains a suitable option.
Topics: Corneal Diseases; Humans; Limbus Corneae; Prospective Studies; Randomized Controlled Trials as Topic; Retrospective Studies; Stem Cell Transplantation; Stem Cells; Transplantation, Autologous
PubMed: 34782530
DOI: 10.4103/ijmr.IJMR_1139_18 -
Neurology Apr 2016We aimed to provide recommendations for addressing comorbidity in clinical trial design and conduct in multiple sclerosis (MS).
OBJECTIVE
We aimed to provide recommendations for addressing comorbidity in clinical trial design and conduct in multiple sclerosis (MS).
METHODS
We held an international workshop, informed by a systematic review of the incidence and prevalence of comorbidity in MS and an international survey about research priorities for studying comorbidity including their relation to clinical trials in MS.
RESULTS
We recommend establishing age- and sex-specific incidence estimates for comorbidities in the MS population, including those that commonly raise concern in clinical trials of immunomodulatory agents; shifting phase III clinical trials of new therapies from explanatory to more pragmatic trials; describing comorbidity status of the enrolled population in publications reporting clinical trials; evaluating treatment response, tolerability, and safety in clinical trials according to comorbidity status; and considering comorbidity status in the design of pharmacovigilance strategies.
CONCLUSION
Our recommendations will help address knowledge gaps regarding comorbidity that interfere with the ability to interpret safety in monitored trials and will enhance the generalizability of findings from clinical trials to "real world" settings where the MS population commonly has comorbid conditions.
Topics: Clinical Trials as Topic; Comorbidity; Humans; Multiple Sclerosis
PubMed: 26888986
DOI: 10.1212/WNL.0000000000002471