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European Journal of Ophthalmology May 2023This article is about the accommodation spasm. The primary rule for near vision is ciliary muscle constriction, synchronised convergence of both eyes, and pupil... (Review)
Review
This article is about the accommodation spasm. The primary rule for near vision is ciliary muscle constriction, synchronised convergence of both eyes, and pupil constriction. Any weaknesses in these components could result in an accommodative spasm. Variable retinoscopic reflex, unstable refractive error, and lead of accommodation in near retinoscopy are common causes of spasm. We conducted a thorough literature search in the PubMed and Google Scholar databases for published journals prior to June 2022, with no data limitations. This review contains twenty-eight case reports, six cohort studies, four book references, four review articles, and two comparative studies after applying the inclusion and exclusion criteria. The majority of studies looked at accommodative spasm, near reflex spasm, and pseudomyopia. The most common causes of accommodative spasm are excessive close work, emotional distress, head injury, and strabismus. Despite side effects or an insufficient regimen, cycloplegic drops are effective in diagnosing accommodation spasm. The modified optical fogging technique is also effective and may be an option for treating accommodative spasm symptoms. Bifocals for near work, manifest refraction, base-in prisms, and vision therapy are some of the other management options. As a result, it requires a comprehensive clinical treatment strategy. This review aims to investigate the various aetiology and treatments responsible for accommodative spasm and proposes widely implementing the modified optical fogging method and vision therapy in clinics as comprehensive management to reduce the future upward trend of accommodative spasm.
Topics: Humans; Refractive Errors; Accommodation, Ocular; Spasm; Myopia; Mydriatics; Vision, Low
PubMed: 36384286
DOI: 10.1177/11206721221136438 -
The Cochrane Database of Systematic... Jul 2020This is an update of a Cochrane Review published in 2014. Chronic non-specific low back pain (LBP) has become one of the main causes of disability in the adult... (Meta-Analysis)
Meta-Analysis
BACKGROUND
This is an update of a Cochrane Review published in 2014. Chronic non-specific low back pain (LBP) has become one of the main causes of disability in the adult population around the world. Although therapeutic ultrasound is not recommended in recent clinical guidelines, it is frequently used by physiotherapists in the treatment of chronic LBP.
OBJECTIVES
The objective of this review was to determine the effectiveness of therapeutic ultrasound in the management of chronic non-specific LBP. A secondary objective was to determine the most effective dosage and intensity of therapeutic ultrasound for chronic LBP.
SEARCH METHODS
We performed electronic searches in CENTRAL, MEDLINE, Embase, CINAHL, PEDro, Index to Chiropractic Literature, and two trials registers to 7 January 2020. We checked the reference lists of eligible studies and relevant systematic reviews and performed forward citation searching.
SELECTION CRITERIA
We included randomised controlled trials (RCTs) on therapeutic ultrasound for chronic non-specific LBP. We compared ultrasound (either alone or in combination with another treatment) with placebo or other interventions for chronic LBP.
DATA COLLECTION AND ANALYSIS
Two review authors independently assessed the risk of bias of each trial and extracted the data. We performed a meta-analysis when sufficient clinical and statistical homogeneity existed. We determined the certainty of the evidence for each comparison using the GRADE approach.
MAIN RESULTS
We included 10 RCTs involving a total of 1025 participants with chronic LBP. The included studies were carried out in secondary care settings in Turkey, Iran, Saudi Arabia, Croatia, the UK, and the USA, and most applied therapeutic ultrasound in addition to another treatment, for six to 18 treatment sessions. The risk of bias was unclear in most studies. Eight studies (80%) had unclear or high risk of selection bias; no studies blinded care providers to the intervention; and only five studies (50%) blinded participants. There was a risk of selective reporting in eight studies (80%), and no studies adequately assessed compliance with the intervention. There was very low-certainty evidence (downgraded for imprecision, inconsistency, and limitations in design) of little to no difference between therapeutic ultrasound and placebo for short-term pain improvement (mean difference (MD) -7.12, 95% confidence interval (CI) -17.99 to 3.75; n = 121, 3 RCTs; 0-to-100-point visual analogue scale (VAS)). There was also moderate-certainty evidence (downgraded for imprecision) of little to no difference in the number of participants achieving a 30% reduction in pain in the short term (risk ratio 1.08, 95% CI 0.81 to 1.44; n = 225, 1 RCT). There was low-certainty evidence (downgraded for imprecision and limitations in design) that therapeutic ultrasound has a small effect on back-specific function compared with placebo in the short term (standardised mean difference -0.29, 95% CI -0.51 to -0.07 (MD -1.07, 95% CI -1.89 to -0.26; Roland Morris Disability Questionnaire); n = 325; 4 RCTs), but this effect does not appear to be clinically important. There was moderate-certainty evidence (downgraded for imprecision) of little to no difference between therapeutic ultrasound and placebo on well-being (MD -2.71, 95% CI -9.85 to 4.44; n = 267, 2 RCTs; general health subscale of the 36-item Short Form Health Survey (SF-36)). Two studies (n = 486) reported on overall improvement and satisfaction between groups, and both reported little to no difference between groups (low-certainty evidence, downgraded for serious imprecision). One study (n = 225) reported on adverse events and did not identify any adverse events related to the intervention (low-certainty evidence, downgraded for serious imprecision). No study reported on disability for this comparison. We do not know whether therapeutic ultrasound in addition to exercise results in better outcomes than exercise alone because the certainty of the evidence for all outcomes was very low (downgraded for imprecision and serious limitations in design). The estimate effect for pain was in favour of the ultrasound plus exercise group (MD -21.1, 95% CI -27.6 to -14.5; n = 70, 2 RCTs; 0-to-100-point VAS) at short term. Regarding back-specific function (MD - 0.41, 95% CI -3.14 to 2.32; n = 79, 2 RCTs; Oswestry Disability Questionnaire) and well-being (MD -2.50, 95% CI -9.53 to 4.53; n = 79, 2 RCTs; general health subscale of the SF-36), there was little to no difference between groups at short term. No studies reported on the number of participants achieving a 30% reduction in pain, patient satisfaction, disability, or adverse events for this comparison.
AUTHORS' CONCLUSIONS
The evidence from this systematic review is uncertain regarding the effect of therapeutic ultrasound on pain in individuals with chronic non-specific LBP. Whilst there is some evidence that therapeutic ultrasound may have a small effect on improving low back function in the short term compared to placebo, the certainty of evidence is very low. The true effect is likely to be substantially different. There are few high-quality randomised trials, and the available trials were very small. The current evidence does not support the use of therapeutic ultrasound in the management of chronic LBP.
Topics: Adult; Bias; Chronic Pain; Electric Stimulation Therapy; Exercise Therapy; Humans; Low Back Pain; Quality of Life; Randomized Controlled Trials as Topic; Ultrasonic Therapy
PubMed: 32623724
DOI: 10.1002/14651858.CD009169.pub3 -
Ophthalmology Oct 2018Presbyopia prevalence and spectacle-correction coverage were estimated by systematic review and meta-analysis of epidemiologic evidence, then modeled to expand to... (Meta-Analysis)
Meta-Analysis
TOPIC
Presbyopia prevalence and spectacle-correction coverage were estimated by systematic review and meta-analysis of epidemiologic evidence, then modeled to expand to country, region, and global estimates.
CLINICAL RELEVANCE
Understanding presbyopia epidemiologic factors and correction coverage is critical to overcoming the burden of vision impairment (VI) from uncorrected presbyopia.
METHODS
We performed systematic reviews of presbyopia prevalence and spectacle-correction coverage. Accepted presbyopia prevalence data were gathered into 5-year age groups from 0 to 90 years or older and meta-analyzed within World Health Organization global burden of disease regions. We developed a model based on amplitude of accommodation adjusted for myopia rates to match the regionally meta-analyzed presbyopia prevalence. Presbyopia spectacle-correction coverage was analyzed against country-level variables from the year of data collection; variation in correction coverage was described best by a model based on the Human Development Index, Gini coefficient, and health expenditure, with adjustments for age and urbanization. We used the models to estimate presbyopia prevalence and spectacle-correction coverage in each age group in urban and rural areas of every country in the world, and combined with population data to estimate the number of people with near VI.
RESULTS
We estimate there were 1.8 billion people (prevalence, 25%; 95% confidence interval [CI], 1.7-2.0 billion [23%-27%]) globally with presbyopia in 2015, 826 million (95% CI, 686-960 million) of whom had near VI because they had no, or inadequate, vision correction. Global unmet need for presbyopia correction in 2015 is estimated to be 45% (95% CI, 41%-49%). People with presbyopia are more likely to have adequate optical correction if they live in an urban area of a more developed country with higher health expenditure and lower inequality.
CONCLUSIONS
There is a significant burden of VI from uncorrected presbyopia, with the greatest burden in rural areas of low-resource countries.
Topics: Eyeglasses; Global Health; Humans; Presbyopia; Prevalence; Vision Disorders; Visual Acuity; Visually Impaired Persons
PubMed: 29753495
DOI: 10.1016/j.ophtha.2018.04.013 -
The Cochrane Database of Systematic... Apr 2020Acute low back pain (LBP) is a common health problem. Non-steroidal anti-inflammatory drugs (NSAIDs) are often used in the treatment of LBP, particularly in people with... (Meta-Analysis)
Meta-Analysis
BACKGROUND
Acute low back pain (LBP) is a common health problem. Non-steroidal anti-inflammatory drugs (NSAIDs) are often used in the treatment of LBP, particularly in people with acute LBP. In 2008, a Cochrane Review was published about the efficacy of NSAIDs for LBP (acute, chronic, and sciatica), identifying a small but significant effect in favour of NSAIDs compared to placebo for short-term pain reduction and global improvement in participants with acute LBP. This is an update of the previous review, focusing on acute LBP.
OBJECTIVES
To assess the effects of NSAIDs compared to placebo and other comparison treatments for acute LBP.
SEARCH METHODS
We searched CENTRAL, MEDLINE, Embase, PubMed, and two trials registers for randomised controlled trials (RCT) to 7 January 2020. We also screened the reference lists from relevant reviews and included studies.
SELECTION CRITERIA
We included RCTs that assessed the use of one or more types of NSAIDs compared to placebo (the main comparison) or alternative treatments for acute LBP in adults (≥ 18 years); conducted in both primary and secondary care settings. We assessed the effects of treatment on pain reduction, disability, global improvement, adverse events, and return to work.
DATA COLLECTION AND ANALYSIS
Two review authors independently selected trials to be included in this review, evaluated the risk of bias, and extracted the data. If appropriate, we performed a meta-analysis, using a random-effects model throughout, due to expected variability between studies. We assessed the quality of the evidence using the GRADE approach. We used standard methodological procedures recommended by Cochrane.
MAIN RESULTS
We included 32 trials, with a total of 5356 participants (age range 16 to 78 years). Follow-up ranged from one day to six months. Studies were conducted across the globe, the majority taking place in Europe and North-America. Africa and the Eastern Mediterranean region were not represented. We considered seven studies at low risk of bias. Performance and attrition were the most common biases. There was often a lack of information on randomisation procedures and allocation concealment (selection bias); studies were prone to selective reporting bias, since most studies did not register their trials. Almost half of the studies were industry-funded. There is moderate quality evidence that NSAIDs are slightly more effective in short-term (≤ 3 weeks) reduction of pain intensity (visual analogue scale (VAS), 0 to 100) than placebo (mean difference (MD) -7.29 (95% confidence interval (CI) -10.98 to -3.61; 4 RCTs, N = 815). There is high quality evidence that NSAIDs are slightly more effective for short-term improvement in disability (Roland Morris Disability Questionnaire (RMDQ), 0 to 24) than placebo (MD -2.02, 95% CI -2.89 to -1.15; 2 RCTs, N = 471). The magnitude of these effects is small and probably not clinically relevant. There is low quality evidence that NSAIDs are slightly more effective for short-term global improvement than placebo (risk ratio (RR) 1.40, 95% CI 1.12 to 1.75; 5 RCTs, N = 1201), but there was substantial heterogeneity (I² 52%) between studies. There is very low quality evidence of no clear difference in the proportion of participants experiencing adverse events when using NSAIDs compared to placebo (RR 0.86, 95% CI 0.63 to 1.18; 6 RCTs, N = 1394). There is very low quality evidence of no clear difference between the proportion of participants who could return to work after seven days between those who used NSAIDs and those who used placebo (RR 1.48, 95% CI 0.98 to 2.23; 1 RCT, N = 266). There is low quality evidence of no clear difference in short-term reduction of pain intensity between those who took selective COX-2 inhibitor NSAIDs compared to non-selective NSAIDs (mean change from baseline -2.60, 95% CI -9.23 to 4.03; 2 RCTs, N = 437). There is moderate quality evidence of conflicting results for short-term disability improvement between groups (2 RCTs, N = 437). Low quality evidence from one trial (N = 333) reported no clear difference between groups in the proportion of participants experiencing global improvement. There is very low quality evidence of no clear difference in the proportion of participants experiencing adverse events between those who took COX-2 inhibitors and non-selective NSAIDs (RR 0.97, 95% CI 0.63 to 1.50; 2 RCTs, N = 444). No data were reported for return to work.
AUTHORS' CONCLUSIONS
This updated Cochrane Review included 32 trials to evaluate the efficacy of NSAIDs in people with acute LBP. The quality of the evidence ranged from high to very low, thus further research is (very) likely to have an important impact on our confidence in the estimates of effect, and may change the estimates. NSAIDs seemed slightly more effective than placebo for short-term pain reduction (moderate certainty), disability (high certainty), and global improvement (low certainty), but the magnitude of the effects is small and probably not clinically relevant. There was no clear difference in short-term pain reduction (low certainty) when comparing selective COX-2 inhibitors to non-selective NSAIDs. We found very low evidence of no clear difference in the proportion of participants experiencing adverse events in both the comparison of NSAIDs versus placebo and selective COX-2 inhibitors versus non-selective NSAIDs. We were unable to draw conclusions about adverse events and the safety of NSAIDs for longer-term use, since we only included RCTs with a primary focus on short-term use of NSAIDs and a short follow-up. These are not optimal for answering questions about longer-term or rare adverse events.
Topics: Acute Pain; Adolescent; Adult; Aged; Anti-Inflammatory Agents, Non-Steroidal; Cyclooxygenase 2 Inhibitors; Disability Evaluation; Humans; Low Back Pain; Middle Aged; Pain Measurement; Placebos; Randomized Controlled Trials as Topic
PubMed: 32297973
DOI: 10.1002/14651858.CD013581 -
European Journal of Translational... Sep 2022The aim of this study was to identify the efficacy of drug agents for pharmacological Treatment of Presbyopia. Published research papers were reviewed using the relevant...
The aim of this study was to identify the efficacy of drug agents for pharmacological Treatment of Presbyopia. Published research papers were reviewed using the relevant terms in PubMed, Science direct, Google scholar, Medline, Google patent, Ovid, Cochrane Database of Systematic Reviews, Scopus. In the initial search, 2270 records were obtained. By removing duplicate articles and all articles that did not meet the inclusion criteria or were inappropriate due to indirect relevance to the subject, 44 studies were selected. It should be noted that all studies had inclusion criteria. There are a number of topical pharmacological agents available for treating presbyopia such as FOV Tears and PresbiDrop. They consist of parasympathetic agent and non-steroidal anti-inflammatory drugs (NSAIDs), to contract the ciliary and pupil muscle and restore the accommodation. Another example of topical pharmacological agent is EV06. It is a lens-softening eye drop which can affect the rigid lens in presbyopia. Currently there is no pharmacological agent available to treat presbyopia. Although there are limited number of peer-reviewed articles available, the outcome for future agents under investigation are promising.
PubMed: 36121117
DOI: 10.4081/ejtm.2022.10781 -
Annals of the New York Academy of... Dec 2019Accommodation disorders and nonstrabismic binocular dysfunctions affect patients' binocular system and visual performance. These visual disorders could be associated... (Meta-Analysis)
Meta-Analysis
Accommodation disorders and nonstrabismic binocular dysfunctions affect patients' binocular system and visual performance. These visual disorders could be associated with musculoskeletal discomfort in the neck and shoulder area. The purpose of this systematic review and meta-analysis was to ascertain the relationship between visual system disorders and the musculoskeletal system of the neck. The review protocol is available in PROSPERO (CRD42018112771). All articles selected examined the relationship between neck conditions (chronic neck pain and whiplash) and the visual system in adult populations. Studies with optometric or physiotherapeutic measurements were included. Bias risk was evaluated with the modified Cochrane Collaboration Tool and Study Quality Assessment Tool. To provide complete quality assessment evidence, the authors applied the GRADEpro Guideline Development Tool. The literature search was conducted in November 2018 and yielded 745 studies among all the databases. Out of these studies, 21 were finally included. Most of the studies presented a moderate methodological quality. Only one high-quality trial was found. Based on a qualitative assessment, our systematic review and meta-analysis revealed that all included studies established a relationship between the visual system and musculoskeletal system of the neck. However, the methods for the measurement of the visual system lacked uniformity.
Topics: Accommodation, Ocular; Adult; Chronic Pain; Humans; Musculoskeletal Diseases; Neck Pain; Optometry; Physical Therapy Modalities; Vision Disorders; Vision, Ocular; Whiplash Injuries
PubMed: 31432534
DOI: 10.1111/nyas.14224 -
Molecular Psychiatry Dec 2023To conduct a systematic review and meta-analysis assessing whether vision and/or eye disorders are associated with Autism Spectrum Disorder (ASD). (Meta-Analysis)
Meta-Analysis
AIM
To conduct a systematic review and meta-analysis assessing whether vision and/or eye disorders are associated with Autism Spectrum Disorder (ASD).
METHOD
Based on a pre-registered protocol (PROSPERO: CRD42022328485), we searched PubMed, Web of Knowledge/Science, Ovid Medline, Embase and APA PsycINFO up to 5 February 2022, with no language/type of document restrictions. We included observational studies 1) reporting at least one measure of vision in people of any age with a diagnosis of ASD based on DSM or ICD criteria, or ADOS; or 2) reporting the prevalence of ASD 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 49 studies in the narrative synthesis and 46 studies in the meta-analyses (15,629,159 individuals distributed across multiple different measures). We found meta-analytic evidence of increased prevalence of strabismus (OR = 4.72 [95% CI: 4.60, 4.85]) in people with versus those without ASD (non-significant heterogeneity: Q = 1.0545, p = 0.7881). We also found evidence of increased accommodation deficits (Hedge's g = 0.68 [CI: 0.28, 1.08]) (non-significant heterogeneity: Q = 6.9331, p = 0.0741), reduced peripheral vision (-0.82 [CI: -1.32, -0.33]) (non-significant heterogeneity: Q = 4.8075, p = 0.4398), reduced stereoacuity (0.73 [CI: -1.14, -0.31]) (non-significant heterogeneity: Q = 0.8974, p = 0.3435), increased color discrimination difficulties (0.69 [CI: 0.27,1.10]) (non-significant heterogeneity: Q = 9.9928, p = 0.1890), reduced contrast sensitivity (0.45 [CI: -0.60, -0.30]) (non-significant heterogeneity: Q = 9.9928, p = 0.1890) and increased retinal thickness (=0.29 [CI: 0.07, 0.51]) (non-significant heterogeneity: Q = 0.8113, p = 0.9918) in ASD.
DISCUSSION
ASD is associated with some self-reported and objectively measured functional vision problems, and structural alterations of the eye, even though we observed several methodological limitations in the individual studies included in our meta-analyses. Further research should clarify the causal relationship, if any, between ASD and problems of vision during early life.
PROSPERO REGISTRATION
CRD42022328485.
Topics: Autism Spectrum Disorder; Humans; Vision Disorders; Strabismus; Prevalence; Child; Male; Cross-Sectional Studies; Female
PubMed: 37495888
DOI: 10.1038/s41380-023-02143-7 -
Optometry and Vision Science : Official... Aug 2019This study reports prevalence data combined independently for accommodative dysfunction, convergence insufficiency, visual field loss, and visual acuity loss in patients... (Meta-Analysis)
Meta-Analysis
SIGNIFICANCE
This study reports prevalence data combined independently for accommodative dysfunction, convergence insufficiency, visual field loss, and visual acuity loss in patients with traumatic brain injury in the absence of eye injury.
OBJECTIVE
The objective of this study was to conduct a systematic review and meta-analysis to determine the prevalence rates of accommodative dysfunction, convergence insufficiency, visual field loss, and visual acuity loss in TBI patients without concomitant eye injury.
DATA SOURCES
The data sources used in this study were PubMed, EMBASE, EBSCO, and Cochrane Library.
STUDY APPRAISAL AND SYNTHESIS METHODS
Publications reporting the prevalence of diagnosed accommodative dysfunction, convergence insufficiency, visual field loss, or visual acuity loss to the level of legal blindness in TBI patients of any age were included. Univariate metaregression analyses and subgroup analyses were performed to account for statistical heterogeneity.
RESULTS
Twenty-two eligible publications were identified across the four visual conditions. Random-effects models yielded combined prevalence estimates: accommodative dysfunction (42.8; 95% confidence interval [CI], 31.3 to 54.7), convergence insufficiency (36.3%; 95% CI, 28.2 to 44.9%), visual field loss (18.2%; 95% CI, 10.6 to 27.1%), and visual acuity loss (0.0%; 95% CI, 0.0 to 1.1%). Metaregression and subgroup analyses revealed that visual field loss was significantly more prevalent in moderate to severe (39.8%; 95% CI, 29.8 to 50.3%) compared with mild TBI (6.6%; 95% CI, 0 to 19.5%).
CONCLUSIONS AND IMPLICATIONS OF KEY FINDINGS
This study demonstrates that accommodative dysfunction, convergence insufficiency, and visual field loss are common sequelae of TBI. Prospective longitudinal research with rigorous and uniform methodology is needed to better understand short- and long-term effects of TBI on the vision system.
Topics: Accommodation, Ocular; Brain Injuries, Traumatic; Humans; Ocular Motility Disorders; Vision Disorders; Visual Acuity; Visual Fields
PubMed: 31343512
DOI: 10.1097/OPX.0000000000001407 -
European Journal of Ophthalmology Jun 2017Over 8 million cataract surgeries are performed in the United States and the European Union annually, with many patients choosing to pay out of pocket for premium... (Review)
Review
PURPOSE
Over 8 million cataract surgeries are performed in the United States and the European Union annually, with many patients choosing to pay out of pocket for premium options including premium intraocular lens implants (IOLs) or laser-assisted cataract surgery (LACS). This report provides a systematic review evaluating patient-centered and visual quality outcomes comparing standard monofocal IOLs to premium cataract surgery options.
METHODS
PubMed and EMBASE were searched for publications published between January 1, 1980, and September 18, 2016, on multifocal, accommodative, and toric IOLs, monovision, and LACS, which reported on 1) dysphotopsias, 2) contrast sensitivity, 3) spectacle independence, 4) vision-related quality of life or patient satisfaction, and 5) IOL exchange.
RESULTS
Multifocal lenses achieved higher rates of spectacle independence compared to monofocal lenses but also had higher reported frequency of dysphotopsia and worse contrast sensitivity, especially with low light or glare. Accommodative lenses were not associated with reduced contrast sensitivity or more dysphotopsia but had only modest improvements in spectacle independence compared to monofocal lenses. Studies of monovision did not target a sufficiently myopic outcome in the near-vision eye to achieve the full potential for spectacle independence. Patients reported high levels of overall satisfaction regardless of implanted IOL. No studies correlated patient-reported outcomes with patient expectations.
CONCLUSIONS
Studies are needed to thoroughly compare patient-reported outcomes with concomitant patient expectations. In light of the substantial patient costs for premium options, patients and their surgeons will benefit from a better understanding of which surgical options best meet patients' expectations and how those expectations can be impacted by premium versus monofocal-including monovision-options.
Topics: Accommodation, Ocular; Cataract Extraction; Contrast Sensitivity; Eyeglasses; Humans; Lens Implantation, Intraocular; Lenses, Intraocular; Patient Satisfaction; Prosthesis Design; Quality of Life; Visual Acuity
PubMed: 28574135
DOI: 10.5301/ejo.5000978 -
The Cochrane Database of Systematic... Sep 2021Chronic deep venous insufficiency is caused by incompetent vein valves, blockage of large-calibre leg veins, or both; and causes a range of symptoms including recurrent... (Review)
Review
BACKGROUND
Chronic deep venous insufficiency is caused by incompetent vein valves, blockage of large-calibre leg veins, or both; and causes a range of symptoms including recurrent ulcers, pain and swelling. Most surgeons accept that well-fitted graduated compression stockings (GCS) and local care of wounds serve as adequate treatment for most people, but sometimes symptoms are not controlled and ulcers recur frequently, or they do not heal despite compliance with conservative measures. In these situations, in the presence of severe venous dysfunction, surgery has been advocated by some vascular surgeons. This is an update of the review first published in 2000.
OBJECTIVES
To assess the effects of surgical management of deep venous insufficiency on ulcer healing and recurrence, complications of surgery, clinical outcomes, quality of life (QoL) and pain.
SEARCH METHODS
The Cochrane Vascular Information Specialist searched the Cochrane Vascular Specialised Register, CENTRAL, MEDLINE, Embase and CINAHL databases, and the WHO ICTRP and ClinicalTrials.gov trials registries to 23 June 2020.
SELECTION CRITERIA
We considered randomised controlled trials (RCTs) of surgical treatment versus another surgical procedure, usual care or no treatment, for people with deep venous insufficiency.
DATA COLLECTION AND ANALYSIS
Two review authors independently assessed trials for inclusion, extracted data and assessed the risk of bias with the Cochrane risk of bias tool. We evaluated the certainty of the evidence using GRADE. We were unable to pool data due to differences in outcomes reported and how these were measured. Outcomes of interest were ulcer healing and recurrence, complications of surgery, clinical changes, QoL and pain.
MAIN RESULTS
We included four RCTs (273 participants) comparing valvuloplasty plus surgery of the superficial venous system with surgery of the superficial venous system for primary valvular incompetence. Follow-up was two to 10 years. All included studies investigated primary valve incompetence. No studies investigated other surgical procedures for the treatment of people with deep venous insufficiency or surgery for secondary valvular incompetence or venous obstruction. The certainty of the evidence was downgraded for risk of bias concerns and imprecision due to small numbers of included trials, participants and events. None of the studies reported ulcer healing or ulcer recurrence. One study included 27 participants with active venous ulceration at the time of surgery; the other three studies did not include people with ulcers. There were no major complications of surgery, no incidence of deep vein thrombosis and no deaths reported (very low-certainty evidence). All four studies reported clinical changes but the data could not be pooled due to different outcome measures and reporting of the data. Two studies assessed clinical changes using subjective and objective measurements, as specified in the clinical, aetiological, anatomical and pathophysiological (CEAP) classification score (low-certainty evidence). One study reported mean CEAP severity scores and one study reported change in clinical class using CEAP. At baseline, the mean CEAP severity score was 18.1 (standard deviation (SD) 4.4) for limbs undergoing external valvuloplasty with surgery to the superficial venous system and 17.8 (SD 3.4) for limbs undergoing surgery to the superficial venous system only. At three years post-surgery, the mean CEAP severity score was 5.2 (SD 1.6) for limbs that had undergone external valvuloplasty with surgery to the superficial venous system and 9.2 (SD 2.6) for limbs that had undergone surgery to the superficial venous system only (low-certainty evidence). In another study, participants with progressive clinical dynamics over the five years preceding surgery had higher rates of improvement in clinical condition in the treatment group (valvuloplasty plus ligation) compared with the control group (ligation only) (80% versus 51%) after seven years of follow-up. Participants with stable preoperative clinical dynamics demonstrated similar rates of improvement in both groups (95% with valvuloplasty plus ligation versus 90% with ligation only) (low-certainty evidence). One study reported disease-specific QoL using cumulative scores from a 10-item visual analogue scale (VAS) and reported that in the limited anterior plication (LAP) plus superficial venous surgery group the score decreased from 49 to 11 at 10 years, compared to a decrease from 48 to 36 in participants treated with superficial venous surgery only (very low-certainty evidence). Two studies reported pain. Within the QoL VAS scale, one item was 'pain/discomfort' and scores decreased from 4 to 1 at 10 years for participants in the LAP plus superficial venous surgery group and increased from 2 to 3 at 10 years in participants treated with superficial venous surgery only. A second study reported that 'leg heaviness and pain' was resolved completely in 36/40 limbs treated with femoral vein external valvuloplasty plus high ligation and stripping of the great saphenous vein (GSV) and percutaneous continuous circumsuture and 22/40 limbs treated with high ligation and stripping of GSV and percutaneous continuous circumsuture alone, at three years' follow-up (very low-certainty evidence).
AUTHORS' CONCLUSIONS
We only identified evidence from four RCTs for valvuloplasty plus surgery of the superficial venous system for primary valvular incompetence. We found no studies investigating other surgical procedures for the treatment of people with deep venous insufficiency, or that included participants with secondary valvular incompetence or venous obstruction. None of the studies reported ulcer healing or recurrence, and few studies reported complications of surgery, clinical outcomes, QoL and pain (very low- to low-certainty evidence). Conclusions on the effectiveness of valvuloplasty for deep venous insufficiency cannot be made.
Topics: Edema; Humans; Saphenous Vein; Stockings, Compression; Varicose Ulcer; Venous Insufficiency
PubMed: 34591328
DOI: 10.1002/14651858.CD001097.pub4