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This study aimed to investigate the efficacy and safety of quantum molecular resonance (QMR) electrotherapy in patients with dry eye disease (DED).
Methods
A systematic review with meta-analysis, reporting the effects of QMR electrotherapy in three databases, PubMed, Scopus and Web of Science, was performed according to the PRISMA statement with a search period ending on December 24, 2024.
Results
Seven studies, including four open-label, non-comparative trials and three randomized controlled studies (RCTs), were included. Although all studies reported significant improvements in most outcome measures after QMR electrotherapy, the meta-analysis indicated that overall efficacy did not significantly favor either group when comparing QMR electrotherapy to controls (SMD 0.40; 95% CI − 0.06 to 0.86; P = 0.09; I2 = 85%). However, only the change in DED symptoms was significantly favorable for QMR electrotherapy compared to controls (SMD 0.69; 95% CI 0.30–1.08; P = 0.0005; I2 = 28%). In sensitivity analyses, overall efficacy remained non-significant when comparing QMR electrotherapy to placebo QMR electrotherapy (SMD 0.14; 95% CI − 0.24 to 0.52; P = 0.46; I2 = 65%). Additionally, changes in DED symptoms, TBUT, ST, and CFS also showed no statistically significant differences between both groups. Regarding safety, most studies reported no AEs, with a satisfactory tolerability profile for QMR electrotherapy. However, a meta-analysis could not be performed.
Conclusions
With the current scientific literature available to date, QMR electrotherapy seems to show some evidence of alleviating DED symptoms. However, evidence supporting its efficacy in improving DED signs and safety remains limited. Therefore, further RCTs with robust designs are needed to confirm these findings.
Key Summary Points
Why carry out this study?
Given the high prevalence and significant impact of dry eye disease (DED) on patients’ quality of life, developing effective treatments is crucial. Quantum molecular resonance (QMR) electrotherapy represents a novel therapeutic approach for DED, which has shown promising results in several studies.
This study aims to synthesize the available evidence on the efficacy and safety of QMR electrotherapy in patients with DED.
What was learned from the study?
QMR electrotherapy has demonstrated effectiveness in alleviating the symptoms of DED. However, current evidence remains insufficient to confirm its impact on improving clinical signs of DED.
Further well-designed RCTs are needed to determine the efficacy and safety of QMR electrotherapy in patients with DED, while simultaneously stratifying populations by DED symptom severity and exploring the mechanisms underlying differential responses to elucidate the conditions in which QMR electrotherapy should be recommended.
Introduction
Dry eye disease (DED) is a multifactorial and chronic condition of the ocular surface that is characterized by a loss of homeostasis of the tear film, which results in tear film instability, hyperosmolarity, and inflammation [1‐3]. These pathological changes are often accompanied by corneal and conjunctival epithelial cell apoptosis [3‐5], leading to various ocular symptoms, such as foreign body sensation, burning, and visual disturbances, affecting patients’ quality of life [6‐10].
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DED may be classified in aqueous-deficient, evaporative, or mixed dry eye [1, 11]. However, evidence suggests that most forms of DED include an evaporative component, often associated with meibomian gland dysfunction (MGD), the most common cause of evaporative dry eye (EDE) [3, 12]. Traditional management of DED typically includes eyelid hygiene, artificial tears, warm compress, and anti-inflammatory agents [13, 14]. However, these therapies often provide only symptomatic relief and require continuous use, sometimes accompanied by adverse events (AEs) [15‐18]. Emerging devices and pharmacotherapies targeting the underlying mechanisms of DED such as microblepharoexfoliation, vectored thermal pulsation, intense pulsed light and low-level light therapy as well as ophthalmic solutions like cyclosporine, perfluorohexyloctane, and lotilaner have shown promise in recent studies [19‐25].
Quantum molecular resonance (QMR) electrotherapy (Resono Ophthalmic Inc., Italy) represents a novel therapeutic approach for DED. This technology has received CE marking approval and is distributed worldwide, highlighting its compliance with European safety and efficacy standards and its growing adoption in clinical practice. QMR electrotherapy employs low-intensity, high-frequency electrical currents (4 MHz) delivered through contact electrodes. This technology exerts a significant anti-inflammatory effect [26], and promotes cellular metabolism [27] and natural regeneration [28, 29]. QMR electrotherapy has been shown to inhibit COX-2 expression, reduce NF-κB activity, and promote the polarization of macrophages from the pro-inflammatory M1 phenotype to the anti-inflammatory M2 phenotype in an in vitro model of osteoarthritis-related inflammation [26]. These signaling pathways are also known to play a critical role in the pathophysiology of DED, where they contribute to the release of pro-inflammatory cytokines, chemokines, and adhesion molecules by innate immune cells onto the tear film, ultimately leading to ocular surface damage [30‐32]. Beyond its anti-inflammatory effects, QMR electrotherapy also influences cellular dynamics by modulating intra- and extracellular ion fluxes in chronic wounds [29], thereby altering the transmembrane potential of both stem cells and macrophages. This process enhances stem cell replication, generating a “mother cell” that retains its stemness and a “daughter cell” that undergoes differentiation [27]. The immune system subsequently directs the differentiated cells to repair non-functional ocular structures, restoring their physiological function [28, 29]. The therapeutic potential of stem cells in the treatment of DED has also been highlighted in several in vivo studies [33‐35]. Therefore, QMR electrotherapy might exert all these beneficial effects on the tear film and ocular surface, potentially contributing to the alleviation of signs and symptoms of DED.
Several studies have shown that four 20-min sessions of QMR electrotherapy, administered at 1-week intervals, lead to significant improvements in the signs and symptoms of different DED subtypes, including aqueous-deficient, evaporative, and mixed forms [36‐42]. Moreover, QMR electrotherapy has been reported to have a satisfactory tolerability profile [36‐42]. Despite these promising findings, no systematic review with meta-analysis has been conducted to comprehensively evaluate the efficacy and safety of QMR therapy in DED management. Therefore, this study aims to address this gap by synthesizing the available evidence on the efficacy and safety of QMR electrotherapy, offering evidence-based data to inform clinical practice and identify areas for future research.
Methods
Data Sources and Search Strategy
This systematic review with meta-analysis (PROSPERO ID: CRD42024627640) was performed according to the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) [43, 44]. A total of 65 articles published before December 25, 2024 were identified through the following databases: PubMed, Scopus, and Web of Science. The data search strategy with Boolean operators was as follows: (Quantum molecular resonance OR QMR OR Rexon eye) AND (Dry eye disease OR DED OR Evaporative dry eye OR EDE OR Meibomian gland dysfunction OR MGD OR aqueous-deficient dry eye OR ADDE OR Mixed dry eye OR MDE). The references of the retrieved articles were reviewed to identify other related studies if they met the inclusion criteria.
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Study Selection
All 65 articles identified through the search strategy were considered and analyzed. Duplicate studies were removed by Mendeley Reference Manager, version 2.127.1 (Elsevier Ltd., Amsterdam, Netherlands) [45]. The remaining studies underwent additional stages of screening, including title screening, abstract screening, and full-text screening. Studies unrelated to the topic were excluded during the title and abstract screenings. Full-text screening was conducted by a single investigator (ABS), who selected studies on the basis of the inclusion and exclusion criteria. The inclusion criteria were as follows: full-length prospective clinical studies, including single-arm trials and randomized controlled trials (RCTs). The inclusion criteria were as follows: full-length prospective clinical studies, including open-label, non-comparative trials and RCTs conducted in humans, that reported on the efficacy and safety of QMR electrotherapy in the treatment of DED. Exclusion criteria included publications in languages other than English and/or non-indexed journals. There were no restrictions placed on the country in which the study was performed, the follow-up period, the sample size, or results of the studies. The study selection process of this systematic review is summarized in Fig. 1.
Fig. 1
Flowchart study selection process according to the PRISMA statement
The data from each study were independently collected and summarized in tables created by one researcher (DB). The following information was extracted from each article: (1) author and publication year; (2) study design; (3) mean follow-up duration of all patients throughout the procedure (reported in months); (4) total number of patients; (5) mean age of the patients (reported in years); (6) sex distribution (male/female); (7) number of eyes involved; (8) study inclusion criteria; (9) intervention applied to the study group; (10) intervention applied to the control group (for RCTs only); and (11) conflicts of interest. Regarding the results, the following data were gathered: (1) DED symptoms (reported in points); (2) tear film breakup time (TBUT, reported in seconds); (3) Schirmer test (ST, reported in millimeters) and (4) corneal fluorescein staining (CFS, reported in points).
The literature that remained after full-text screening was examined to assess the quality of the studies. To assess the risk of bias, two authors (CRDL and GRT) created a synopsis using either the methodological index for non-randomized studies (MINORS) tool [46] or the Cochrane risk of bias for randomized trials (RoB) tool [47]. The MINORS tool evaluates the methodological quality of non-randomized trials across the following domains: (1) a clearly stated aim, (2) inclusion of consecutive patients, (3) prospective collection of data, (4) endpoints appropriate to the aim of the study, (5) unbiased assessment of the study endpoint, (6) follow-up period appropriate to the aim of the study, (7) loss to follow-up less than 5%, and (8) prospective calculation of the study size. Each domain is scored as 0 (not reported), 1 (reported but inadequate), or 2 (reported and adequate), with a total score of 16 points indicating optimal methodological quality. The RoB tool evaluates the methodological quality of RCTs across the following domains: (1) random sequence generation, (2) allocation concealment, (3) masking of participants and personnel, (4) masking of outcome assessment, (5) incomplete outcome data, (6) selective reporting, and (7) other sources of bias. Each domain includes one or more signaling questions, which guide judgments categorized as “Low risk of bias”, “Unclear risk of bias”, or “High risk of bias”. A third non-masked assessor (JMSG) decided the quality of the studies when disagreements occurred between the two assessors.
Data Synthesis and Analysis
The data were categorized into two sections: (1) open-label, non-comparative trials evaluating the efficacy and safety of QMR electrotherapy; and (2) RCTs comparing the efficacy and safety of QMR electrotherapy versus controls. In terms of study outcome measures, intragroup outcome measures were reported within each section, while intergroup outcome measures were exclusively reported in Sect. “QMR Electrotherapy in Randomized Controlled Trials”. It was indicated whether both intragroup and intergroup differences were statistically significant based on the statistical analysis performed by the authors of each study. Intragroup outcome measures were presented as “Last visit − Baseline differences”, while intergroup outcome measures were reported as “QMR electrotherapy (Last visit − Baseline) − Control (Last visit − Baseline)”.
Additionally, a meta-analysis was performed to synthesize the intergroup outcome measures of the RCTs included in this systematic review using RevMan Web, version 5.7 (The Cochrane Collaboration, Oxford, UK) [48]. This meta-analysis was conducted with the aim of synthesizing the available evidence on the efficacy and safety of QMR electrotherapy in DED. In cases where different data measurement methods were employed across studies, standardized mean differences (SMD) were calculated to analyze continuous parameters such as DED symptoms, TBUT, ST, and CFS [49]. The SMD quantifies the magnitude of the intervention effect in each study relative to the within-study variability, enabling the results to be compared on a standardized scale [49]. In cases where no differences in data measurement methods existed across studies, the mean difference (MD) was calculated [49]. The absolute value of the MD was interpreted alongside the P value and 95% confidence intervals (CI) presented in the forest plots. A P value < 0.05 was considered statistically significant. Heterogeneity among the studies was evaluated using the Cochrane Q-statistics chi-square (χ2) test and the I-square (I2) test, with values below 50% considered low heterogeneity [50]. In the presence of significant heterogeneity (I2 ≥ 50% or χ2 test P < 0.1), a random effects model was employed to pool the data, while a fixed effects model was used when heterogeneity was low [51, 52]. A sensitivity analysis was conducted to assess the robustness and stability of the results, as well as to account for potential heterogeneity [53]. Given that the intervention protocol was consistent across all RCTs, this analysis included exclusively the RCTs with similar methodology, specifically (1) masked studies; (2) 1-month follow-up period; (3) four 20-min sessions of QMR electrotherapy (intervention); and (4) four 20-min sessions of sham QMR electrotherapy (control). The sensitivity analysis was applied in meta-analyses that included at least two studies, ensuring that the exclusion of any single study or adjustment of assumptions did not compromise the reliability of the overall results [54]. More detailed information on the data synthesis and analysis is provided in Fig. 2.
The study was registered in PROSPERO (ID: CRD42024627640) to promote transparency, help reduce potential for bias, and avoid unintended duplication of reviews. This article is based on previously conducted studies and does not contain any new studies with human participants or animals performed by any of the author.
Results
Study Characteristics
The main DED questionnaires and tests performed in the included studies are presented Table 1.
Table 1
Main DED questionnaires and tests performed in the studies included
CCRLU: Center for Contact Lens Research Unit, DED: dry eye disease, NIBUT: non-invasive tear film breakup time, NR: not reported, OSDI: Ocular Surface Disease Index, TBUT: tear film breakup time, SPEED: Standard Patient Evaluation of Eye Dryness, ST: Schirmer test, CFS: corneal fluorescein staining
aOSDI (0–100 points); SPEED (0–28 points)
bTBUT with fluorescein was assessed using a slit lamp, while NIBUT was evaluated with an Oculus Keratograph 5M (Oculus, Wetzlar, Germany)
cThe ST strip was placed into the lower temporal lid margin of each eye of the participant. Subjects were instructed to close their eyes. After 5 min, the Schirmer strip was removed. The length of the moistened area was recorded in millimeters for each eye separately
dModified Oxford grading scale (0–5 points); CCLRU system (0–20 points); and scale based on the dots of staining (0–6 points): 0 points = 0 dots, 1 point = 1–5 dots, 2 points = 6–30 dots, and 3 points 30 dots. Additional extra points are collected for patches of confluent staining (+ 1 point), staining in the pupillary area (+ 1 point), and the presence of one or more filaments (+ 1 point)
Open-Label, Non-comparative Trials
This systematic review included four open-label, non-comparative trials [36‐39] published between 2016 and 2023, involving 148 eyes from 121 patients with a mean age of 57.0 ± 14.3 years. The sex distribution was 97 female patients (80.2%) and 24 male patients (19.8%). Patient follow-up, expressed in months, ranged from 1 to 12 months, with a mean follow-up of 3.8 ± 5.5 months. Regarding the study group interventions, all studies applied QMR electrotherapy using the settings recommended by the manufacturer. Specifically, three studies performed four 20-min sessions, using the following settings: an average power of 12 W, with a voltage of 60 V and a current of 200 mA between the mask electrodes and the neutral plate electrode. In contrast, one study conducted twelve 20-min sessions, applying a voltage of 80 V. Two studies reported conflicts of interest as they were supported by the device’s manufacturer [37, 38]. A more detailed description of the study characteristics is listed in Table 2.
CFS: corneal fluorescein staining, CoI: conflict of interest, FU: follow-up, M/F: male/female, MG: meibomian gland, NIBUT: non-invasive tear film breakup time, OSDI: Ocular Surface Disease Index, QMR: quantum molecular resonance, ST: Schirmer test, TBUT: tear film breakup time
aExpressed in months
bExpressed as mean ± standard deviation
Randomized Controlled Trials
This systematic review included three RCTs [40‐42] published between 2023 and 2024, involving 201 eyes from 161 patients with a mean age of 63.6 ± 11.2 years. The sex distribution was 121 female patients (75.2%) and 40 male patients (24.8%). Patient follow-up, expressed in months, ranged from 1 to 3 months, with a mean follow-up of 1.7 ± 1.2 months. Regarding the study group interventions, all studies performed four 20-min sessions of QMR electrotherapy, using the following settings recommended by the manufacturer: an average power of 12 W, with a voltage of 60 V and a current of 200 mA between the mask electrodes and the neutral plate electrode. However, the control group received four 20-min sessions of placebo QMR, with the device set to zero power during the treatment or tear substitute containing 0.15% sodium hyaluronate and 3% trehalose (Thealoz Duo, Thea Pharma, France) four times daily. All studies reported no conflicts of interest. A more detailed description of the study characteristics is listed in Table 3.
Table 3
Summary of included RCTs comparing QMR electrotherapy vs. control
QMR Electrotherapy in Open-Label, Non-comparative Trials
Efficacy outcome measures are shown in Table 4. Overall, the studies reported significant improvements in most outcome measures after QMR electrotherapy. Pedrotti et al. [36] reported significant reduction in DED symptoms (− 13.1 ± 17.6 points, P = 0.001) and CFS (− 0.5 ± 0.5 points, P = 0.014), as well as significant increases in TBUT (2.2 ± 3.4 s, P = 0.007) and ST (4.0 ± 5.8 mm, P < 0.050). Similar trends were observed by Ferrari et al. [37], with significant decrease in DED symptoms (− 15.3 ± 22.2 points, P < 0.001) and CFS (− 0.8 ± 0.5 points, P < 0.001), along with significant improvements in TBUT (1.8 ± 1.1 s, P < 0.001) and ST (1.5 ± 5.0 mm, P = 0.010). Trivli et al. [38] also reported significant reduction in DED symptoms (− 11 ± 22.9 points, P = 0.013). and CFS (− 0.8 ± 0.8 points, P = 0.002), alongside significant increase in TBUT (2.8 ± 3.7 s, P < 0.001). However, no significant changes were observed in ST (0.4 ± 5.3 mm, P = 0.675). Kavroulaki et al. [39] reported the smallest reduction in DED symptoms (− 3.2 ± 0.6 points, P < 0.010) and did not report significant changes in TBUT (0.0 ± 0.2 s, P = 0.891).
Table 4
Baseline, last visit, and difference in dry eye outcomes following QMR electrotherapy in open-label, non-comparative trials
CFS: corneal fluorescein staining, DED: dry eye disease, TBUT: tear film breakup time, NR: not reported, QMR: quantum molecular resonance, ST: Schirmer test
aDefined as “Last visit − Baseline”
bOcular Surface Disease Index (OSDI, 0–100 points)
cModified Oxford grading scale (0–5 points)
*Statistical significance with a P value < 0.05
Regarding QMR electrotherapy safety, Pedrotti et al. [36] reported that two patients experienced transient erythema following the first application of treatment, while one patient reported general discomfort during the first session of treatment. In contrast, Trivli et al. [38] observed that all patients showed a high tolerability profile for QMR electrotherapy and no AEs were reported. Similarly, Ferrari et al. [37] and Kavroulaki et al. [39] reported no AEs after QMR electrotherapy.
QMR Electrotherapy in Randomized Controlled Trials
Intragroup and intergroup efficacy outcome measures are shown in Table 5. Regarding intragroup outcome measures, Ballesteros-Sánchez et al. [41] reported that QMR electrotherapy led to significant reduction in DED symptoms (− 23.3 ± 16.5 points, P = 0.020) and CFS (− 1.6 ± 0.6 points, P = 0.010), as well as an increase in TBUT (1.7 ± 1.5 s, P = 0.010). In the control group, significant improvements were observed in TBUT (3.0 ± 1.6 s, P = 0.010) and CFS (− 0.4 ± 0.5 points, P = 0.040), whereas changes in DED symptoms (− 10.9 ± 10.8 points, P > 0.060) were not significant. Shemer et al. [42] also reported significant reductions in DED symptoms (− 8.7 ± 7.8 points, P < 0.001) and CFS (− 1.2 ± 2.3 points, P = 0.045) after QMR electrotherapy, while non-significant changes were observed in TBUT (1.6 ± 4.1 s, P = 0.112) and ST (0.9 ± 5.0 mm, P = 0.433). However, the control group reported non-significant changes in DED symptoms (1.1 ± 9.4 points, P = 0.830), TBUT (− 0.5 ± 3.3 s, P = 0.549), ST (1.7 ± 6.7 mm, P = 0.289), and CFS (0.3 ± 1.9 points, P = 0.500). Foo et al. [40] also observed significant improvements after QMR electrotherapy, with a reduction in DED symptoms (− 1.7 ± 4.2 points, P = 0.031). However, non-significant changes were observed in non-invasive tear film breakup time (NIBUT) (1.1 ± 4.3 s, P = 0.259), ST (− 0.2 ± 5.5 mm, P = 0.789), and CFS (− 0.1 ± 2.7 points, P = 0.703). Similarly, the control group reported significant reduction in DED symptoms (− 0.3 ± 7.4 points, P = 0.008), while non-significant changes were observed in NIBUT (0.7 ± 2.3 s, P = 0.353), ST (0.8 ± 5.5 mm, P = 0.407), and CFS (− 0.2 ± 1.3 points, P = 0.551). Regarding intergroup outcome measures, Foo et al. [40] and Shemer et al. [42] found favorable results for QMR electrotherapy in reducing DED symptoms, with values of − 1.4 points (P = 0.040) and − 9.8 points (P = 0.002), respectively. Additionally, Shemer et al. [42] reported that QMR electrotherapy was more effective than the control in reducing CFS, with a value of − 1.5 points (P < 0.044).
In terms of QMR electrotherapy safety, Ballesteros-Sánchez et al. [41] observed no significant changes in best-corrected visual acuity, intraocular pressure, slit-lamp biomicroscopy, or dilated funduscopy following QMR electrotherapy. Moreover, no AEs were documented during the study. Similarly, Foo [40] and Shemer et al. [42] reported the absence of AEs, as well as no significant changes in best-corrected visual acuity during the follow-up period (Table 5).
Table 5
Intragroup and intergroup differences in dry eye outcomes of QMR electrotherapy vs. control
cFoo et al. [40] used the Standard Patient Evaluation of Eye Dryness questionnaire (SPEED, 0–28 points), while Ballesteros-Sánchez et al. [41] and Shemer et al. [42] used the Ocular Surface Disease Index (OSDI, 0–100 points).
dFoo et al. [40] used the non-invasive tear film breakup time (NIBUT), while Ballesteros-Sánchez et al. [41] and Shemer et al. [42] used TBUT with fluorescein
eFoo et al. [40] used the Center for Contact Lens Research Unit (CCLRU) system (0–20 points), Ballesteros-Sánchez et al. [41] used the modified Oxford grading scale (0–5 points), and Shemer et al. [42] used a scale based on the dots of staining (0–6 points): 0 points = 0 dots, 1 point = 1–5 dots, 2 points = 6–30 dots, and 3 points 30 dots. Additional extra points are collected for patches of confluent staining (+ 1 point), staining in the pupillary area (+ 1 point), and the presence of one or more filaments (+ 1 point)
*Statistical significance with a P value < 0.05
Meta-analysis
Forest plot showing the results of the meta-analysis is presented in Fig. 3. Three studies were included in the meta-analysis. The overall efficacy did not favor either group (SMD 0.40; 95% CI − 0.06 to 0.86; P = 0.090; I2 = 85%). However, only the change in DED symptoms (SMD 0.69; 95% CI 0.30–1.08; P < 0.001; I2 = 28%) indicated that QMR electrotherapy had significantly better outcome than the control groups. In the sensitivity analysis, overall efficacy was also not in favor of either group (SMD 0.14; 95% CI − 0.24 to 0.52; P = 0.460; I2 = 65%). In addition, the change in DED symptoms (SMD 0.55; 95% CI − 0.06 to 1.16; P = 0.080; I2 = 44%), TBUT (SMD − 0.13; 95% CI − 1.49 to 1.22; P = 0.850; I2 = 89%), ST (SMD − 0.17; 95% CI − 0.61 to 0.28; P = 0.460; I2 = 0%), and CFS (SMD 0.33; 95% CI − 0.40 to 1.05; P = 0.380; I2 = 62%) showed no statistical significance between the two groups.
Fig. 3
Overall efficacy of quantum molecular resonance (QMR) electrotherapy compared to the control groups. Forest plot showing the standardized mean difference (SMD), 95% confidence intervals (CI), and P value for the change in DED symptoms (points), tear film breakup time (TBUT, seconds), Schirmer test (ST, millimeters), and corneal fluorescein staining (CFS, points). A random effects model was performed, revealing no statistically significant difference between QMR electrotherapy and the control group. To assess DED symptoms, Foo et al. [40] used the Standard Patient Evaluation of Eye Dryness (SPEED) questionnaire (0–28 points), while Ballesteros-Sánchez et al. [41] and Shemer et al. [42] used the Ocular Surface Disease Index (0–100 points). To assess TBUT, Foo et al. [40] used the non-invasive tear film breakup time, while Ballesteros-Sánchez et al. [41] and Shemer et al. [42] used TBUT with fluorescein. To assess CFS, Foo et al. [40] used the Center for Contact Lens Research Unit (CCLRU) system (0–20 points), Ballesteros-Sánchez et al. [41] used the modified Oxford grading scale (0–5 points), and Shemer et al. [42] used a scale based on the dots of staining (0–6 points): 0 points = 0 dots, 1 point = 1–5 dots, 2 points = 6–30 dots, and 3 points 30 dots. Additional extra points are collected for patches of confluent staining (+ 1 point), staining in the pupillary area (+ 1 point), and the presence of one or more filaments (+ 1 point)
The risk of bias summary for the open-label, non-comparative trials is presented in Table 6. All studies, except Kavroulaki et al. [39], achieved a MINORS score greater than 8 points. In addition, the average MINORS score for the included studies was 10.8 ± 2.9 points.
Each domain is scored as 0 (not reported), 1 (reported but inadequate), or 2 (reported and adequate), with a total score of 16 points indicating optimal methodological quality
D domain, D1 a clearly stated aim, D2 inclusion of consecutive patients, D3 prospective collection of data, D4 endpoints appropriate to the aim of the study, D5 unbiased assessment of the study endpoint, D6 follow-up period appropriate to the aim of the study, D7 loss to follow-up less than 5%, D8 prospective calculation of the study size
Randomized Controlled Trials
The risk of bias summary for the RCTs is presented in Fig. 4a. The risk of bias assessment was categorized into three evidence levels: (1) studies with a low risk of bias (Shemer et al. [42]), (2) studies with an unclear risk of bias (Foo et al. [40] and Ballesteros-Sánchez et al. [41]), and (3) studies with a high risk of bias (none). The overall summary of the risk of bias across the domains assessed in each study is shown in Fig. 4b. The items used to evaluate the risk of bias indicated that more than 50% of the overall risk of bias was unclear.
Fig. 4
Risk of bias assessment. a) Risk of bias summary of the included studies with traffic light plot. The traffic lights represent the authors’ risk of bias judgment in each domain (D) used to assess the quality of the studies. b) Overall risk of bias summary of the domains with bar plot. Bars represent the overall authors’ risk of bias judgment in each domain presented as percentages
DED is a multifactorial disease of the ocular surface that affects up to 30% of adults over 50, especially women, and its prevalence increases with age [1, 2]. In recent years, novel in-office treatments targeting the underlying mechanisms of DED have emerged, showing promising results in improving both symptoms and signs of DED [19‐22]. Among these, QMR electrotherapy represents an innovative approach. Therefore, this systematic review with meta-analysis aimed to investigate the efficacy and safety of eyelid QMR electrotherapy in patients with DED.
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Regarding QMR electrotherapy efficacy, the meta-analysis showed that overall efficacy did not favor either group when comparing QMR electrotherapy to controls. This result may be explained by the variability in the severity of DED symptoms among the included RCTs, suggesting that QMR electrotherapy could be more effective in patients with severe DED symptoms. Consistent with this hypothesis, Ballesteros-Sánchez et al. [41] was the only to include patients with severe DED symptoms (OSDI score between 33 and 100 points), reporting the most favorable outcome measures. In contrast, Shemer et al. [42] and Foo et al. [40] focused on patients with mild (OSDI score between 13 and 22 points) and moderate (SPEED score between 5 and 8 points) DED symptoms, respectively. Further insights were obtained from the sensitivity analysis, which was restricted to studies with similar methodologies to address heterogeneity. Specifically, Foo et al. [40] and Shemer et al. [42] conducted masked studies evaluating the same intervention (QMR electrotherapy) with a negative control (sham QMR electrotherapy) over a 1-month follow-up period. Although Ballesteros-Sánchez et al. [41] investigated the same intervention (QMR electrotherapy), their study followed an open-label design, included a positive control group (artificial tears), and extended the follow-up period to 3 months. As a result of these methodological differences, this study was excluded from the sensitivity analysis. This analysis revealed a reduction in overall efficacy, with the effect size decreasing from 1.96 (P = 0.090; I2 = 85%) to 0.75 (P = 0.460; I2 = 65%). Additionally, improvements in DED symptoms that initially favored QMR electrotherapy lost statistical significance, with the effect size also decreasing from 3.49 (P < 0.001; I2 < 50%) to 1.76 (P = 0.080; I2 < 50%). Open-label, non-comparative trials reinforce this trend. Pedrotti et al. [36], Ferrari et al. [37], and Trivli et al. [38] included patients with severe DED symptoms (OSDI score between 33 and 100 points), reporting significant improvements in most of the outcome measures. In contrast, Kavroulaki et al. [39] included patients with no DED symptoms (OSDI score between 0 and 12 points), showing the smallest outcomes measures. Overall, these findings indicate that QMR electrotherapy could be potentially effective in patients with severe DED symptoms, emphasizing the importance of tailoring treatment approaches to DED symptoms severity. Therefore, future research should aim to stratify patient populations by symptom severity and further investigate the mechanisms driving these differential responses to elucidate the contexts in which QMR electrotherapy should be recommended.
It is also important to mention some aspects regarding the design of the RCTs included in this review. The study by Ballesteros-Sánchez et al. [41] used a positive control group (artificial tears). Therefore, it is expected to have an effect on the signs and symptoms of DED [55]. However, patients who received QMR electrotherapy reported greater improvements in the signs and symptoms of DED compared to this control group. Artificial tears are the first-line treatment for DED [13]. However, they provide only temporary relief of DED symptoms in most case [16]. The lack of blinding in this study may have influenced the results, as patients receiving QMR electrotherapy might have expected greater improvements as they were receiving a novel treatment. Similarly, patients who received artificial tear might have felt that they would not experience as much improvement compared to those receiving QMR electrotherapy. To avoid such patient suggestions and potential biases in the results, it is crucial to implement blinding in clinical trials [56]. This could be achieved by ensuring both groups receive similar treatments, such as comparing QMR electrotherapy vs. sham QMR electrotherapy combined with artificial tears. In line with this, Foo et al. [40] and Shemer et al. [42] included a negative control group (sham QMR electrotherapy). Therefore, no effects on the signs and symptoms of DED would be expected [55]. However, the sensitivity analysis did not reveal statistically significant results favoring either treatment. This raises questions about the potential placebo effect of sham QMR electrotherapy. Nevertheless, these studies reported that patients who received QMR electrotherapy experienced greater improvements in DED symptoms and TBUT compared to those receiving sham QMR electrotherapy. Therefore, the lack of statistical significance is more likely due to the limited number of studies rather than a placebo effect.
Despite the low overall efficacy observed in the meta-analysis, the benefits of QMR electrotherapy reported in the studies included in this systematic review may be explained by its mechanism of action. It is hypothesized that electrical stimulation of the ethmoidal nerve by QMR electrotherapy could modulate the activity of the meibomian glands, leading to improved tear film stability [20, 41]. Aligned with this hypothesis, Ferrari et al. [37] reported a significant improvement in meibomian gland expressibility and quality, with increases of 12.5% (P < 0.001) and 35.7% (P < 0.001), respectively. Similar results were observed by Trivli et al. [38], who found a significant improvement of 33% (P = 0.001) and 50% (P < 0.001) in MG expressibility and quality, respectively. These findings are further supported by the results of Kavroulaki et al. [39] and Ballesteros-Sánchez et al. [41], which demonstrated a significant increase in the lipid layer thickness of 4.8 ± 2 nm (P = 0.021), and 10.8 ± 2.4 nm (P = 0.002), respectively. However, the effects of QMR electrotherapy on the morphology of the meibomian glands remain unclear, as no significant changes were reported in the studies included in this systematic review [38, 39]. On the other hand, it is also theorized that QMR electrotherapy may exert anti-inflammatory effects by decreasing leukocyte infiltration in tissues and regulating the expression of metalloproteinases. These enzymes are widely recognized as potential biomarkers for tear film osmolarity [57]. Recent Trivli et al. [38] reported a significant reduction of 75% in metalloproteinases levels (P = 0.003). Additionally, Ballesteros-Sánchez et al. [41] observed a significant decrease in osmolarity of − 17.4 ± 2.5 mOsm/L (P < 0.001), resulting in a mean value below the 308 mOsm/L threshold, which is the diagnostic cutoff value for DED [58, 59].
Regarding QMR electrotherapy safety, most studies reported no AEs, and the treatment tolerability profile was satisfactory. Pedrotti et al. [36] was the only study to report mild cutaneous transitory erythema following the first application of QMR electrotherapy. This AE may be explained by the use of a voltage of 80 V in their study, whereas the other studies employed a voltage of 60 V. However, erythema resolved spontaneously, without recurrences during the following sessions of treatment. Despite its safety profile, special caution should be exercised when it is applied in patients with implanted medical devices, oncological conditions, or during pregnancy [36‐42]. Furthermore, it is important to mention that most studies did not provide detailed data on AEs, best-corrected visual acuity, intraocular pressure, corneal sensitivity, slit-lamp biomicroscopy, or dilated funduscopy. Consequently, a meta-analysis could not be performed. This highlights the need for future studies to rigorously evaluate safety parameters, such as ocular and non-ocular treatment-emergent AEs, as well as treatment-related AEs, reporting the results as frequencies (n) and percentages (%) [60]. This information will allow for a more precise determination of its benefit–risk profile.
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Strengths and Limitations
To the best of our knowledge, this is the first systematic review and meta-analysis to evaluate the efficacy of QMR electrotherapy in patients with DED. However, this study has certain limitations that should be acknowledged. Differences in inclusion and exclusion criteria between the included studies, as well as the variability in study designs and intervention protocols, may have influenced the overall findings. This lack of standardized selection criteria, treatment regimens, and follow-up periods, combined with the inclusion of only three studies in the meta-analysis and an overall risk of bias that remained unclear in more than 50%, may significantly affect the results and limit the reliability of the comparative analysis. Moreover, although the studies included 201 eyes from 161 patients, the high prevalence of DED in the general population and the distribution of eyes among the study groups reduced the sample size in each group, potentially diminishing the statistical power. Nevertheless, this study included patients from diverse countries and ethnicities, such as Italy, Greece, Israel, and Singapore. Moreover, none of the included studies were funded or supported by the device manufacturer, reducing the potential for bias related to financial conflicts of interest. It is also important to mention that the meta-analysis did not include variables related to meibomian gland function, as RCTs primarily assessed MGD grade, which was reported as an ordinal variable. Therefore, future research should include meibum-related continuous variables, such as meibomian gland yielding secretion score, meibomian gland yielding liquid secretion, and meibomian gland yielding clear secretion [61]. Given these limitations, the results should be interpreted with caution. Therefore, further RCTs that rigorously adhered to the Consolidated Standards of Reporting Trials guidelines are needed to better evaluate the long-term efficacy and safety of QMR electrotherapy in patients with DED [62].
Conclusion
On the basis of the data included in the meta-analysis, QMR electrotherapy is an effective treatment to reduce DED symptoms. However, there is still insufficient evidence to suggest that this treatment option is able to improve DED signs, such as TBUT, ST, and CFS. Despite these findings, the results should be approached with consideration due to the heterogeneity of the RCTs regarding DED symptom severity and the overall unclear risk of bias. Therefore, further well-designed RCTs are needed to determine the efficacy and safety of QMR electrotherapy in patients with DED, while simultaneously stratifying populations by DED symptom severity and exploring the mechanisms underlying differential responses to elucidate the conditions in which QMR electrotherapy should be recommended.
Medical writing/Editorial Assistance
The authors declare that no medical writing or editorial assistance, including AI tools, was employed in the preparation of this manuscript.
Declarations
Conflict of Interest
Antonio Ballesteros-Sánchez is an Editorial Board member of Ophthalmology and Therapy. Antonio Ballesteros-Sánchez was not involved in the selection of peer reviewers for the manuscript nor any of the subsequent editorial decisions. The authors, Carlos Rocha-de-Lossada, José-María Sánchez-González, Giovanni Roberto Tedesco and Davide Borroni declare that they have no conflict of interest relevant to the content of this article.
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Ethical Approval
The study was registered in PROSPERO (ID: CRD42024627640) to promote transparency, help reduce potential for bias, and avoid unintended duplication of reviews. This article is based on previously conducted studies and does not contain any new studies with human participants or animals performed by any of the author.
Open Access This article is licensed under a Creative Commons Attribution-NonCommercial 4.0 International License, which permits any non-commercial use, sharing, adaptation, distribution and reproduction in any medium or format, as long as you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons licence, and indicate if changes were made. The images or other third party material in this article are included in the article's Creative Commons licence, unless indicated otherwise in a credit line to the material. If material is not included in the article's Creative Commons licence and your intended use is not permitted by statutory regulation or exceeds the permitted use, you will need to obtain permission directly from the copyright holder. To view a copy of this licence, visit http://creativecommons.org/licenses/by-nc/4.0/.
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Wenn ein Speiserest die Atemwege blockiert, zählt jede Minute. Um gravierende neurologische Schäden zu vermeiden, sollten vor allem ältere Menschen in die Notaufnahme gebracht werden – selbst wenn der Übeltäter bereits entfernt wurde. Das verdeutlicht eine Studie aus Japan.
Deutschland ist ein Koloskopieland. Doch ist das eine gute Idee? Oder würde der Stuhltest ausreichen, um Darmkrebs im frühen Stadium zu erkennen? Prof. Markus M. Lerch und Prof. Ulrike Denzer diskutieren die Vor- und Nachteile der Screening-Verfahren. Außerdem gibt die Endoskopie-Expertin Prof. Denzer Tipps, wie suspekte Darmpolypen effektiv erkannt und abgetragen werden können.
Je höher der BMI, umso höher ist das Risiko, bei einer Infektion zu sterben. Das gilt nicht nur für Covid-19, sondern für Infektionen allgemein. Bei einer Grad-III-Adipositas ist die Mortalität während einer Infektion sogar verdreifacht. Darauf deuten Daten aus Finnland und Großbritannien.
Periphere Fazialisparesen sollten nicht vorschnell als idiopathisch klassifiziert werden. Vor allem bei atypischen Manifestationen gilt es, auf dem Quivive zu sein. Der Fall einer 73-Jährigen zeigt, warum.
