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Cataract surgery is one of the most common operations in health care. Femtosecond laser-assisted cataract surgery (FLACS) enables more precise ocular incisions and lens fragmentation than does phacoemulsification cataract surgery (PCS). We hypothesised that FLACS might improve outcomes in cataract surgery compared with PCS despite having higher costs. We did a participant-masked randomised superiority clinical trial comparing FLACS and PCS in two parallel groups (permuted block randomisation stratified on centres via a centralised web-based application, allocation ratio 1:1, block size of 2 or 4 for unilateral cases and 2 or 6 for bilateral cases). Five French University Hospitals enrolled consecutive patients aged 22 years or older who were eligible for unilateral or bilateral cataract surgery. Participants, outcome assessors, and technicians carrying out examinations were masked to the surgical treatment allocation until the last follow-up visit and a sham laser procedure was set up for participants randomly assigned to the PCS arm. The primary clinical endpoint was the success rate of surgery, defined as a composite of four outcomes at a 3-month postoperative visit: absence of severe perioperative complication, a best-corrected visual acuity (BCVA) of 0·0 LogMAR (logarithm of the minimum angle of resolution) or better, an absolute refractive error of 0·75 dioptres or less, and unchanged postoperative corneal astigmatism power (≤0·5 dioptres) and axis (≤20°). The primary economic endpoint was the incremental cost per additional patient who had treatment success at 3 months. Primary outcomes were assessed in all randomly assigned patients who met all eligibility criteria (missing data considered as failure). We used mixed logistic regression models or mixed linear regression models for statistical comparisons, adjusted on centres and whether cataract surgery was bilateral or unilateral. The study is registered with ClinicalTrials.gov, NCT01982006. Of the 907 patients (1476 eyes) randomly assigned between Oct 9, 2013, and Oct 30, 2015, 870 (704 eyes in FLACS group and 685 eyes in the PCS group) were analysed. We identified no significant difference in the success rate of surgery between the FLACS and PCS groups (FLACS: 41·1% [289 eyes]; PCS: 43·6% [299 eyes]); adjusted odds ratio 0·85, 95% CI 0·64–1·12, p=0·250). The incremental cost-effectiveness ratio was €10 703 saved per additional patient who had treatment success with PCS compared with FLACS. We observed no severe adverse events during the femtosecond laser procedure, and most of the complications in the FLACS group related to the primary outcome measures occurred during the phacoemulsification phase or postoperatively. Despite its advanced technology, femtosecond laser was not superior to phacoemulsification in cataract surgery and, with higher costs, did not provide an additional benefit over phacoemulsification for patients or health-care systems. French Ministry of Social Affairs and Health.

IntroductionWhile laser technology has expanded the armamentarium of treatment for various skin diseases during the past years, heterogeneity in study outcomes hampers comparability and appropriate evidence synthesis. Part of these issues can be addressed by developing a generic outcome set. Using the Delphi method, this study aims to seek consensus between key stakeholders on relevant generic outcomes (what to measure) for implementation in the international registry on Laser trEAtments in Dermatology (LEAD). The registry is focused on collecting research data on various laser treatments for skin disorders.Methods and analysisBy reviewing the literature and involvement of key stakeholder groups and adult patients in need or after laser surgery and health professionals, a preliminary list of outcomes will be generated and categorised into domains. Using these outcomes, an international three-round Delphi study will be performed to rate the importance of outcomes in the selection of a generic outcome set. Participants are allowed to provide new outcomes to the preliminary list for revisions during the first Delphi round. Finally, results will be discussed during a consensus meeting to agree on generic outcomes to be used in the LEAD registry.Ethics and disseminationAn ethics approval was not applicable (W19_290 # 18.336). The study is registered with the Cochrane Skin Core OUtcome Set INitiative) and the Core Outcome Measures in Effectiveness Trials initiative. Procedures will be conducted according to the Declaration of Helsinki. The findings will be disseminated through peer-reviewed publications and conference presentations.

PurposeThe Laser in Glaucoma and Ocular Hypertension (LiGHT) Trial aims to establish whether initial treatment with selective laser trabeculoplasty (SLT) is superior to initial treatment with topical medication for primary open-angle glaucoma (POAG) or ocular hypertension (OHT).DesignThe LiGHT Trial is a prospective, unmasked, multicentre, pragmatic, randomised controlled trial. 718 previously untreated patients with POAG or OHT were recruited at six collaborating centres in the UK between 2012 and 2014. The trial comprises two treatment arms: initial SLT followed by conventional medical therapy as required, and medical therapy without laser therapy. Randomisation was provided online by a web-based randomisation service. Participants will be monitored for 3 years, according to routine clinical practice. The target intraocular pressure (IOP) was set at baseline according to an algorithm, based on disease severity and lifetime risk of loss of vision at recruitment, and subsequently adjusted on the basis of IOP control, optic disc and visual field. The primary outcome measure is health-related quality of life (HRQL) (EQ-5D five-level). Secondary outcomes are treatment pathway cost and cost-effectiveness, Glaucoma Utility Index, Glaucoma Symptom Scale, Glaucoma Quality of Life, objective measures of pathway effectiveness, visual function and safety profiles and concordance. A single main analysis will be performed at the end of the trial on an intention-to-treat basis.ConclusionsThe LiGHT Trial is a multicentre, pragmatic, randomised clinical trial that will provide valuable data on the relative HRQL, clinical effectiveness and cost-effectiveness of SLT and topical IOP-lowering medication.Trial registration numberISRCTN32038223, Pre-results.

IntroductionLaser trabeculoplasty is an effective and widely used treatment for glaucoma. A new laser technology, the Eagle direct selective laser trabeculoplasty (DSLT) device, may provide automated, fast, simple, safe and effective laser treatment for glaucoma in a broader range of clinical settings. This trial aims to test the hypothesis that translimbal DSLT is effective and not inferior to selective laser trabeculoplasty (SLT) in reducing intraocular pressure (IOP) in open angle glaucoma (OAG).Methods and analysisThis is a multicentre, randomised, controlled, investigator-masked study. The primary efficacy outcome is intergroup difference in mean change from baseline IOP measured at 6 months. Secondary outcomes include mean percentage reduction in IOP at 3, 6 and 12 months; proportion of participants with at least 20% reduction in IOP from baseline at 6 months; change in ocular hypotensive medications at 12 months and evaluation of safety. Participants were aged >= 40 years with OAG, including exfoliative or pigmentary glaucoma, or ocular hypertension with untreated or washed out IOP 22–35 mm Hg. Treatments: DSLT: 120 shots, 3 ns, 400 µm spot size, energy 1.4–1.8 mJ delivered at the limbus over 2 s. SLT: approximately 100 shots, 3 ns, 400 µm spot size administered 360 degrees at the limbus using any gonioscopy lens, energy 0.3–2.6 mJ. A sample size of 164 is sufficient to detect a non-inferiority margin of 1.95 mm Hg for change from baseline IOP.Clinical trial registration number NCT03750201, ISRCTN14033075.

Abstract Context Radiofrequency ablation (RFA) seems to achieve a significantly larger nodule volume reduction rate (VRR) than laser ablation (LA) in benign nonfunctioning thyroid nodules (BNTNs) Objective To compare the efficacy and safety of both treatments at 12-month follow-up in patients with solid or predominantly solid BNTN. Methods This was a single-center, 12-month, randomized, superiority, open-label, parallel-group trial conducted in an outpatient clinic. Sixty patients with a solitary BNTN or dominant nodule characterized by pressure symptoms/cosmetic problems were randomly assigned (1:1 ratio) to receive either a single session of RFA or LA. Twenty-9 patients per group completed the study. The main outcome measures were VRR and proportion of nodules with more than 50% reduction (technical success rate). Results At 12 months, VRR was 70.9 ± 16.9% and 60.0 ± 19.0% in the RFA and LA groups, respectively (P = .024). This effect was confirmed in the linear regression model that was adjusted for age, sex, nodule baseline volume, and proportion of cellular components (RFA treatment: β = .390; P = .009). No significant between-group difference was observed in the technical success rate at 12 months after treatment. A statistically significant improvement was observed from the baseline to the 12-month follow-up for compression (RFA: 4.6 ± 2.6 and 1.3 ± 0.8, P < .001; and LA: 4.6 ± 2.1 and 1.6 ± 0.8, respectively, P < .001) and cosmetic (RFA: 3.4 ± 0.6 and 1.3 ± 0.5, P < .001; and LA: 3.4 ± 0.5 and 1.4 ± 0.6, P < .001) scores although the between-group differences were not significant. Conclusion RFA achieved a significantly larger nodule volume reduction at 12 months; however, the technical success rate was similar in the RFA and LA groups.

High-intensity laser therapy (HILT) has recently been incorporated into wound management therapeutic protocols (Mosca RC et al. (2019) Photobiomodulation Therapy for Wound Care: A Potent, Noninvasive, Photoceutical Approach. Adv Skin Wound Care 32(4):157–167. https://doi.org/10.1097/01.ASW.0000553600.97572.d2). Laser therapy is increasingly used as an adjunct to therapeutic interventions in clinical practice (Dundar U et al. (2015) Effect of high-intensity laser therapy in the management of myofascial pain syndrome of the trapezius: a double-blind, placebo-controlled study. Lasers Med Sci 30(1):325–332. https://doi.org/10.1007/s10103-014-1671-8). This study aimed to evaluate the efficacy of HILT and the potential benefits of incorporating co- interventions alongside HILT in wound management. The following databases were searched up to April 2023: Embase, MEDLINE, PubMed, and Cinahl, as well as manual searches. The search keywords included high- intensity laser therapy, high-power laser therapy, laser therapy, wound, ulcer, and wound healing. The primary measures were decreased wound surface area (WSA) and improved wound appearance (WA) or other objective wound assessment tools containing these two values. Six human studies investigating HILT in wound healing treatment and one animal study assessing the wound-healing effects of HILT in acute wounds of mice were selected (Thabet AAE, Mahran HG, Ebid AA, Alshehri MA. Effect of pulsed high intensity laser therapy on delayed caesarean section healing in diabetic women. J Phys Ther Sci.;30(4):570–575. doi:, Ebid AA, Thabet A, Helal O (2018) (2011) Efficacy of pulsed high intensity Nd: Yag Laser in Treatment of Chronic Diabetic Foot Ulcer. Energy for Health pp. 25–30); (Ebid AA, El-Kafy EM, Alayat MS (2013) Effect of pulsed Nd: YAG laser in the treatment of neuropathic foot ulcers in children with spina bifida: a randomized controlled study. Photomed Laser Surg 31(12):565–570. https://doi.org/10.1089/pho.2013.3533); (Hong SE et al. (2016) Effects of neodymium-yttrium-aluminum garnet (Nd: YAG) pulsed high-intensity laser therapy on full thickness wound healing in an experimental animal model. J Cosmet Laser Ther 18(8):432–437. https://doi.org/10.1080/14764172.2016.1202421); (Lu Q et al. (2021) Clinical effects of high-intensity laser therapy on patients with chronic refractory wounds: a randomised controlled trial. BMJ Open 11(7):e045866. https://doi.org/10.1136/bmjopen-2020-045866); (Pereira FLC et al. (2020) Use of a High-Power Laser for Wound Healing: A Case Report. J Lasers Med Sci 11(1):112–114. https://doi.org/10.15171/jlms.2020.19); (Thabet AAE et al. (2018) Effect of pulsed high intensity laser therapy on delayed caesarean section healing in diabetic women. J Phys Ther Sci 30(4):570–575. https://doi.org/10.1589/jpts.30.570); (Nussbaum EL, Baxter GD, Lilge L (2003) A Review of Laser Technology and Light-Tissue Interactions as a Background to Therapeutic Applications of Low Intensity Lasers and Other Light Sources. Phys Therapy Reviews 8(1):31–44. https://doi.org/10.1002/lsm.20769). This limited number of studies exhibited varying treatment parameters, blinding procedures, wound etiologies, irradiation protocols, and testing areas (Thabet AAE, Mahran HG, Ebid AA, Alshehri MA. Effect of pulsed high intensity laser therapy on delayed caesarean section healing in diabetic women. J Phys Ther Sci. ;30(4):570–575. doi:, Ebid AA, Thabet A, Helal O (2018) (2011) Efficacy of pulsed high intensity Nd: Yag Laser in Treatment of Chronic Diabetic Foot Ulcer. Energy for Health pp. 25–30); (Ebid AA, El-Kafy EM, Alayat MS (2013) Effect of pulsed Nd: YAG laser in the treatment of neuropathic foot ulcers in children with spina bifida: a randomized controlled study. Photomed Laser Surg 31(12):565–570. https://doi.org/10.1089/pho.2013.3533); (Hong SE et al. (2016) Effects of neodymium-yttrium-aluminum garnet (Nd: YAG) pulsed high-intensity laser therapy on full thickness wound healing in an experimental animal model. J Cosmet Laser Ther 18(8):432–437. https://doi.org/10.1080/14764172.2016.1202421); (Lu Q et al. (2021) Clinical effects of high-intensity laser therapy on patients with chronic refractory wounds: a randomised controlled trial. BMJ Open 11(7):e045866. https://doi.org/10.1136/bmjopen-2020-045866); (Pereira FLC et al. (2020) Use of a High-Power Laser for Wound Healing: A Case Report. J Lasers Med Sci 11(1):112–114. https://doi.org/10.15171/jlms.2020.19); (Thabet AAE et al. (2018) Effect of pulsed high intensity laser therapy on delayed caesarean section healing in diabetic women. J Phys Ther Sci 30(4):570–575. https://doi.org/10.1589/jpts.30.570); (Nussbaum EL, Baxter GD, Lilge L (2003) A Review of Laser Technology and Light-Tissue Interactions as a Background to Therapeutic Applications of Low Intensity Lasers and Other Light Sources. Phys Therapy Reviews 8(1):31–44. https://doi.org/10.1002/lsm.20769). All selected studies demonstrated favorable results in improving wound conditions (Thabet AAE, Mahran HG, Ebid AA, Alshehri MA. Effect of pulsed high intensity laser therapy on delayed caesarean section healing in diabetic women. J Phys Ther Sci. ;30(4):570–575. doi:, Ebid AA, Thabet A, Helal O (2018) (2011) Efficacy of pulsed high intensity Nd: Yag Laser in Treatment of Chronic Diabetic Foot Ulcer. Energy for Health pp. 25–30); (Ebid AA, El-Kafy EM, Alayat MS (2013) Effect of pulsed Nd: YAG laser in the treatment of neuropathic foot ulcers in children with spina bifida: a randomized controlled study. Photomed Laser Surg 31(12):565–570. https://doi.org/10.1089/pho.2013.3533); (Hong SE et al. (2016) Effects of neodymium-yttrium-aluminum garnet (Nd: YAG) pulsed high-intensity laser therapy on full thickness wound healing in an experimental animal model. J Cosmet Laser Ther 18(8):432–437. https://doi.org/10.1080/14764172.2016.1202421); (Lu Q et al. (2021) Clinical effects of high-intensity laser therapy on patients with chronic refractory wounds: a randomised controlled trial. BMJ Open 11(7):e045866. https://doi.org/10.1136/bmjopen-2020-045866); (Pereira FLC et al. (2020) Use of a High-Power Laser for Wound Healing: A Case Report. J Lasers Med Sci 11(1):112–114. https://doi.org/10.15171/jlms.2020.19); (Thabet AAE et al. (2018) Effect of pulsed high intensity laser therapy on delayed caesarean section healing in diabetic women. J Phys Ther Sci 30(4):570–575. https://doi.org/10.1589/jpts.30.570); (Nussbaum EL, Baxter GD, Lilge L (2003) A Review of Laser Technology and Light-Tissue Interactions as a Background to Therapeutic Applications of Low Intensity Lasers and Other Light Sources. Phys Therapy Reviews 8(1):31–44. https://doi.org/10.1002/lsm.20769). Although insufficient data support using HILT in wound management, the promising results encourage further research. HILT appears effective in wound healing, but more high-quality studies are needed to identify optimal laser protocols.

Poor central nervous system penetration of cytotoxic drugs due to the blood brain barrier (BBB) is a major limiting factor in the treatment of brain tumors. Most recurrent glioblastomas (GBM) occur within the peritumoral region. In this study, we describe a hyperthemic method to induce temporary disruption of the peritumoral BBB that can potentially be used to enhance drug delivery. Twenty patients with probable recurrent GBM were enrolled in this study. Fourteen patients were evaluable. MRI-guided laser interstitial thermal therapy was applied to achieve both tumor cytoreduction and disruption of the peritumoral BBB. To determine the degree and timing of peritumoral BBB disruption, dynamic contrast-enhancement brain MRI was used to calculate the vascular transfer constant (Ktrans) in the peritumoral region as direct measures of BBB permeability before and after laser ablation. Serum levels of brain-specific enolase, also known as neuron-specific enolase, were also measured and used as an independent quantification of BBB disruption. In all 14 evaluable patients, Ktrans levels peaked immediately post laser ablation, followed by a gradual decline over the following 4 weeks. Serum BSE concentrations increased shortly after laser ablation and peaked in 1-3 weeks before decreasing to baseline by 6 weeks. The data from our pilot research support that disruption of the peritumoral BBB was induced by hyperthemia with the peak of high permeability occurring within 1-2 weeks after laser ablation and resolving by 4-6 weeks. This provides a therapeutic window of opportunity during which delivery of BBB-impermeant therapeutic agents may be enhanced. ClinicalTrials.gov NCT01851733.

Purpose Holmium laser enucleation of the prostate (HoLEP) represents the current standard procedure for size-independent surgical therapy of benign prostatic obstruction (BPO). With advent of the novel laser technology thulium fiber laser (TFL), we hypothesized that the functional outcome of TFL enucleation of the prostate (ThuFLEP) is non-inferior compared to HoLEP. Methods From October 2021 to October 2022, 150 patients with BPO were recruited for the prospective randomized trial in accordance with CONSORT. Stratified randomization into the arms ThuFLEP ( n  = 74) or HoLEP ( n  = 76) was carried out. The primary endpoint was non-inferior international prostate symptom score (IPSS) and quality of life (QoL) at three months after treatment. Secondary endpoints were rates of complications, peak flow, residual urine and operation times. Results Preoperative characteristics showed no significant differences. Overall IPSS and QoL improved from 21 to 8 and 4 to 1.5, respectively, after three months of follow-up. No statistically significant differences between ThuFLEP and HoLEP were observed regarding median postoperative IPSS (8.5 vs. 7, p  > 0.9), QoL (1 vs. 2, p  = 0.6), residual urine (48 vs. 30ml, p  = 0.065) and peak flow (19 vs. 17ml/s, p  > 0.9). Similarly, safety profile was comparable with no statistically significant differences regarding rate of major complications (5.3 vs. 5.4%, p  = 0.5), laser hemostasis time (3 vs. 2min, p  = 0.2), use of additive electric coagulation (74 vs. 87%, p  = 0.06) or electric coagulation time (8 vs. 8min, p  = 0.4). Conclusions In this prospective, randomized trial ThuFLEP showed non-inferior results compared to HoLEP in terms of functional outcomes measured by IPSS and QoL as primary endpoint. Trial registration number DRKS00032699 (18.09.2023, retrospectively registered).

Background/AimsTo determine if selective laser trabeculoplasty (SLT) is superior to topical medication as a first-line treatment for glaucoma on quality of life (QoL) and clinical outcomes.MethodsIn this international, longitudinal, multisite randomised controlled trial, treatment naïve mild-to-moderate primary open angle or exfoliation glaucoma patients were randomised 1:1 to SLT or topical medication. Glaucoma-specific QoL (primary outcome) was measured using the Glaucoma Outcomes Assessment Tool (GOAT; 342 items, 12 domains). Secondary outcomes included rate of successful intraocular pressure (IOP) reduction (>25% reduction from baseline) and presence of ocular surface disease including conjunctival hyperaemia and eyelid erythema. Our intention-to-treat analysis was performed at months 12 and 24.ResultsOf 167 enrolled patients, 83 and 84 were randomised to SLT and topical medication, respectively; and 145 (n=75 SLT, n=70 medication) completed 24-month follow-up. While both treatment arms achieved significant within-group gains in GOAT outcomes at both endpoints, SLT patients reported a greater between-group improvement in ‘social well-being’ compared with medication patients (mean±SE=0.28±0.13; p=0.034) at 24 months. At month 24, the rate of successful IOP reduction was 18.6% (95% CI 3.0% to 34.3%, p=0.022) higher (absolute difference) in the medication compared with SLT group. More individuals in the medication group had conjunctival hyperaemia and eyelid erythema compared with SLT at 24 months.ConclusionOverall, we did not find evidence that SLT was superior to medication in improving glaucoma-specific QoL. While we found superior IOP reduction in the medication arm, eyelid erythema and conjunctival hyperaemia were more prevalent in these patients compared with the SLT group.Trial registrationACTRN12611000720910.

PurposeTo compare the perioperative and functional outcomes of holmium laser enucleation of the prostate (HoLEP) and thulium laser enucleation of the prostate (ThuLEP) for the treatment of large-volume benign prostatic hyperplasia (BPH) (> 80 ml).MethodsA total of 116 consecutive patients with BPH were randomized to be treated surgically with either HoLEP (n = 58) or ThuLEP (n = 58), following the classical three-lobe enucleation technique. Follow-up was assessed at 1, 3, 6, 12 and 18 months after surgery.ResultsAt 18 months, the lower urinary tract symptom index was improved significantly in both groups compared with the baseline values. The operative time (78.4 ± 8.0 vs. 71.4 ± 6.4 min) and enucleation time (61.2 ± 5.4 vs. 56.4 ± 8.4 min) were significantly shorter for ThuLEP compared to HoLEP (both p < 0.001). There were no significant differences between the two groups regarding morcellation time, resected weight, hemoglobin decrease, catheter time and hospital stay (p > 0.05). The HoLEP and ThuLEP groups had equivalent International Prostate Symptom Scores (3 [3–3] vs. 3 [3–3], p = 0.776), quality of life (1 [1–2] vs. 2 [1–2], p = 0.809), Qmax (25.3 ± 4.8 ml/s vs. 24.7 ± 4.4 ml/s, p = 0.470), postvoid residual urine (PVR) (6.1 [2.6–20.8] vs. 7.7 [3.1–22.8] ml, p = 0.449) and PSA (0.84 ± 0.32 vs. 0.90 ± 0.34 ml, p = 0.309) at 18 months postoperatively.ConclusionBoth HoLEP and ThuLEP relieve lower urinary tract symptoms in a comparable way with high efficacy and safety. ThuLEP was statistically superior to HoLEP in operation time and enucleation time, although the differences were clinically negligible.