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"Laser Therapy - adverse effects"
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Femtosecond laser-assisted versus phacoemulsification cataract surgery (FEMCAT): a multicentre participant-masked randomised superiority and cost-effectiveness trial
2020
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.
Journal Article
Efficacy of Intravitreal Bevacizumab for Stage 3+ Retinopathy of Prematurity
by
Chuang, Alice Z
,
Mintz-Hittner, Helen A
,
Kennedy, Kathleen A
in
Angiogenesis Inhibitors - adverse effects
,
Angiogenesis Inhibitors - therapeutic use
,
Antibodies, Monoclonal - adverse effects
2011
In this trial, one intravitreal injection of bevacizumab was administered to treat retinopathy of prematurity of stage 3+. Bevacizumab was more effective than conventional laser therapy in preventing recurrence of neovascularization in infants with zone I but not zone II posterior retinopathy.
Retinopathy of prematurity is a neovascular retinal disorder of childhood that causes loss of vision by means of macular dragging and retinal detachment. It is a leading cause of childhood blindness in the United States and other highly industrialized nations, occurring primarily in infants of low birth weight (≤1250 g; mean, 700 g).
1
The incidence of blindness in infants due to retinopathy of prematurity is relatively low, about 1 case in 820 infants,
2
because of good neonatal care and appropriate screening and treatment.
1
The disorder is a major cause of childhood blindness in developing countries, manifesting in larger premature infants . . .
Journal Article
A clinical experience of thulium fibre laser in miniperc to dust with suction: a new horizon
2021
PurposeTo report safety and efficacy of mini-PCNL with suction attached to sheath combined with high-power Thulium Fibre laser (TFL). The secondary aim was to evaluate optimal laser settings for maximum stone dusting.Materials and methodsProspective, single arm study was conducted from June 2019–December 2019 using miniPCNL with suction and TFL in 54 patients with renal stones < 3 cm. Stone fragments for each laser setting were independently retrieved and segregated according to size(< 1 mm,1-3 mm, > 3 mm) and weighed. Xray/CT scan imaging was performed in all patients within 48 h and 30 days to assess stone clearance. Optimal laser settings were evaluated for maximum dusting.ResultsMean stone size was 18.32 ± 6.37 mm, volume was 2337.75 ± 1996.84mm3 and stone density was 1300.55 ± 435.32 HU. Total operative time was 39.85 ± 20.52 min, laser time was 10.08 ± 7.41 min and stone fragmentation rate was 5.02 ± 3.93 mm3/s. The procedure was completely tubeless in 37.04%, nephrostomy tube in 37.04% and DJ stent placed in 25.92%. Postoperatively, three patients had urinary infection (Clavien 2). Complete stone clearance at 48 h was achieved in 35 (64.8%) cases. 19 patients (35.2%) who had residual fragments at 48 h, had 100% clearance at one month on CT/Xray KUB.ConclusionsMiniPCNL using a nephrostomy sheath with suction along with high power Thulium Fibre Laser is safe and effective modality for lithotripsy. An initial laser setting of 0.2 J and 125–200 Hz was optimal for maximum dusting and simultaneous aspiration. Randomized comparative studies with other energy sources are being considered.
Journal Article
A Randomized Trial Comparing Treatments for Varicose Veins
by
Ramsay, Craig R
,
Baker, Sara A
,
Francis, Jill
in
Ablation
,
Adult
,
Biological and medical sciences
2014
This trial of varicose-vein treatments showed no substantial differences in quality of life 6 months after ultrasound-guided foam sclerotherapy, endovenous laser ablation, or surgery, but disease-specific quality of life was slightly worse after foam treatment than after surgery.
Ultrasound-guided foam sclerotherapy and thermal ablation techniques such as endovenous laser ablation have become widely used alternatives to surgery for the treatment of varicose veins. Previous randomized trials and meta-analyses have shown these treatments to be effective in terms of short-term technical success and clinician-reported outcomes.
1
–
19
Clinical practice guidelines recommend the use of patient-reported quality of life to assess the outcomes of treatment of varicose veins.
20
Quality of life was a primary outcome measure in two small randomized trials that compared surgery and endovenous laser ablation,
5
,
9
but to our knowledge, it has not been assessed as a primary . . .
Journal Article
Efficacy of Carboxytherapy Mask in Post‐Fractional Ablative Laser Recovery: A Randomized Pilot Trial
by
Carvajal, Catherine
,
Dayan, Steven
,
McGinn, Lander
in
Aged
,
Carbon Dioxide - administration & dosage
,
Carbon Dioxide - adverse effects
2025
Background Fractional ablative CO2 lasers are widely used for skin rejuvenation but are associated with post‐procedural erythema, crusting, tenderness, and downtime. Carboxytherapy masks, a modality utilizing carbon dioxide, have been suggested to enhance healing and aesthetic outcomes post CO2 laser treatment; however, controlled clinical data remain limited. Objective To evaluate the efficacy and safety of a topical carboxytherapy mask in enhancing recovery, reducing adverse effects, and improving patient satisfaction following fractional ablative CO2 laser treatment. Methods Ten subjects (aged 45–70 years, Fitzpatrick skin types I–III) undergoing full‐face fractional CO2 laser resurfacing were enrolled in this randomized pilot study. Participants were assigned to either the active arm (n = 8, carboxytherapy mask was applied pre‐ and post‐procedure and at designated intervals for 14 days) or placebo arm (n = 2, bland moisturizer). Outcomes included blinded investigator assessments of erythema, edema, crusting, healing rate, pigmentation, and wrinkle severity at Days 28 and 84; patient‐reported diaries of discomfort and healing parameters; and self‐assessments of satisfaction and global aesthetic improvement. Results The active group demonstrated reduced erythema during the first week (mean scores: Day 1, 3.1 vs. 3.5; Day 7, 0.6 vs. 1.0 for placebo). By Day 7, healing surface area averaged 97% in the active group with no crusting. At Day 28, the active group exhibited fewer fine and coarse lines (mean coarse line score 2 vs. 4 in placebo). At Day 84, coarse line reduction and abnormal pigmentation improvement favored the active group (0.75 vs. 1.5, respectively). Patient‐reported tenderness, burning, and crusting were consistently lower in the active group, with higher satisfaction and confidence scores at both Day 28 and 84. No adverse effects were reported. Conclusion In this pilot study, the carboxytherapy mask enhanced post‐laser healing, reduced erythema and discomfort, and improved long‐term wrinkle and pigmentation outcomes compared to placebo. These findings support the adjunctive use of the carboxytherapy mask to improve recovery and patient satisfaction after ablative CO2 laser resurfacing. Larger, controlled trials are warranted to confirm these results.
Journal Article
Efficacy and Safety of Combined Topical Lidocaine and Tetracaine Cream for Facial Fractional Laser Resurfacing Compared With Its Reference Product in Chinese Adults: A Multicenter, Randomized, Double‐Blind Phase 3 Study
by
Lin, Xiaoxi
,
Wang, Haiying
,
Zhao, Yi
in
Administration, Cutaneous
,
Adult
,
Anesthetics, Local - administration & dosage
2025
Background As a potentially effective anesthetic, CU‐30101 is comprised of 7% lidocaine and 7% tetracaine and is a generic drug of Pliaglis. This study aimed to investigate the equivalence between CU‐30101 and Pliaglis as topical anesthetics for fractional laser. Methods This Phase 3 trial recruited Chinese adults scheduled for facial fractional laser resurfacing. Participants were randomized to receive opposite treatment sequences of CU‐30101 and Pliaglis on contralateral sides of the face prior to laser application. Visual Analog Scale (VAS), participant and investigator satisfaction ratings, local tolerability, and safety were assessed. Results Two hundred eighty‐four participants completed the study, with mean VAS scores of 35.3 ± 24.51 for CU‐30101 and 37.3 ± 24.17 for Pliaglis. The 95% confidence interval of −3.78 to −0.13 for the VAS difference laid within the predefined equivalence margin of ±4.7, confirming equivalence in efficacy. The results in the per‐protocol set further corroborated the equivalence. Both participants and investigators expressed consistently high satisfaction with CU‐30101 and Pliaglis. Furthermore, both treatments were well tolerated and exhibited favorable safety profiles. Conclusion This study demonstrated the equivalent efficacy of CU‐30101 to its reference product, Pliaglis, among Chinese adults undergoing facial fractional laser resurfacing. CU‐30101 showed commendable local tolerability and safety profiles, consistent with those of Pliaglis.
Journal Article
Nd:YAG laser therapy on postoperative pain, swelling, and trismus after mandibular third molar surgery: a randomized double-blinded clinical study
2023
This study aims to evaluate the effect of Nd:YAG laser therapy (NdLT) on postoperative pain, swelling, and trismus after mandibular third molar (M3) surgery. Three hundred patients were randomly divided into the Nd group (n = 100), medication group (n = 100), and Nd+medication (Nd+m) group (n = 100). The WHARFE classification system was used to assess surgical difficulty. After surgery, the Nd group was irradiated by the Nd:YAG laser in very long-pulsed mode (VLP, pulse duration 1 ms, 20 Hz, 4 W, R21-C3) in 6 regions of the extraction socket with a total energy of 300 J. For the medication group, dexamethasone 0.75 mg and loxoprofen 60 mg were prescribed immediately and every 12 h thereafter for 3 days. The Nd+m group received both treatments mentioned above. Pain assessment was performed at 6, 24, 48, and 72 h postoperatively using the visual analog scale (VAS). Swelling was evaluated by changes in the distance from (1) the tragus to the labial commissure, (2) the tragus to the pogonion, and (3) the mandibular angle to the lateral canthus preoperatively and 72 h postoperatively. Trismus was assessed by the change in maximum mouth opening. Groups Nd and Nd+m had lower VAS scores at 6 h, 24 h, and 48 h (F = 13.80, p = 0.00), but the difference between the two groups was not significant (F = 1.34, p = 0.11). However, no significant difference was observed at 72 h (p = 0.10). There was no significant difference in swelling or trismus among the three groups (p > 0.05). NdLT is an effective approach to improve complications after M3 surgery.
Journal Article
Efficacy of autologous platelet-rich plasma combined with fractional ablative carbon dioxide resurfacing laser in treatment of facial atrophic acne scars: A split-face randomized clinical trial
by
Faghihi, Gita
,
Nouraei, Saeid
,
Nilforoushzadeh, Mohamad
in
Acne
,
Acne Vulgaris - diagnosis
,
Acne Vulgaris - therapy
2016
Background: Autologous platelet-rich plasma has recently attracted significant attention throughout the medical field for its wound-healing ability. Aims: This study was conducted to investigate the potential of platelet-rich plasma combined with fractional laser therapy in the treatment of acne scarring. Methods: Sixteen patients (12 women and 4 men) who underwent split-face therapy were analyzed in this study. They received ablative fractional carbon dioxide laser combined with intradermal platelet-rich plasma treatment on one half of their face and ablative fractional carbon dioxide laser with intradermal normal saline on the other half. The injections were administered immediately after laser therapy. The treatment sessions were repeated after an interval of one month. The clinical response was assessed based on patient satisfaction and the objective evaluation of serial photographs by two blinded dermatologists at baseline, 1 month after the first treatment session and 4 months after the second. The adverse effects including erythema and edema were scored by participants on days 0, 2, 4, 6, 8, 15 and 30 after each session. Results: Overall clinical improvement of acne scars was higher on the platelet-rich plasma-fractional carbon dioxide laser treated side but the difference was not statistically significant either 1 month after the first treatment session (P = 0.15) or 4 months after the second (P = 0.23). In addition, adverse effects (erythema and edema) on the platelet-rich plasma-fractional carbon dioxide laser-treated side were more severe and of longer duration. Limitations: Small sample size, absence of all skin phototypes within the study group and lack of objective methods for the evaluation of response to treatment and adverse effects were the limitations. Conclusion: This study demonstrated that adding platelet-rich plasma to fractional carbon dioxide laser treatment did not produce any statistically significant synergistic effects and also resulted in more severe side effects and longer downtime.
Journal Article
A prospective, randomized trial comparing thulium vapoenucleation with holmium laser enucleation of the prostate for the treatment of symptomatic benign prostatic obstruction: perioperative safety and efficacy
2017
Introduction and objectives
To compare the perioperative outcomes of thulium vapoenucleation of the prostate (ThuVEP) with holmium laser enucleation of the prostate (HoLEP) for patients with symptomatic benign prostatic obstruction (BPO).
Methods
Forty-eight and 46 patients were prospectively randomized to ThuVEP and HoLEP. All patients were assessed preoperatively and 4-week postoperatively. The complications were noted and classified according to the modified Clavien classification system. Patient data were expressed as median (interquartile range) or numbers (%).
Results
Median age at surgery was 73 (67–76) years and median prostate volume was 80 (46.75–100) cc and not different between the groups (
p
= 0.207). The median operative time was 60 (41–79) minutes without significant differences between both groups (
p
= 0.275). There were no significant differences between the groups regarding catheterization time [2 (2–2) days,
p
= 0.966] and postoperative stay [2 (2–3) days,
p
= 0.80]). Clavien 1 (13.8%), Clavien 2 (3.2%), Clavien 3a (2.1%), and Clavien 3b (4.3%) complications occurred without significant differences between the groups. However, the occurrence of acute postoperative urinary retention was higher after HoLEP compared to ThuVEP (15.2 vs. 2.1%,
p
≤ 0.022). At 1-month follow-up, peak urinary flow rates (10.7 vs. 22 ml/s), post-void residual volumes (100 vs. 20 ml), International Prostate Symptom Score (20 vs. 10) and Quality of Life (4 vs. 3) had improved significantly (
p
≤ 0.005) without significant differences between the groups.
Conclusions
ThuVEP and HoLEP are safe and effective procedures for the treatment of symptomatic BPO. Both procedures give equivalent and satisfactory immediate micturition improvement with low perioperative morbidity.
Journal Article
A randomized controlled trial comparing high and medium power settings for holmium laser enucleation of prostate
by
Shah, Hemendra N
,
Garcia Lopez Emmanuel A
,
Katz, Jonathan E
in
Catheterization
,
Clinical trials
,
Enucleation
2021
PurposeTo report the results of a randomized controlled trial comparing outcomes between medium power (MP) and high power (HP) laser settings for HoLEPs.MethodsThe primary objective was to compare the enucleation efficiency (EE) of HP- HoLEP (80–100 W) with MP-HoLEP (50 − 60 W). The secondary objectives were to compare treatment efficacy and safety between both groups. To show a 25% difference in EE, a sample size of 45 individuals per treatment arm was required (alpha = 0.05; Beta = 0.80). Patients demographic and perioperative factors were analyzed, including EE, hemoglobin drop, duration of catheterization, and length of hospital stay. The surgical outcome was evaluated with AUA symptom score, maximum flow rate, postvoid residual urine, and complications to assess differences between MP and HP HoLEP at baseline, 3 months, 1, and 5 years. Quantitative outcomes were compared with independent sample t tests (2-tailed) and qualitative outcomes were compared with chi-square tests.ResultsPreoperative data with the exception of indication for surgery were comparable in both treatment arms. There was no statistically significant difference in enucleation efficiency between the HP-HoLEP and MP-HoLEP laser setting (0.97 ± 0.47 vs. 0.85 ± 0.47 gm/min, p = 0.209). MP laser settings did not increase perioperative or postoperative complications and resulted in durable outcome comparable with HP laser settings at 5-year follow-up.ConclusionsMP-HoLEP is safe and efficient and does not compromise the outcome for HoLEPs when compared with HP-HoLEP.
Journal Article