The effect of sodium hyaluronate on dry eye and corneal epithelial thickness following cataract surgery.

PURPOSE: To evaluate the effects of sodium hyaluronate drops on dry eye parameters and corneal epithelial thickness following cataract surgery. METHODS: The study included 84 patients who underwent uncomplicated phacoemulsification. In Group A, 0.15% sodium hyaluronate drops were added to the postoperative antibiotic/anti-inflammatory treatment. In Group B, only antibiotic/anti-inflammatory treatment was applied. Preoperatively and at 1 week and 1 month postoperatively, all the patients were evaluated in respect of tear break-up time (TBUT), the Schirmer test under anesthesia, the corneal fluorescein staining (CFS) score, mean central corneal thickness (CCT) and mean central corneal epithelial thickness (CCET), and the two groups were compared. RESULTS: A statistically significant difference was determined between the two groups at postoperative 1 month in respect of TBUT, Schirmer test, CFS score, and CCET (p < 0.01). In Group A, a statistically significant increase was determined in the TBUT and Schirmer values at 1 month postoperatively (p < 0.01, p = 0.01, respectively) and in Group B, these values were decreased compared to preoperatively (p < 0.01). The CCET was determined to be significantly thinner in Group B 1 month postoperatively (p < 0.01). A significant increase in CCT was observed in both groups at postoperative 1 week (p < 0.01) and preoperative values were reached at 1 month postoperatively. CONCLUSION: In the patient group using sodium hyaluronate, significant differences were determined in all dry eye parameters and CCET. The use of hyaluronate sodium drops after cataract surgery was seen to improve dry eye parameters and contribute to a healthy ocular surface by ensuring continuity of the corneal epithelium.

Platelet-Rich Plasma, Bone Marrow Aspirate Concentrate, and Hyaluronic Acid Injections Outperform Corticosteroids in Pain and Function Scores at a Minimum of 6 Months as Intra-Articular Injections for Knee Osteoarthritis: A Systematic Review and Network Meta-analysis.

PURPOSE: To compare the efficacy of common intra-articular injections used in the treatment of knee osteoarthritis, including corticosteroid (CS), hyaluronic acid (HA), platelet-rich plasma (PRP), and bone marrow aspirate concentrate (BMAC), with a minimum follow-up of 6-months. METHODS: A literature search was conducted using the 2020 Preferred Reporting Items for Systematic Reviews and Meta-Analyses guidelines in August 2022 in the following databases: PubMed/MEDLINE, Scopus, Cochrane Database of Controlled Trials, and the Cochrane Database of Systematic Reviews. Level I to II randomized clinical trials with a minimum follow-up of 6 months that investigated the treatments of interest were included. Patient-reported outcome scores for pain and function at baseline and at latest follow-up were extracted, and the change in scores was converted to uniform 0 to 100 scales. Arm-based Bayesian network meta-analysis using a random-effects model was created to compare the treatment arms in pain and function. RESULTS: Forty-eight studies comprising a total of 9,338 knees were included. The most studied intra-articular injection was HA (40.9%), followed by placebo (26.2%), PRP (21.5%), CS (8.8%), and then BMAC (2.5%). HA and PRP both led to a significant improvement in pain compared with placebo. HA, PRP, and BMAC all led to a significant improvement in function scores when compared with placebo. Surface under the cumulative ranking curves (SUCRAs) of the interventions revealed that PRP, BMAC, and HA were the treatments with the highest likelihood of improvement in both pain and function, with overall SUCRA scores of 91.54, 76.46, and 53.12, respectively. The overall SUCRA scores for CS and placebo were 15.18 and 13.70, respectively. CONCLUSIONS: At a minimum 6-month follow-up, PRP demonstrated significantly improved pain and function for patients with knee osteoarthritis compared with placebo. Additionally, PRP exhibited the highest SUCRA values for these outcomes when compared with BMAC, HA, and CS. LEVEL OF EVIDENCE: Level II, meta-analysis of Level I to II studies.

A New Cross-Linked Hyaluronic Acid Gel for Preventing Adhesion After Thyroid Surgery: An Animal Study.

BACKGROUND: Revision of any neck surgeries is usually associated with increased rate of complications compared to the initial surgery due to adhesions. Especially, recurrent laryngeal nerve injury and hypoparathyroidism are most important postoperative complications of thyroid revision surgery. This study aimed to reveal anti-adhesive effects of cross-linked hyaluronic acid gel (NCHAG) in thyroid surgery. MATERIALS AND METHODS: This study was performed in 16 adult male rats who underwent hemithyroidectomy in the right lobe and randomized into two experimental groups: Group I (control group) was given any substance and Group II (NCHA group) received NCHA spray into their perithyroidal area. The rats were sacrificed after three weeks of thyroidectomy for assessment. RESULTS: Gross adhesions score (x̄ = 2.500) was significantly higher in Group I than Group II (x̄=1.750; P = 0.031). Group II showed significantly less fibrosis compared to the Group I (P = 0.002). The rate of inflammation was found to be significantly higher in group I (P = 0.008). Vascular proliferation was not different between two groups (p=0.083). CONCLUSIONS: Our study showed that NCHA can reduce postoperative adhesion and might be effective in preventing fibrosis after the thyroidectomy. Although this study could not demonstrate that application of NCHA is able to reduce complication rate in revision neck surgery, it could be safely used after thyroidectomy and neck surgeries to prevent adhesions.

A randomized study protocol comparing the platelet-rich plasma with hyaluronic acid in the treatment of symptomatic knee osteoarthritis.

BACKGROUND: In recent years, intra articular injection of platelet rich plasma has attracted increasing attention. The major aim of our current randomized controlled double-blind study was to compare long-term outcomes of intra-articular injection of hyaluronic acid or platelet rich plasma in the treatment of the patients with knee osteoarthritis. METHODS: This is a kind of double-blind, randomized, prospective, and comparative clinical investigation with the allocation ratio of 1:1 and was approved by our institutional review Committee. Between 2020 and 2021, altogether 2 hundred patients will be selected to participate in our present study. We will report the randomized experiments in accordance with the guidelines of Consolidated Standards of Reporting Trials and then offer the Consolidated Standards of Reporting Trials flow chart. The inclusion criteria were: patients aged from 40 to 70 years old, patients with chief complaint history of at least 1 month and knee joint pain for nearly 6 months, need the analgesic drug treatment, and radiology confirmed knee osteoarthritis. The eligible patients would be randomly divided into 2 groups through applying the random numbers generated by computer before surgery. Outcomes after treatment were assessed using the Western Ontario and McMaster University and the scoring systems of visual analogue scale which were recorded through questionnaires accomplished via the patients prior to the first injection and then at three and six months, 1 and 2 years follow-up. Any adverse events occurred within 1 year after surgery were recorded during follow-up. RESULTS: This should suggest whether biological methods can offer more lasting outcomes than the viscosification. TRIAL REGISTRATION: This study protocol was registered in Research Registry (researchregistry6265).

Intra-Articular Injections of Hyaluronic Acid or Steroids Associated With Better Outcomes Than Platelet-Rich Plasma, Adipose Mesenchymal Stromal Cells, or Placebo in Knee Osteoarthritis: A Network Meta-analysis.

PURPOSE: To evaluate the clinical effects of hyaluronic acid (HA), steroids, platelet-rich plasma (PRP), or adipose mesenchymal stromal cell (MSC) injections in the treatment of knee osteoarthritis (OA). METHODS: Randomized controlled trials with OA of the knee that compared HA, steroids, PRP, adipose MSC, or their combination with placebo or in head-to-head combination were identified from the MEDLINE, EMBASE, Cochrane Library, Web of Science, and SCOPUS databases up to June 30, 2019. We performed a network meta-analysis of the relevant literature to determine whether there was benefit from HA, steroids, PRP, or adipose MSC treatment as compared with placebo. RESULTS: A total of 43 trials covering 5554 patients were included. Steroids were ranked most likely to be effective for the management of pain or function, with adipose MSC and multiple PRP appearing least likely to be effective. Although no significant difference was observed among the 6 interventions, except for single PRP with respect to adverse effects, steroids and HA exhibited a lower rate of AEs compared with the placebo. In view of severe adverse effects, only single PRP was superior to placebo. Direct pairwise meta-analysis for pain relief showed that HA was superior to placebo or single PRP, but steroids had a significantly worse effect than single PRP. In addition, direct pairwise meta-analysis for adverse effects favored steroids in comparison to HA. CONCLUSIONS: The ranking statistics like surface under the cumulative ranking curve values of our network meta-analysis support the use of steroids and HA for appropriate patients with knee OA. For pain relief and AEs, steroids are most likely the best treatment, followed by HA. Single PRP, multiple PRP, and adipose MSC interventions do not result in a relevant reduction of joint pain nor improvement of joint function compared with placebo. However, treatment effect differences were small and potentially not clinically meaningful, indicating that other factors, such as cost and patient preferences, may be more important in patients with knee OA. LEVEL OF EVIDENCE: meta-analysis of non-homogenous randomized controlled trials, Level II.

Platelet-Rich Plasma Versus Hyaluronic Acid in the Treatment of Knee Osteoarthritis: A Meta-analysis of 26 Randomized Controlled Trials.

PURPOSE: To compare the effectiveness and safety of platelet-rich plasma (PRP) and hyaluronic acid (HA) in patients with adult knee osteoarthritis (KOA) and to explore the most effective and safe protocol by using a meta-analysis method. METHODS: This study was based on Cochrane methodology for conducting a meta-analysis. Only randomized controlled trials with an experimental group that used PRP and a control group that received HA were eligible for this study. The participants were adults who had KOA. The outcome measures were the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC), the visual analog scale (VAS), the EuroQol VAS, the International Knee Documentation Committee, the Tegner score, the Lequesne Scale, the Knee injury Osteoarthritis Outcome Score, satisfaction rate, and adverse events. Subgroup analyses was performed for patients with different doses, types, and times of PRP interventions and grades of OA. The Review Manager Database was used to analyze the included studies. RESULTS: Twenty-six randomized controlled trials involving 2430 patients were included. The WOMAC total scores, WOMAC physical function scores, and VAS scores of the PRP group were better than the those of the HA group at 3, 6, and 12 months. The PRP group had better WOMAC pain, WOMAC stiffness, EuroQol VAS, and International Knee Documentation Committee scores than the HA group at 6 and 12 months. There was no significant difference in adverse events between the 2 groups (relative risk 1.21, 95% confidence interval 0.95-1.54; P = .13). CONCLUSIONS: For the nonsurgical treatment of KOA, compared with HA, intra-articular injection of PRP could significantly reduce patients' early pain and improve function. There was no significant difference in adverse events between the 2 groups. PRP was more effective than HA in the treatment of KOA, and the safety of these 2 treatment options was comparable. LEVEL OF EVIDENCE: Level I, meta-analysis of Level I RCTs.

The effect of new cross linked hyaluronan gel on quality of life of patients after deep infiltrating endometriosis surgery: a randomized controlled pilot study.

In this prospective randomised placebo-controlled study, we aimed to evaluate the effect of New Cross linked Hyaluronan Gel (NCH gel) on the quality of life of patients who underwent laparoscopic surgery due to Deep Infiltrating Endometriosis (DIE). The intervention group received 40 mL of NCH gel, and the control group had a 40 mL sterile saline solution instilled into the peritoneal cavity following standard laparoscopic procedures. The patients were called in the third and sixth postoperative months and requested to fill the Visual Analogue Scale (VAS), Endometriosis Health Profile (EHP-5), and Short Form for Mental and Physical Health (SF-12) questionnaires. There was a significant reduction in dysmenorrhoea, dyschezia, dyspareunia VAS scores at 3rd, and 6th-month visits in NCH gel group. The postoperative 6th-month EHP-5 scores were significantly lower (1.16 ± 1.51, p-value: .02) in NCH gel group. Besides, NCH gel group had higher SF-12 mental and SF-12 physical scores. Clinical Trials registration number: NCT04023383IMPACT STATEMENTWhat is already known on this subject? Application of solid or liquid physical barriers is believed to be a promising strategy to reduce adhesions after laparoscopic endometriosis surgery. However, comparable data regarding the effects of adhesion barriers are still lacking.What the results of this study add? We revealed that there was a significantly higher decrease in VAS and EHP-5 scores and an increase in SF-12 physical-mental ratings after surgery in NCH gel group.What are the implications of these findings for clinical practice and/or further research? Using NHC gel in addition to standard surgical procedure improves postoperative VAS scores, and provides better quality of life scores.

A Novel Marking Technique for Descemet Membrane Endothelial Graft Using an Ophthalmic Viscoelastic Device.

PURPOSE: To describe the viscoelastic marking technique, a novel marking technique of Descemet membrane endothelial keratoplasty (DMEK) grafts that enables usage of a single donor cornea for 2 surgeries-one that uses Descemet membrane and endothelium (DMEK) and the other using the stroma and Bowman layer. METHODS: A retrospective case analysis was performed on 26 eyes of 26 consecutive patients who underwent DMEK using the "viscoelastic marking technique." In this novel technique, an ophthalmic viscoelastic device (Healon 5) is placed over the endothelial side. Descemet membrane is then folded in half over the ophthalmic viscoelastic device with the stromal side up, and the F mark is drawn on the stromal side of the folded Descemet membrane. Primary outcome was best spectacle-corrected visual acuity, and secondary outcomes included graft detachment and rebubble rate, graft failure, and endothelial cell density. RESULTS: Mean best spectacle-corrected visual acuity improved significantly from 1.0 ± 0.7 logarithm of the minimum angle of resolution (LogMAR) before the surgery to 0.9 ± 0.7 LogMAR, 0.5 ± 0.6 LogMAR, 0.4 ± 0.2 LogMAR, and 0.4 ± 0.4 LogMAR at 1, 3, 6, and 12 months after surgery, respectively. Seven eyes (27%) had partial graft detachment that required air injection. Primary failure occurred in 3 eyes (11%). There were no free-floating donors or recognized inverted donors. The endothelial cell density loss at 12 months after surgery was a cell-loss rate of 38.3%. CONCLUSIONS: The viscoelastic marking technique is a simple, approachable, and safe technique for marking DMEK grafts while preserving the anterior cornea for additional surgery.

Histopathologic reaction patterns to differentially cross-linked hyaluronic acid fillers: A retrospective case series.

BACKGROUND: Hyaluronic acid filler reactions have been increasingly observed in recent years. Our study investigates whether the increased number of filler reactions observed since 2014 is associated with a specific histopathologic inflammatory pattern and type of filler. METHODS: The institution's dermatopathology electronic database was retrospectively searched for histopathologic reactions to hyaluronic acid from January 2014 to December 2019. The age, sex, type of filler, procedure, location, and histopathologic patterns were recorded. RESULTS: From 2014 to 2019, there were 15 cases of granulomatous reactions to hyaluronic acid filler. In 10 of these cases, there was a characteristic inflammatory pattern characterized by tightly cuffed palisades of histiocytes with varying numbers of eosinophils. Of the 11 cases in which the type of filler was known, all used Vycross technology, a novel manufacturing process in the production of hyaluronic acid filler. CONCLUSION: A characteristic histopathologic pattern of discrete foci of tightly cuffed palisaded granulomas with eosinophils is associated with fillers manufactured using Vycross technology.

Cooled Radiofrequency Ablation Compared with a Single Injection of Hyaluronic Acid for Chronic Knee Pain: A Multicenter, Randomized Clinical Trial Demonstrating Greater Efficacy and Equivalent Safety for Cooled Radiofrequency Ablation.

BACKGROUND: Knee osteoarthritis is a painful and sometimes debilitating disease that often affects patients for years. Current treatments include short-lasting and often repetitive nonsurgical options, followed by surgical intervention for appropriate candidates. Cooled radiofrequency ablation (CRFA) is a minimally invasive procedure for the treatment of pain related to knee osteoarthritis. This trial compared the efficacy and safety of CRFA with those of a single hyaluronic acid (HA) injection. METHODS: Two hundred and sixty subjects with knee osteoarthritis pain that was inadequately responsive to prior nonoperative modalities were screened for enrollment in this multicenter, randomized trial. One hundred and eighty-two subjects who met the inclusion criteria underwent diagnostic block injections and those with a minimum of 50% pain relief were randomized to receive either CRFA on 4 genicular nerves or a single HA injection. One hundred and seventy-five subjects were treated (88 with CRFA and 87 with HA). Evaluations for pain (Numeric Rating Scale [NRS]), function (Western Ontario and McMaster Universities Osteoarthritis Index [WOMAC]), quality of life (Global Perceived Effect [GPE] score and EuroQol-5 Dimensions-5 Level [EQ-5D-5L] questionnaire), and safety were performed at 1, 3, and 6 months after treatment. RESULTS: Demographic characteristics did not differ significantly between the 2 study groups. A total of 158 subjects (76 in the CRFA group and 82 in the HA group) completed the 6-month post-treatment follow-up. In the CRFA group, 71% of the subjects had ≥50% reduction in the NRS pain score (primary end point) compared with 38% in the HA group (p < 0.0001). At 6 months, the mean NRS score reduction was 4.1 ± 2.2 for the CRFA group compared with 2.5 ± 2.5 for the HA group (p < 0.0001). The mean WOMAC score improvement at 6 months from baseline was 48.2% in the CRFA group and 22.6% in the HA group (p < 0.0001). At 6 months, 72% of the subjects in the CRFA group reported improvement in the GPE score compared with 40% in the HA group (p < 0.0001). CONCLUSIONS: CRFA-treated subjects demonstrated a significant improvement in pain relief and overall function compared with subjects treated with a single injection of HA. No serious adverse events related to either procedure were noted, and the overall adverse-event profiles were similar. LEVEL OF EVIDENCE: Therapeutic Level I. See Instructions for Authors for a complete description of levels of evidence.

Intra-articular Injections of Hyaluronic Acid on Osteochondral Lesions of the Talus After Failed Arthroscopic Bone Marrow Stimulation.

BACKGROUND: The purpose of the study was to compare clinical and functional outcomes before and after hyaluronic acid (HA) injections in patients with osteochondral lesions of the talus who experienced a failure of their primary treatment with arthroscopic microfracture surgery. METHODS: A total of 40 patients were included in the final study. These patients had received microfracture surgery but continued to experience postoperative pain over an average of 13.0 months (range, 0-81 months) and were available for investigation with a mean follow-up for 29.1 months (SD 14.7; range 2.6-79.6 months). All patients received intra-articular injections of HA once per week for 3 weeks. We assessed clinical and functional outcomes before and after injection using the American Orthopaedic Foot & Ankle Society (AOFAS) score, Foot and Ankle Outcome Score (FAOS), Short Form Health Survey (SF-36), the visual analog scale (VAS) for pain, and the Alexander subjective scale. RESULTS: The AOFAS score significantly increased from 50.7 ± 13.8 to 79.9 ± 13.8 and the FAOS scores for symptom, pain, daily living, and sports were significantly higher postinjection compared to preinjection (all P < .001). Similarly, the mean VAS for pain was significantly decreased after 6 weeks following injection and continued to decrease over the follow-up period; the mean VAS was significantly lower postinjection compared to preinjection at 12 months (P < .001). CONCLUSION: Intra-articular HA injections on average significantly improved clinical and functional scores after failed primary operative treatment. HA injections may provide an alternative to secondary operative treatment and provide better clinical outcomes than other conservative treatments. LEVEL OF EVIDENCE: Level II, prospective observational cohort study.

Knee OA cost comparison for hyaluronic acid and knee arthroplasty.

BACKGROUND: Limiting treatment to those recommended by the American Academy of Orthopaedic Surgeon Clinical Practice Guidelines has been suggested to decrease costs by 45% in the year prior to total knee arthroplasty, but this only focuses on expenditures leading up to, but not including, the surgery and not the entire episode of care. We evaluated the treatment costs following knee osteoarthritis (OA) diagnosis and determined whether these are different for patients who use intra-articular hyaluronic acid (HA) and/or knee arthroplasty. METHODS: Claims data from a large commercial database containing de-identified data of more than 100 million patients with continuous coverage from 2012 to 2016 was used to evaluate the cumulative cost of care for over 2 million de-identified members with knee OA over a 4.5-year period between 2011 and 2015. Median cumulative costs were then stratified for patients with or without HA and/or knee arthroplasty. RESULTS: Knee OA treatment costs for 1,567,024 patients over the 4.5-year period was $6.60 billion (mean $4210/patient) as calculated by the authors. HA and knee arthroplasty accounted for 3.0 and 61.5% of the overall costs, respectively. For patients who underwent knee arthroplasty, a spike in median costs occurred sooner for patients without HA use (around the 5- to 6-month time point) compared to patients treated with HA (around the 16- to 17-month time point). CONCLUSIONS: Non-arthroplasty therapies, as calculated by the authors, accounted for about one third of the costs in treating knee OA in our cohort. Although some have theorized that limiting the use of HA may reduce the costs of OA treatment, HA only comprised a small fraction (3%) of the overall costs. Among patients who underwent knee arthroplasty, those treated with HA experienced elevated costs from the surgery later than those without HA, which reflects their longer time to undergoing knee arthroplasty. The ability to delay or avoid knee arthroplasty altogether can have a substantial impact on the cost to the healthcare system.

Multimodal approach to intraarticular drug delivery in knee osteoarthritis.

The expectations from any future disease-modifying treatment for knee osteoarthritis (KOA) are extremely high as it has to impact the joint as a whole leading to favorable alterations of diverse tissues and functions. In this light, targeting the knee only from the inside may not be biologically justified for the management of a whole joint disease such as KOA. Our hypothesis to test is whether any injectable therapeutic intervention alone can lead to disease modification of KOA which is viewed in the complexity of the modern concept of osteoarthritis (OA) as a whole joint disease. Therefore, we aimed at analyzing the intraarticular route to the KOA patient in an attempt to unveil its "biological" constraints. A comprehensive search through databases was carried out using specific keywords to add objectivity to the main messages. The literature analysis has shown that "cutting-edge" intraarticular therapies may offer a key to non-invasive symptomatic relief. Changing the course of KOA, however, may necessitate a multimodal approach towards the knee joint including a combination of intraarticular injections with interventions on multiple levels. Importantly, our understanding of OA has evolved redefining the concept of the disease, being in interaction with the human body as a whole. Any future conservative disease-modifying treatment of KOA should aim at a multimodal, holistic approach towards the knee joint including but not limited only to intraarticular injections. A combination with other interventions should be further researched.

The Cost-Effectiveness of Platelet-Rich Plasma Compared With Hyaluronic Acid Injections for the Treatment of Knee Osteoarthritis.

PURPOSE: To examine the cost-effectiveness of a series (total of 3 injections) of intra-articular platelet-rich plasma (PRP) injections in comparison to that of hyaluronic acid (HA) viscosupplementation for the treatment of symptomatic knee osteoarthritis. METHODS: Outcome data regarding the use of PRP or HA injections for the treatment of symptomatic knee osteoarthritis were determined from the highest-quality data (Level I) available in the literature until 2015. Health utility values were then derived from these high-quality data. Costs were determined by examining typical charges for patients undergoing a series of either PRP or HA injections for the treatment of this condition at a large private orthopaedic practice. These health utility values and costs were used to create an expected-value decision analysis model. RESULTS: The results of the model revealed that the cost per quality-adjusted life-year (QALY) of a series of PRP injections was $8,635.23/QALY and that of a series of HA injections was $5,331.75/QALY. A series of PRP injections was associated with a higher initial cost than a series of HA injections (difference, $1,433.67); however, PRP was also more effective (higher utility value) than HA by 0.11 QALYs (0.69 vs 0.58, P = .0062) at 1 year. The incremental cost-effectiveness ratio of the use of PRP injections as opposed to HA was $12,628.15/QALY. CONCLUSIONS: Although a series of either PRP ($8,635.23/QALY) or HA ($5,331.75/QALY) injections for the treatment of symptomatic knee osteoarthritis would be considered cost-effective (cost per QALY < $50,000), PRP injections were not more cost-effective than HA injections. However, PRP was significantly more effective at 1 year, and being associated with an incremental cost-effectiveness ratio of $12,628.15/QALY when compared with HA, a series of PRP injections should be considered a reasonable and acceptable alternative to HA injections for the treatment of symptomatic knee osteoarthritis. LEVEL OF EVIDENCE: Level II, economic and decision analysis of Level I studies.

Intraoperative Evaluation of Phacoemulsification Cataract Surgery with and without the Use of Ophthalmic Viscosurgical Devices.

PURPOSE: The purpose of this study was to compare the efficacy and safety of cataract surgery by the phacoemulsification technique with and without the use of ophthalmic viscosurgical devices (OVDs). SETTING: This study was conducted at a tertiary eye care center in a rural area of Central India. DESIGN: This was a prospective, randomized, observational study. METHODS: In this study, 220 patients underwent phacoemulsification for cataract surgery with OVDs (OVD group) or without OVDs (BSS group) (n = 110 in each group). Patients with operable, nuclear Grade 2-4 cataracts were included in the study. The study was conducted from June 2017 to September 2018. The frequency of intraoperative complications, surgical time, and ease of the surgical procedure (easy, difficult, or very difficult) were recorded. RESULTS: There was no statistically significant difference in the nuclear opalescence, axial length, and intraocular lens (IOL) power between the two groups. Capsulorhexis extension was seen in two eyes in the OVD group and none of the eyes in the BSS group. The problems that occurred during IOL implantation included flip (OVD group, 2; BSS group, 1), haptic breakage (OVD group, 1; BSS group, 1), sulcus implantation (OVD group, 0; BSS group, 2), and stuck haptic (OVD group, 1; BSS group, 3). The total surgical time was almost equal in the two groups (OVD group, 9.2 min ± 3; BSS group, 9.5 min ± 3.5; P = 0.521). None of the patients had iris trauma or posterior capsular rupture. CONCLUSIONS: OVD-less phacoemulsification surgery is a safe and effective technique for treating age-related cataracts that requires no additional instrumentation and saves the cost of the OVD.

Intratumoral Hydrogen Peroxide With Radiation Therapy in Locally Advanced Breast Cancer: Results From a Phase 1 Clinical Trial.

PURPOSE: Hydrogen peroxide (H2O2) plays a vital role in normal cellular processes but at supraphysiological concentrations causes oxidative stress and cytotoxicity, a property that is potentially exploitable for the treatment of cancer in combination with radiation therapy (RT). We report the first phase 1 trial testing the safety and tolerability of intratumoral H2O2 + external beam RT as a novel combination in patients with breast cancer and exploratory plasma marker analyses investigating possible mechanisms of action. METHODS AND MATERIALS: Twelve patients with breast tumors ≥3 cm (surgically or medically inoperable) received intratumoral H2O2 with either 36 Gy in 6 twice-weekly fractions (n = 6) or 49.5 Gy in 18 daily fractions (n = 6) to the whole breast ± locoregional lymph nodes in a single-center, nonrandomized study. H2O2 was mixed in 1% sodium hyaluronate gel (final H2O2 concentration 0.5%) before administration to slow drug release and minimize local discomfort. The mixture was injected intratumorally under ultrasound guidance twice weekly 1 hour before RT. The primary endpoint was patient-reported maximum intratumoral pain intensity before and 24 hours postinjection. Secondary endpoints included grade ≥3 skin toxicity and tumor response by ultrasound. Blood samples were collected before, during, and at the end of treatment for cell-death and immune marker analysis. RESULTS: Compliance with H2O2 and RT was 100%. Five of 12 patients reported moderate pain after injection (grade 2 Common Terminology Criteria for Adverse Events v4.02) with median duration 60 minutes (interquartile range, 20-120 minutes). Skin toxicity was comparable to RT alone, with maintained partial/complete tumor response relative to baseline in 11 of 12 patients at last follow-up (median 12 months). Blood marker analysis highlighted significant associations of TRAIL, IL-1ß, IL-4, and MIP-1α with tumor response. CONCLUSIONS: Intratumoral H2O2 with RT is well tolerated with no additional toxicity compared with RT alone. If efficacy is confirmed in a randomized phase 2 trial, the approach has potential as a cost-effective radiation response enhancer in multiple cancer types in which locoregional control after RT alone remains poor.

Hyaluronic acid spacer in focal prostate reirradiation: A single centre experience.

PURPOSE: The optimal management of locally recurrent prostate cancer after curative radiotherapy is still unknown. In this study, we evaluated the preliminary results of reirradiation using stereotactic body radiotherapy for locally recurrent prostate cancer after initial definitive local radiotherapy. MATERIALS AND METHODS: Between April 2016 and February 2019, 11 patients with recurrent disease at the previously irradiated prostate were treated. Local recurrence was detected by radiological with or without functional imaging modalities including prostate multiparametric/pelvic MRI or positron-emission tomography-computerised tomography with (68Ga)-labelled prostate-specific membrane antigen performed after rising prostate specific antigen serum level during follow-up. All patients received stereotactic body radiotherapy to the recurrent nodule to a total dose of 30Gy in five fractions. Hyaluronic acid spacer was injected between prostate and rectum in seven patients to decrease the rectal dose. Acute toxicity was evaluated by using Common Terminology Criteria for Adverse Events version 4.0, and late toxicity was evaluated by using Radiation Therapy Oncology Group/European Organisation for Research and Treatment of Cancer late radiation morbidity scoring schema. RESULTS: At the diagnosis, the median age was 64 years, and the mean prostate specific antigen serum concentration was 17.7ng/mL. The median interval time between local recurrence and initial definitive radiotherapy was 63 months. Mean prostate specific antigen concentration nadir value during follow-up was 0.43ng/mL. With a median follow up of 19 months, three patients developed either local or distant relapse. One patient had grade 3 acute rectal toxicity, and one patient had grade 2 late urinary toxicity. We did not observe any acute or late toxicity due to hyaluronic acid spacer injection. CONCLUSION: Reirradiation after local recurrence following initial definitive radiotherapy together with hyaluronic acid spacer use seems to be effective and safe.

Preoperative hyaluronic acid injection modulates postoperative functional outcome in patients undergoing arthroscopic rotator cuff repair.

BACKGROUND: Arthroscopic rotator cuff repair (ARCR) generally yields acceptable clinical results. Hyaluronic acid (HA), a high-molecular-weight polysaccharide, is present in the extracellular matrix of soft connective tissue and synovial fluid, and its injection is known to significantly improve pain and clinical outcomes after rotator cuff injury. Some studies have described the role of HA injections as conservative therapy for rotator cuff tears. Since the subacromial bursa is believed to be the main source of shoulder pain in rotator cuff tears, subacromial injection is frequently used before surgery; however, its relationship with the clinical outcome after surgery remains unclarified. Therefore, we aimed to examine effects of preoperative subacromial HA injection on postoperative clinical outcome in patients with ARCR. METHODS: Ninety-eight patients were divided into a HA injection group and a non-injection group. The functional outcome measured was the University of California, Los Angeles (UCLA) score. Univariate analysis was performed to obtain variables with p values less than 0.1; we then used propensity score analysis, adjusting for pre- and post-operative confounding factors. RESULTS: The UCLA scores of all patients significantly improved 1 year postoperatively (PO) (p < 0.05). Subacromial HA injections were performed in patients with worse preoperative function. Univariate analysis showed significantly greater improvements in the injection group than in the non-injection group in terms of preoperative UCLA score, trauma, diabetes mellitus, UCLA score 3 months PO, abduction strength 4 months PO, and internal rotation (IR) strength 6 and 12 months PO. Propensity score analysis demonstrated that UCLA scores 3 months PO and IR strength 12 months PO in the injection group were significantly greater than those in the non-injection group. There were no significant differences in postoperative re-tear rates between the groups. In sub-analysis of the injection group, propensity scores showed that concurrent use of local anesthetics did not affect the data, suggesting that HA was effective. CONCLUSION: Subacromial injection was administered to patients with worse function before ARCR. Propensity score analysis successfully demonstrated that functional outcome after surgery was improved in patients who were administered this injection compared with patients who were not administered this injection before surgery.

Refractive Changes After Corneal Stromal Filler Injection for the Correction of Hyperopia.

PURPOSE: To evaluate a new non-ablative and adjustable procedure for laser ablative refractive corneal surgery in hyperopia using the injection of a biocompatible liquid filler material into a stromal pocket. METHODS: A total of 120 stromal pockets were created using a clinical femtosecond laser system in 96 rabbit corneoscleral discs and 24 whole globes. Pockets were cut at a depth of 120 or 250 µm below the epithelial surface. Hyaluronic acid was injected manually into the pocket. To determine the refractive changes, three-dimensional optical coherence tomography images and a specifically developed picture recognition Matlab (The Mathworks) routine were used. RESULTS: After injection, a steepening of the anterior and flattening of the posterior corneal surface was observed, which led to hyperopic correction. The two main factors determining the amount of correction were the pocket depth and the injected volume. After the pocket was homogeneously filled, an initial refractive increase was observed, followed by a linear relation between the injected volume and the refraction increase. CONCLUSIONS: This possible clinical protocol for controlled refraction correction of hyperopia suggests a potential readjustable clinical application. [J Refract Surg. 2020;36(6):406-414.].

Outcomes of Ahmed Glaucoma Valve Implantation With Viscoelastic Fill at Both Beginning and End of Surgery.

PRéCIS:: Intracameral injection of viscoelastic at the beginning of Ahmed FP7 implantation did not reduce early postoperative complication rates. PURPOSE: To evaluate early postoperative complication rates after a modified technique in which the anterior chamber (AC) is filled with viscoelastic at the beginning of Ahmed FP7 implantation before conjunctival peritomy. SUBJECTS AND METHODS: A retrospective chart review was performed of eyes that underwent Ahmed FP7 implantation with or without viscoelastic fill to ~20 mm Hg by finger tension by a single surgeon (M.R.M). Viscoelastic prevented the AC from becoming shallow at any time during surgery, and additional viscoelastic was injected into the AC at the end of surgery to achieve a final intraocular pressure (IOP) of 20 mm Hg. RESULTS: A total of 159 eyes of 159 patients were included. Mean age was 76.4±10.4 years. Mean preoperative IOP was 30.3±9.7 mm Hg on 2.7±1.2 glaucoma medications. On postoperative day 1, there was an IOP spike ≥30 mm Hg in 0% of patients. Within the first postoperative month, hypotony (<5 mm Hg) occurred in 19 (21.8%) eyes that received viscoelastic fill compared with 5 (13.2%) eyes that did not receive viscoelastic fill (P=0.26). During the early postoperative period (≤3 mo), there was no difference in AC depth, microhyphema, choroidal effusion, or leakage between the 2 groups (P≥0.30 for all). There was a higher rate of layered hyphemas in the viscoelastic-fill group at postoperative week 1 (P=0.01). At 3-month follow-up, mean IOP was 14.9±5.5 mm Hg on 1.6±0.8 medications in the viscoelastic-fill group and 16.0±5.2 mm Hg on 1.0±1.2 medications in the nonviscoelastic-fill group (IOP P=0.35). Compared with baseline, change in IOP at 3 months was similar between both groups (P=0.15). Rates of additional medications and procedures did not differ between the 2 groups at any postoperative visit. CONCLUSIONS: Early intracameral injection of viscoelastic during Ahmed glaucoma valve implantation did not reduce early postoperative complication rates.