One-Year Outcomes of the ROBUST II Study Evaluating the Use of a Drug-Coated Balloon for Treatment of Urethral Stricture

Objective To report 1-year results of the ROBUST II study investigating the safety and efficacy of a paclitaxel-coated balloon for the treatment of recurrent urethral strictures. Methods Subjects were adult men with a single anterior urethral stricture ≤ 3 cm in length and at least 2 prior stricture treatments. After treatment with the Optilume urethral drug-coated balloon (DCB), subjects were followed through 1 year. The primary safety endpoint was the rate of treatment-related serious complications at 90 days post-procedure. Efficacy outcomes included symptomatic assessments, erectile function measured using the International Index of Erectile Function (IIEF), Qmax, and anatomic success. Results Sixteen men with an average of 4.1 prior dilations were treated with the DCB. Anatomic success was achieved at 6 months in 73%. Average IPSS improved from 18.4 to 6.0 at 1 year (P < 0.001). Qmax improved from 6.9 mL/sec to 20.8 mL/sec (P < 0.001). There was no change in IIEF. Four subjects received additional treatment within 1 year. There were no treatment-related serious complications. Conclusions Short-term follow-up of men with urethral stricture treated with the Optilume DCB showed durable anatomic results at 6 months and sustained symptomatic improvement through 1 year. Treatment with the device was safe.

A systematic review and meta-analysis of treatment modalities for anterior accessory saphenous vein insufficiency

Objective To investigate and compare the outcomes of the available treatment modalities for anterior accessory saphenous vein (AASV) incompetence. Methods A systematic literature search was performed in MEDLINE, Embase, and the Cochrane Library. Studies reporting the outcomes of patients who were treated for primary AASV incompetence were included. The methodologic quality of the articles was assessed using the Methodological Index for Non-Randomized Studies (MINORS). A random-effects model was used to estimate anatomic success, defined as AASV occlusion. The secondary outcomes were pain during and after treatment, venous clinical severity score, quality of life, esthetic result, time to return to daily activities, and complications. Results The search identified 860 articles, of which 16 met the inclusion criteria. A total of 609 AASVs were reported. The included studies were of poor or moderate quality according to MINORS score. The pooled anatomic success rates were 91.8% after endovenous laser ablation and radiofrequency ablation (EVLA, RFA, 11 studies), 93.6% after cyanoacrylate closure (3 studies), and 79.8% after sclerotherapy (2 studies). The non-pooled anatomic success rate was 97.9% after phlebectomy and 82% after CHIVA. Paresthesia was seen after EVLA in 0.7% of patients (6 studies). Phlebitis was seen in 2.6% of patients after RFA (2 studies), 27% after sclerotherapy (1 study), and 12% after the phlebectomy (1 study). Deep venous thrombosis and skin burn did not occur. Conclusion Treatment of AASV incompetence is safe and effective. Despite limited evidence, occlusion of the AASV can be achieved with endovenous thermal ablation and cyanoacrylate. There does not appear to be a benefit of EVLA compared to RFA regarding treatment efficacy. Phlebectomy shows promising results if the saphenofemoral junction is competent. Lower results are seen after sclerotherapy and CHIVA. However, studies with sufficient sample sizes of solely treatment of AASV incompetence are needed to draw firm conclusions.

Outcomes of Primary Rhegmatogenous Retinal Detachment Repair in Eyes With Preoperative Grade B or C Proliferative Vitreoretinopathy

Purpose: This work evaluates the anatomic and functional outcomes of primary rhegmatogenous retinal detachments (RRDs) with preoperative grade B and C proliferative vitreoretinopathy (PVR) vs eyes without PVR. Methods: As a multi-institutional, interventional, retrospective study of all patients undergoing primary RRD surgical procedures from January 1, 2015, through December 31, 2015, this study evaluated the visual acuity (VA) outcomes and single-surgery anatomic success rates (SSAS) of patients with primary grade B and C PVR at the time of RRD repair. Results: A total of 2486 eyes underwent primary RD surgery during the study period, of which 153 eyes (6.2%) had documented preoperative PVR grade B or C. Eyes without PVR had better SSAS compared with eyes with grade B or C PVR (87% vs 83% vs 75%, respectively, P < .0001). Eyes without PVR also had better final mean (SD) logMAR VA (0.35 [0.47]; 20/45 Snellen equivalent) than eyes with PVR of grade B (0.50 [0.56]; 20/63 Snellen equivalent) or grade C ( P < .0001). In only eyes with preoperative PVR, there were no significant differences in final VA or SSAS on multivariate analysis based on surgical approach or use of retinectomy or membrane peeling alone in the intraoperative management of PVR. Conclusions: Eyes with primary preoperative grade B and C PVR appear to have significantly worse VA outcomes and lower surgical success rates. Surgical approach and management of PVR membranes did not appear to affect VA or success rates, indicating that preoperative PVR severity may dictate these outcomes.

How effective is cyanoacrylate closure in small saphenous vein insufficiency? A single center experience

Objectives The present study was aimed to evaluate the efficacy and early outcomes of n-butyl cyanoacrylate (NBCA) ablation in small saphenous vein (SSV) insufficiency. Methods In this single-center, retrospective, single-arm study, NBCA ablation was performed in 80 patients with SSV insufficiency between September 2018 and May 2020. Primary outcomes (anatomic success rate and occlusion rate) and secondary outcomes (VCSS and AVVQ scores) of the patients were analyzed. Results No technical failure and device-related complications were encountered. Anatomic success rate was 100% after procedures. Each treated SSV was occluded on colored Doppler ultrasonography immediately after the procedure, and all veins remained occluded at 2 weeks after the procedure. Partial recanalization was observed in five patients at 12-month follow-up. Kaplan–Meier analysis revealed an occlusion rates at 6 months and 12 months follow-up were 97.5% and 93.75%, respectively. The mean pretreatment VCSS (4.72 ± 2.04) decreased to 1.61 ± 0.93, 0.87 ± 0.58, and 0.73 ± 0.52 at 2 weeks, 6 months, and 12 months after treatment, respectively ( p < .001). The mean pretreatment AVVQ score (11.92 ± 2.23) decreased to 8.2 ± 1.89, 4.2 ± 1.16, and 3.32 ± 1.19 at 2 weeks, 6 months, and 12 months after treatment, respectively ( p < .001). The Clinical, Etiologic, Anatomic, and Pathophysiology clinical classification at 12 months demonstrated a significant reduction in disease severity compared with preoperative values ( p < .001). There was no mortality and major adverse events including anaphylaxis and pulmonary thromboembolism (PTE) related to procedure after follow-ups. Moreover, there were no symptoms or signs of any sural nerve injury and no cases of skin necrosis, infection, or hyperpigmentation. In addition, no hematoma, deep venous thrombosis, and hypersensitivity reactions were observed. Phlebitis-like abnormal reaction was observed in three patients (3.8%). Conclusions In conclusion, in patients with SSV insufficiency, NBCA ablation with VenaBlock® system appears to be an effective and reliable treatment method. At the 12-month follow-up, the NBCA of SSVs showed a low recanalization rate and had a satisfactory improvement on the VCSS and AVVQ scores.

Scleral Buckling for Primary Retinal Detachment: Outcomes of Scleral Tunnels versus Scleral Sutures

Purpose: There are primarily two techniques for affixing the scleral buckle (SB) to the sclera in the repair of rhegmatogenous retinal detachment (RRD): scleral tunnels or scleral sutures. Methods: This retrospective study examined all patients with primary RRD who were treated with primary SB or SB combined with vitrectomy from January 1, 2015 through December 31, 2015 across six sites. Two cohorts were examined: SB affixed using scleral sutures versus scleral tunnels. Pre- and postoperative variables were evaluated including visual acuity, anatomic success, and postoperative strabismus. Results: The mean preoperative logMAR VA for the belt loop cohort was 1.05 ± 1.06 (Snellen 20/224) and for the scleral suture cohort was 1.03 ± 1.04 (Snellen 20/214, p = 0.846). The respective mean postoperative logMAR VAs were 0.45 ± 0.55 (Snellen 20/56) and 0.46 ± 0.59 (Snellen 20/58, p = 0.574). The single surgery success rate for the tunnel cohort was 87.3% versus 88.6% for the suture cohort (p = 0.601). Three patients (1.0%) in the scleral tunnel cohort developed postoperative strabismus, but only one patient (0.1%) in the suture cohort (p = 0.04, multivariate p = 0.76). All cases of strabismus occurred in eyes that underwent SB combined with PPV (p = 0.02). There were no differences in vision, anatomic success, or strabismus between scleral tunnels versus scleral sutures in eyes that underwent primary SB. Conclusion: Scleral tunnels and scleral sutures had similar postoperative outcomes. Combined PPV/SB in eyes with scleral tunnels might be a risk for strabismus post retinal detachment surgery.

Clinical characteristics and surgical outcomes of rhegmatogenous retinal detachment in patients ages 18-40 years

The risk of rhegmatogenous retinal detachment (RRD) increases with age and its more common in the older age group, but several studies report a secondary peak of RRD in young patients. At the same time, RRD in young patients has clinical features. Purpose. To describe clinical features and surgical outcomes of RRD in young adults. Materials and мethods. Retrospective study of 33 patients (33 eyes) aged between 18 and 40 years, who underwent primary surgery between June 2018 and February 2021. The mean age of the patients was 33.9±6.7 years. All patients underwent either scleral buckling or pars plana vitrectomy. We analyzed demographic data, RRD characteristics, primary and final anatomic anatomic success rate and best-corrected visual acuity (BCVA) at the conclusion of follow-up. Results. The main etiologies were myopia (87.8%) and trauma (15%). were Macula on RRD was in 69.7% of patients. Primary anatomic success was in 69.7% cases, final anatomic success- 94%. (14 out of 16 eyes) after vitrectomy. The mean BCVA value improved to 0.65±0.35 (p=0.042). Conclusion. RRD in young adults aged between 18 and 40 years has clinical features and differs from that in older adults. The main causes are myopia, especially of high myopia and trauma. Macula off RRD is less common than macula on RRD. Primary anatomic success is less favorable compared to final anatomic success. The functional prognosis remains satisfactory and increased to 0.65±0.35 (p=0.042).

Surgical repair of primary non-complex rhegmatogenous retinal detachment in the modern era of small-gauge vitrectomy

ObjectiveTo report anatomic and visual outcomes of pars plana vitrectomy (PPV), as well as scleral buckling (SB) and PPV/SB as surgical treatments for the management of primary, non-complex rhegmatogenous retinal detachment (RRD).Methods and analysisData from 751 eyes that underwent PPV, SB or combined PPV/SB as a surgical treatment for primary non-complex RRD with at least 3 months of follow-up were analysed to determine rates of single surgery anatomic success (SSAS) and final anatomic success (FAS). Patients or the public were not involved in the design, conduct or reporting of this research.ResultsPPV accounted for 89.0% (n=668), PPV/SB for 6.8% (n=51) and SB for 4.2% (n=32) cases. Overall SSAS (91.2% PPV, 84.3% PPV/SB, 93.8% SB; p=0.267) and FAS (96.7% PPV, 94.1% PPV/SB and 100.0% SB; p=0.221) were reported for the three surgical groups. SSAS and FAS were similar for lens status, macular detachment status and the presence or absence of inferior retinal breaks for each of the PPV, PPV/SB and SB groups.ConclusionsIn this large, single institution, retrospective case series, we report surgical outcomes for patients with primary non-complex RRD managed with PPV, SB or PPV/SB in the modern era of small-gauge vitrectomy. We demonstrate that primary PPV without adjunct SB provides excellent anatomic and visual outcomes irrespective of lens status, macular involvement or pathology location.

SURGICALOUTCOMESOF23-GAUGEPARSPLANA VITRECTOMYFOR RETINALDETACHMENT PATIENTS IN TRIPOLI

Aim:To evaluate the outcomes and complications of 23-gauge (G) pars plana vitrectomy (PPV) for repair of retinal detachment (RD). Method:Retrospective review of consecutive, single-surgeon 23-G PPV cases between January 2017 and December 2017. 117 eyes from 117 patients were operated on for RD all eyes were tamponaded with , silicone oil,Air. Mean age at surgery was 48.69 years (range 8-75 years), and mean length of follow-up was 5 weeks (range2weeks — 32 weeks). Primaryoutcomesincludedbest-correctedvisualacuity(BCVA),intraocular pressure (IOP), anatomic success, redetachment, andendophthalmitis. Result:We included 117 consecutive patients (117eyes).Males and females are equal . The average age was 48,69 years(range 8-75), The primary success rate with a single procedure was 98%. However, redetachment occurred in two eyes only (1.7%). Visual acuity was improve in 89.74% of the eyes. Mean IOP increased from 11.16 to 12.58mm Hg aftersurgery. ElevatedpostoperativeIOP(>22mmHg)occurredin10eyes,andnolowIOP There were no cases of endophthalmitis .The average follow-up periodfor all patients was 2weeks (range 2-32 weeks) Conclusion:Twenty-three-G PPV repair was safe and effective in the repair of RD.

Vitrectomy with fovea-sparing ILM peeling versus total ILM peeling for myopic traction maculopathy: A meta-analysis

Purpose: To evaluate the effect and safety of fovea-sparing internal limiting membrane (ILM) peeling (FSIP) for myopic traction maculopathy comparing with that of total ILM peeling (TP). Methods: PubMed, Web of science, Embase, Cochrane, EBSCO and CNKI, published until January 2020, were searched. Postoperative best-corrected visual acuity (BCVA), postoperative central foveal thickness (CFT), the rate of visual improvement and anatomic success were the main outcome parameters, and the secondary outcome parameters were postoperative complications. Random-effects models were chosen in regard with multi-studies. Standard mean difference (SMD) with 95% confidence interval (CI) and odds ratio (OR) were applied as effect sizes of continuous and binomial data, respectively. Results: Six comparative studies involving 193 eyes were included. Better postoperative BCVA was detected in the FSIP group (SMD = −0.39, 95%CI: −0.69 to −0.09, p = 0.01). The FSIP group had a higher rate of vision improvement with statistical significance (OR = 3.86, 95%CI: 1.36 to 10.97, p = 0.01). Both surgical methods had similar outcomes for postoperative CFT (SMD = 0.07, 95%CI: −0.27 to 0.40, p = 0.70). The FSIP group had a higher rate of anatomic success, though there was no obvious significance (OR = 2.54, 95%CI: 0.96 to 6.74, p = 0.06). For the development of postoperative full-thickness macular hole (FTMH), the rate was lower in the FSIP group (OR = 0.18, 95%CI: 0.05 to 0.64, p = 0.008). Conclusion: Vitrectomy with fovea-sparing ILM peeling for myopic traction maculopathy could gain better visual outcomes and decrease incidence of FTMH development, though there was no obvious difference in postoperative CFT and the rate of anatomic success between two groups.

Lens-sparing vitrectomy for stage 4A retinopathy of prematurity in infants with aggressive-posterior ROP: Anatomic and functional results

Aim: To assess long-term anatomic and functional outcomes of early lens-sparing vitrectomy (LSV) for stage 4A retinopathy of prematurity (ROP) in infants with aggressive-posterior ROP (AP-ROP) which progressed to retinal detachment despite laser treatment. Methods: Chart review of infants who underwent early 25-gage LSV for stage 4A ROP. Outcomes were anatomic success, mean visual acuity (VA), development of postoperative complications, and refractive changes. Follow-up examinations were performed at 1, 3, 6, 12, and then every 6 months. Results: Ten eyes of seven preterm infants who underwent LSV were included. Mean follow-up was 36 ± 13.4 months and mean postmenstrual age (PMA) at last follow-up was 37 ± 13.7 months. Mean gestational age (GA) and weight at birth was 26 ± 1.4 weeks and 639 ± 180 g. Two eyes had vitreous hemorrhage 4 and 14 days after surgery, respectively. At last follow-up anatomic success was 100%, mean VA was 20/80 and eight eyes (80%) had high myopic refractive correction (mean spherical equivalent –11.25 D). Conclusion: Early LSV for stage 4A ROP with AP-ROP and progression to retinal detachment is efficacious in terms of anatomic and functional outcomes. Anatomic success is associated with visual improvement despite possible myopic refraction changes during follow-up.