Capsular bag performance of a novel hydrophobic acrylic single-piece intraocular lens: Two-year results of a randomised controlled trial

2020 ◽  
pp. 112067212096059
Author(s):  
Andreea D Fișuș ◽  
Nino D Hirnschall ◽  
Sophie Maedel ◽  
Maria Fichtenbaum ◽  
Petra Draschl ◽  
...  

Purpose: To determine the visual outcome, intraocular lens (IOL) stability and posterior capsule opacification (PCO) rate of a hydrophobic acrylic intraocular lens. Setting: Vienna Institute for Research in Ocular Surgery, Hanusch Hospital, Vienna, Austria Design: This double-masked randomised study included patients who underwent standard cataract surgery. Method: Patients received either the hydrophobic acrylic IOL (iPure, PhysIOL) or the hydrophobic acrylic control IOL (Tecnis ZCB00, Johnson&Johnson). Subjective refraction, uncorrected and corrected distance visual acuity (UDVA, CDVA), IOL tilt and decentration (Purkinje meter) and PCO intensity using retroillumination images with automated image analysis (automated quantification of after-cataract, AQUA), were evaluated for both groups 2 years after surgery. Results: A total number of 31 patients completed the 2-year follow-up, 16 in the study group and 15 in the control group. The CDVA was 0.0 logMAR (standard deviation – SD: 0.1) for the study IOL and 0.1 logMAR (SD: 0.2) for the control IOL, p = 0.001. The AQUA PCO score for the study group was 2.1 and 1.4 for the control group, p = 0.44. Mean IOL tilt was 2.9° (SD: 1.8) in the study group and 5.0° (SD: 4.5) in the control group, whilst the mean decentration was 0.37 mm (SD: 0.18) and 0.45 mm (SD: 0.3), p = 0.610. Conclusion: The studied parameters revealed a good performance for both IOLs. Both IOLs had good CDVA, a small amount of tilt and decentration and none of the patients required laser capsulotomies during the follow-up time of 2 years after surgery. Presented at the 37th ESCRS Congress Paris, France, September 2019

2018 ◽  
Vol 23 (4) ◽  
pp. 199-207 ◽  
Author(s):  
Ilyoung Cho ◽  
Hyun-Min Lee ◽  
Sung-Won Choi ◽  
Soo-Keun Kong ◽  
Il-Woo Lee ◽  
...  

Objectives: This study aimed to investigate the efficacy of simultaneous steroid and hyperbaric oxygen therapy (HBOT) in patients with severe to profound idiopathic sudden sensorineural hearing loss (ISSNHL), which has a poor prognosis. Methods: Sixty patients diagnosed with severe to profound ISSNHL (≥70 dB HL) were randomly divided into two groups in a prospective controlled trial: an oral steroid + intratympanic steroid injection (ITSI) group (control group) and an oral steroid + ITSI + HBOT group (study group). Pure-tone audiometry (PTA) results and word discrimination scores (WDS) were compared between the two groups before treatment and 10 days and 1, 2, and 3 months after treatment. Hearing improvement was assessed using the modified American Academy of Otolaryngology-Head and Neck Surgery criteria. Analyses were by both intention to treat and per protocol. Results: A total of 58 patients completed the 3-month follow-up, and 2 patients in the study group were excluded due to follow-up loss in the per-protocol analysis. In the intention-to-treat and per-protocol analyses, the study group showed significantly better hearing levels than did the control group at 500 Hz (p < 0.05) 1 month after treatment and at 1 kHz (p < 0.05) 3 months after treatment. However, the average PTA values and PTA at 2, 4, and 8 kHz showed no significant difference. WDS improvement was significantly higher in the study group compared to the control group 3 months after treatment by both per-protocol (66.4 ± 13.3 and 56.7 ± 19.1%, respectively; p = 0.029) and intention-to-treat analyses (65.9 ± 14.1 and 56.7 ± 19.1%, respectively; p = 0.035). The sum of complete and partial hearing recovery for the study group was significantly higher than that for the control group by per-protocol analysis (60.7 vs. 33.3%; p = 0.037) and intention-to-treat analysis (60.0 vs. 33.3%; p = 0.038). Conclusion: These results demonstrate that the addition of HBOT to steroid combination therapy does not improve the average PTA values in severe to profound ISSNHL; however, it was associated with a better outcome at 500 Hz 1 month after treatment and, at 1 kHz, WDS 3 months after treatment. The sum of complete and partial hearing recovery was significantly higher for the study group than for the control group.


2018 ◽  
Vol 29 (1) ◽  
pp. 28-32
Author(s):  
Mahmoud Fathy Rateb ◽  
Zeiad Hasan Eldaly ◽  
Walid Saad Eldein Ibrahim ◽  
Ahmed Hasan Eldoghaimy

Purpose: To compare surface alterations between preloaded and manually loaded intraocular lens. Methods: Scanning electron microscope was utilized to evaluate surface alteration and deposits in four different types of intraocular lenses: preloaded hydrophobic acrylic, preloaded hydrophilic acrylic, manually loaded hydrophobic acrylic, and manually loaded hydrophilic acrylic. Six lenses with different powers (+6 D, +22 D, and +29 D) were used from each category, to represent different thickness categories of the intraocular lenses. Results: In total, 30 intraocular lenses have been evaluated in this study: 4 from the control group (2 hydrophobic and 2 hydrophilic lenses) and 12 from the preloaded intraocular lens and manually loaded groups (6 hydrophilic and 6 hydrophobic lenses with different powers). Surface deposits were found in eight hydrophobic intraocular lenses compared to a single intraocular lens with scattered deposits on the optical surface of a hydrophilic intraocular lens. In manually loaded intraocular lens group, five hydrophobic and one hydrophilic intraocular lenses showed identifiable marks on the optical surface. In the preloaded intraocular lens group, three hydrophobic intraocular lenses showed identifiable marks on the optical surface and three hydrophobic intraocular lenses showed surface wrinkling. All hydrophilic intraocular lenses revealed no identifiable marks. Conclusion: Surface alterations and deposits are a common finding in both preloaded and manually loaded intraocular lenses. Water content of acrylic intraocular lenses is an important factor predisposing to these changes, and hydrophobic intraocular lenses are more vulnerable than hydrophilic lenses. The impact on the final visual outcome needs further studies.


2019 ◽  
Vol 7 (7_suppl5) ◽  
pp. 2325967119S0038
Author(s):  
Danielle G. Weekes ◽  
Eric D. Wicks ◽  
Richard E. Campbell ◽  
Christopher Hadley ◽  
Aaron Carter ◽  
...  

Objectives: During the last decade, concern about opioid dependence and abuse has spurred an increasing interest within orthopedic surgery to decrease reliance on narcotics for pain management. Non-pharmacologic interventions, such as patient opioid education, can decrease narcotic consumption after arthroscopic rotator cuff repair (ARCR). Another non-pharmacologic intervention, the use of relaxation exercises, has been promoted for pain management following surgical procedures; however, its’ effect has not been investigated following ARCR. The purpose of this investigation was to evaluate the effects of relaxation exercises on post-operative pain and narcotics use after ARCR. Methods: This was a prospective, randomized, controlled trial evaluating 151 consecutive patients undergoing ARCR. The treatment group (n: 75) received and reviewed relaxation education materials including a 5 minute video explaining relaxation breathing techniques, while the control group (n: 75) received no relaxation education materials. Both groups received a standardized pre-operative interscalene nerve block as well as the same standardized post-op care, including oxycodone 5mg/acetaminophen 325 mg, and cryotherapy. Patients recorded a 5-day journal of their pain level and opioid consumption. Patients were then queried with the American Shoulder and Elbow Surgeons (ASES) Shoulder Score, Single Assessment Numerical Evaluation (SANE) score, and Visual Analog Score (VAS) for pain pre-operatively, and at 2, 6, 12, 18, and 24 weeks post-operatively. Additionally, patients were given a follow-up survey at 2 weeks post-operative to assess subjective pain relief efficacy of the relaxation techniques. T-test analyses were utilized to compare differences between the treatment group and the control group. Results: Ninety-five percent of patients completed the follow-up survey. Sixty-three percent (43/68) of study group patients reported that the relaxation techniques decreased their pain levels, while 37% said that it had no effect on their pain. There were no significant differences between the study and control groups in mean post-op VAS pain scores on post-op day 1 (treatment: 55.40, control: 59.5; p= 0.94), post-op day 2 (treatment: 56.15, control: 56.93; p= 0.88), post-op day 3 (treatment: 48.38, control: 47.07; p= 0.52), post-op day 4 (treatment: 40.03, control: 45.54; p= 0.79) and post-op day 5 (treatment: 38.57, control: 40.57; p= 0.71). At two weeks post-op the study group consumed significantly less narcotics than the control group (mean: 21.7 doses vs. 29.7; p= 0.016, Cohen’s d: 0.42), and 51% were still performing the relaxation techniques. There were no significant differences in ASES and SANE scores at each time point throughout the study period. Conclusion: Although nearly two-thirds of patients in the treatment group believed that the use of relaxation breathing techniques decreased their pain, there was no difference in pain measures between the treatment group and the control group. However, the treatment group did utilize less opioid medication than the control group. While the effect on post-op pain is uncertain, the use of relaxation techniques can provide an easy to implement, non-pharmacologic strategy to significantly decrease narcotics consumption after ARCR.


2020 ◽  
Vol 34 (4) ◽  
pp. 471-479
Author(s):  
Nabil Mahmoud Abdel-Aal ◽  
Hany Mohamed Elgohary ◽  
Elsadat Saad Soliman ◽  
Intsar Salem Waked

Objective: To investigate the effect of kinesiotaping and a designed exercise program versus sham kinesiotaping and the same exercise program on pain, range of motion, and activities of daily living in obese patients suffering from coccydynia. Design: A double-blinded, randomized, sham-controlled trial. Setting: Outpatient, Cairo University hospitals. Participants: Sixty patients with coccydynia randomized equally into kinesiotape plus exercise and sham kinesiotape plus exercise groups. Intervention: The kinesiotape was worn for three days and replaced for three weeks. Each patient practiced exercises for three weeks. Outcome measures: All patients were examined by visual analogue scale (VAS) for rating pain, Modified Modified Schober Test (MMST), and Oswestry Disability Index (ODI). All outcomes were measured at baseline, three weeks postintervention, and four weeks follow-up. Results: There were no statistically significant differences between groups at baseline ( P < 0.05), but there were statistically significant differences between groups for pain score, MMST, and ODI at post and follow-up data in favor of the kinesiotape group ( P < 0.001). For the three weeks postintervention, mean (SD) for pain score, MMST, and ODI was 33.07 ± 3.8, 6.6 ± 0.7, and 8.7 ± 2.1 in the study group and 39.9 ± 4.7, 5.8 ± 1.4, and 14.4 ± 2.7 in the control group, respectively. For the four weeks follow-up, mean (SD) for pain score, MMST, and ODI was 32.2 ± 3.4, 7.13 ± 0.6, and 7.2 ± 1.8 in the study group and 40.9 ± 4.4, 6.6 ± 0.75, and 13 ± 2 in the control group, respectively. Conclusion: Experimental kinesiotape intervention and exercise program provided significant improvements in pain, range of motion, and disability. It is suggested as an adjunctive therapy in treating obese patients with coccydynia.


2000 ◽  
Vol 45 (2) ◽  
pp. 45-48 ◽  
Author(s):  
C. Martin ◽  
T. Obonyo ◽  
T. Carney ◽  
L. Lamont

A controlled trial of an outpatient cognitive behavioural pain management programme for sufferers of non-cancer chronic pain is described. A multidisciplinary team set up a programme of ten half day sessions for groups of ten to fourteen patients aiming to improve activity levels and control over pain; to reduce maladaptive pain behaviours and drug intake; to mitigate negative mood; to modify unhelpful beliefs and to maintain treatment gains by operant and cognitive methods. Self report questionnaires were employed before and six weeks, six months and one year after the programme. Fifty-eight patients entered the study group and 39 patients completed the programme and initial follow up with further attrition in long term follow up. There were no changes in the waiting list control group of twelve subjects but the study group made significant short and long term improvements in pain severity, activity levels, mood, coping and experienced fewer catastrophizing thoughts.


Author(s):  
Ningthemba Yumnam ◽  
Joy Singh Akoijam ◽  
Joymati Oinam

Background: Upper limbs are very important to motor functionality. However, in majority of stroke patients, arm functions are impaired resulting in disabilities and restrictions to function. Therefore, the objective of this study was to assess the effectiveness of mirror therapy in the motor recovery of upper extremity in the post stroke hemiplegic patient.Methods: A prospective randomized controlled trial was conducted among 72 post stroke patients aged 35-65 years having hemipa­resis attending the PMR OPD in RIMS, Manipur from 2013 to 2016. Assessment was done for FIM self care and Brunnstrom stages of motor recovery at baseline and 1 month and 6 month of post treatment. Both the study and control group participated in a stroke rehabilitation programme and study group was given mirror therapy in addition. Descriptive statistics such as mean, standard deviation and inferential statistics like Chi-square test, Student’s t test, and ANOVA were used. A p-value <0.05 was taken as statistically significant.Results: Mean age were 54.56±7.61 years (study) and 55.11±7.99 years (control). Majority of them were males (61.1%). Significant improvement was noted in the study group from baseline to 1 month and 6 months follow up. Mean score comparison of FIM self care between study and control group from baseline to 1 month was (28.28±3.11 to 34.11±2.59 vs 28.00±4.30 to 29.50±4.58) and from 1 to 6 months follow up was (34.11±2.59 to 37.83±2.04 vs 29.50±4.58 to 32.44±4.82) respectively.Conclusions: There was a significant improvement in hand function regarding both motor recovery and daily self care activities in the study group.


2019 ◽  
Vol 33 (5) ◽  
pp. 904-912 ◽  
Author(s):  
Angelo Cacchio ◽  
Giancarlo Di Carlo ◽  
Cofini Vincenza ◽  
De Blasis Elisabetta

Objective: To evaluate the effectiveness and safety of oral administration of Linfadren® in addition to conventional treatment in patients with post-trauma/surgery persistent hand edema. Design: Parallel-group randomized controlled trial. Setting: Outpatient rehabilitation center. Subjects: A total of 60 outpatients (mean age 48.5 (standard deviation (SD) = 12.3) years) with post-trauma/surgery persistent hand edema. Interventions: Patients were randomized to either receive six-week conventional treatment plus Linfadren® (Study Group) or conventional treatment (Control Group). Main Measures: Primary outcome was hand edema as measured by figure-of-eight method. Secondary outcomes were hand function, patient’s overall perceived treatment effectiveness and rescue medication request. Tolerability of Linfadren® was also evaluated. Assessments were performed at baseline, at the end of treatment and three months after the end of treatment. Results: All patients completed the six-week program and 57 patients (95%) completed the three-month follow-up. At six weeks, the Study Group had significantly greater improvement in hand edema (423.3 (SD = 23.8) mm vs 439.4 (SD = 22.6) mm; P = 0.009) and upper limb function ( Quick Disabilities of Arm, Shoulder and Hand questionnaire: 23.6 (SD = 13.6) vs 37.7 (SD = 15.9); P = 0.005) compared to the Control Group. Moreover, the percentage of patients who perceived treatment as effective was significantly higher in the Study Group than in the Control Group both after treatment (70% vs 37%, P = 0.002) and at follow-up (77% vs 30%, P < 0.0001). The rescue medication request was not different between groups. No adverse events were recorded. Conclusion: Linfadren® in addition to conventional treatment was safe and more effective than conventional treatment alone in patients with post-trauma/surgery persistent hand edema.


2017 ◽  
Vol 45 (5) ◽  
pp. 1004-1011 ◽  
Author(s):  
Xin Liu ◽  
Hui Zhang ◽  
Hua Feng ◽  
Lei Hong ◽  
Xue-song Wang ◽  
...  

Background: A special type of meniscal lesion involving the peripheral attachment of the posterior horn of the medial meniscus (PHMM), termed a “ramp lesion,” is commonly associated with an anterior cruciate ligament (ACL) injury. However, its treatment is still controversial. Recently, stable ramp lesions treated with abrasion and trephination alone have been shown to have good clinical outcomes after ACL reconstruction. Hypothesis: Stable ramp lesions treated with abrasion and trephination alone during ACL reconstruction will result in similar clinical outcomes compared with those treated with surgical repair. Study Design: Randomized controlled trial; Level of evidence, 2. Methods: A prospective randomized controlled study was performed in 91 consecutive patients who had complete ACL injuries and concomitant stable ramp lesions of the medial meniscus. All patients were randomly allocated to 1 of 2 groups based on whether the stable ramp lesions were surgically repaired (study group; n = 50) or only abraded and trephined (control group; n = 41) during ACL reconstruction. All surgical procedures were performed by a single surgeon who was blinded to the functional assessment findings of the patients. The Lysholm score, subjective International Knee Documentation Committee (IKDC) score, and stability assessments (pivot-shift test, Lachman test, KT-1000 arthrometer side-to-side difference, and KT-1000 arthrometer differences of <3, 3-5, and >5 mm) were evaluated preoperatively and at the last follow-up. Moreover, magnetic resonance imaging (MRI) was used to evaluate the healing status of the ramp lesions. Results: All consecutive patients who were screened for eligibility from August 2008 to April 2012 were enrolled and observed clinically. There were 40 patients in the study group and 33 patients in the control group who were observed for at least 2 years. At the final follow-up, there were no significant differences between the study group and the control group in terms of the mean Lysholm score (88.7 ± 4.8 vs 90.4 ± 5.8, respectively; P = .528), mean subjective IKDC score (83.6 ± 3.7 vs 82.2 ± 4.5, respectively; P = .594), pivot-shift test results ( P = .658), Lachman test results ( P = .525), KT-1000 arthrometer side-to-side difference (1.6 ± 1.2 vs 1.5 ± 1.1, respectively; P = .853), or KT-1000 arthrometer grading ( P = .738). Overall, for both groups (n = 73), 67 patients showed completely healed (38 study, 29 control), 3 showed partially healed (1 study, 2 control), and 3 showed nonhealed (1 study, 2 control) signals on follow-up MRI when evaluating the healing status of the ramp lesions. There was no significant difference regarding the healing status of the ramp lesions between the 2 groups ( P = .543). Conclusion: This prospective randomized controlled trial showed that, in terms of subjective scores, knee stability, and meniscal healing status, concomitant stable ramp lesions of the medial meniscus treated with abrasion and trephination alone during ACL reconstruction resulted in similar clinical outcomes compared with those treated with surgical repair.


Blood ◽  
2005 ◽  
Vol 106 (11) ◽  
pp. 48-48 ◽  
Author(s):  
Issa F. Khouri ◽  
Rima M. Saliba ◽  
Chitra M. Hosing ◽  
Sandra A. Acholonu ◽  
Luis E. Fayad ◽  
...  

Abstract We evaluated the safety and efficacy of NMT vs. AUTO as a treatment modality for patients (pts) with relapsed chemosensitive FL. Pts were considered for AUTO if they did not have a matched sibling donor. Pts were eligible for NMT if they had a donor, especially if pts were &gt; 1st relapse or failed a prior AUTO. Between March 1999 and April 2005, 68 consecutive pts were treated. 47 received a NMT after conditioning with fludarabine, cyclophosphamide, HD-R (Blood89:3595, 2001). Twenty-one other pts received AUTO after either Cy/TBI/HD-R (N=8) or BEAM/HD-R (N= 13) (JCO23:2240,2005). The HD-R regimen consisted of 2 injections pre-transplant in NMT or during cell mobilization for AUTO, at 375 mg/m2 and 1000 mg/m2, respectively. Pts then received two additional doses of 1000 mg/m2 at days +1 and +8 post-transplant. Median age of pts (53 yrs), time from diagnosis to transplant (3yrs), % pts in PR (57%) at study entry were equal in both groups. There was no statistically significant difference in gender distribution, histology subtypes of FL grades, history of marrow involvement, beta-2 microglobulin (b2-m), IPI and LDH levels between the two groups. There were however more pts in the NMT group who had &gt; 1 relapse (38% vs 19%, P = 0.09), or had &gt; 3 lines of therapy (28% vs none). Eight pts (17%) in the NMT group had failed a prior AUTO. Sixty-six pts (97%) had peripheral blood (PB) transplant, two other pts with NMT received marrow from an unrelated donor. With a median follow-up time of 34 months, overall survival rates at 3-year were 88% and 84% for the NMT and AUTO groups, respectively (P=0.8). DFS and risk of progression were comparable between the two groups (85% vs 84%, and 3% vs 5%, respectively). DFS for the 8 pts who received NMT after failing a prior AUTO was 87% at 4-year. Causes of death varied between the AUTO group [Secondary leukemia (2), viral encephalitis (1)] and the NMT group [acute GVHD (2), chronic GVHD (2), unknown (1)]. We compared the outcome of AUTO in this study [AUTO Study Group), to a historical group [AUTO Control Group] of pts who received an AUTO under an immediately preceding protocol (years of therapy: 1994-1998). Pts in the AUTO Control Group were younger [Median age was 47 vs. 53 yrs, respectively, P = 0.007)], received Cy/VP-16/TBI without HD-R as conditioning regimen, and mostly (84% of pts) received in-vitro purged marrow as the source of graft (P &lt; 0.001). Other disease characteristics were not statistically different between them. Results at 3-years demonstrated a higher risk of progression in the AUTO Control Group compared to the AUTO Study Group (26% vs. 5%, respectively, P = 0.09), an inferior DFS (58% vs. 84%, respectively, P = 0.04), and a tendency for a shorter survival (74% vs 84%, respectively, P = 0.2). These data suggest that NMT has a spectrum of safety that becoming comparable to AUTO. HD-R appears to improve the outcome after AUTO. Longer follow-up is needed to assess remission duration in the 2 study groups. A prospective controlled trial of AUTO vs. NMT using HD-R in each arm is warranted to assess the optimal strategy for treatment of relapsed FL.


Author(s):  
Phoebe Ullrich ◽  
Christian Werner ◽  
Martin Bongartz ◽  
Tobias Eckert ◽  
Bastian Abel ◽  
...  

Abstract Background Community-dwelling older persons with cognitive impairment (CI) following discharge from geriatric rehabilitation are at high risk of losing life-space mobility (LSM). Interventions to improve their LSM are, however, still lacking. The aim of this study was to evaluate the effects of a CI-specific, home-based physical training and activity promotion program on LSM. Methods Older persons with mild-to-moderate CI (Mini-Mental State Examination: 17–26 points) discharged home from rehabilitation were included in this double-blinded, randomized, placebo-controlled trial with a 12-week intervention period and 12-week follow-up period. The intervention group received a CI-specific, home-based strength, balance, and walking training supported by tailored motivational strategies. The control group received a placebo activity. LSM was evaluated by the Life-Space Assessment in Persons with Cognitive Impairment, including a composite score for LSM and 3 subscores for maximal, equipment-assisted, and independent life space. Mixed-model repeated-measures analyses were used. Results One hundred eighteen participants (82.3 ± 6.0 years) with CI (Mini-Mental State Examination: 23.3 ± 2.4) were randomized. After the intervention, the home-based training program resulted in a significant benefit in the Life-Space Assessment in Persons with Cognitive Impairment composite scores (b = 8.15; 95% confidence interval: 2.89–13.41; p = .003) and independent life-space subscores (b = 0.39; 95% confidence interval: 0.00–0.78; p = .048) in the intervention group (n = 63) compared to control group (n = 55). Other subscores and follow-up results were not significantly different. Conclusions The home-based training program improved LSM and independent life space significantly in this vulnerable population. Effects were not sustained over the follow-up. The program may represent a model for improved transition from rehabilitation to the community to prevent high risk of LSM restriction.


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