Comparison Between Nylon and Polyglactin Sutures in Pediatric Cataract Surgery: A Randomized Controlled Clinical Trial.
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ABSTRACT: Purpose: To compare the performance of nylon sutures to that of polyglactin sutures in pediatric patients undergoing cataract surgery. Setting: University of Campinas (UNICAMP), Campinas, São Paulo, Brazil Design: A prospective, randomized, partially masked, single-site clinical trial. (https://clinicaltrials.gov/ct2/show/NCT03812640). Methods: A total of 80 eyes from 80 patients who underwent pediatric cataract surgery were randomized into two groups in block sizes of four. Group A consisted of 41 patients whose surgical incisions were sutured with polyglactin 10-0 material. Group B consisted of 39 patients whose surgical incisions were sutured with nylon 10-0 material. The primary outcome was frequency of suture-related complications in each group. Secondary outcomes were the frequency with which suture removal was necessary. Results: The incidence of suture-related complications within 6 months of follow up was 0 out of 41 eyes (0.00%) in the polyglactin group and 17 out of 39 eyes (43.59%) in the nylon control group (p < 0.001). In all of the eyes with suture-related complications, the sutures were promptly removed. The most frequent complications were vascularization near the suture (17.95%) and loose sutures (17.95%). No ocular or systemic study-related adverse events were observed. Conclusions: Polyglactin sutures were found to be safe and effective for pediatric patients undergoing cataract surgery. Their lower rate of complications and reduced likelihood of removal (and the subsequent need for general anesthesia) make their use preferrable to that of nylon sutures. This study represents the first controlled randomized clinical trial to compare nylon sutures to polyglactin sutures in pediatric patients undergoing cataract surgery. Clinical Trial Registration: URL: https://clinicaltrials.gov/ct2/show/, Identifier: NCT03812640.
Project description:Controversy remains regarding the optimal technique and suture type for wound closure after carpal tunnel surgery. Adult patients undergoing open carpal tunnel release were prospectively randomized to receive either interrupted, buried Monocryl sutures or traditional nylon horizontal mattress sutures for their wound closures. At the 2-week and 6-week postoperative visits, Patient and Observer Scar Assessment Scale questionnaires were completed. At 2 weeks, patients and observers had a significantly better opinion of incisions closed with Monocryl. By 6 weeks, neither patients nor observers found a difference between suture types in any category. Scars of wounds closed with Monocryl did not change appreciably in appearance between 2 and 6 weeks. However, patients and observers noted significant improvement in scar appearance in the nylon group over time. Monocryl suture represents an effective method for carpal tunnel closure that leads to improved patient- and observer-reported outcome scores in the early postoperative period compared with nylon.Level of evidence: II.
Project description:Capsular outcomes of anterior/posterior capsulorhexis opening (ACO/PCO) are essential for performing a secondary in-the-bag intraocular lens implantation. To compare the capsular outcomes with different primary capsulorhexis sizes, Thirty-eight eligible patients (45 eyes) were randomly assigned to three groups by anterior capsulorhexis diameter (Group A: 3.0-3.9, Group B: 4.0-5.0, and Group C: 5.1-6.0 mm). The areas of ACO/PCO and posterior capsule opening opacity (PCOO) as primary outcomes, while, the incidence of visual axis opacity (VAO) as secondary outcome were measured at follow-up visits. Among the thirty eyes included in the final analysis, the mean area of the ACO decreased significantly, whereas the PCO enlarged with time. Group A had the highest anterior capsule constriction and percentage reduction, which increased with time. There were significant differences in the percentage reductions at 6 months and 1 year compared to 1 month in Group A and B. Group C had the highest posterior capsule enlargement. The percentage of PCOO to PCO area and the incidence of VAO was highest in Group A and lowest in Group C. Thus, Capsulorhexis diameter of 4.0-5.0 mm may yield better capsular outcomes, considering moderate contraction of ACO, moderate enlargement of PCO, and lower percentage of PCOO and VAO.
Project description:BACKGROUND:A recently published meta-analysis comparing metallic staples to sutures in orthopaedic procedures revealed three fold increase in risk for infection in stapled wounds. The studies included in the meta-analysis are at risk of bias due to experimental design limitations. A large randomized controlled trial is proposed to direct orthopaedic surgeons in their choice of wound closure material. METHODS/DESIGN:A parallel group randomized controlled trial with institutional review board approval will be conducted. Patients will be randomized intraoperatively to have skin wounds closed with sutures or staples. Dressings will be used to maintain blinding outcome assessors. The primary outcome measure will be a composite all-cause wound complication outcome measure composed of: infection, wound drainage, wound necrosis, blistering, dehiscence, suture abscess and material sensitivity reaction. An independent review board blinded to treatment assignment will adjudicate suspected complications based on clinical data. All deceased patients will also be reviewed. An interim analysis of complications will take place after half of the patients have been recruited. All data will be analyzed by a blinded statistician. Dichotomous primary and secondary outcome measures will be analyzed using the Chi-squared statistic. Continuous outcome measures will be analyzed using Student's?t-test. Subgroup analysis will compare infection rates using sutures versus staples in each anatomic area (upper extremity, pelvis/acetabulum, hip/femur, knee, ankle). A further subgroup analysis will be conducted comparing trauma patients to elective surgery patients. Non-infected revision surgery will also be compared to primary surgery. DISCUSSION:Wound closure material is an afterthought for many orthopaedic surgeons. The combined results of several comparative trials suggests that the choice of wound closure materials may have an impact on the rate of surgical site infections. However, the strength of the evidence is poor given the heterogeneity of the methods employed in previous studies. The following study protocol aims to guide surgeons in their choice of wound closure material by determining if there is a difference in complication rates in sutured and stapled wounds. TRIAL REGISTRATION:This trial was registered at ClinicalTrials.gov under the identifier NCT01146236 (registered June 14, 2010).
Project description:Purpose. To investigate whether adding video assistance to traditional verbal informed consent advisement improved satisfaction among cataract surgery patients. Methods. This trial enrolled 80 Chinese patients with age-related cataracts scheduled to undergo unilateral phacoemulsification surgery. Patients were randomized into two groups: the video group watched video explaining cataract-related consent information and rewatched specific segments of the video at their own discretion, before receiving traditional verbal consent advisement; the control group did not watch the video. Outcomes included patient satisfaction, refusal to consent, time to complete the consent process, and comprehension measured by a ten-item questionnaire. Results. All 80 enrolled patients signed informed consent forms. Compared with the control group, members of the video group exhibited greater satisfaction (65% versus 86%, p = 0.035) and required less time to complete the consent process (12.3 ± 6.7 min versus 5.6 ± 5.4 min, p < 0.001), while also evincing levels of comprehension commensurate with those reported for patients who did not watch the video (accuracy rate, 77.5% versus 80.2%, p = 0.386). Conclusion. The video-assisted informed consent process had a positive impact on patients' cataract surgery experiences. Additional research is needed to optimize patients' comprehension of the video.
Project description:BACKGROUND:In the spectrum of surgical decision-making, wound closure material is often an afterthought. However, the findings of a recent meta-analysis suggest that the rate of surgical site infections (SSIs) is increased by using staples to close surgical wounds. Less clear is the effect of closure material on the incidence of non-infectious wound complications.The aim of this study was to compare sutures and staples in terms of: incidence of wound complications to determine the sample size for a definitive trial comparing wound closure methods. METHODS:Eligible adult orthopaedic patients were randomized to have wounds closed with sutures or staples. Time for skin closure was recorded. Wounds were assessed for complications for six weeks. The incidence of complications was compared using Fisher's exact test. Time to close and pain with removal of closure material were compared using a Student's t-test. RESULTS:The total number of patients reporting a wound complication was 59 of 148 patients completing six-week followup (41%), with no differennce between sutures and staples (RR = 0.77, CI = 0.52-1.14). The time to close wounds was shorter in the staple group (mean=4.8 min, CI = 2.6-7.1) than the suture group (mean=12 min, CI = 7.9-16). Patients in the staple group (mean=3.7, CI =2.8-4.6) reported more pain with removal than suture group (mean=2.5, CI =1.6-3.4). CONCLUSIONS:This study suggests that 42% of patients report a wound complication with no difference between sutures and staples. It was demonstrated that suturing skin requires more time and staples are more painful to remove. TRIAL REGISTRATION:Clinicaltrials.gov identifier NCT01146236 (registered June 14, 2010).
Project description:The purpose of this study is to assess the efficacy and safety of intracameral mydriatic solution, as compared to preoperative topical mydriatics, in patients undergoing manual small incision cataract surgery (MSICS) under peribulbar anesthesia. To assess the sustainability of intracameral mydriasis in MSICS by monitoring pupil size at specific junctures during the surgery.This trial recruited 127 patients, who underwent MSICS under peribulbar block. Mydriasis in topical group was achieved with preoperative topical dilating drops while patients in intracameral group were taken up for surgery without dilation, and mydriasis was achieved intraoperatively with intracameral solution. Pupil sizes were measured serially, at six different junctures during surgery. Time duration of surgery, any intraoperative complications and first postoperative day visual acuity, corneal edema score, and anterior chamber inflammation score were noted in all patients.Mean pupil size just before peribulbar block was 7.3 mm in topical group and 3.3 mm in intracameral group (P < 0.001). Mean pupil size in intracameral group increased to 7.3 mm 30 s after injecting intracameral dilating solution. Mean pupil size in both groups progressively reduced, reaching 5.5 mm (topical group) and 6.2 mm (intracameral group) just before intraocular lens implantation (P = 0.001), and measured 5.1 mm and 5.5 mm, respectively, at the end of surgery (P = 0.048). On first postoperative day, there was no significant difference in distribution of corneal edema scores, AC inflammation scores, and in median logMAR visual acuity between the two groups.MSICS can be performed effectively and safely utilizing intracameral mydriatic solution, without the use of preoperative dilating drops.CTRI/2016/06/007036.
Project description:PurposeTo report the 3-month results of a randomized trial (Femtosecond Laser-Assisted Cataract Trial [FACT]) comparing femtosecond laser-assisted cataract surgery (FLACS) with standard phacoemulsification cataract surgery (PCS).DesignMulticenter, randomized controlled trial funded by the UK National Institute of Health Research (HTA 13/04/46/).ParticipantsSeven hundred eighty-five patients with age-related cataract.MethodsThis trial took place in 3 hospitals in the UK National Health Service (NHS). Randomization (1:1) was stratified by site, surgeon, and 1 or both eyes eligible using a secure web-based system. Postoperative assessments were masked to the allocated intervention. The primary outcome was unaided distance visual acuity (UDVA) in the study eye at 3 months. Secondary outcomes included corrected distance visual acuity, complications, and patient-reported outcomes measures. The noninferiority margin was 0.1 logarithm of the minimum angle of resolution (logMAR). ISRCTN.com registry, number ISRCTN77602616.Main outcome measuresWe enrolled 785 participants between May 2015 and September 2017 and randomly assigned 392 to FLACS and 393 to PCS. At 3 months postoperatively, mean UDVA difference between treatment arms was -0.01 logMAR (-0.05 to 0.03), and mean corrected distance visual acuity difference was -0.01 logMAR (95% confidence interval [CI], -0.05 to 0.02). Seventy-one percent of both FLACS and PCS cases were within ±0.5 diopters (D) of the refractive target, and 93% of FLACS and 92% of PCS cases were within ±1.0 D. There were 2 posterior capsule tears in the PCS arm and none in the FLACS arm. There were no significant differences between arms for any secondary outcome.ConclusionsFemtosecond laser-assisted cataract surgery is not inferior to conventional PCS surgery 3 months after surgery. Both methods are as good in terms of vision, patient-reported health, and safety outcomes at 3 months. Longer-term outcomes of the clinical effectiveness and cost-effectiveness are awaited.
Project description:PurposeTo assess the effects of the American Academy of Ophthalmology's 2015 patient education video on patient information retention and anxiety preoperatively, on the day of surgery and postoperatively.MethodsThis is a prospective, surgeon-blinded randomized controlled trial at the University of Chicago Medical Center. Ninety-one patients with a diagnosis of first-eye cataract were randomized into either a video or control group. Subjects in both groups received face-to-face discussion with the surgeon and an informational brochure at the preoperative evaluation. Participants in the video group then viewed a four-minute educational video at the preoperative evaluation and on the day of surgery. Both groups completed an information retention quiz and a state anxiety assessment at the preoperative visit, on the day of surgery, and on the postoperative week one visit. Subject understanding of cataract surgery was measured using a twelve-question multiple choice quiz. State anxiety was measured by State Trait Anxiety Inventory-Y1 survey score.ResultsParticipants in the video group did not score significantly higher on the information retention quiz compared with the control group at the preoperative evaluation (8.7 ± 2.4 vs 7.7 ± 2.5, P = 0.07), but did so on the day of surgery (11.2 ± 0.8 vs 8.4 ± 1.7, P < 0.001) and postoperative week 1 visit (10.8 ± 1.5 vs 9.0 ± 2.0, P < 0.001). Subjects in the video group were significantly less anxious on the day of surgery (26.4 ± 5.1 vs 41.1 ± 10.3, P < 0.001).ConclusionsVideo supplementation to the traditional informed consent process demonstrated an improvement in patient understanding of cataract surgery at multiple timepoints and decreased anxiety on the day of surgery.
Project description:AIM:To compare visual prognoses and postoperative adverse events of congenital cataract surgery performed at different times and using different surgical approaches. METHODS:In this prospective, randomized controlled trial, we recruited congenital cataract patients aged 3mo or younger before cataract surgery. Sixty-one eligible patients were randomly assigned to two groups according to surgical timing: a 3-month-old group and a 6-month-old group. Each eye underwent one of three randomly assigned surgical procedures, as follows: surgery A, lens aspiration (I/A); surgery B, lens aspiration with posterior continuous curvilinear capsulorhexis (I/A+PCCC); and surgery C, lens aspiration with posterior continuous curvilinear capsulorhexis and anterior vitrectomy (I/A+PCCC+A-Vit). The long-term best-corrected visual acuity (BCVA) and the incidence of complications in the different groups were compared and analyzed. RESULTS:A total of 57 participants (114 eyes) with a mean follow-up period of 48.7mo were included in the final analysis. The overall logMAR BCVA in the 6-month-old group was better than that in the 3-month-old group (0.81±0.28 vs 0.96±0.30; P=0.02). The overall logMAR BCVA scores in the surgery B group were lower than the scores in the A and C groups (A: 0.80±0.29, B: 1.02±0.28, and C: 0.84±0.28; P=0.007). A multivariate linear regression revealed no significant relationships between the incidence of complications and long-term BCVA. CONCLUSION:It might be safer and more beneficial for bilateral total congenital cataract patients to undergo surgery at 6mo of age than 3mo. Moreover, with rigorous follow-up and timely intervention, the postoperative complications in these patients are treatable and do not compromise visual outcomes.
Project description:BackgroundCataract surgery has become one of the most performed surgical procedures worldwide. Postoperative management consists of routine clinical examinations to assess post-operative visual function and detect possible adverse events. Due to the low incidence of complications, the majority of clinic visits after cataract surgery are uneventful. Nonetheless, valuable time and hospital resources are consumed. We hypothesize that remote post-operative follow-up involving teleconsultations and self-assessments of visual function and health status, could be a valid alternative to face-to-face clinical examinations in selected patient groups. The practice of remote follow-up after cataract surgery has not yet been evaluated. The aim of this study is to investigate the validity, safety and cost-effectiveness of remote cataract surgery follow-up, and to report on the patients' experiences with remotely self-assessing visual function.MethodsThis study is a multicenter, open-label, randomized controlled trial. Patients planned for cataract surgery on both eyes, without ocular comorbidities, are eligible for participation. Participants will be allocated (1:1) into one of the two study groups: 'telemonitoring' or 'usual care'. Participants in the 'telemonitoring' group will perform in-home assessments after cataract surgery (remote web-based eye exams and digital questionnaires on their own devices). Participants in the 'usual care' group will have regular post-operative consultations, according to the study site's regular practice. Outcome measures include accuracy of the web-based eye exam for assessing visual acuity and refraction, patient-reported outcome measures (visual function and quality of life), adverse events, and cost aspects.DiscussionInvestigating remote follow-up after cataract surgery fits the current trends of digitization of health care. We believe that remote self-care can be a promising avenue to comply with the increasing demands of cataract care. This randomized controlled trial provides scientific evidence on this unmet need and delivers the desired insights on (cost)effectiveness of remote follow-up after cataract surgery.Trial registrationClinicalTrials.gov: NCT04809402. Date of registration: March 22, 2021.