Incidence and causes of negative dysphotopsia after uncomplicated cataract surgery - A randomized clinical trial.
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ABSTRACT: Purpose
The purpose of this study is to find incidence of negative dysphotopsia (ND) in eyes undergoing clear corneal phacoemulsification and identify its causes including corneal wound hydration and type of intraocular lens (IOL).Methods
In this randomized clinical trial, consenting adult patients undergoing phacoemulsification were randomized to receive a hydrophobic (Alcon Acrysof® SN60WF) or a hydrophilic acrylic IOL (CT Asphina® 603P, Carl Zeiss Meditec) in a 1:1 ratio. At time of surgery, eyes were again randomized in 1:1 fashion to receive stromal wound hydration or not (n = 80 each in four groups). Primary outcome measure was the incidence of ND between eyes receiving stromal hydration versus no hydration. Those with ND were observed for 5 years after surgery.Results
Of the 320 eyes, 29 (9.06%) reported ND of which 24 (83%) were transient. Eyes with wound hydration had significantly higher proportion of ND (n = 21/160, 13%) compared to no hydration (n = 8/160, 5%) (P = 0.01). Additionally, eyes with wound hydration were three times more likely to experience ND (odds ratio = 3.29, 95% CI = 1.3-8.2, P = 0.01). Majority of eyes (20/21, 95%) with ND after hydration had it transiently while half (4/8, 50%) of those with ND without wound hydration had it persistently at 6 weeks (P < 0.001) and continued to experience ND for 5 years but did not request intervention.Conclusion
ND occurred in 9% cases with majority being transient. Corneal wound hydration led to significant higher likelihood of experiencing transient ND. Those with persistent ND for more than 6 weeks (1.5%) continue to experience ND for at least 5 years.
SUBMITTER: Sharma P
PROVIDER: S-EPMC8374810 | biostudies-literature |
REPOSITORIES: biostudies-literature
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Project description:Cataract, one of the most frequent causes of blindness in developed countries, is strongly associated with aging. The exact mechanisms underlying cataract formation are still unclear, but growing evidence suggests a potential role of inflammatory and oxidative processes. Therefore, antioxidant and anti-inflammatory factors of the diet, such as vitamin K1, could play a protective role.To examine the association between dietary vitamin K1 intake and the risk of incident cataracts in an elderly Mediterranean population.A prospective analysis was conducted in 5860 participants from the Prevención con Dieta Mediterránea Study, a randomized clinical trial executed between 2003 and 2011. Participants were community-dwelling men (44.2%) and women (55.8%), and the mean (SD) age was 66.3 (6.1) years.Dietary vitamin K1 intake was evaluated using a validated food frequency questionnaire. The time to the cataract event was calculated as the time between recruitment and the date of the occurrence to cataract surgery, the time to the last visit of the follow-up, date of death, or the end of the study. Hazard ratios and 95% CIs for cataract incidence were estimated with a multivariable Cox proportional hazards model.Participants were community-dwelling men (44.2%; n?=?868) and women (55.8%; n?=?1086), and the mean (SD) age was 66.3 (6.1) years. After a median of 5.6 years follow-up, we documented a total of 768 new cataracts. Participants in the highest tertile of dietary vitamin K1 intake had a lower risk of cataracts than those in the lowest tertile (hazard ratio, 0.71; 95% CI, 0.58-0.88; P =?.002), after adjusting for potential confounders.High intake of dietary vitamin K1 was associated with a reduced risk of cataracts in an elderly Mediterranean population even after adjusting by other potential confounders.isrctn.org: ISRCTN35739639.
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Project description:ImportanceHypertensive events during cataract surgery may induce complications. Information and communication technologies applied to health are popular, but clinical evidence of its usefulness is rare and limited to treating anxiety without specific analysis. Recent publications have described the potential effects of personalized music choices as mobile-based intervention on pain but not on anxiety.ObjectiveTo demonstrate the effects of a web app-based music intervention on the incidence of hypertension in participants during cataract surgery performed under local anesthesia.Design, setting, and participantsThis randomized, single masked, controlled clinical trial was composed of 2 arms and took place at a single center at Cochin Hospital in Paris, France. A total of 313 participants were screened between February 2017 and July 2018. Among these, 311 participants undergoing a phacoemulsification procedure for elective surgery for their first eye cataract under local anesthesia were enrolled. Analysis was intention to treat and began in September 2018 and ended November 2018.InterventionsParticipants requiring cataract surgery were assigned randomly to either the experimental arm (web app-based music listening intervention delivered via headphones) or control arm (noise-canceling headphones without music) for 20 minutes before surgery.Main outcomes and measuresThe occurrence of at least 1 hypertensive event during surgery.ResultsA total of 310 participants were randomized in the study (155 to each arm) and 309 were analyzed (1 participant in the music arm had already undergone cataract surgery to the other eye). The mean (SD) age of the participants was 68.9 (10.8) years, and there were 176 female individuals (57%). On the primary end point, the incidence of hypertension was significantly lower in the music arm (21 [13.6%]) than in the control arm (82 [52.9%]), with a difference between the 2 arms of 39.3% (95% CI, 21.4%-48.9%; P < .001). Regarding the secondary end points, the mean (SD) visual measure of anxiety was lower in the music arm (1.4 [2.0]) than in the control arm (3.1 [2.4]), with a difference of 1.5 (95% CI, 1.0-2.1; P = .005). The mean (SD) number of sedative drug injections required during surgery was 0.04 (0.24) vs 0.54 (0.74) in the music vs control arms, respectively, with a difference of 0.50 (95% CI, 0.43-0.57; P < .001).Conclusions and relevanceFor participants similar to those enrolled in this study, the trial suggests that a web app-based personalized music intervention before cataract surgery may be considered to lower anxiety levels and hypertension or reduce the need for sedative medication.Trial registrationClinicalTrials.gov Identifier: NCT02892825.
| S-EPMC8323047 | biostudies-literature
Project description:PURPOSE:Post-operative cystoid macular oedema (CMO) can cause deterioration of vision following routine cataract surgery. The incidence of persistent CMO (pCMO; defined as CMO present after 3 months) following uncomplicated surgery is uncertain. We wished to identify the incidence, management and visual outcomes of such patients. METHODS:A Scottish Ophthalmological Surveillance Unit (SOSU) questionnaire was sent monthly to every ophthalmic specialist in Scotland over an 18-month period from 1st January 2018 asking them to report all new patients with pCMO confirmed on OCT scanning following uncomplicated cataract surgery. A follow-up questionnaire was sent 9 months after initial presentation. RESULTS:Fourteen cases of pCMO were reported, giving an incidence of 2.2 cases of pCMO per 10,000 uncomplicated cataract surgeries. Mean age was 74.9 years (SD 10.2; range 44-86) with a male preponderance (72.7%). Two patients developed pCMO in each eye. Six cases (46.2%) had hypertension and one had diabetes. Three eyes required intracameral adjuncts (two iris hooks, one intracameral phenylephrine). Postoperative visual acuity (VA) at 3 months was logMAR 0.48 (0.2-0.8). Average mean central retinal thickness (CRT) at 3 months was 497microns (270-788). The most common initial treatment comprised topical steroids and topical NSAIDs (61.5%). Other management strategies included systemic steroids, intravitreal steroids and oral acetazolamide. At 1-year post-op, mean VA was logMAR 0.18 (0.1-0.3) with average mean CRT of 327microns (245-488). CONCLUSIONS:We identified a low incidence of pCMO following uncomplicated cataract surgery in Scotland (0.02%), with inconsistent and variable management regimes. A nationally agreed treatment protocol is required.
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Project description:Objective The purpose of this multicenter pilot study was to determine the feasibility of randomizing uncomplicated pregnancies (UPs) to have third trimester ultrasonographic exams (USE) versus routine prenatal care (RPNC) to improve the detection of small for gestational age (SGA; birth weight < 10% for GA). Material and Methods At three referral centers, 50 UPs were randomized after gestational diabetes was ruled out. Women needed to screen, consenting, and loss to follow-up was ascertained, as was the detection rate of SGA in the two groups. Results During the study period at the three centers, there were 7,680 births, of which 64% were uncomplicated. Of the 234 women approached for randomization, 36% declined. We recruited 149 women and had follow-up delivery data on 97%. The antenatal detection rate of SGA in the intervention group was 67% (95% confidence intervals 31-91%) and 9% (0.5-43%) in control. Conclusion The pilot study provides feasibility data for a multicenter randomized clinical trial to determine if third trimester USE, compared with RPNC, improves the detection of SGA and composite neonatal morbidity.
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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.
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Project description:Intraocular lens (IOL) exchange after cataract surgery is unusual but may be associated with suboptimal visual outcome. The incidence of IOL exchange has not been consistently estimated. Such information is invaluable when counseling patients prior to cataract surgery. We examined the incidence of, and indications and risk factors for, IOL exchange after cataract surgery. We also assessed visual outcome of eyes that had an IOL exchange. A cohort design was used to estimate the incidence of IOL exchange and a case-control design to identify factors associated with it. All phacoemulsification surgeries with IOL (n = 17415 eyes) during 2010-2017 and those that had a subsequent IOL removal or replacement during the same time period were identified (n = 34 eyes). The incidence of IOL exchange was 2 per 1000 surgeries (95% confidence interval [CI] 1 to 3) over 8 years. Eyes that underwent subsequent IOL removal or replacement were compared with eyes that had cataract surgery only (n = 47) across demographic and clinical characteristics. In a binary logistic regression analysis, two factors were significantly associated with IOL exchange/removal: an adverse event during cataract surgery (adjusted odds ratio [aOR] 19.45; 95% CI 4.89-77.30, P < 0.001) and a pre-existing ocular comorbidity (aOR 10.70; 95% CI 1.69-67.63, P = 0.021). The effect of gender was marginally significant (P = 0.077). Eyes that underwent IOL exchange or explantation were nearly two and a half times more likely to have a final best-corrected visual acuity of <20/60 compared to those that had cataract surgery alone (adjusted RR 2.60 95% CI, 1.13-6.02; P = 0.025).
| S-EPMC6733834 | biostudies-literature
Project description:ImportanceCataracts account for 40% of cases of blindness globally, with surgery the only treatment.ObjectiveTo determine whether adding simulation-based cataract surgical training to conventional training results in improved acquisition of surgical skills among trainees.Design, setting, and participantsA multicenter, investigator-masked, parallel-group, randomized clinical educational-intervention trial was conducted at 5 university hospital training institutions in Kenya, Tanzania, Uganda, and Zimbabwe from October 1, 2017, to September 30, 2019, with a follow-up of 15 months. Fifty-two trainee ophthalmologists were assessed for eligibility (required no prior cataract surgery as primary surgeon); 50 were recruited and randomized. Those assessing outcomes of surgical competency were masked to group assignment. Analysis was performed on an intention-to-treat basis.InterventionsThe intervention group received a 5-day simulation-based cataract surgical training course, in addition to standard surgical training. The control group received standard training only, without a placebo intervention; however, those in the control group received the intervention training after the initial 12-month follow-up period.Main outcomes and measuresThe primary outcome measure was overall surgical competency at 3 months, which was assessed with a validated competency assessment rubric. Secondary outcomes included surgical competence at 1 year and quantity and outcomes (including visual acuity and posterior capsule rupture) of cataract surgical procedures performed during a 1-year period.ResultsAmong the 50 participants (26 women [52.0%]; mean [SD] age, 32.3 [4.6] years), 25 were randomized to the intervention group, and 25 were randomized to the control group, with 1 dropout. Forty-nine participants were included in the final intention-to-treat analysis. Baseline characteristics were balanced. The participants in the intervention group had higher scores at 3 months compared with the participants in the control group, after adjusting for baseline assessment rubric score. The participants in the intervention group were estimated to have scores 16.6 points (out of 40) higher (95% CI, 14.4-18.7; P < .001) at 3 months than the participants in the control group. The participants in the intervention group performed a mean of 21.5 cataract surgical procedures in the year after the training, while the participants in the control group performed a mean of 8.5 cataract surgical procedures (mean difference, 13.0; 95% CI, 3.9-22.2; P < .001). Posterior capsule rupture rates (an important complication) were 7.8% (42 of 537) for the intervention group and 26.6% (54 of 203) for the control group (difference, 18.8%; 95% CI, 12.3%-25.3%; P < .001).Conclusions and relevanceThis randomized clinical trial provides evidence that intense simulation-based cataract surgical education facilitates the rapid acquisition of surgical competence and maximizes patient safety.Trial registrationPan-African Clinical Trial Registry, number PACTR201803002159198.
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Project description:This study aimed to investigate the prevalence and clinical determinants of cataract and cataract surgery in Korean population. The 2008-2012 Korean National Health and Nutrition Examination Survey was analyzed, which included 20,419 participants aged ? 40 years. The survey is a multistage, probability-cluster survey, which can produce nationally representative estimates. Prevalence of cataract and cataract surgery was estimated. Clinical determinants for those were investigated using logistic regression analyses (LRAs). The prevalence of cataract was 42.28% (95% confidence interval [CI], 40.67-43.89); 40.82% (95% CI, 38.97-42.66) for men and 43.62% (95% CI, 41.91-45.33) for women (P = 0.606). The prevalence of cataract surgery was 7.75% (95% CI, 7.30-8.20); 6.38% (95% CI, 5.80-6.96) for men and 9.01% (95% CI, 8.41-9.61) for women (P < 0.001). Cataract was associated with older age (P < 0.001), men (P = 0.032), lower household income (P = 0.031), lower education (P < 0.001), hypertension (P < 0.001), and diabetes mellitus (DM) (P < 0.001). Cataract surgery was consistently associated with older age, occupation, DM, asthma, and anemia in two LRAs, which compared participants with cataract surgery to those without cataract surgery and those having a cataract but without any cataract surgery, respectively. Hypertension, arthritis, and dyslipidemia were associated with cataract surgery at least in one of these LRAs. These results suggest that there are 9.4 million individuals with cataract and 1.7 million individuals with cataract surgery in Korea. Further studies are warranted to reveal the causality and its possible mechanism of developing/exacerbating cataract in novel determinants (i.e., anemia, asthma, and arthritic conditions) as well as well-known determinants.
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