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"Cataract Extraction"
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Femtosecond laser-assisted versus phacoemulsification cataract surgery (FEMCAT): a multicentre participant-masked randomised superiority and cost-effectiveness trial
2020
Cataract surgery is one of the most common operations in health care. Femtosecond laser-assisted cataract surgery (FLACS) enables more precise ocular incisions and lens fragmentation than does phacoemulsification cataract surgery (PCS). We hypothesised that FLACS might improve outcomes in cataract surgery compared with PCS despite having higher costs.
We did a participant-masked randomised superiority clinical trial comparing FLACS and PCS in two parallel groups (permuted block randomisation stratified on centres via a centralised web-based application, allocation ratio 1:1, block size of 2 or 4 for unilateral cases and 2 or 6 for bilateral cases). Five French University Hospitals enrolled consecutive patients aged 22 years or older who were eligible for unilateral or bilateral cataract surgery. Participants, outcome assessors, and technicians carrying out examinations were masked to the surgical treatment allocation until the last follow-up visit and a sham laser procedure was set up for participants randomly assigned to the PCS arm. The primary clinical endpoint was the success rate of surgery, defined as a composite of four outcomes at a 3-month postoperative visit: absence of severe perioperative complication, a best-corrected visual acuity (BCVA) of 0·0 LogMAR (logarithm of the minimum angle of resolution) or better, an absolute refractive error of 0·75 dioptres or less, and unchanged postoperative corneal astigmatism power (≤0·5 dioptres) and axis (≤20°). The primary economic endpoint was the incremental cost per additional patient who had treatment success at 3 months. Primary outcomes were assessed in all randomly assigned patients who met all eligibility criteria (missing data considered as failure). We used mixed logistic regression models or mixed linear regression models for statistical comparisons, adjusted on centres and whether cataract surgery was bilateral or unilateral. The study is registered with ClinicalTrials.gov, NCT01982006.
Of the 907 patients (1476 eyes) randomly assigned between Oct 9, 2013, and Oct 30, 2015, 870 (704 eyes in FLACS group and 685 eyes in the PCS group) were analysed. We identified no significant difference in the success rate of surgery between the FLACS and PCS groups (FLACS: 41·1% [289 eyes]; PCS: 43·6% [299 eyes]); adjusted odds ratio 0·85, 95% CI 0·64–1·12, p=0·250). The incremental cost-effectiveness ratio was €10 703 saved per additional patient who had treatment success with PCS compared with FLACS. We observed no severe adverse events during the femtosecond laser procedure, and most of the complications in the FLACS group related to the primary outcome measures occurred during the phacoemulsification phase or postoperatively.
Despite its advanced technology, femtosecond laser was not superior to phacoemulsification in cataract surgery and, with higher costs, did not provide an additional benefit over phacoemulsification for patients or health-care systems.
French Ministry of Social Affairs and Health.
Journal Article
Cataracts
by
Mehta, Jodhbir S
,
Wilkins, Mark
,
Liu, Yu-Chi
in
Astigmatism
,
Blindness
,
Cataract - epidemiology
2017
An estimated 95 million people worldwide are affected by cataract. Cataract still remains the leading cause of blindness in middle-income and low-income countries. With the advancement of surgical technology and techniques, cataract surgery has evolved to small-incisional surgery with rapid visual recovery, good visual outcomes, and minimal complications in most patients. With the development of advanced technology in intraocular lenses, the combined treatment of cataract and astigmatism or presbyopia, or both, is possible. Paediatric cataracts have a different pathogenesis, surgical concerns, and postoperative clinical course from those of age-related cataracts, and the visual outcome is multifactorial and dependent on postoperative visual rehabilitation. New developments in cataract surgery will continue to improve the visual, anatomical, and patient-reported outcomes. Future work should focus on promoting the accessibility and quality of cataract surgery in developing countries.
Journal Article
Safety, effectiveness, and cost-effectiveness of immediate versus delayed sequential bilateral cataract surgery in the Netherlands (BICAT-NL study): a multicentre, non-inferiority, randomised controlled trial
by
Simons, Rob
,
Winkens, Bjorn
,
Dirksen, Carmen
in
Antibiotics
,
Cataract - epidemiology
,
Cataract - etiology
2023
In an ageing population, efficiency improvements are required to assure future accessibility of cataract care. We aim to address remaining knowledge gaps by evaluating the safety, effectiveness, and cost-effectiveness of immediate sequential bilateral cataract surgery (ISBCS) versus delayed sequential bilateral cataract surgery (DSBCS). We hypothesised that ISBCS is non-inferior to DSBCS, regarding safety and effectiveness, and being superior in cost-effectiveness.
We did a multicentre, non-inferiority, randomised controlled trial, which included participants from ten Dutch hospitals. Eligible participants were 18 years or older, underwent expected uncomplicated surgery, and had no increased risk of endophthalmitis or refractive surprise. Participants were randomly assigned (1:1) to either the ISBCS (intervention) group or DSBCS (conventional procedure) group, using a web-based system stratified by centre and axial length. Participants and outcome assessors were not masked to the treatment groups because of the nature of the intervention. The primary outcome was the proportion of second eyes with a target refractive outcome of 1·0 dioptre (D) or less 4 weeks postoperatively, with a non-inferiority margin of –5% for ISBCS versus DSBCS. For the trial-based economic evaluation, the primary endpoint was the incremental societal costs per quality-adjusted life-year. All analyses were done by a modified intention-to-treat principle. Costs were calculated by multiplying volumes of resource use with unit cost prices and converted to 2020 Euros (€) and US$. This study was registered with ClinicalTrials.gov, number NCT03400124, and is now closed for recruitment.
Between Sept 4, 2018, and July 10, 2020, a total of 865 patients were randomly assigned to either the ISBCS group (427 [49%] patients; 854 eyes) or DSBCS group (438 [51%] patients; 876 eyes). In the modified intention-to-treat analysis, the proportion of second eyes with a target refraction of 1·0 D or less was 97% (404 of 417 patients) in the ISBCS group versus 98% (407 of 417) in the DSBCS group. The percentage difference was –1% (90% CI –3 to 1; p=0·526), thereby establishing non-inferiority for ISBCS compared with DSBCS. Endophthalmitis was not observed or reported in either group. Adverse events were comparable between groups, with only a significant difference in disturbing anisometropia (p=0·0001). Societal costs were €403 (US$507) lower with ISBCS than with DSBCS. The cost-effectiveness probability of ISBCS versus DSBCS was 100% across the willingness-to-pay range of €2500–80 000 (US$3145–100 629) per quality-adjusted life-year.
Our results showed non-inferiority of ISBCS versus DSBCS regarding effectiveness outcomes, comparable safety, and superior cost-effectiveness of ISBCS. National cost savings could amount to €27·4 million (US$34·5 million) annually, advocating for ISBCS if strict inclusion criteria are applied.
Research grant from The Netherlands Organization for Health Research and Development (ZonMw) and Dutch Ophthalmological Society.
Journal Article
Comparative analysis of fluidics and efficiency among different phaco-emulsifying machines employed for cataract surgery
by
Boccuzzi, Domenico
,
Giannaccare, Giuseppe
,
Taloni, Andrea
in
692/700/565/2194
,
692/700/565/545
,
Aged
2025
To analyze and compare the efficiency of three phaco-emulsifying machines by evaluating parameters related to fluidics and ultrasound time (UST). Pilot, prospective, observational, comparative study conducted at the “Mediterranea” Clinic Ophthalmology Operative Unit, Naples, Italy. A total of 145 consecutive cases of phacoemulsification were included in the study. Patients were randomized into 4 arms and operated using three phaco-emulsifying machines in 4 configurations equipped with three different infusion systems. The phaco machines were: (1) Centurion
®
, with and without the Active Sentry
®
handpiece (Alcon), (2) Stellaris Elite™ (Bauch & Lomb), and (3) Whitestar Signature
®
Pro (Johnson & Johnson). The primary outcomes were UST and fluid aspiration volume. Centurion, with and without Active Sentry, required less UST compared to other phaco machines (
P
< 0.001). Furthermore, Centurion required lower values of intraocular pressure (IOP) to complete the procedure and aspirated less fluid compared to the Stellaris Elite. No statistical differences in UST, aspirated fluid, and IOP have been found between Centurion and Centurion with Active Sentry. Centurion, with and without Active Sentry required lower UST and IOP for cataract removal compared to Stellaris Elite and Whitestar Signature Pro. Less fluid is necessary to complete the procedure compared to the Stellaris Elite.
Journal Article
Corneal endothelial changes following cataract surgery in hard nuclear cataract: Randomized trial comparing phacoemulsification to manual small-incision cataract surgery
by
Singh, Ritu
,
Katiyar, Vishal
,
Sharma, Arun K
in
Anterior chamber
,
Cataract
,
Cataract - complications
2022
Purpose:
To evaluate and compare endothelial cell changes in phacoemulsification and manual small-incision cataract surgery (MSICS) in patients with uncomplicated senile cataracts.
Methods:
This was a prospective, tertiary care hospital-based, randomized, double-blinded interventional study. In total, 152 patients with an uncomplicated senile cataract of nuclear grade III and above were recruited. Exclusion criteria included patients with preoperative endothelial cell density (ECD) less than 1500 cells/mm3, a history of previous ocular surgery, any other coexisting ocular disease, and intraoperative or postoperative surgical complications. Preoperative and postoperative values of ECD and central corneal thickness (CCT) were measured, analyzed, and correlated with various factors.
Results:
Patients were randomized into two interventional groups-MSICS and phacoemulsification. Factors associated with significant drop in postoperative ECD following phacoemulsification were patients with advanced age (P = 0.01), higher grades of cataract (P = 0.01), and longer effective phacoemulsification time (P = 0.007). Shallow anterior chamber depth (ACD) was strongly associated with greater ECD loss in both groups (P < 0.0001). A threshold value of 2.86 mm of ACD was defined for minimal endothelial cell loss following phacoemulsification. CCT was observed to slightly increase postoperatively in both groups but was insignificant (P > 0.05).
Conclusion:
Both MSICS and phacoemulsification have similar postoperative visual outcomes. An increase in postoperative CCT is insignificant following surgery. Greater postoperative ECD loss is associated with phacoemulsification with advanced age, hard nuclear cataracts, and longer effective phacoemulsification time. ACD can be used as an essential parameter preoperatively to determine the choice of surgical technique between MSICS and phacoemulsification.
Journal Article
A double-blind, randomized controlled pilot study comparing the safety of intracameral levofloxacin and intracameral cefazolin in patients undergoing cataract surgery
2025
To compare the safety of intracameral levofloxacin and intracameral cefazolin in patients undergoing cataract surgery. In this prospective, double-blind, randomized study, patients with senile cataracts who were undergoing phacoemulsification were assigned to receive intracameral levofloxacin (0.1 ml/0.5 mg; Cravit® 0.5%; Santen Pharmaceutical Ltd.) or intracameral cefazolin (0.1 ml/1 mg; generic). The endpoints were the occurrence of endophthalmitis during the 3-month follow-up period, best-corrected visual acuity (BCVA), the presence of anterior chamber (AC) inflammation with grading of AC cells and presence of flare, along with intraocular pressure (IOP), central corneal thickness (CCT), central foveal thickness (CFT), and cell density. A total of 50 patients (50 eyes) were enrolled, randomized, and completed the study. No cases of endophthalmitis were reported in either treatment group. There were no significant differences in BCVA, AC inflammation, IOP, CCT, CFT, or cell density between the groups at any timepoint. Importantly, no dose errors or serious adverse events were reported in either group. This study provides proof of concept that prophylactic intracameral levofloxacin (0.1 ml/0.5 mg) may have a comparable safety profile to intracameral cefazolin (0.1 ml/1 mg) in patients undergoing cataract surgery. Intracameral levofloxacin (0.1 ml/0.5 mg) may offer a viable alternative to cefazolin (0.1 ml/1 mg), particularly for patients with penicillin allergies, while also reducing the risk of dilution errors by eliminating the need for reconstitution. Larger, multicenter studies are warranted to confirm the efficacy of levofloxacin (0.1 ml/0.5 mg) in preventing endophthalmitis.
NCT06710977, 02/12/2024, retrospectively registered.
Journal Article
Microinterventional endocapsular nucleus disassembly: novel technique and results of first-in-human randomised controlled study
by
Ahmed, Iqbal Ike K
,
Vasquez, Andrea
,
MacDonald, Susan
in
Aged
,
Cataract - complications
,
Cataract Extraction - instrumentation
2019
AimTo assess the safety and efficacy of microinterventional endocapsular nuclear fragmentation in moderate to severe cataracts.MethodsThis was a prospective single-masked multisurgeon interventional randomised controlled trial (ClinicalTrials.gov NCT02843594) where 101 eyes of 101 subjects with grade 3‒4+ nuclear cataracts were randomised to torsional phacoemulsification alone (controls) or torsional phacoemulsification with adjunctive endocapsular nuclear fragmentation using a manual microinterventional nitinol filament loop device (miLOOP group). Outcome measures were phacoemulsification efficiency as measured by ultrasound energy (cumulative dispersed energy (CDE) units) and fluidics requirements (total irrigation fluid used) as well as incidence of intraoperative and postoperative complications.ResultsOnly high-grade advanced cataracts were enrolled with more than 85% of eyes with baseline best corrected visual acuity (BCVA) of 20/200 or worse in either group. Mean CDE was 53% higher in controls (32.8±24.9 vs 21.4±13.1 with miLOOP assistance) (p=0.004). Endothelial cell loss after surgery was low and similar between groups (7‒8%, p=0.561) One-month BCVA averaged 20/27 Snellen in miLOOP eyes and 20/24 in controls. No direct complications were caused by the miLOOP. In two cases, capsular tears occurred during IOL implantation and in all remaining cases during phacoemulsification, with none occurring during the miLOOP nucleus disassembly part of the procedure.ConclusionsMicrointerventional endocapsular fragmentation with the manual, disposable miLOOP device achieved consistent, ultrasound-free, full-thickness nucleus disassembly and significantly improved overall phaco efficiency in advanced cataracts.Trial registration numberNCT02843594
Journal Article
Effective cataract surgical coverage: An indicator for measuring quality-of-care in the context of Universal Health Coverage
2017
To define and demonstrate effective cataract surgical coverage (eCSC), a candidate UHC indicator that combines a coverage measure (cataract surgical coverage, CSC) with quality (post-operative visual outcome).
All Rapid Assessment of Avoidable Blindness (RAAB) surveys with datasets on the online RAAB Repository on April 1 2016 were downloaded. The most recent study from each country was included. By country, cataract surgical outcome (CSOGood, 6/18 or better; CSOPoor, worse than 6/60), CSC (operated cataract as a proportion of operable plus operated cataract) and eCSC (operated cataract and a good outcome as a proportion of operable plus operated cataract) were calculated. The association between CSC and CSO was assessed by linear regression. Gender inequality in CSC and eCSC was calculated.
Datasets from 20 countries were included (2005-2013; 67,337 participants; 5,474 cataract surgeries). Median CSC was 53.7% (inter-quartile range[IQR] 46.1-66.6%), CSOGood was 58.9% (IQR 53.7-67.6%) and CSOPoor was 17.7% (IQR 11.3-21.1%). Coverage and quality of cataract surgery were moderately associated-every 1% CSC increase was associated with a 0.46% CSOGood increase and 0.28% CSOPoor decrease. Median eCSC was 36.7% (IQR 30.2-50.6%), approximately one-third lower than the median CSC. Women tended to fare worse than men, and gender inequality was slightly higher for eCSC (4.6% IQR 0.5-7.1%) than for CSC (median 2.3% IQR -1.5-11.6%).
eCSC allows monitoring of quality in conjunction with coverage of cataract surgery. In the surveys analysed, on average 36.7% of people who could benefit from cataract surgery had undergone surgery and obtained a good visual outcome.
Journal Article
Falls and health status in elderly women following first eye cataract surgery: a randomised controlled trial
by
Harwood, R H
,
Masud, T
,
Zaman, A
in
Accidental Falls - prevention & control
,
Accidental Falls - statistics & numerical data
,
Activities of daily living
2005
Background/aim: A third of elderly people fall each year. Poor vision is associated with increased risk of falls. The authors aimed to determine if first eye cataract surgery reduces the risk of falling, and to measure associated health gain. Methods: 306 women aged over 70, with cataract, were randomised to expedited (approximately 4 weeks) or routine (12 months wait) surgery. Falls were ascertained by diary, with follow up every 3 months. Health status was measured after 6 months. Results: Visual function improved in the operated group (corrected binocular acuity improved by 0.25 logMAR units; 8% had acuity worse than 6/12 compared with 37% of controls). Over 12 months of follow up, 76 (49%) operated participants fell at least once, and 28 (18%) fell more than once. 69 (45%) unoperated participants fell at least once, 38 (25%) fell more than once. Rate of falling was reduced by 34% in the operated group (rate ratio 0.66, 95% confidence interval 0.45 to 0.96, p = 0.03). Activity, anxiety, depression, confidence, visual disability, and handicap all improved in the operated group compared with the control group. Four participants in the operated group had fractures (3%), compared with 12 (8%) in the control group (p = 0.04). Conclusion: First eye cataract surgery reduces the rate of falling, and risk of fractures and improves visual function and general health status.
Journal Article
Heat Generation and Efficiency of a New Modified Phaco Tip and Sleeve
by
Kim, Myoung Joon
,
Nam, Ki Yeun
,
Tchah, Hungwon
in
Animals
,
Biology and Life Sciences
,
Cameras
2016
To compare a modified phacoemulsification tip with the established micro tip, in terms of temperature at the corneal wound, efficiency, and chatter events, using the Centurion® Vision system.
Eighty porcine eyes were randomized into 4 groups: 1)sleeveless conventional 45D MiniFlared ABS® Kelman tip (1.1-mm incision); 2)sleeveless new modified 45D ABS® INTREPID® balanced tip(1.1-mm incision); 3) Kelman tip with own sleeve (2.2-mm incision); 4)Balanced tip with modified 4-rib sleeve (2.2-mm incision). Measurements were taken with 2 settings: longitudinal(power 40% and 70%) and torsional mode (power 40% and 100%). Peak temperatures were measured 0, 10, 30, and 60 seconds after continuous ultrasound power. For the efficiency test, porcine lens nuclei were formalin soaked and cut into 2.0 mm3 cubes. Efficiency and chatter were examined.
In all longitudinal settings, the sleeveless groups(1 and 2) showed lower temperatures than the sleeved groups(3 and 4) (P = 0.003). In 100% torsional mode, groups 3 and 4 produced significantly different temperatures(37.13 ± 1.44 and 35.14 ± 0.54, respectively; P = 0.007).The efficiency, in a 100% power torsional setting, was13.52 ± 2.60 sec for group 4, and 44.45± 14.75 sec for group 3 (P<0.001).
The two different bare tips show no significant differences in thermogenesis. However, the balanced tip with sleeve produces lower temperaturesat100% torsional power and better efficiency than the Kelman tip.
Journal Article