A randomised controlled trial comparing femtosecond laser-assisted cataract surgery versus conventional phacoemulsification surgery: 12-month results

2020 ◽  
pp. bjophthalmol-2020-316311
Author(s):  
Nick Stanojcic ◽  
Harry William Roberts ◽  
Vijay K Wagh ◽  
Ji-Peng Olivia Li ◽  
Khayam Naderi ◽  
...  
Keyword(s):  
Visual Acuity ◽  
Randomised Controlled Trial ◽  
Femtosecond Laser ◽  
Cataract Surgery ◽  
Controlled Trial ◽  
Corneal Thickness ◽  
Posterior Capsular Opacification ◽  
Distance Visual Acuity ◽  
Patient Reported ◽  
Randomised Controlled

AimsTo report 12-month outcomes of randomised controlled trial comparing conventional phacoemulsification surgery (CPS) with femtosecond laser-assisted cataract surgery (FLACS).MethodsThis was a single-centre, prospective single-masked randomised case-controlled trial. Four hundred patients were randomised to CPS or FLACS with the LenSx platform (Alcon Laboratories Inc.). Visual acuity, refraction, central corneal thickness, endothelial cell loss (ECL), adverse events and quality of life outcomes, using EuroQOL 5-dimensions (EQ-5D-3 L) and cataract surgery patient-reported outcome measures (PROMs) questionnaires (Cat-PROM5), were recorded.ResultsTwo hundred and thirty four patients (58.5%) attended 12-month follow-up (116 FLACS, 118 CPS). Mean LogMAR unaided distance visual acuity) (±SD) was 0.12 (0.18) with FLACS and 0.13 (0.19) with CPS (p=0.68; 95% Confidence Interval [CI]−0.06,0.04). Mean spherical equivalent (SE) refraction was −0.1±0.6 diopters (D) with FLACS and −0.2±0.6 D with CPS (p=0.44; 95% CI −0.09, 0.21). Mean corrected distance visual acuity (±SD) was −0.01 (0.1) with FLACS and 0(0.1) with CPS (p=0.45; 95% CI −0.04,0.02). Two patients per group underwent YAG laser capsulotomy for posterior capsular opacification (p=1). Mean ECL (per mm2±SD) was 301±320 with FLACS and 228±303 with CPS (p=0.07; 95% CI −7.26, 153.26). Mean Cat-PROM scores (±SD) were −5.5 (2.6) with FLACS and −5.8 (2.5) with CPS (p=0.3; 95% CI 0.31,1.01). EQ5-3DL mean index score (±SD) was 0.92 (0.13) with FLACS and 0.89 (0.14) with CPS (p=0.1; 95% CI −0.1, 0.01). Vector analysis comparing manual limbal relaxing incisions (LRIs) and intrastromal femtosecond laser-assisted astigmatic keratotomies (iFAKs) showed a greater correction index (p=0.02; 95% CI 0.06 to 0.60) and smaller difference vector (p=0.046; 95% CI −0.54, −0.01) with iFAK.ConclusionsThere were no differences in vision, refraction, adverse postoperative events or PROMs between FLACS and CPS groups at 12 months. iFAKs may provide more effective astigmatic correction compared to LRIs, 12 months postoperatively.

scholarly journals Evaluation of a hub-and-spoke model for the delivery of femtosecond laser-assisted cataract surgery within the context of a large randomised controlled trial

2018 ◽  
Vol 102 (11) ◽  
pp. 1556-1563 ◽  
Author(s):  
Harry W Roberts ◽  
Vijay K Wagh ◽  
Isabella J M Mullens ◽  
Simone Borsci ◽  
Melody Z Ni ◽  
...  
Keyword(s):  
Randomised Controlled Trial ◽  
Femtosecond Laser ◽  
Cataract Surgery ◽  
Economic Model ◽  
Controlled Trial ◽  
High Volume ◽  
Hub And Spoke ◽  
Number Of Patients ◽  
Additional Costs ◽  
Randomised Controlled

AimsTo test a hypothesis that cataract operating room (OR) productivity can be improved with a femtosecond laser (FL) using a hub-and-spoke model and whether any increase in productivity can offset additional costs relating to the FL.Methods400 eyes of 400 patients were enrolled in a randomised-controlled trial comparing FL-assisted cataract surgery (FLACS) with conventional phacoemulsification surgery (CPS). 299 of 400 operations were performed on designated high-volume theatre lists (FLACS=134, CPS=165), where a hub-and-spoke FLACS model (1×FL, 2×ORs=2:1) was compared with independent CPS theatre lists. Details of operative timings and OR utilisation were recorded. Differences in productivity between hub-and-spoke FLACS and CPS sessions were compared using an economic model including testing hypothetical 3:1 and 4:1 models.ResultsThe duration of the operation itself was 12.04±4.89 min for FLACS compared with CPS of 14.54±6.1 min (P<0.001). Total patient time in the OR was reduced from 23.39±6.89 min with CPS to 20.34±5.82 min with FLACS (P<0.001)(reduction of 3.05 min per case). There was no difference in OR turnaround time between the models. Average number of patients treated per theatre list was 9 for FLACS and 8 for CPS. OR utilisation was 92.08% for FLACS and 95.83% for CPS (P<0.001). Using a previously established economic model, the FLACS service cost £144.60 more than CPS per case. This difference would be £131 and £125 for 3:1 and 4:1 models, respectively.ConclusionThe FLACS hub-and-spoke model was significantly faster than CPS, with patients spending less time in the OR. This enabled an improvement in productivity, but insufficient to meaningfully offset the additional costs relating to FLACS.

Visual and refractive outcomes and complications in femtosecond laser-assisted versus conventional phacoemulsification cataract surgery: findings from a randomised, controlled clinical trial

2020 ◽  
pp. bjophthalmol-2019-314548
Author(s):  
Daliya Dzhaber ◽  
Osama M Mustafa ◽  
Fares Alsaleh ◽  
Yassine J Daoud
Keyword(s):  
Clinical Trial ◽  
Visual Acuity ◽  
Femtosecond Laser ◽  
Cataract Surgery ◽  
Controlled Clinical Trial ◽  
Distance Visual Acuity ◽  
Refractive Outcomes ◽  
Randomised Controlled Clinical Trial ◽  
Randomised Controlled

Background/aimTo compare visual and refractive outcomes, changes in intraocular pressure (IOP), and complications of femtosecond laser-assisted cataract surgery (FLACS) to conventional phacoemulsification surgery (CPS) in paired eyes from the same patients.MethodsThis is a secondary analysis of an intraindividual, randomised, controlled clinical trial including 110 paired eyes from 55 patients that were randomised into either FLACS or CPS groups. Outcomes were recorded at baseline and postoperatively during a 3-month follow-up period.ResultsUncorrected distance visual acuity and corrected distance visual acuity were similar between FLACS and CPS over the follow-up period (p>0.05). The mean absolute refractive error was not significantly different between the two groups at postoperative month 1 (POM1) (0.3±0.2 D in FLACS vs 0.4±0.3 D in CPS, p=0.18) and month 3 (POM3) (0.3±0.3 D in FLACS vs 0.3±0.3 D in CPS, p=0.71). IOP was statistically higher in the FLACS group on postoperative day 1 (20.6±5.7 mm Hg for FLACS and 18.0±4.9 mm Hg for CPS, p=0.01). However, it was similar between the two groups subsequently (p>0.05). Intraoperatively, one case of posterior capsular block syndrome was observed in the FLACS group. Postoperatively, one case of newly developed glaucoma was observed in the FLACS group and one case of retinal tears in the CPS group.ConclusionThe 3-month postoperative refractive and visual outcomes were comparable between FLACS and CPS in paired eyes from the same patients. Complication rate was low in the study population.

scholarly journals Foldable vs rigid lenses after phacoemulsification for cataract surgery: a randomised controlled trial

Eye ◽  
2014 ◽  
Vol 28 (5) ◽  
pp. 567-575 ◽  
Author(s):  
A Hennig ◽  
L R Puri ◽  
H Sharma ◽  
J R Evans ◽  
D Yorston
Keyword(s):  
Randomised Controlled Trial ◽  
Cataract Surgery ◽  
Controlled Trial ◽  
Randomised Controlled

scholarly journals The Surveillance After Extremity Tumor Surgery (SAFETY) trial: protocol for a pilot study to determine the feasibility of a multi-centre randomised controlled trial

BMJ Open ◽  
2019 ◽  
Vol 9 (9) ◽  
pp. e029054 ◽  
Author(s):  
Keyword(s):  
Pilot Study ◽  
Randomised Controlled Trial ◽  
Primary Outcome ◽  
Controlled Trial ◽  
Systemic Disease ◽  
Chest Ct ◽  
Tumor Surgery ◽  
Free Survival ◽  
Patient Reported ◽  
Randomised Controlled

IntroductionFollowing the treatment of patients with soft tissue sarcomas (STS) that are not metastatic at presentation, the high risk for local and systemic disease recurrence necessitates post-treatment surveillance. Systemic recurrence is most often detected in the lungs. The most appropriate surveillance frequency and modality remain unknown and, as such, clinical practice is highly varied. We plan to assess the feasibility of conducting a multi-centre randomised controlled trial (RCT) that will evaluate the effect on overall 5-year survival of two different surveillance frequencies and imaging modalities in patients with STS who undergo surgical excision with curative intent.Methods and analysisThe Surveillance After Extremity Tumor Surgery trial will be a multi-centre 2×2 factorial RCT. Patients with non-metastatic primary Grade II or III STS treated with excision will be allocated to one of four treatment arms1: chest radiograph (CXR) every 3 months for 2 years2; CXR every 6 months for 2 years3; chest CT every 3 months for 2 years or4 chest CT every 6 months for 2 years. The primary outcome of the pilot study is the feasibility of a definitive RCT based on a combination of feasibility endpoints. Secondary outcomes for the pilot study include the primary outcome of the definitive trial (overall survival), patient-reported outcomes on anxiety, satisfaction and quality of life, local recurrence-free survival, metastasis-free survival, treatment-related complications and net healthcare costs related to surveillance.Ethics and disseminationThis trial received provisional ethics approval from the McMaster/Hamilton Health Sciences Research Ethics Board on 7 August 2019 (Project number 7562). Final ethics approval will be obtained prior to commencing patient recruitment. Once feasibility has been established and the definitive protocol is finalised, the study will transition to the definitive study.Trial registrationNCT03944798; Pre-results.

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