AI Article Synopsis
- The study aimed to assess the effectiveness of femtosecond laser-assisted cataract surgery (FLACS) compared to traditional phacoemulsification cataract surgery (PCS) over a 3-month period in a randomized trial involving 785 patients.
- The trial, conducted across three UK hospitals, found no significant differences in unaided distance visual acuity and other outcomes between the two surgical methods, indicating that FLACS is comparable to PCS.
- Both surgical techniques showed similarly positive results in terms of visual acuity post-surgery, with low rates of complications, suggesting that FLACS is a viable alternative to PCS.
Article Abstract
Purpose: To 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).
Design: Multicenter, randomized controlled trial funded by the UK National Institute of Health Research (HTA 13/04/46/).
Participants: Seven hundred eighty-five patients with age-related cataract.
Methods: This 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 Measures: We 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.
Conclusions: Femtosecond 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.
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| http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7397499 | PMC |
| http://dx.doi.org/10.1016/j.ophtha.2020.02.028 | DOI Listing |
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