Femtosecond Laser-Assisted Cataract Surgery Versus Phacoemulsification Cataract Surgery (FACT): A Randomized Noninferiority Trial.
Ophthalmology
; 127(8): 1012-1019, 2020 08.
Article
en En
| MEDLINE
| ID: mdl-32386810
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 (11) 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 OUTCOMEMEASURES:
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.
Texto completo:
1
Banco de datos:
MEDLINE
Asunto principal:
Agudeza Visual
/
Facoemulsificación
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Terapia por Láser
Tipo de estudio:
Health_technology_assessment
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Observational_studies
/
Prognostic_studies
Límite:
Aged
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Female
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Humans
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Male
Idioma:
En
Año:
2020
Tipo del documento:
Article