Randomised single-masked non-inferiority trial of femtosecond laser-assisted vs manual phacoemulsification cataract surgery for adults with visually significant cataract: the FACT trial

Session Details

Session Title: Femtolaser-Assisted Cataract Surgery (FLACS)

Session Date/Time: Monday 16/09/2019 | 08:30-10:30

Paper Time: 09:08

Venue: Free Paper Forum: Podium 4

First Author: : A.Day UK

Co Author(s): :    M. Wilkins                             

Abstract Details

Purpose:

To report the 3 month outcomes of a randomised trial (FACT) comparing the outcomes of laser assisted to manual phacoemulsification (standard) cataract surgery.

Setting:

Moorfields Eye Hospital, Sussex Eye Hospital and New Cross Hospital, UK

Methods:

Participants with age related cataract were eligible. Participants were randomly assigned (1:1) to laser assisted or standard cataract surgery, stratified by centre with blocks of variable size; the study was open-label, with no masking. The primary endpoint was unaided distance visual acuity (UDVA) in the study eye at three months postoperatively. Secondary end points included corrected distance visual acuity (CDVA), intraoperative and postoperative complications, patient reported outcomes measures, health economic analysis and endothelial cell loss at three and twelve months postoperatively. This study is registered at ISRCTN.com registry, number ISRCTN77602616, and is now completed.

Results:

785 participants were randomly assigned to laser assisted (n=392) or standard cataract surgery (n=393). In the per-protocol analysis, mean participant age was 68 years and 411 (52%) were female. At three months postoperatively mean UDVA difference was -0.01 logMAR (-0.05 to 0.03) and mean CDVA difference -0.01 logMAR (-0.05 to 0.02). There were two posterior capsule tears in the standard phacoemulsification arm and none in the laser assisted arm. There were two anterior capsule tears in the standard phacoemulsification arm compared to four in the laser assisted arm. There were no statistically significant differences between arms for all outcomes.

Conclusions:

Standard phacoemulsification cataract surgery is not inferior to laser assisted cataract surgery. Both methods have excellent safety and efficacy profiles.

Financial Disclosure:

None