An Umbrella Review Comparing the Safety and Effectiveness of Femtosecond Laser-Assisted Cataract Surgery with Manual Cataract Surgery

Author(s)

Hsiao C1, Ferko N2, Ainslie-Garcia M2, Pan SM3, Cheng H4
1Alcon Inc., Fort Worth, TX, USA, 2EVERSANA, Burlington, ON, Canada, 3Alcon Vision LLC, West Covina, CA, USA, 4Alcon Vision LLC, Fort Worth, TX, USA

OBJECTIVES

Femtosecond laser-assisted cataract surgery (FLACS) automates corneal incision, capsulotomy, and lens fragmentation steps of manual cataract surgery (MCS) which may provide advantages in clinical effectiveness and safety outcomes. A narrative umbrella review of systematic reviews and meta-analyses (MAs) was conducted to summarize the totality of evidence available for clinical effectiveness and safety outcomes.

METHODS

MEDLINE was searched using the terms “Femtosecond or femtolaser” and “cataract” from 2014-01-01 to 2019-11-01 for systematic reviews and MAs comparing FLACS and MCS.

RESULTS

The search returned seven MAs that studied clinical effectiveness or safety outcomes. Meta-analyses assessed randomized controlled trials only (n=2), or a mix of randomized and non-randomized studies (5). All reviews assessing phacoemulsification time (3), mean phacoemulsification power (2), corneal thickness at one day (2), and corrected distance visual acuity (DVA) at 6-months (2) found significantly more favorable outcomes for FLACS compared with MCS. Results favored FLACS but were mixed (significant; trending towards significance) for better corrected DVA at 1-week (2; 1), reduced endothelial cell loss overall (2; 1), and lower corneal thickness overall (1; 1). There was disagreement in the literature (FLACS significantly favored; no difference) for capsulorhexis circularity (3; 1), mean absolute error (3; 1) and cumulative dissipated energy (1; 1). There was no difference in uncorrected DVA. Results were mixed for the rate of complications (no difference, MCS significantly favored), but the majority of analyses found no difference in the rate of anterior (3; 1) and posterior capsular tears (2; 1), corneal or macular edema (3; 1), and intraocular pressure (3; 1), including the review with the lowest heterogeneity.

CONCLUSIONS

Conclusions generally favored FLACS, with good alignment between reviews. This research area would benefit from consistent reporting of outcomes to increase comparability within meta-analyses. Future assessment of this meta-analytic evidence with quantitative techniques would be valuable.

Conference/Value in Health Info

2021-05, ISPOR 2021, Montreal, Canada

Value in Health, Volume 24, Issue 5, S1 (May 2021)

Code

PSU1

Topic

Clinical Outcomes

Topic Subcategory

Clinical Outcomes Assessment, Clinician Reported Outcomes

Disease

Medical Devices

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