Adverse Events And Patient-Reported Optical Aberrations: A Comparative Analysis Of Systematic Reviews And Meta-Analyses With Primary Randomized Controlled Trials On Bilateral Multifocal Intraocular Lenses After Cataract Surgery.

This study assesses the congruence of meta-analysis methodologies with established guidelines for reporting patient-reported optical aberrations and adverse events in systematic reviews and meta-analyses (SRMAs) of multifocal intraocular lenses (mIOL) for presbyopia correction post-cataract surgery.

We conducted a methodological comparison of patient-reported optical aberration estimates from high-quality systematic reviews and meta-analyses against those from primary randomized controlled trials (RCTs).

In this ESCRS systematic review award funded project we performed searches on electronic databases Ovid MEDLINE, Ovid EMBASE, Cochrane Central Register of Controlled Trials (CENTRAL), Web of Science, Scopus, and ClinicalTrials.gov were searched. We selected systematic reviews and meta-analyses using the AMSTAR-2 tool and randomized controlled trials assessing at least one outcome related to optical aberrations. Our analysis assessed methodological consistencies across four key areas: pre-specification, searching, analysis, and reporting. We assessed relative risks of glare between monovision, monofocal, extended depth of focus (EDOF) IOLs and multifocal IOLs (mIOLs). We classified mIOLs into diffractive, refractive and hybrid IOLs.

Of the 2179 screened records, 7 SRMAs and 36 RCTs met our inclusion criteria. Risk ratio estimates of glare from SRMAs favoured monovison procedures 0.42, (95% CI: 0.00, 0.19) monofocal IOLs 1.36 (1.15, 1.61), and EDOF IOLs 0.29 (0.01, 8.07) compared to mIOLs. Prevalence rates of glare from RCTs were 0.26 (0.13,0.41), 0.22 (0.14, 0.32), 0.05 (0.00, 0.19) for diffractive, refractive and hybrid mIOLs respectively. Prevalence of moderate to severe glare was 0.15(0.08, 0.24), 0.15 (0.10, 0.20), 0.05 (000, 0.19) for diffractive, refractive and hybrid mIOLs respectively. Up to 5.7% of patients required IOL exchange due to dissatisfaction or late mIOL decentration.

We found a lack of methodological rigor in SRMAs, with a preference for highlighting benefits over potential negative outcomes. While adhering to general guidelines, none followed specific advice for synthesizing adverse event data. This oversight in evaluating adverse events may undermine the reliability of SRMA findings crucial for clinical decisions. For more precise estimates on optical distortions and adverse events, a focused primary meta-analysis of RCTs aimed at these outcomes is advised. Urgent reform in SRMA methodologies is needed to better incorporate information on optical aberrations and adverse events, enhancing decision-making quality.