The Combination Of A Monofocal And Extended Depth-Of-Focus Intraocular Lens In Bilateral Cataract Surgery (Comedi Trial): Clinical And Patient-Reported Outcomes On Quality Of Vision Compared To Bilateral Monofocal Iol Implantation.

The Comedi trial aimed to assess whether combining a monofocal intraocular lens (IOL) in one eye and an extended depth of focus (EDOF) IOL in the fellow eye (combi group) offers benefits over bilateral monofocal IOL implantation (mono group) in cataract patients. The primary goal was to compare binocular distance-corrected intermediate visual acuity (DCIVA) at 66cm measured 3 months post-surgery. The hypothesis was that the combi group would achieve better unaided intermediate vision without visual disturbances. Secondary objectives explored the impact of this mix and match strategy on overall visual function as well as patient reported satisfaction and spectacle independence.

This was a single-centre, double masked, randomised parallel group prospective study. The study was conducted at the Department of Ophthalmology, University Hospital of Brussels, Belgium, between October 2023 and December 2026, enrolling patients undergoing bilateral phacoemulsification cataract surgery.

Participants were randomized 1:1 into the mono or combi group. Inclusion criteria were patients aged 50-90 with bilateral cataract. Exclusion criteria included prior refractive surgery or significant ocular diseases. Primary outcomes included binocular photopic DCIVA at 66 cm at 3 months, while secondary outcomes included (un)corrected visual acuity for far and near, patient reported quality of life using NEI VFQ-25, Patient Reported Spectacle Independence (PRSIQ) and satisfaction questionnaires. Contrast sensitivity and stereopsis were also measured. IOL power was calculated using the Barrett Universal II Formula. Lentis L(S)-313 for monofocal IOL and Lentis Comfort LS-313 MF15 for EDOF IOL was implanted. 

Fifty patients (19 males, 31 females) were included, with 6 drop-outs. Mean age was 73.3 ± 8.0 years in the combi group vs 72.3 ± 8.5 years in the mono group. Binocular visual acuity outcomes were comparable for all distances (all p>0.05), with a numerical trend toward better UIVA and UNVA in the combi group. Contrast sensitivity was comparable between groups (all p>0.05). Postoperative stereopsis was similar (median 60 arcsec; p=0.41). NEI VFQ-25 showed a non-significant trend favoring the combi group (91.11 ± 8.30 vs 87.06 ± 8.02; p=0.107). PRSIQ demonstrated less intermediate spectacle dependence in the combi group (100% vs 81%; p=0.049). Likert-based satisfaction was higher in the combi group (4.05 ± 0.64 vs 3.62 ± 0.68; p=0.036).

These findings suggest that combining an EDOF with a monofocal IOL may improve subjective spectacle independence and patient satisfaction despite similar objective visual results, highlighting the importance of patient-reported outcomes when evaluating refractive cataract surgery strategies. This trial can guide surgeons in IOL selection in a second eye of cataract patients who already received monofocal IOL implantation in the first eye but want to improve spectacle independence for intermediate and near while maintaining optical quality.