Purpose To evaluate long-term clinical and patient-reported outcomes (PROMs) following the implantation of an enhanced monofocal intraocular lens (IOL).
Methods This ambispective non-comparative single-centre study involved 41 patients (ages 48-84) who underwent bilateral cataract surgery with the Tecnis Eyhance IOL (model ICB00, Johnson & Johnson Vision). Distance and intermediate visual acuities, refraction, and PROMs were assessed 18 months or more after surgery. Spectacle independence was evaluated using the PRSIQ questionnaire, with patients self-reporting on visual quality, difficulties in performing specific tasks and perception of photic phenomena at distance and intermediate vision.
Results At 18 months or later, 100.0%, 73.2%, 100% and 79.5% of patients achieved a binocular uncorrected distance, uncorrected intermediate, corrected distance, and distance-corrected intermediate visual acuity of 0.20 logMAR or better, respectively. Less than 10% of patients reported photic phenomena. Mean visual quality scores were 1.68±0.72 for distance and 2.05±0.92 for intermediate vision (1=very good to 6=very poor). The dashboard was clearly visible while driving for 95.1% of patients, while 45.0% could perform screen work without glasses; an additional 40.0% could do so with enlarged fonts. Complete spectacle independence was reported by 87.8% for distance vision, and 53.7% for intermediate vision. At least moderately satisfied were 90.2% with distance vision, 87.8% with intermediate vision, and 51.2% with near vision.
Conclusions The enhanced monofocal IOL ICB00 provides good long-term distance and intermediate visual quality, leading to considerable spectacle independence and patient satisfaction. Most patients required near vision correction.
Competing Interest StatementI have read the journal's policy and the authors of this manuscript have the following competing interests:AM has received consulting and lecture fees from Ziemer Ophthalmic Systems AG and Alcon Deutschland GmbH. AL has received consulting fees from Bayer AG.
Funding StatementYes
Author DeclarationsI confirm all relevant ethical guidelines have been followed, and any necessary IRB and/or ethics committee approvals have been obtained.
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The details of the IRB/oversight body that provided approval or exemption for the research described are given below:
Before inclusion in the study, signed informed consent was given by the patient according to the tenets of the Declaration of Helsinki. This study was approved by the medical ethics committee of the Medical Chamber of North-Rhine, Germany (No: 2023012).
I confirm that all necessary patient/participant consent has been obtained and the appropriate institutional forms have been archived, and that any patient/participant/sample identifiers included were not known to anyone (e.g., hospital staff, patients or participants themselves) outside the research group so cannot be used to identify individuals.
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I understand that all clinical trials and any other prospective interventional studies must be registered with an ICMJE-approved registry, such as ClinicalTrials.gov. I confirm that any such study reported in the manuscript has been registered and the trial registration ID is provided (note: if posting a prospective study registered retrospectively, please provide a statement in the trial ID field explaining why the study was not registered in advance).
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I have followed all appropriate research reporting guidelines, such as any relevant EQUATOR Network research reporting checklist(s) and other pertinent material, if applicable.
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Data AvailabilityAll relevant data are within the manuscript and its Supporting Information files.
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