A Prospective Comparative Study On The Clinical Evaluation Of The Elon And Monofocal Iol Models

Within the scope of this investigation, we compared two different IOL models manufactured by Medicontur in terms of visual performance and patient satisfaction. We examined the clinical performance of the new generation EDOF (elongated depth of focus; ELON) in a prospective, randomized design, comparing it to the international EDOF criteria and to a monofocal aspheric model with the same parameters.

A total of 64 binocularly implanted patients participated in this clinical investigation, which was conducted in a comparative, prospective and randomized design. After all the exclusions, 48 patients (96 eyes) were included in the final statistical analysis, out of which 58 eyes were implanted with EDOF, and 38 eyes with the monofocal model.

During a 12-month follow-up period, distance, intermediate and near visual acuities were measured, both corrected and uncorrected. At month 3, month 6 and month 12, visual acuity defocus curves and contrast sensitivity defocus curves were also taken. Contrast sensitivity was measured by CSV-1000 as well. VFQ-25 visual function questionnaire was used to evaluate patient satisfaction at month 3 and month 12.

We achieved a 12-month follow-up for a total of 68 eyes of 34 patients. In case of the EDOF model, the mean binocular uncorrected visual acuity was better than 0.2 logMAR both in the near and intermediate range, and the median monocular distance-corrected intermediate visual acuity was also better than 0.2 logMAR. The EDOF IOL demonstrated 0.5 D greater monocular photopic negative lens induced distance-corrected depth of focus compared to the monofocal IOL at 0.2 logMAR threshold. In addition, the mean corrected- and uncorrected distance visual acuity did not prove to be inferior to the monofocal model, using a non-inferiority margin of 0.1 logMAR. Both contrast sensitivity and patient satisfaction results supported these findings.

The ELON lens fulfills the international EDOF criteria particularly well, while in terms of other characteristics it does not perform inferior to the monofocal model. Based on our results, the ELON lens is an optimal choice for patients who live an active lifestyle and would like to improve their visual quality but would not mind occasionally wearing spectacles for close-up activities. This lens is recommended to patients when a trifocal IOL would be contraindicated.