Visual, Refractive, Functional, and Patient Satisfaction Outcomes After Implantation of a New Extended Depth-of-Focus Intraocular Lens.

Abstract

Purpose: To describe the visual, refractive, functional, and patient satisfaction outcomes of the Bi-Flex POB-MA 877PEY (Elon^®, Medicontur Medical Engineering Ltd. Zsámbék, Hungary) extended depth-of-focus intraocular lens (EDoF IOL).

Patients and methods: This was a prospective longitudinal descriptive study. Patients who underwent cataract surgery with the implantation of Bi-Flex POB-MA 877PEY IOL were included. Monocular refractive outcomes and visual acuity at distance, intermediate, and near were evaluated 1- and 3-month post-op. Binocular contrast sensitivity (CSV-1000, VectorVision, USA), binocular defocus curve, and patient satisfaction with the Visual Functioning Questionnaire (VFQ) were assessed at 3-month post-op.

Results: 20 Bi-Flex POB-MA 877PEY IOL were implanted bilaterally in 10 patients. The mean age of the patients was 68.60±4.45 years. At 1-month post-op the monocular Corrected Distance Visual Acuity (CDVA), intermediate (CIVA) and near (CNVA) was 0.02±0.03, 0.29±0.08, and 0.40±0.05 LogMAR respectively. At 3-month post-op the CDVA decrease to 0.05±0.06 LogMAR (p=0.042), and CIVA and CNVA remained stable at 3-month post-op (p>0.05). No statistical differences were found in post-op spherical equivalent at 1 and 3 month (-0.03±0.19 D and -0.03±0.13 D; p=1.000). 100% of eyes were within ±0.5 D at 1 month and 3-month post-op. Binocular defocus curve shows a peak of maximum visual acuity (VA) at 0 D (0.00±0.04 LogMAR), and a constant and progressive decrease at -1.50 D, and -2.50 D (0.15±0.08 LogMAR and 0.33±0.10 LogMAR, respectively). Contrast sensitivity decreased at high spatial frequencies. In patient satisfaction at 3 months post-op, VFQ reveals that 90% of patients revealed no or minor difficulty with glare/flare and 100% of patients have no or minor difficulty with halos. In overall satisfaction, 80% of patients rate their vision between 8 and 9 from a scale from 0 to 10.

Conclusion: The Bi-Flex POB-MA 877PEY EDoF IOL provides good visual outcomes for distance, and adequate intermediate vision, with low visual disturbances.