Post-Market Observational Study Of Preloaded Hydrophobic Acrylic Aspheric Intraocular Lens With Blue Light Filter Bi-Flex Edof Pob-Ma 877Pey (Elon®) For Implantation In The Capsular Bag.

To assess the functional and refractive performance, as well as the positional stability, of the preloaded hydrophobic acrylic aspheric intraocular lens with blue light filter Bi-Flex EDOF POB-MA (Elon®) in cataract surgery patients.

The study included ten patients who, following preoperative evaluation by an ophthalmologist, met primary inclusion criteria and did not meet major exclusion criteria. The study was conducted at the University Hospital of Donostia and lasted for 3 months.

This was a prospective, observational, descriptive study in patients undergoing cataract surgery with implantation of Elon® IOL. The study included 3-months follow-up visits. IOLMaster500^® was used to perform the biometry. All surgeries were done by one experienced surgeon. IOL power was calculated using SRK/T formula with an A-constant (manufacturer) of 118.9. Monocular visual acuity at distance, intermediate, near, and refractive outcomes were assessed at 1-month post-op. The monocular defocus curve and contrast sensitivity were also obtained. Quantitative outcomes were presented as mean, standard deviation, median, interquartile range and extreme values. Qualitative outcomes were presented as number and percentage of each modality.

Twenty Elon® IOLs were implanted bilaterally in 10 patients, surgeries proceeded without any adverse events. The mean age was 68.60 ± 4.45 years, mean AXL was 23.34 ± 0.90mm and the mean IOL implanted power was 21.10 ± 3.08D. At 1-month post-op the monocular CDVA, CIVA and CNVA was 0.02±0.03, 0.29 ± 0.08, and 0.40 ± 0.05LogMAR respectively. 90% of eyes achieved 20/25LogMAR or better post-op UDVA. The post-op spherical equivalent at 1-month was -0.03 ± 0.19D with a range between -0,38 D and +0,38 D. 80% had a post-operative refractive cylinder ≤ -0.50D. Monocular defocus curve shows a peak of maximum VA at 0D (0.00±0.04LogMAR), and a constant and progressive decrease at -1.50D and -2.50D(0.15±0.08LogMAR and 0.33±0.10LogMAR respectively).

Elon® IOL implantation demonstrated excellent visual outcomes, predictability, and stability in refractive and visual parameters up to 3 months postoperatively. Patients reported high satisfaction levels with minimal visual disturbances, indicating favourable outcomes following surgery. These findings support the efficacy and safety of Elon® IOLs in improving visual function and quality of life in patients undergoing cataract surgery.