A new accommodative sulcus-based intraocular lens, two years follow-up clinical observations and complications.

Purpose: To report the clinical outcome, observations and complications related to the sulcus implantations of a new accommodative intraocular lens, the Lumina (AkkoLens Clinical b.v., Breda, The Netherlands) along the twenty-four-month period.

Methods: This prospective, observational multicenter study included 103 eyes from 66 patients who underwent implantation of the Lumina accommodative intraocular lens (IOL) at two specialized centers, each employing a distinct sulcus-based implantation model. At Resbiomed-Vissum Eye Clinic (Sofia, Bulgaria), 54 eyes were treated using the Initial Model, in which the main corneal incision was aligned with the patient's positive corneal meridian. In contrast, at Vissum Instituto Oftalmológico (Alicante, Spain), 49 eyes were treated with the Optimized Model, characterized by a standardized horizontal access tunnel (0-180°), regardless of corneal topography. Patients were evaluated at predefined postoperative intervals (1 day; 1, 3, 6, 12, and 24 months). Visual and refractive parameters-including UDVA, CDVA, UNVA, BCNVA, and CDNVA-along with postoperative observations and complications, were systematically documented. Due to statistically significant differences observed in several baseline and postoperative parameters, the two cohorts were analyzed separately.

Results: On postoperative day one, non-severe clinical biomicroscopic findings were observed in 21,35 % of eyes, including mild corneal edema (8.74 %), transient ocular hypertension (5.83 %), pigment dispersion (1.94 %), and moderate IOL tilting (1.94 %). At the first postoperative month, the rate of clinical observations related to the surgery was 8.73 %, with additional findings including moderate IOL decentration and one case of macular edema. From month three onward, abnormal findings such as remained below 1 % due to one case of ocular hypertension. From 12-24 months, the abnormal findings were observed at 2.91 %, such as pigment deposits (1.94 %), IOL decentration (0.97 %), and delayed ocular hypertension (0.97 %). Despite these events, both cohorts with two sulcus-based models achieved excellent final outcomes. Among patients who experienced complications from the first postoperative month onward, visual acuity at 24 months remained highly favorable. In the Sofia group (Center 1): UDVA 0.08 ± 0.05, CDVA - 0.02 ± 0.02, UNVA 0.4 ± 0.15, BCNVA 0.10 ± 0.04, and CDNVA 0.20 ± 0.03 logMAR. In the Alicante group (Center 2): UDVA was 0.04 ± 0.11 logMAR, CDVA - 0.05 ± 0.04, UNVA 0.38 ± 0.18, BCNVA 0.03 ± 0.05, and CDNVA 0.34 ± 0.11.

Conclusion: The Lumina IOL exhibited a favorable long-term safety profile, with no major sight-threatening adverse events. Early postoperative observations were transient and clinically insignificant, while late complications-though likely lens-related-did not compromise visual quality. These findings support the anatomical and functional safety of sulcus implantation for accommodative IOLs, confirming its viability as an effective and stable alternative to capsular bag fixation.