[Safety assessment of using collamer phakic implants in the correction of refractive errors].

BACKGROUND: An increasing number of patients with refractive visual impairments, in whom the correction using spectacles or contact lenses does not meet expectations, consider the possibility of undergoing refractive surgery. Phakic implants are an alternative for patients who are not eligible for laser correction.

OBJECTIVES: The aim of the study is to assess the safety of using collamer phakic implants in the correction of vision defects during the annual follow-up.

MATERIAL AND METHODS: The study included 24 eyes in 12 patients who were implanted with Visian ICL phakic posterior chamber lenses in order to correct myopia. The examinations carried out before the surgery were as follows: objective refractometry, the assessment of distant visual acuity with the best correction, intraocular pressure measurement, evaluation of the endothelium, corneal topography, and depth of the anterior chamber measurement. The final examinations included visual acuity, refraction, intraocular pressure, implant placement, endothelial microscopy, and funduscopic examination.

RESULTS: Mean objective refraction was: sphere -7.77 ±3.55 diopters and cylinder 1.18 ±0.87 diopters. Spectacle correction produced the mean visual acuity of 0.91 ±0.20 (Snellen). During the period of 1-year follow-up, the mean spherical power was 0.475 ±0.39 diopters, cylinder 0.46 ±0.27 diopters and the visual acuity after the procedure 1.05 ±0.22 (Snellen). The results of the 12-month evaluation showed a statistically significant greater improvement in patients using phakic implants compared to those subjected to spectacle correction (p < 0.05). The preand post-operative evaluation demonstrated no significant differences in endothelial cell density (p < 0.05). No complications were reported both during the surgery and the entire follow-up period.

CONCLUSIONS: The results of the safety assessment of using properly implanted ICL phakic lenses show good tolerance of collomer implants in the posterior chamber. They do not have a negative effect on the structures located in the anterior segment of the eye, including the corneal endothelium and the lens.