Alfredo Vega-Estrada1,2, Elisabet Chorro1,2, Ashraf Sewelam3, Jorge L Alio1,2. 1. Keratoconus Unit, Vissum/Instituto Oftalmológico de Alicante, Alicante, Spain. 2. Pathology and Surgery Department, Universidad Miguel Hernández, Alicante, Spain. 3. Mansoura Ophthalmic Center, Mansoura University, Mansoura, Egypt.
Abstract
PURPOSE: To report visual, refractive, and corneal aberrations after implantation of a new asymmetric intracorneal ring segment (ICRS). METHODS: This was a prospective, multicenter clinical study including 30 eyes of 26 patients with keratoconus. All cases were implanted with an ICRS, named the VISUMRING (VR), which had an arc length of 353 degrees and 2 asymmetric sections that can be customized in base width, length, and thickness. Ophthalmic evaluation included uncorrected distance visual acuity (UDVA), corrected distance visual acuity (CDVA), refraction, topography, and anterior corneal aberrations using the Sirius System (CSO, Firenze, Italy). Mean follow-up period was 14.7 ± 7.9 months. RESULTS: Significant improvement of both UDVA and CDVA was observed after 1 year. UDVA improved from 0.08 ± 0.22 to 0.22 ± 0.16 and CDVA from 0.24 ± 0.29 to 0.43 ± 0.18 (P = 0.01). A significant reduction of more than 7 D in the spherical equivalent from -12.38 ± 3.77 D to -5.00 ± 3.26 D (P < 0.05) was noted 1 year after the procedure. In terms of higher-order aberrations, a slight reduction that was not statistically significant in the higher-order and coma-like aberrations was noted at 1 year from 4.32 and 3.82, to 4.12 and 3.55, respectively. Regarding complications, 5 of the 30 cases needed to have the VR explanted throughout the follow-up period due to severe corneal melting. CONCLUSIONS: VR ICRS improves vision and refraction and induces major corneal flattening in patients with keratoconus. Further design enhancement is needed to increase the reduction of the asymmetric corneal aberrations and reduce the extrusion rate.
PURPOSE: To report visual, refractive, and corneal aberrations after implantation of a new asymmetric intracorneal ring segment (ICRS). METHODS: This was a prospective, multicenter clinical study including 30 eyes of 26 patients with keratoconus. All cases were implanted with an ICRS, named the VISUMRING (VR), which had an arc length of 353 degrees and 2 asymmetric sections that can be customized in base width, length, and thickness. Ophthalmic evaluation included uncorrected distance visual acuity (UDVA), corrected distance visual acuity (CDVA), refraction, topography, and anterior corneal aberrations using the Sirius System (CSO, Firenze, Italy). Mean follow-up period was 14.7 ± 7.9 months. RESULTS: Significant improvement of both UDVA and CDVA was observed after 1 year. UDVA improved from 0.08 ± 0.22 to 0.22 ± 0.16 and CDVA from 0.24 ± 0.29 to 0.43 ± 0.18 (P = 0.01). A significant reduction of more than 7 D in the spherical equivalent from -12.38 ± 3.77 D to -5.00 ± 3.26 D (P < 0.05) was noted 1 year after the procedure. In terms of higher-order aberrations, a slight reduction that was not statistically significant in the higher-order and coma-like aberrations was noted at 1 year from 4.32 and 3.82, to 4.12 and 3.55, respectively. Regarding complications, 5 of the 30 cases needed to have the VR explanted throughout the follow-up period due to severe corneal melting. CONCLUSIONS: VR ICRS improves vision and refraction and induces major corneal flattening in patients with keratoconus. Further design enhancement is needed to increase the reduction of the asymmetric corneal aberrations and reduce the extrusion rate.