Clinical research of the phakic foldable angle-supported intraocular lens for the correction of high myopia

Abstract

To assess the safety, efficacy, predictability and stability of the phakic foldable angle-supported intraocular lens (IOL) (CACHET IOL, Alcon Inc., USA.) for correction of high-to-extremely high myopia in adults. In this prospective study, 29 eyes of 15 patients were implanted with CACHET phakic angle-supported IOL and followed for 1 year postoperatively. Preoperative manifest refractive sphere was -12.08 ± 2.44 diopters (D). Visual acuity(uncorrected visual acuity, UCVA; best spectacle-corrected visual acuity, BSCVA), predictability and stability of manifest refraction spherical equivalent (MRSE), adverse events, and endothelial cell density were analyzed primarily during 1-year of follow-up. After 1 year of follow-up, a BSCVA of 0.6 or better was achieved by 100% of eyes; 9.7% (26/29) had a BSCVA of 1.0 or better; no eyes lost ≥ 1 line BSCVA, 62.1%(18/29) had no change in lines of BSCVA, 31.0% (9/29) gained 1 line of BSCVA, 3.4% (1/29) gained 2 line of BSCVA, and 3.4% (1/29) gained more than 2 line of BSCVA; the safety index was 1.13 (1.08/0.96); UCVA of 1.0 or better was achieved by 58.6% (17/29), 100% had an UCVA of 0.5 or better, 86.2% (25/29) of eyes achieved a UCVA of 0.8 or better, and 93.1% (27/29) of eyes achieved a UCVA of 0.6 or better; the efficacy index was 1.03(0.99/0.96). The overall mean percentage change in endothelial cell density 1 year after surgery was -0.23% ± 4.80%. Five eyes (17.2%) had increased intraocular pressure (IOP) on the day of surgery. No pupil ovalization, pupillary block, or retinal detachment events were observed. Glare (6.9%, 2/29) and halo (13.8%, 4/29) mainly appeared in the first month after surgery, and had no influence on driving in night. After 1 year of follow-up, the implantation of phakic foldable angle-supported IOL was proved to be safe, effective and predictable with minimal complications in patients with high myopia. Due to the limitation of visiting time, long-term of clinical investigation is necessary to verify the safety and efficacy of this IOL.