title: [Clinical research of the phakic foldable angle-supported intraocular lens for the correction of high myopia].
abstract: OBJECTIVE
  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.
  
  
  METHODS
  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.
  
  
  RESULTS
  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.
  
  
  CONCLUSIONS
  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.
authors.affiliation: Tianjin Medical University Eye Center & College of Optometry, Tianjin, China.
authors.forename: Rui-bo
authors.initials: RB
authors.lastname: Yang
authors.forename: Shao-zhen
authors.initials: SZ
authors.lastname: Zhao
authors.forename: Rui-hua
authors.initials: RH
authors.lastname: Wei
authors.forename: Yue
authors.initials: Y
authors.lastname: Huang
authors.forename: Chen
authors.initials: C
authors.lastname: Zhang
authors.forename: Xiao-rong
authors.initials: XR
authors.lastname: Li
mesh_terms: D000328:Adult; D005260:Female; D006801:Humans; D007429:Intraocular Pressure; D019654:Lens Implantation, Intraocular / Q000009:adverse effects* / Q000379:methods*; D008297:Male; D008875:Middle Aged; D009216:Myopia / Q000601:surgery*; D054120:Phakic Intraocular Lenses / Q000009:adverse effects; D011446:Prospective Studies; D016896:Treatment Outcome; D055815:Young Adult