RISKS AND BENEFITS OF ACRYSOF® CACHETTM IMPLANTATION IN HIGH MYOPIA (≥-6 DIOPTRE)- A SYSTEMATIC LITERATURE REVIEW
Author(s)
Siddiqui MK1, Mann K1, VonMaltzahn R2, Ternouth AM2, Verboven Y3, Berdeaux G41Heron Health Private Ltd, Chandigarh, Chandigarh, India, 2HERON Evidence Development Ltd, Luton, United Kingdom, 3Alcon Research Ltd, Puurs, Belgium, 4ALCON RESEARCH LTD, RUEIL-
OBJECTIVES: To assess risks and benefits associated with AcrySof® Cachet™, other marketed phakic intraocular lenses (PIOLs) in Europe, and laser refractive surgery (RS) in patients with high myopia (HM). METHODS: MEDLINE, Embase, and Cochrane databases were searched for randomised controlled trials and observational studies conducted in HM patients. Two reviewers undertook data extraction followed by reconciliation of included studies. Meta-analysis was performed to combine comparative data; weighted means were calculated for single arm studies. The quality of single arm studies was assessed using Downs and Black checklist (score ≥12: excellent quality). RESULTS: Of 1853 abstracts screened, 51 studies (23 comparative, 28 single arm studies) were included. Results were statistically significant in favour (OR, 95% CI) of PIOLs compared to RS for manifest refractive spherical equivalent (MRSE) within ±0.50D (3.42, 1.19–9.90), gain of ≥1 lines of best spectacles corrected visual acuity (BSCVA) (5.28, 1.26-21.97), and fewer secondary refractive procedures (0.18, 0.10–0.33). Mean quality index score was 15.04. Baseline characteristics including myopia severity and anterior chamber depth were comparable across studies. AcrySof® Cachet™ showed favourable efficacy for uncorrected distance visual acuity of 20/20 in 46.2% eyes at 3 years post-operative (Artisan and Visian had 40.8% and 31.0% eyes respectively). Percentage of eyes needing spectacles (criteria: MRSE not within ±0.50D) were 43.45%, 17.19%, and 6.14% for Visian, Artisan, and AcrySof® Cachet™ respectively. For safety, the loss of ≥1 lines of BSCVA was 0.56% in AcrySof® Cachet™ and 2.25%, 13.16% for Artisan and Visian respectively. Annualized post 6 month endothelial cell loss (0.41%) was within the expected rate of natural loss (0.6%±0.5%). CONCLUSIONS: PIOLs were associated with proven favourable efficacy and safety compared to RS. Amongst PIOLs, within the first 3 years AcrySof® Cachet™ has shown favourable efficacy and safety. Comparative trials are required to confirm the robustness of results.
Conference/Value in Health Info
2011-11, ISPOR Europe 2011, Madrid, Spain
Value in Health, Vol. 14, No. 7 (November 2011)
Code
PSU8
Topic
Clinical Outcomes
Topic Subcategory
Comparative Effectiveness or Efficacy
Disease
Sensory System Disorders