Post-market clinical follow-up study – Retrospective evaluation of endothelial cell density and IOL explants related to the clinical use of AcrySof® CACHET® Phakic Lens in three European countries

Study type

• Study topic:
  Medical device
• Study type:
  Non-interventional study
• Scope of the study:
  Assessment of risk minimisation measure implementation or effectiveness
• Data collection methods:
  Secondary data collection

Non-interventional study

• Non-interventional study design:
  Cohort

Population studied

• Short description of the study population:
  Patients implanted with AcrySof® CACHET® Phakic Lens between 2008 and 2013.
• Age groups:
  Adults (18 to < 46 years)

  Adults (46 to < 65 years)

  Adults (65 to < 75 years)

  Adults (75 to < 85 years)

  Adults (85 years and over)
• Estimated number of subjects:
  200

Study design details

• Main study objective:
  The primary goals of the study are to capture data on endothelial cell density in a real-life setting and to quantify the frequency of endothelial cell loss and AcrySof® CACHET® Phakic Lens explants.
• Outcomes:
  1) Acute ECL (detected ≤ 6 months after implant)- ECD < 1,500 cells/mm2- ECL > 30% of preoperative value2) Chronic ECL (thresholds as above, detected > 6 months of implant)3) Explant of the AcrySof® CACHET® Phakic Lens ≤ months after implant
• Data analysis plan:
  The main outcome will be the Frequency of endothelial cell loss (ECL) and explants. Kaplan-Meier estimates of cumulative endothelial cell loss (ECL) will be provided as graphics. Point estimates of the proportion of subjects who experienced the outcome at months 3 and 12 with 95% confidence intervals will be provided. To incorporate the variance correlation expected in the data, we will implement marginal regression models for correlated responses. We plan to create two different sets of models: one with a binary outcome, ECL, and the other with a continuous outcome, ECD. Depending on the number of explants, a third model can be built to explore the risk factors for this binary outcome, These models will be used to estimate the probability of ECL (model 1), the ECD (model 2) and of explants (if model 3 is built) per month.The unit of analysis will be operated eyes.

Documents

Study results

RTI-HS_Alcon Cachet Study_EU_PAS_SummaryResults Repag