Posters

3 year endothelial cell analysis post iStent inject implantation

Poster Details

First Author: I.SIngh USA

Co Author(s):                        

Abstract Details

Purpose:

There is continued interest in long-term corneal endothelial safety with MIGS technology and there is sparse patient reported outcomes data with MIGS. Endothelial cells were assessed to 3 years in a subset of subjects randomized in the iStent inject pivotal randomized controlled trial. Patient reported outcomes (PRO) were collected over 2 years

Setting:

Data analyzed from the phase 3 pivotal trials. Endothelial cell counts performed in an office setting.

Methods:

Endothelial cell loss (ECL) was assessed in 2 study groups (iStent inject + phaco (INJ; n=135); phaco alone (CS; n=40)) over 3 years. PRO were collected using Visual Function Questionnaire (VFQ-25) and Ocular Surface Disease Index (OSDI). A post-hoc exploratory analysis was conducted. PRO responders were compared using logistic repeated measures mixed model and stratified by (1) baseline IOP (<25 mmHg and ≥25 mmHg) and (2) prostaglandin use at screening (yes/no). Minimal important difference (MID) was calculated for composite scores using a distributional approach whereby MID was defined as half the SD of baseline scores.

Results:

At 3-years follow-up, mean central ECD % change from Screening was similar between INJ and CS (-12% vs -14%, respectively). ECL >30% was also similar (6.7% in INJ eyes vs 10.0% CS eyes). For PROs, a greater percentage of responders was observed at all follow-up visits over 2 years in the INJ group compared with the CS group for the ≥25 mmHg IOP and for no prostaglandin use strata, with treatment differences in composite score responder rates ranging from 10.8% to 21.7% and 13.7% to 28.8%, respectively. A 10% difference in the percentage of PRO responders between study groups, rather than statistical significance, was considered to be clinically meaningful.

Conclusions:

The 3-year data demonstrates similar long-term corneal endothelial safety in both the iStent inject + phaco and phaco alone groups. Results of a post-hoc exploratory analysis of the VFQ-25 and OSDI suggest cataract surgery plus iStent inject may improve overall ocular symptoms and visual functioning compared with cataract surgery alone.

Financial Disclosure:

receives consulting fees, retainer, or contract payments from a company producing, developing or supplying the product or procedure presented