P91: Clinical Performance of Phakic Angle-Supported Investigational IOL in Prospective Global Trials, ASCRS 2010, Boston P91: Clinical performance of phakic angle-supported investigational IOL in prospective global trials Thomas Kohnen Department of Ophthalmology Goethe-University Frankfurt am Main Financial disclosure in field of phakic IOL : Alcon, Ft.Worth, Tex, USA: Scientific consultant, research funding and travel expense reimbursement
Transcript
P91: Clinical Performance of Phakic Angle-Supported Investigational IOL in Prospective Global Trials, ASCRS 2010, Boston
P91:Clinical performance of phakic angle-supported investigational IOL in prospective global trials
Thomas Kohnen
Department of OphthalmologyGoethe-University Frankfurt am Main
Financial disclosure in field of phakic IOL :
Alcon, Ft.Worth, Tex, USA: Scientific consultant, research funding and travel expense reimbursement
P91: Clinical Performance of Phakic Angle-Supported Investigational IOL in Prospective Global Trials, ASCRS 2010, Boston
Purpose
To evaluate the safety and effectiveness of an angle-
supported phakic lens (PIOL) in clinical trials conducted
in the U.S., Europe and Canada
P91: Clinical Performance of Phakic Angle-Supported Investigational IOL in Prospective Global Trials, ASCRS 2010, Boston
Methods
Prospective, global clinical studies
360 subjects underwent implantation of the AcrySof Cachet phakic lens
United States: 50 subjects
Canada: 120 subjects
Europe: 190 subjects
Study participants
≥18 years of age (age cap of 49 years for U.S. & Canada studies)
Stable moderate to high myopia (refractions within ±0.5 D at least 12 months prior to surgery)
No previous corneal or ocular surgery
≤2.0 D of preop corneal astigmatism
≤7.0 mm mesopic pupil size
Preop endothelial cell density per age criteria
P91: Clinical Performance of Phakic Angle-Supported Investigational IOL in Prospective Global Trials, ASCRS 2010, Boston
Methods / materials
Angle-Supported Phakic Lens Single piece design Soft acrylic IOL material Foldable insertion via Monarch® II IOL
Delivery System Lens placement in irido-corneal junction Peripheral iridotomy or iridectomy optional
(preventive iridotomy performed in 1 of 360 subjects)
Optic Size: 6.0 mmOverall length (OAL): 12.5 mm to 14.0 mmDiopter range: -6.0 to -16.5 D Investigational Lens
P91: Clinical Performance of Phakic Angle-Supported Investigational IOL in Prospective Global Trials, ASCRS 2010, Boston
Methods
Clinical evaluation at 3 year visit
1st eye outcomes
Spherical equivalent (SE)
Uncorrected visual acuity (UCVA)
Endothelial cell density (ECD)
Contrast sensitivity substudy
VectorVision CSV-1000E
Mesopic lighting conditions with & without glare
@ 3, 6 , 12, 18 cycles per degree (cpd )
P91: Clinical Performance of Phakic Angle-Supported Investigational IOL in Prospective Global Trials, ASCRS 2010, Boston
Spherical equivalent
Postop SE at 3 years was within ± 0.5 D of target in 75.6% (239/316) of subjects.
Mean and Standard Deviation
P91: Clinical Performance of Phakic Angle-Supported Investigational IOL in Prospective Global Trials, ASCRS 2010, Boston
Uncorrected visual acuity at 3 year visit
Mean logMAR UCVA: 0.03 ± 0.17
P91: Clinical Performance of Phakic Angle-Supported Investigational IOL in Prospective Global Trials, ASCRS 2010, Boston
Corrected visual acuity at 3 year visit
Mean logMAR CVA: -0.09 ± 0.11
P91: Clinical Performance of Phakic Angle-Supported Investigational IOL in Prospective Global Trials, ASCRS 2010, Boston
Central endothelial cell density
% Change= -0.4%@ 3 yrs from 6 m
(N=311)
% Change= -0.4%@ 3 yrs from 6 m
(N=311)
Corneal endothelium response stable over time.
Mean and Standard Deviation
P91: Clinical Performance of Phakic Angle-Supported Investigational IOL in Prospective Global Trials, ASCRS 2010, Boston
Peripheral endothelial cell density
% Change= -0.7%@ 3 yrs from 6 m
(N=299)
% Change= -0.7%@ 3 yrs from 6 m
(N=299)
Mean and Standard Deviation
Corneal endothelium response stable over time.
P91: Clinical Performance of Phakic Angle-Supported Investigational IOL in Prospective Global Trials, ASCRS 2010, Boston
Change in mean contrast sensitivityPreop vs. 3 Year Visit
Mean mesopic contrast sensitivity, with and without glare, improved at all spatial frequencies, with greatest improvement
observed at higher spatial frequencies.
Mean CS and 90% lower confidence limit
P91: Clinical Performance of Phakic Angle-Supported Investigational IOL in Prospective Global Trials, ASCRS 2010, Boston
