p91: clinical performance of phakic angle-supported investigational iol in prospective global...

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

Conclusions

3 year visit outcomes demonstrated:

Good visual acuity

Accurate predictability of refraction

Maintenance of endothelial cell density

Improvements in contrast sensitivity

Clinical investigation continuing through 5 years

postoperative