LaserACE® Safety & Efficacy
LaserACE® improves uncorrected intermediate and near visual acuity as well as distance corrected near and intermediate visual acuity with stable distance vision.
LaserACE® Stability of Distance Vision
UVA Post-Operative Summary Data at 24 months
DCVA Post-Operative Summary Data at 24 months
Stereopsis showed improvement over time through 24 months
IOP Reduction over baseline through 24 months
Patient Quality of Life Improvement
as per the CatQuest-9sf Standardized Questionnaire at 24 months as Measured by a Standardized Questionnaire (CATQuest 9sf) Before & After LaserACE®.
Safety Profile for LaserACE® Procedure
The procedure spares conjunctival tissue and preserves tissue via small transconjunctival 600um spot size. There is minimal risk due to the procedure being performed off the visual axis. The LaserACE® procedure can therefore improve visual function without touching the optics of the eye. This avoids any side effects such as halos, starbursts and glare that can occur when the eyes natural optics are modified to create multimodality for various distances to of hypotony with a trained surgeon. The proprietary collagen matrix allows for easy intraoperative management of any micro perforation with no lasting impact.
LaserACE® IRB Registered Taiwan Clinical Trial Visual Outcomes
24 month results from a single arm Taiwan Clinical Trial at Chang Gung Memorial Hospital for patients 40 years or older with presbyopia requiring a minimum of 1.5D reading add and best corrected distance of 20/40 or better in otherwise health eyes have been analyzed. All patients achieved improvement of near and intermediate vision. Visual Function and acuity improvement had clinical significance. The subjects gained an average of 1.5D added accommodative reading power after the procedure. No statistical change was noted in UCDVA post operatively. Stereoacuity was improved by the procedure. Patient satisfaction was high post operatively and sustained over 24 months in this group of Asian eyes. Preliminary results of the Taiwan IRB monitored clinical trial of the LaserACE® procedure utilizing the Er:YAG laser appears to show promise for restoring range of visual performance for near and intermediate visual tasks without compromising distance vision and without touching the visual axis.