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

In this single arm clinical trial 24 month study 100% of the patients had no statistically significant change in distance vision after the procedure through 24 months. ( P VALUE HERE)

UVA Post-Operative Summary Data at 24 months

In this same study for Uncorrected Distance Visual Acuity 100% of the patients had no statistically significant change after the procedure. For Uncorrected Intermediate Visual Acuity (60cm) 94% of the patients achieved 20/32 or better vision; 89% of the patients achieved 20/25; and 78% achieved 20/20 or better vision. For Uncorrected Near Visual Acuity (40cm) 83% achieved 20/32 or better vision;72% achieved 20’25 or better vision; 22% achieved 20/20 or better vision.

DCVA Post-Operative Summary Data at 24 months

In this same study for Distance Corrected Visual Acuity 100% of the patients had no statistically significant change after the procedure. For Distance Corrected Intermediate Visual Acuity (60cm) 100% of the patients achieved 20/32 or better vision; 94% of the patients achieved 20/25; and 78% achieved 20/20 or better vision. For Distance Corrected Near Visual Acuity (40cm) 67% achieved 20/32 or better vision;56% achieved 20/25 or better vision; 22% achieved 20/20 or better vision.

Stereopsis showed improvement over time through 24 months

LaserACE® Mean Stereopsis improved from less than 70” than 60” at 1 yr and continued to improve at 24mos. This is unique to LaserACE® Procedure. Most corneal based presbyopic treatments reduce stereopsis and can lead to asthenopia.

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.

Note: LaserACE® is not yet FDA approved or available in the United States. It is currently in clinical trials only in select areas outside of the United States.

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