Abstract
Purpose:
To evaluate accommodative benefits for near and intermediate visual performance after bilateral LaserACE procedure in Asian eyes.
Methods:
This prospective single arm design clinical study evaluated the LaserACE procedure results over 12 months. 20 Subjects ≧40 years of age with a demonstrated loss of accommodative function that had good uncorrected distance vision with less than 1.0 D of refractive astigmatism or hyperopia were enrolled.<br /> LaserACE surgery was performed using the VisioLite Er:YAG ophthalmic laser system in 4 oblique quandrants on the sclera over the ciliary muscle. The 9-spot matrix microexcisions were made with a hand held probe at 600 um spot size.<br /> Primary study targets were binocular defocus curve and unaided near and intermediate visual acuity, with a secondary target of stereoacuity and Patient Reported Outcome Questionnaire.
Results:
All patients achieved some improvement of near & intermediate vision. An average of 2-4 lines of improvement of reading vision was demonstrated. At Post-operative 1 year, UCIVA was 93% 20/30 or better; 86% 20/25 or better; 80% 20/20 or better; UCNVA was 85% 20/30 or better; 80% 20/25 or better; 46% 20/20 or better. The patients gained an averaged 1.5 D added accommodative reading power after the procedure. No statistically significant change was noted in UCDVA post-operatively, and stereoacuity was unaffected. All patients improved from "very great difficulty-some difficulty" pre-operatively to "some difficulty-no difficulty" at post-OP 6 months in the CatQuest 9SF Activities of Daily Living Questionairre.
Conclusions:
Preliminary results of the Taiwan IRB-monitored clinical trial of the LaserACE procedure appears to show promising results for restoring range of visual performance for near and intermediate visual tasks without compromising distance vision or offending the visual axis. Patient satisfaction was high post-operatively and sustained beyond 1 year in this group of Asian eyes.