LaserACE® Procedure Restore Visual Function and Range of Accommodation LaserACE® Procedure
|ClinicalTrials.gov Identifier: NCT01491360|
Recruitment Status : Unknown
Verified April 2014 by ACE Vision Group, Inc..
Recruitment status was: Enrolling by invitation
First Posted : December 14, 2011
Last Update Posted : April 29, 2014
|Condition or disease||Intervention/treatment||Phase|
|Presbyopia||Procedure: LaserACE(R)||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||146 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Evaluation of the Safety & Efficacy of the LaserACE® Procedure to Restore Visual Function and Range of Accommodation|
|Study Start Date :||December 2013|
|Estimated Primary Completion Date :||December 2015|
|Estimated Study Completion Date :||January 2016|
Experimental: LaserACE(R) procedure performed
The LaserACE(R) procedure (partial depth scleral micro-excisions with an Er:YAG laser in a specified pattern) will be performed.
Partial depth scleral micro-excisions with an Er:YAG laser in a predetermined pattern.
Other Name: LaserACE
- Percent of subjects with binocular near visual acuity of 20/32 (logMAR 0.20) or better at six months postoperatively with distance correction in place measured at 40cm and 60cm. [ Time Frame: 6 months ]binocular near visual acuity of 20/32 (logMAR 0.20) or better at six months postoperatively with distance correction in place measured at 40cm and 60cm.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01491360
|Chang Gung Memorial Hospital|
|Principal Investigator:||David Ma, MD||Chang Gung Memorial Hospital, Taipei, Taiwan|