LaserACE® Procedure Restore Visual Function and Range of Accommodation LaserACE® Procedure
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|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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
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|