Near and Intermediate Vision and Binocular Defocus Curves Before and After the LaserACE® Procedure

This study is enrolling participants by invitation only.
Sponsor:
Collaborator:
Vision Renu Taiwan Corporation
Information provided by (Responsible Party):
ACE Vision Group, Inc.
ClinicalTrials.gov Identifier:
NCT01491360
First received: November 22, 2011
Last updated: January 25, 2013
Last verified: January 2013
  Purpose

A new minimally invasive procedure for treating presbyopia is being evaluated to determine if there is improvement in near and intermediate vision after treatment.


Condition Intervention Phase
Presbyopia
Procedure: LaserACE(R)
Phase 3

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Near and Intermediate Vision and Binocular Defocus Curves Before and After the LaserACE® Procedure

Further study details as provided by ACE Vision Group, Inc.:

Primary Outcome Measures:
  • Change in uncorrected near visual acuity [ Time Frame: 1 month, 3 months, 6 months ] [ Designated as safety issue: No ]
    Uncorrected high contrast logMAR visual acuity at 40cm compared to preoperative

  • Change in uncorrected intermediate visual acuity [ Time Frame: preoperative, 1 month, 3 months, 6 months ] [ Designated as safety issue: No ]
    High contrast uncorrected logMAR visual acuity at 60cm


Secondary Outcome Measures:
  • Binocular defocus curve [ Time Frame: 6 months postoperative ] [ Designated as safety issue: No ]
    Binocular defocus curve compared to preoperative

  • Intraocular pressure [ Time Frame: Preoperative, 1 month, 3 months, 6 months ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 40
Study Start Date: December 2011
Estimated Study Completion Date: January 2014
Estimated Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
Procedure: LaserACE(R)
Partial depth scleral micro-excisions with an Er:YAG laser in a predetermined pattern.
Other Name: LaserACE

  Eligibility

Ages Eligible for Study:   40 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Are willing and able to understand and sign an informed consent
  • Are willing and able to attend postoperative examinations per protocol schedule
  • Are more than 40 years of age, of either gender and any race
  • Have ≤1 D of preoperative refractive astigmatism in both eyes, measured in their manifest refraction
  • Have a mean spherical equivalent refraction of +/- 0.50D for distance vision. Patients who meet this criterion as a result of prior laser refractive surgery (LASIK or PRK) are eligible for inclusion
  • Have demonstrated stereoacuity of 100 seconds of arc or better, using a standard stereoscopic test
  • Are in good ocular health, with the exception of presbyopia;
  • have a demonstrated loss of accommodative range as evidenced by reduced near vision when corrected for distance

Exclusion Criteria:

  • Amblyopia
  • Previous radial keratotomy, or other corneal surgery besides LASIK or PRK (e.g. corneal transplant, DSAEK, lamellar keratoplasty)
  • Previous anterior or posterior chamber surgery (e.g., vitrectomy, laser iridotomy)
  • Diabetic retinopathy
  • Macular degeneration
  • Subjects with pupil abnormalities (e.g., corectopia)
  • History of retinal detachment
  • Subjects that have an acute or chronic disease or illness that would increase the operative risk or confound the results of this investigation (e.g., immunocompromised, connective tissue disease, clinically significant atopic disease, diabetes, and any other such disease or illness)
  • Keratoconus
  • Near vision at 40cm equivalent to their distance vision when corrected for distance (i.e., no evident effect of reduced accommodative range).
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01491360

Locations
Taiwan
Chang Gung Memorial Hospital
Taipei, Taiwan
Sponsors and Collaborators
ACE Vision Group, Inc.
Vision Renu Taiwan Corporation
Investigators
Principal Investigator: David Ma, MD Chang Gung Memorial Hospital, Taipei, Taiwan
  More Information

No publications provided

Responsible Party: ACE Vision Group, Inc.
ClinicalTrials.gov Identifier: NCT01491360     History of Changes
Other Study ID Numbers: AVG-2011-02
Study First Received: November 22, 2011
Last Updated: January 25, 2013
Health Authority: Taiwan: Department of Health

Keywords provided by ACE Vision Group, Inc.:
Presbyopia
sclera
LaserACE

Additional relevant MeSH terms:
Presbyopia
Refractive Errors
Eye Diseases

ClinicalTrials.gov processed this record on April 15, 2014