LaserACE® Procedure Restore Visual Function and Range of Accommodation 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: April 25, 2014
Last verified: April 2014
  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: Evaluation of the Safety & Efficacy of the LaserACE® Procedure to Restore Visual Function and Range of Accommodation

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

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
    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.


Estimated Enrollment: 146
Study Start Date: December 2013
Estimated Study Completion Date: January 2016
Estimated Primary Completion Date: December 2015 (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:   50 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Willing and able to understand and sign an informed consent;
  2. Willing and able to attend postoperative examinations per protocol schedule;
  3. 50 years of age or greater, of either gender or any race;
  4. Less than (<) 1.00D of astigmatism in each eye, measured in their manifest refraction;
  5. Mean refractive spherical equivalent refraction (MRSE) of +/- 0.50D for distance vision; Note: Subjects who meet this criterion as a result of prior laser refractive surgery (LASIK, LASEK or PRK) may qualify; however, the subject must have had the LVC procedure performed at least 12 months prior to the LaserACE® procedure and be stable.
  6. Uncorrected distance visual acuity (UDVA) is better than or equal to 20/40 (logMAR 0.30) in each eye, and a Corrected Distance Visual Acuity (CDVA) is better than or equal to 20/25 (logMAR 0.10) in each eye;
  7. Demonstrate Stereopsis of 100 seconds of arc or better using a Randot stereoscopic fly test and reading correction;
  8. In good ocular health with the exception of presbyopia;
  9. Presbyopia as demonstrated by:

    1. Currently wearing reading glasses and/or bifocals with an ADD of +1.50D or more; and
    2. Reduced near visual acuity when corrected for distance (DCNVA of 20/50 (logMAR 0.40) or worse; and
    3. Amplitude of accommodation (AA) of 1.50D or less as measured by the minus lens test; OR
    4. Amplitude of accommodation (AA) of 1.50D or less as measured by the iTrace aberrometer.
  10. Intraocular pressure (IOP) >11mmHg and < 30 mmHg in each eye without IOP-lowering medication;
  11. Less than or equal to (≤) 0.50D difference between the manifest refraction and the cycloplegic refraction;
  12. Stable distance refraction is present, defined as ≤ 0.50D variation of refraction in the 12 months prior to the LaserACE® procedure. Manifest refraction cannot vary more than 0.50D from current spectacles that are at least 12 months of age, or from a documented refraction at least 12 months prior to the preoperative baseline exam;
  13. Completed a washout period of two weeks (14 days) prior to LaserACE® procedure from prior treatment with:

    • NSAIDS, blood thinners, aspirin, and other substances which may increase bleeding;
    • Any anti-oxidant supplements (e.g., Vitamin B6, Vitamin B12, Vitamin E, Vitamin C, Acai, Ocuvite, etc);
    • Anti-oxidant food supplements, such as shitake mushroom, mushroom extract and oral anti-oxidants.

Exclusion Criteria

  1. Self-reported current pregnancy or breast-feeding, or plans to become pregnant during the entire study period;
  2. History of ocular trauma or prior ocular surgery, or expected to require retinal laser treatment or other ocular surgical intervention;
  3. Presence of ocular pathology other than cataract such as:

    • Amblyopia or strabismus
    • Corneal abnormalities or disease
    • Dry Eye (International Task Force Level 3 or greater)
    • Pupil abnormalities (e.g., corectopia, Adie's)
    • Capsule or zonnular abnormalities
    • Intraocular inflammation
    • Retinal disease or pathology
    • Glaucoma (any type)
    • History of prior ocular surgery other than keratorefractive surgery;
  4. Known pathology that may affect visual acuity and/or are predicted to cause future acuity losses to a level of 20/30 (logMAR 0.18) or worse (e.g., macular degeneration);
  5. Previous radial keratotomy or other corneal surgery (e.g., corneal transplant, DSAEK/DSEK, lamellar keratoplasty), except for LASIK, EpiLASIK/LASEK, or PRK;
  6. Previous anterior or posterior chamber surgery (e.g., vitrectomy, laser iridotomy);
  7. Keratoconus or keratoconus suspect with CDVA of less than (<) 20/20 (< logMAR 0.00) at distance;
  8. Near visual acuity at 40cm equivalent to their distance vision with distance correction (i.e., no evident effect of reduced accommodative range);
  9. Use of systemic or ocular medications that may affect vision (the use of any miotic or cycloplegic agent is specifically contraindicated);
  10. Acute or chronic disease or illness that could increase the operative risk or confound the study outcome(s) (e.g., diabetes mellitus, immunocompromised, connective tissue disease);
  11. Uncontrolled systemic or ocular disease;
  12. Any abnormality preventing reliable applanation tonometry in EITHER eye;
  13. Undilatable pupil such that one cannot examine the periphery of the retina;
  14. Functional eye preference, defined as phoria measuring over 15dp horizontally and/or over 2dp vertically, any strabismus, or suppression.
  15. History of scleral ectasia, scleritis, or episcleritis; or thin sclera < 400 microns, as determined by taking the average of three measurements with ultrasound biomicroscopy (UBM) pachymetry;
  16. History of nuclear sclerosis LOCS III grade 2 or worse and/or other cataracts reducing CDVA;
  17. Known allergies to study medications including topical steroids, antibiotics and NSAIDS;
  18. Per PI discretion
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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-2013-01
Study First Received: November 22, 2011
Last Updated: April 25, 2014
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 July 23, 2014