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LaserACE® Procedure Restore Visual Function and Range of Accommodation LaserACE® Procedure

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. 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
Vision Renu Taiwan Corporation
Information provided by (Responsible Party):
ACE Vision Group, Inc.

Brief Summary:
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 or disease Intervention/treatment Phase
Presbyopia Procedure: LaserACE(R) Phase 3

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 146 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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

Arm Intervention/treatment
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

Primary Outcome Measures :
  1. 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.

Information from the National Library of Medicine

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Ages Eligible for Study:   50 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

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 identifier (NCT number): NCT01491360

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

Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: ACE Vision Group, Inc. Identifier: NCT01491360     History of Changes
Other Study ID Numbers: AVG-2013-01
First Posted: December 14, 2011    Key Record Dates
Last Update Posted: April 29, 2014
Last Verified: April 2014
Keywords provided by ACE Vision Group, Inc.:
Additional relevant MeSH terms:
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Refractive Errors
Eye Diseases