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

Evaluation of the Safety & Efficacy of the LaserACE® Procedure to Restore Visual Function and Range of Accommodation

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

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. 40 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 20/32 (logMAR 0.20) in each eye;

7. Demonstrate Stereopsis of 200 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