| Eligibility |
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
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