Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 2:02 AM
Ignite Modification Date:
2025-12-25 @ 2:02 AM
NCT ID:
NCT01491360
Eligibility 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. 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
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
40 Years
Study:
NCT01491360
Study Brief:
Protocol Section:
NCT01491360