laserace® procedure restore visual function and range of accommodation laserace® procedure

Conditions: Presbyopia

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.


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

Keywords: presbyopia sclera laserace