Presbyopia
Conditions
Keywords
Presbyopia, sclera, LaserACE
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.
Interventions
PROCEDURELaserACE(R)
Partial depth scleral micro-excisions with an Er:YAG laser in a predetermined pattern.
Sponsors
Vision Renu Taiwan Corporation
ACE Vision Group, Inc.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
40 Years to No maximum
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. 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. | 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. |
Countries
Taiwan
Outcome results
None listed