Status:
COMPLETED
LaserACE® Procedure Restore Visual Function and Range of Accommodation LaserACE® Procedure
Lead Sponsor:
ACE Vision Group, Inc.
Collaborating Sponsors:
Vision Renu Taiwan Corporation
Conditions:
Presbyopia
Eligibility:
All Genders
40+ years
Phase:
NA
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.
Eligibility Criteria
Inclusion
- Inclusion Criteria:
- Willing and able to understand and sign an informed consent;
- Willing and able to attend postoperative examinations per protocol schedule;
- 40 years of age or greater, of either gender or any race;
- Less than (\<) 1.00D of astigmatism in each eye, measured in their manifest refraction;
- 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.
- 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;
- Demonstrate Stereopsis of 200 seconds of arc or better using a Randot stereoscopic fly test and reading correction;
- In good ocular health with the exception of presbyopia;
- Presbyopia as demonstrated by:
- Currently wearing reading glasses and/or bifocals with an ADD of +1.50D or more; and
- Reduced near visual acuity when corrected for distance (DCNVA of 20/50 (logMAR 0.40) or worse; and
- Amplitude of accommodation (AA) of 1.50D or less as measured by the minus lens test; OR
- Amplitude of accommodation (AA) of 1.50D or less as measured by the iTrace aberrometer.
- Intraocular pressure (IOP) \>11mmHg and \< 30 mmHg in each eye without IOP-lowering medication;
- Less than or equal to (≤) 0.50D difference between the manifest refraction and the cycloplegic refraction;
- 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;
- 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
- Self-reported current pregnancy or breast-feeding, or plans to become pregnant during the entire study period;
- History of ocular trauma or prior ocular surgery, or expected to require retinal laser treatment or other ocular surgical intervention;
- 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;
- 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);
- Previous radial keratotomy or other corneal surgery (e.g., corneal transplant, DSAEK/DSEK, lamellar keratoplasty), except for LASIK, EpiLASIK/LASEK, or PRK;
- Previous anterior or posterior chamber surgery (e.g., vitrectomy, laser iridotomy);
- Keratoconus or keratoconus suspect with CDVA of less than (\<) 20/20 (\< logMAR 0.00) at distance;
- Near visual acuity at 40cm equivalent to their distance vision with distance correction (i.e., no evident effect of reduced accommodative range);
- Use of systemic or ocular medications that may affect vision (the use of any miotic or cycloplegic agent is specifically contraindicated);
- 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);
- Uncontrolled systemic or ocular disease;
- Any abnormality preventing reliable applanation tonometry in EITHER eye;
- Undilatable pupil such that one cannot examine the periphery of the retina;
- Functional eye preference, defined as phoria measuring over 15dp horizontally and/or over 2dp vertically, any strabismus, or suppression.
- 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;
- History of nuclear sclerosis LOCS III grade 2 or worse and/or other cataracts reducing CDVA;
- Known allergies to study medications including topical steroids, antibiotics and NSAIDS;
- Per PI discretion
Exclusion
Key Trial Info
Start Date :
December 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2016
Estimated Enrollment :
8 Patients enrolled
Trial Details
Trial ID
NCT01491360
Start Date
December 1 2013
End Date
January 1 2016
Last Update
October 27 2021
Active Locations (1)
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1
Chang Gung Memorial Hospital
Taipei, Taiwan