LaserACE® Procedure Restore Visual Function and Range of Accommodation LaserACE® Procedure

Study Overview
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Brief Summary
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A new minimally invasive procedure for treating presbyopia is being evaluated to determine if there is improvement in near and intermediate vision after treatment.

Official Title
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Evaluation of the Safety & Efficacy of the LaserACE® Procedure to Restore Visual Function and Range of Accommodation

Conditions
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Presbyopia

Intervention / Treatment
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* Procedure: LaserACE(R)


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 40 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: LaserACE(R) procedure performed<br>The LaserACE(R) procedure (partial depth scleral micro-excisions with an Er:YAG laser in a specified pattern) will be performed. | Procedure: LaserACE(R)<br>* Partial depth scleral micro-excisions with an Er:YAG laser in a predetermined pattern.<br>* Other names: LaserACE;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Presbyopia, sclera, LaserACE