Safety & Efficacy of the Laser Scleral Microporation Procedure (Philippines)

ACE Vision Group, Inc.50 enrolled

Overview

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

This is a prospective, controlled, single-center clinical study to evaluate the safety and efficacy of the Laser Scleral Microporation Procedure. Laser Scleral Microporation Procedure is a treatment to restore visual and accommodative function in presbyopic patients. The subjects are bilaterally treated with the Laser Scleral Microporation procedure.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Presbyopia

Interventions

Bilateral Laser Scleral Microporation procedureDEVICE

Device: Laser Scleral Microporation Partial depth scleral microporations with an Er:YAG laser in a predetermined pattern.

Eligibility

Sex: ALLMin age: 48 YearsHealthy volunteers:

Medical Language ↔ Plain English

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. 48 years of age or greater, of either gender or any race; 4. Less than (\<) 1.00D of astigmatism in each eye, measured by manifest refraction; 5. Mean Refractive Spherical Equivalent (MRSE) of less than or equal to 0.50D for distance vision; 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 20/25 (logMAR 0.10) in each eye; 7. Demonstrate stereopsis of 100 seconds of arc or better using a Stereo Fly test with near 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 at 40cm in each eye; and 2. Reduced near visual acuity at 40cm when corrected for distance (DCNVA) of 20/50 (logMAR 0.40) or worse in each eye; 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 spherical equivalent and the cycloplegic refraction spherical equivalent; 12. If the subject has had Laser Vision Correction (LVC) within 1-2 years prior to the LSM procedure, stable distance refraction is present, defined as ≤ 0.50D variation of refraction in the 12 months prior to the LSM procedure. Manifest refraction spherical equivalent (MRSE) 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; if baseline data is available. 13. Completed a washout period of two weeks (14 days) prior to LSM procedure from prior treatment with: a) With prior medical clearance: non-steroidal anti-inflammatory drugs (NSAIDs), blood thinners, aspiring and other substances which may increase bleeding; b) Anti-oxidants, which could affect blood thinning: (i) Any antioxidant supplements (e.g., Vitamin E, Acai, Ocuvite, greater than 1000mg of Omega-3, etc.); (ii) Antioxidant food supplements, such as shitake mushroom, mushroom extract and oral antioxidants 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: 1. Amblyopia or strabismus 2. Corneal abnormalities or disease 3. History of Dry Eye treatments/devices 4. Pupil abnormalities (e.g., corectopia, Adie's) 5. Capsule or zonular abnormalities 6. Intraocular inflammation 7. Retinal/macular disease or pathology 8. Glaucoma (any type) 4. History of prior ocular surgery, including: 1. Previous corneal surgery (e.g., penetrating keratoplasty, DSEAK/DSEK/DMEK, lamellar keratoplasty), except for LASIK, SMILE, EpiLASEK, or PRK; 2. Previous anterior or posterior chamber surgery (e.g., vitrectomy, laser iridotomy) with the exception of uncomplicated phacoemulsification with intraocular lens implantation; 3. Previous retinal surgery (e.g, retinal break, repair related to ocular trama or detachment, or pathology that is likely to require surgical intervention such as lattice degeneration. 5. 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); 6. Keratoconus or keratoconus suspect with CDVA of less than (\<) 20/20 (logMAR 0.00) at distance; 7. Near visual acuity at 40cm equivalent to their distance vision with distance correction (i.e., no evident effect of reduced accommodative range); 8. Use of systemic or ocular medications that may affect vision (the use of any miotic or cycloplegic agent is specifically contraindicated); 9. 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); 10. Uncontrolled systemic or ocular disease; 11. Any abnormality preventing reliable applanation tonometry in EITHER eye; 12. Undilatable pupil such that one cannot examine the periphery of the retina; 13. Functional eye preference, defined as phoria measuring over 15 prism diopters (PD) horizontally and/or over 2 PD vertically, any strabismus, or suppression. 14. 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 or ocular coherence tomography; 15. History of nuclear sclerosis LOCS III grade 2 or worse and/or other cataracts reducing CDVA or OSI \> 2.5; 16. Known allergies to study medications including topical steroids, antibiotics and NSAIDs; 17. Per Principal Investigator (PI) discretion

Locations (1)

Asian Eye Institute

Makati City, Philippines

Outcomes

Primary Outcomes

Binocular Distance Corrected Near Visual Acuity (DCNVA) @40cm

Binocular DCNVA is measured with ETDRS charts placed in 40cm distance. This assessment is performed under photopic lighting conditions.

Time frame: 12 months postoperative

Secondary Outcomes

Autorefraction

An autorefractor or automated refractor is a computer-controlled machine used during an eye examination to provide an objective measurement of a subject's refractive error.

Time frame: 1 week; 1 month; 3 months; 6 months; 12 months; 18 months & 24 months postoperative

Monocular Uncorrected Distance Visual Acuity (UDVA) @4m

UDVA is measured with ETDRS charts placed at 4m distance. This assessment is performed monocularly under photopic lighting conditions.

Time frame: 1 day; 1 week; 1 month; 3 months; 6 months; 12 months; 18 months & 24 months postoperative

Binocular Uncorrected Distance Visual Acuity (UDVA) @4m

UNVA is measured with ETDRS charts placed at 4m distance. This assessment is performed binocularly under photopic lighting conditions.

Time frame: 1 week; 1 month ; 3 months; 6 months; 12 months; 18 months & 24 months postoperative

Monocular & Binocular Uncorrected Intermediate Visual Acuity (UIVA) @60cm

UIVA is measured with ETDRS charts placed at 60cm distance. This assessment is performed monocularly, then binocularly under photopic lighting conditions.

Time frame: 1 week 1 month; 3 months 6 months; 12 months; 18 months & 24 months postoperative

Monocular & Binocular Uncorrected Near Visual Acuity (UNVA) @40cm

UNVA is measured with ETDRS charts placed at 40cm distance. This assessment is performed monocularly, then binocularly under photopic lighting conditions.

Data from ClinicalTrials.gov

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