Safety & Efficacy of the Laser Scleral Microporation Procedure

Evaluation of the Safety & Efficacy of the Laser Scleral Microporation Procedure to Restore Visual Function and Range of Accommodation

A new 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.

Inclusion Criteria:

1. Willing and able to understand and sign an informed consent;

2. Willing and able to adhere to the instructions set forth in this protocol;

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. Manifest refraction spherical equivalent refraction (MRSE) of less than or equal to +/- 0.50D for distance vision; Note: Subjects who meet this criterion as a result of prior laser refractive surgery may qualify; however, the subject must have had the Laser Vision Correction (LVC) at least 12 months prior to the LSM 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 20/25 (logMAR 0.10) in each eye;

7. Demonstrate Stereopsis of 100 seconds of arc or better using a Randot stereoscopic 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; and
   3. Minimum non-adjusted NAVQ score of 10;

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 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:

With prior medical clearance: non steroidal anti-inflammatory drugs (NSAIDs), blood thinners, aspirin, and other substances which may increase bleeding; Anti-oxidants, which could affect blood thinning: Any antioxidant supplements (e.g., Vitamin E, Acai, Ocuvite, greater than 1000mg of Omega-3, etc); 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:

   Amblyopia or strabismus Corneal abnormalities or disease History of Dry Eye treatments/devices (example: hot compresses, punctal plugs, automated or manual thermal expression, intense pulse light, nasolacrimal stimulation, thermal lid treatments, or any dry eye medications such as Cyclosporine, liftegrast, or topical steroids) Pupil abnormalities (e.g., corectopia, Adie's) Capsule or zonular abnormalities Intraocular inflammation Retinal/macular disease or pathology Glaucoma (any type)

4. History of prior ocular surgery, including:

   Previous corneal surgery (e.g. penetrating keratoplasty, DSEAK/DSEK/DMEK/ lamellar keratoplasty), except for LASIK, SMILE, EpiLASIK/LASEK, or PRK; Previous anterior or posterior chamber surgery (e.g., vitrectomy, laser iridotomy); Previous retinal surgery (e.g. retinal break, repair related to ocular trauma 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 15dp horizontally and/or over 2dp 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 optical coherence tomography (OCT);

15. History of nuclear sclerosis LOCS III grade 2 or worse and/or other cataracts reducing CDVA or (where measured at select sites) OSI > 2.5;

16. Known allergies tp study medications including topical steroids, antibiotics and NSAIDs;

17. Per Principal Investigator (PI) discretion, as described below:

Note: This above list of exclusion criteria is not all inclusive. Investigators should use medical judgement to exclude patients that have diseases/conditions which may compromise study results and/or patients that are not ideal candidates. Patient affect and/or expectations may be included in the evaluation of candidacy.