Trial Search Results

Investigation of the Presbia Flexivue Microlens™

The Presbia Flexivue Microlens is a corneal inlay.

Stanford is currently not accepting patients for this trial.

Lead Sponsor:

PresbiBio, LLC

Stanford Investigator(s):

Intervention(s):

  • Device: Corneal inlay

Phase:

Phase 3

Eligibility


Inclusion Criteria:

   - Subjects must be emmetropes with presbyopia, between ≥ 45 years and ≤ 60 years of age
   at time of eligibility visit.

   - Subjects must need a reading add of +1.50 D to +3.50 D.

   - Subjects must have uncorrected near visual acuity of 20/50 or worse.

   - Subjects must have near visual acuity correctable to 20/20 or better in each eye.

   - Subjects must have distance visual acuity correctable to 20/25 or better in each eye.

   - Subjects must have a preoperative spherical equivalent of +1.00 D to -0.75 D with no
   more than 0.75 D of refractive cylinder as determined by cycloplegic refraction in
   each eye.

   - Subjects must have a photopic pupil size of > 1.6 mm in the eye to be implanted.

Exclusion Criteria:

   - Subjects in whom the non-dominant eye cannot be determined using one of the methods
   identified in the test of ocular dominance.

   - Subjects who do not complete the monovision tolerance trial (minimum of 5 to 7 days).

   - Subjects who report that they were not completely satisfied with their vision during
   the monovision tolerance trial.

   - Subjects who report that they experienced debilitating or significant visual symptoms
   such as halos, glare, double vision, etc. during the monovision tolerance trial.

   - Subjects with a difference of ≥ 1.00 D between the spherical equivalent manifest
   refraction and the spherical equivalent cycloplegic refraction.

   - Subject with a preferred near working distance of < 35 cm or > 45 cm.

   - Subjects with corneal thickness < 500 microns in the eye to be implanted.

   - Subjects with clinically significant anterior segment pathology, including cataracts,
   in either eye.

   - Subjects with residual, recurrent, active ocular or uncontrolled eyelid disease or any
   progressive corneal abnormalities (including endothelial dystrophy, guttata in the
   central cornea, etc.) in the eye to be treated.

   - Subjects with keratoconus (or keratoconus suspect), amblyopia, recurrent erosion
   syndrome or corneal dystrophy in the eye to be treated.

   - Subjects with a history of chronic dry eye not controlled on therapy or with
   superficial punctuate keratitis (SPK) grade > II (i.e., greater than mild) based on
   Oxford Grading Scale in the eye to be treated.

   - Subjects with abnormal corneal mires on topography maps of the eye to be treated.

   - Subjects who require canthotomy to generate a corneal tunnel in the eye to be treated.

   - Subjects with progressive retinal pathology with a reasonable chance of causing a
   reduction in BCVA from preoperative in the eye to be treated.

   - Subjects who have undergone previous intraocular or corneal surgery including cataract
   and refractive surgery (e.g., LASIK surgery) in either eye.

   - Subjects using ophthalmic medication(s) other than artificial tears for treatment of
   ocular pathology.

   - Subjects with a history of autoimmune disease, connective tissue disease, or
   clinically significant atopic syndrome.

   - Subjects with a history of herpes zoster or herpes simplex keratitis.

   - Subjects with a history of steroid-responsive rise in intraocular pressure (IOP), or a
   preoperative IOP > 21 mmHg or glaucoma.

   - Subjects with distorted, non-reactive, or decentered pupils.

   - Subjects taking medication for the control of diabetes.

   - Subjects on chronic systemic or topical corticosteroids or other immunosuppressive
   therapy that may affect wound healing, and any immuno-compromised subjects (use of
   intranasal steroids for seasonal allergies are acceptable).

   - Subjects using systemic medications (e.g., amiodarone) or medications with significant
   ocular side effects.

   - Subjects who are pregnant, or are considering becoming pregnant during the time of the
   study.

Ages Eligible for Study

45 Years - 60 Years

Genders Eligible for Study

All

Not currently accepting new patients for this trial

Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305
Not Recruiting