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.
- Device: Corneal inlay
- 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
- Subjects must have a photopic pupil size of > 1.6 mm in the eye to be implanted.
- 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
- 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
Ages Eligible for Study
45 Years - 60 Years
Genders Eligible for Study