Investigation of the Presbia Flexivue Microlens™
Trial ID or NCT#
NCT02110472
Status
NOT RECRUITING
Purpose
The Presbia Flexivue Microlens is a corneal inlay.
Official Title
Prospective, Non-randomized, Unmasked, Multicenter Clinical Investigation of the Presbia Flexivue Microlens™ for the Improvement of Near Vision in Emmetropic Presbyopes
Eligibility Criteria
Ages Eligible for Study: 45 Years to 60 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers: Yes
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.
Investigator(s)
View on ClinicalTrials.gov
