Investigation of the Presbia Flexivue Microlens™

Status unconfirmed · Phase 3

Conditions studied: Presbyopia

In brief

The Presbia Flexivue Microlens is a corneal inlay.

Key facts

Study ID

NCT02110472

Run by

PresbiBio, LLC

People needed

412

Starts

2014-05-01

Expected to finish

2019-02-01

Last updated by the study team

2016-09-28

Who can join

Age: 45 and older, up to 60. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Assil Eye Institute — Beverly Hills, California, United States
• Gordon-Weiss-Schanzlin — La Jolla, California, United States
• Maloney Vision Institute — Los Angeles, California, United States
• Stanford Eye and Laser Center — Palo Alto, California, United States
• Center for Sight — Sarasota, Florida, United States
• Kraft Eye Institute — Chicago, Illinois, United States
• Physicians Protocol — Greensboro, North Carolina, United States
• Cleveland Eye Clinic — Brecksville, Ohio, United States
• Berkeley Eye and Laser Center — Houston, Texas, United States
• Hoopes Vision, Laser Correction Center — Draper, Utah, United States
• The Eye Center — Fairfax, Virginia, United States

Full record on ClinicalTrials.gov

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