Safety and Effectiveness Study of the AcuFocus Corneal Inlay ACI 7000PDT in Presbyopes

Completed · Not applicable

Conditions studied: Presbyopia

In brief

The purpose of this study is to determine if the AcuFocus Corneal Inlay ACI 7000PDT will provide an effective method for the correction of presbyopia in patients who have normal distance vision but need a correction such as glasses or contact lenses to see clearly at near.

Key facts

Study ID

NCT00819299

Run by

AcuFocus, Inc.

People needed

359

Starts

2008-12-01

Expected to finish

2013-09-01

Last updated by the study team

2018-02-05

Who can join

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

You may qualify if…

• Subjects must be natural emmetropes needing a minimum magnitude of +1.00D to +2.50D of reading add.
• Subjects must have uncorrected near visual acuity worse than 20/40 and better than 20/100 in the eye to be implanted.
• Subject must have distance visual acuity correctable to at least 20/20 in both eyes.
• Subjects must have a preoperative spherical equivalent of plano defined as +0.50D to -0.75D with no more than 0.75D of refractive cylinder as determined by cycloplegic refraction in the eye to be implanted.

You may not qualify if…

• Subjects with a difference of > 1.00D between the spherical equivalent manifest refraction and the spherical equivalent cycloplegic refraction.
• Subjects with anterior segment pathology, including cataracts, in the eye to be implanted.
• Subjects with residual, recurrent, active ocular or uncontrolled eyelid disease, or any corneal abnormalities (including endothelial dystrophy, guttata, recurrent corneal erosion, etc.) in the eye to be implanted.
• Subjects with ophthalmoscopic signs of keratoconus (or keratoconus suspect) in the eye to be implanted.
• Subjects with a history of chronic dry eye not responding to therapy.
• Subjects with distorted or unclear corneal mires on topography maps of the eye to be implanted.
• Subjects who require canthotomy to generate a corneal flap in the eye to be implanted.
• Subjects with macular degeneration, retinal detachment, or any other fundus pathology that would prevent an acceptable visual outcome in the eye to be implanted.
• Subjects who have undergone previous intraocular or corneal surgery including cataract and LASIK surgery.
• Subjects with a history of herpes zoster or herpes simplex keratitis.
• Subjects who have a history of steroid-responsive rise in intraocular pressure, preoperative IOP > 21 mmHg, glaucoma, or is a glaucoma suspect.
• Subjects with a history of diagnosed diabetes, autoimmune disease, connective tissue disease, or clinically significant atopic syndrome.
• Subjects on chronic systemic corticosteroids or other immunosuppressive therapy that may affect wound healing, and any immunocompromised subjects.
• Subjects who are using ophthalmic medication(s) other than artificial tears for treatment of any ocular pathology including ocular allergy.
• Subjects using systemic medications with significant ocular side effects.
• Subjects who are pregnant, lactating, or of child-bearing potential and not practicing a medically approved method of birth control.
• Subjects with known sensitivity to planned study concomitant medications.
• Subjects who are participating in any other ophthalmic drug or device clinical trial during the time of this clinical investigation.

Where it is running

• McDonald Eye Associates — Fayetteville, Arkansas, United States
• Maloney Vision — Los Angeles, California, United States
• TLC Laser Eye Center — Newport Beach, California, United States
• Gordon Binder Weiss Vision Institute — San Diego, California, United States
• Eye Center NOCO — Fort Collins, Colorado, United States
• Kraff Eye Institute — Chicago, Illinois, United States
• Eye Surgeons of Indiana — Indianapolis, Indiana, United States
• Durrie Vision — Overland Park, Kansas, United States
• Pepose Vision Institute — Chesterfield, Missouri, United States
• The Cornea & Laser Eye Institute, P.A — Teaneck, New Jersey, United States
• Coleman Vision — Albuquerque, New Mexico, United States
• University of Rochester Eye Institute - Strong Vision — Rochester, New York, United States
• Vance Thompson Vision — Sioux Falls, South Dakota, United States
• Hoopes Vision — Sandy City, Utah, United States
• Davis Duehr Dean — Madison, Wisconsin, United States

Full record on ClinicalTrials.gov

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