Safety and Effectiveness of the AcuFocus Corneal Inlay ACI7000PDT in Presbyopes
The purpose of this study is to determine if the AcuFocus Corneal Inlay ACI 7000PDT will provide an effective method of for the correction of presbyopia in patients who have normal distance vision but need correction such as glasses or contact lenses to see clearly at near.
|Study Design:||Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A Prospective Multicenter Clinical Trial to Evaluate the Safety and Effectiveness of the AcuFocus Corneal Inlay ACI 7000PDT Implanted Intrastromally for Modified Monovision in Presbyopic Subjects|
- Improvement in uncorrected near visual acuity. [ Time Frame: 12 months ] [ Designated as safety issue: No ]
- Subjective improvement in near visual acuity as measured by subjective questionnaire. [ Time Frame: 12 months ] [ Designated as safety issue: No ]
|Study Start Date:||May 2011|
|Estimated Study Completion Date:||December 2013|
|Estimated Primary Completion Date:||November 2013 (Final data collection date for primary outcome measure)|
Experimental: AcuFocus Corneal Inlay
Implantation of the AcuFocus Corneal Inlay in emmetropic presbyopic patients.
Device: AcuFocus Corneal Inlay ACI 7000PDT
Other Name: AcuFocus KAMRA inlay
The design and mechanism of action of the AcuFocus™ Corneal Inlay (ACI 7000PDT) is based on the well-established concept of small-aperture optics. In cameras, depth of focus is controlled by reducing the aperture through which light enters; the smaller the aperture, the greater the depth of focus. This concept also applies to the human eye. In the eye of an emmetropic presbyope, the natural lens cannot fully accommodate to focus the light rays from a near object onto a single point on the retina. Thus, a point object is imaged as a blur circle on the retina, and images of extended objects are degraded as well. If an opaque disc with a small aperture in the center is placed in front of the eye, the peripheral rays will be obscured while the central rays pass unaffected. Since peripheral rays enter the eye at a larger angle, they create a larger blur circle at the retinal image plane. Eliminating these peripheral rays reduces the size of the blur circle, improving image resolution.
When the inlay is implanted in one eye, the increased depth of focus provides near and intermediate visual acuity while having a minimal effect on distance acuity. Under binocular conditions, the effect of having an inlay eye with a range of vision from distance to near combined with the uncorrected vision in the fellow presbyopic eye, which will essentially have good distance acuity with reduced near acuity, is similar to the contact lens modality known as "modified monovision."
The ACI is expected to provide presbyopic patients with improvement in near and intermediate vision.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01352442
|Univ. Klinik fur Agugenheilkunde und Optometrie, Paracelsus Medzinishe Privatuniversitat Salzburg|
|Salzburg, Austria, A-5020|
|Study Director:||Perry Binder, MD|