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

A Prospective, Multicenter Clinical Trial to Evaluate the Safety and Effectiveness of the AcuFocus Corneal Inlay (ACI)™ ACI 7000PDT in Presbyopic Subjects

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.

Study Overview

• Status: Completed
• Conditions: Presbyopia
• Intervention / Treatment: Device: AcuFocus Corneal Inlay ACI 7000PDT

Detailed Description

The loss of near vision and the ability to perform tasks that require near vision is part of the normal aging process. This natural transformation in the eye occurs as a result of the loss of accommodation of the crystalline lens, a condition known as presbyopia. The crystalline lens is responsible for the accommodative properties of the human eye, as established by Young in 1801, over 200 years ago.1 During accommodation, the ciliary muscle contracts, decreasing tension on the zonules, and allowing the crystalline lens to thicken, increasing its refractive power. This mechanism of accommodation and thickening of the lens provides the eye with adequate refractive power for near vision. The loss of accommodation with aging is the result of changes in the crystalline lens composition that prevent the natural accommodative process from occurring. This is associated with the gradual loss of near vision without external correction, generally in the form of spectacles.

The AcuFocus™ ACI 7000PDT represents new technology based on the well-established concept of small-aperture optics. In early cameras, depth of focus was controlled by reducing the aperture through which light enters. The smaller the aperture, the greater the depth of focus will be. This concept also applies to the human eye. In the eye of a presbyopic emmetrope, the lens cannot accommodate sufficiently 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.

In presbyopic subjects, objects closer than arm's length are focused behind the retina, thus creating blurred retinal images (which are composed of blur circles). A small aperture inlay placed in front of the eye of these subjects allows them to see at near by reducing the size of the blur circle.

AcuFocus, Inc. has developed a stationary intracorneal inlay designed to create a small aperture effect. The implant is intended to be placed intra-stromally; the corneal flap will be newly created and fully lifted for presbyopic emmetropes. Placement of the ACI on the stromal bed centered over the pupil in the non-dominant eye is expected to increase the depth of focus of the eye by reducing the circle of blur. Based on theoretical calculations of small aperture optics, the ACI is expected to provide presbyopic subjects with improvement of near and intermediate vision.

• Study Type: Interventional
• Enrollment (Actual): 359
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Arkansas
    • Fayetteville, Arkansas, United States, 72703
      • McDonald Eye Associates
  • California
    • Los Angeles, California, United States, 90024
      • Maloney Vision
    • Newport Beach, California, United States, 92660
      • TLC Laser Eye Center
    • San Diego, California, United States, 92122
      • Gordon Binder Weiss Vision Institute
  • Colorado
    • Fort Collins, Colorado, United States, 80525
      • Eye Center NOCO
  • Illinois
    • Chicago, Illinois, United States, 60602
      • Kraff Eye Institute
  • Indiana
    • Indianapolis, Indiana, United States, 46256
      • Eye Surgeons of Indiana
  • Kansas
    • Overland Park, Kansas, United States, 66211
      • Durrie Vision
  • Missouri
    • Chesterfield, Missouri, United States, 63017
      • Pepose Vision Institute
  • New Jersey
    • Teaneck, New Jersey, United States, 07666
      • The Cornea & Laser Eye Institute, P.A
  • New Mexico
    • Albuquerque, New Mexico, United States, 87109
      • Coleman Vision
  • New York
    • Rochester, New York, United States, 14618
      • University of Rochester Eye Institute - Strong Vision
  • South Dakota
    • Sioux Falls, South Dakota, United States, 57105
      • Vance Thompson Vision
  • Utah
    • Sandy, Utah, United States, 84070
      • Hoopes Vision
  • Wisconsin
    • Madison, Wisconsin, United States, 53715
      • Davis Duehr Dean

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 45 years to 60 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. Subjects must be natural emmetropes needing a minimum magnitude of +1.00D to +2.50D of reading add.
2. Subjects must have uncorrected near visual acuity worse than 20/40 and better than 20/100 in the eye to be implanted.
3. Subject must have distance visual acuity correctable to at least 20/20 in both eyes.
4. 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.

Exclusion Criteria:

1. Subjects with a difference of > 1.00D between the spherical equivalent manifest refraction and the spherical equivalent cycloplegic refraction.
2. Subjects with anterior segment pathology, including cataracts, in the eye to be implanted.
3. 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.
4. Subjects with ophthalmoscopic signs of keratoconus (or keratoconus suspect) in the eye to be implanted.
5. Subjects with a history of chronic dry eye not responding to therapy.
6. Subjects with distorted or unclear corneal mires on topography maps of the eye to be implanted.
7. Subjects who require canthotomy to generate a corneal flap in the eye to be implanted.
8. Subjects with macular degeneration, retinal detachment, or any other fundus pathology that would prevent an acceptable visual outcome in the eye to be implanted.
9. Subjects who have undergone previous intraocular or corneal surgery including cataract and LASIK surgery.
10. Subjects with a history of herpes zoster or herpes simplex keratitis.
11. Subjects who have a history of steroid-responsive rise in intraocular pressure, preoperative IOP > 21 mmHg, glaucoma, or is a glaucoma suspect.
12. Subjects with a history of diagnosed diabetes, autoimmune disease, connective tissue disease, or clinically significant atopic syndrome.
13. Subjects on chronic systemic corticosteroids or other immunosuppressive therapy that may affect wound healing, and any immunocompromised subjects.
14. Subjects who are using ophthalmic medication(s) other than artificial tears for treatment of any ocular pathology including ocular allergy.
15. Subjects using systemic medications with significant ocular side effects.
16. Subjects who are pregnant, lactating, or of child-bearing potential and not practicing a medically approved method of birth control.
17. Subjects with known sensitivity to planned study concomitant medications.
18. Subjects who are participating in any other ophthalmic drug or device clinical trial during the time of this clinical investigation.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: AcuFocus Corneal Inlay; Implantation of the AcuFocus Corneal Inlay ACI 7000PDT in emmetropic presbyopic patients.	Device: AcuFocus Corneal Inlay ACI 7000PDT; corneal inlay; Other Names: AcuFocus KAMRA inlay

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Improvement in uncorrected near visual acuity	Increased depth of focus created by the small aperture of the ACI to improve near visual acuity, while maintaining a range of focus over intermediate and distance.	12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Subjective improvement in near visual acuity as measured by subjective questionnaire.	Questionnaire assessed 1) improvement in near vision 2) satisfaction with the outcome of procedure 3) near vision tasks for exploratory analysis 4) distance vision tasks for exploratory analysis	12 months

Collaborators and Investigators

• Sponsor: AcuFocus, Inc.
• Investigators: Study Director: Perry Binder, MD

Publications and helpful links

Helpful Links

• Sponsor website

Study record dates

Study Major Dates

• Study Start: December 1, 2008
• Primary Completion (Actual): September 1, 2013
• Study Completion (Actual): September 1, 2013

Study Registration Dates

• First Submitted: January 6, 2009
• First Submitted That Met QC Criteria: January 7, 2009
• First Posted (Estimate): January 8, 2009

Study Record Updates

• Last Update Posted (Actual): February 5, 2018
• Last Update Submitted That Met QC Criteria: January 31, 2018
• Last Verified: January 1, 2018

More Information

Terms related to this study

• Keywords: LASIK; Presbyopia; accommodation; near visual acuity
• Additional Relevant MeSH Terms: Eye Diseases; Refractive Errors; Presbyopia
• Other Study ID Numbers: ACU-P08-020

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes