NCT00819299

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
359

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Dec 2008

Longer than P75 for not_applicable

Geographic Reach
1 country

15 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2008

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

January 6, 2009

Completed
2 days until next milestone

First Posted

Study publicly available on registry

January 8, 2009

Completed
4.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2013

Completed
Last Updated

February 5, 2018

Status Verified

January 1, 2018

Enrollment Period

4.8 years

First QC Date

January 6, 2009

Last Update Submit

January 31, 2018

Conditions

Presbyopia

Keywords

Presbyopiaaccommodationnear visual acuityLASIK

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • Subjective improvement in near visual acuity as measured by subjective questionnaire.

    12 months

Study Arms (1)

AcuFocus Corneal Inlay

EXPERIMENTAL

Implantation of the AcuFocus Corneal Inlay ACI 7000PDT in emmetropic presbyopic patients.

Device: AcuFocus Corneal Inlay ACI 7000PDT

Interventions

AcuFocus Corneal Inlay ACI 7000PDTDEVICE

corneal inlay

Also known as: AcuFocus KAMRA inlay
AcuFocus Corneal Inlay

Eligibility Criteria

Age45 Years - 60 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

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.
  • +3 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (15)

McDonald Eye Associates

Fayetteville, Arkansas, 72703, United States

Location

Maloney Vision

Los Angeles, California, 90024, United States

Location

TLC Laser Eye Center

Newport Beach, California, 92660, United States

Location

Gordon Binder Weiss Vision Institute

San Diego, California, 92122, United States

Location

Eye Center NOCO

Fort Collins, Colorado, 80525, United States

Location

Kraff Eye Institute

Chicago, Illinois, 60602, United States

Location

Eye Surgeons of Indiana

Indianapolis, Indiana, 46256, United States

Location

Durrie Vision

Overland Park, Kansas, 66211, United States

Location

Pepose Vision Institute

Chesterfield, Missouri, 63017, United States

Location

The Cornea & Laser Eye Institute, P.A

Teaneck, New Jersey, 07666, United States

Location

Coleman Vision

Albuquerque, New Mexico, 87109, United States

Location

University of Rochester Eye Institute - Strong Vision

Rochester, New York, 14618, United States

Location

Vance Thompson Vision

Sioux Falls, South Dakota, 57105, United States

Location

Hoopes Vision

Sandy City, Utah, 84070, United States

Location

Davis Duehr Dean

Madison, Wisconsin, 53715, United States

Location

Related Links

MeSH Terms

Conditions

Presbyopia

Condition Hierarchy (Ancestors)

Refractive ErrorsEye Diseases

Study Officials

  • Perry Binder, MD

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 6, 2009

First Posted

January 8, 2009

Study Start

December 1, 2008

Primary Completion

September 1, 2013

Study Completion

September 1, 2013

Last Updated

February 5, 2018

Record last verified: 2018-01

Locations

US(15)