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

NCT00850031 | Completed Results

• 1 other identifier: ACU-P08-020A
• Study Type: interventional
• Target: 119
• Locations: 5 countries
• Sites: 6

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.

Conditions

Presbyopia

Keywords

Presbyopia; Accommodation; Near visual acuity; LASIK

Outcome Measures

Primary Outcomes (1)

• Improvement in Uncorrected Near Visual Acuity

  Percent of subjects who achieved UCNVA of 20/40 or better.

  12 months

Secondary Outcomes (1)

• Improvement of Near Uncorrected Visual Acuity

  12 months

Study Arms (1)

AcuFocus Corneal Inlay

EXPERIMENTAL

Implantation of the AcuFocus Corneal Inlay in emmetropic presbyopic patients.

Device: AcuFocus Corneal Inlay

Interventions

AcuFocus Corneal Inlay DEVICE

Inlay implanted in cornea for improvement of near vision

Also known as: AcuFocus Corneal Inlay ACI 7000 PDT, AcuFocus KAMRA inlay

AcuFocus Corneal Inlay

Eligibility Criteria

• Age: 45 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (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.

Sponsors & Collaborators

• AcuFocus, Inc.: lead

Study Sites (8)

Vista Laser Eye Clinics

Melbourne, Victoria, 3185, Australia

Location

The Eye Institute

Bondi Junction, 2022, Australia

Location

Paracelsus Medizinische Privat-Universität, PMU, Universitätsklinikum

Salzburg, 5020, Austria

Location

Universitats-Augenklinik, Department of Ophthalmology

Bochum, 44892, Germany

Location

The Fendalton Eye Clinic

Fendalton, Christchurch, New Zealand

Location

Auckland Eye

Auckland, New Zealand

Location

Singapore National Eye Centre

Singapore, 168751, Singapore

Location

Optical Express

London, W1G 9AP, United Kingdom

Location

Related Publications (1)

• Dexl AK, Seyeddain O, Riha W, Hohensinn M, Ruckl T, Hitzl W, Grabner G. Reading performance after implantation of a modified corneal inlay design for the surgical correction of presbyopia: 1-year follow-up. Am J Ophthalmol. 2012 May;153(5):994-1001.e2. doi: 10.1016/j.ajo.2011.08.044. Epub 2011 Nov 20.

  PMID: 22105801 DERIVED

Related Links

• Sponsor website

MeSH Terms

Conditions

Presbyopia

Condition Hierarchy (Ancestors)

Refractive Errors; Eye Diseases

Results Point of Contact

• Title: Eugenia Thomas, Director Clinical Trials
• Organization: AcuFocus, Inc

nthomas@acufocus.com

949/585-9511

Study Officials

• Perry Binder, MD

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

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: February 20, 2009
• First Posted: February 24, 2009
• Study Start: January 1, 2009
• Primary Completion: October 1, 2013
• Study Completion: October 1, 2013
• Last Updated: February 28, 2018
• Results First Posted: February 6, 2017

Record last verified: 2018-01

Data Sharing

• IPD Sharing: Will not share

Locations

SG (1); NZ (2); AU (1); GB (1); DE (1)