Safety and Effectiveness of the AcuFocus Corneal Inlay ACI7000PDT in Presbyopes

NCT01352442 | Completed Results

• 1 other identifier: ACU-P10-020B
• Study Type: interventional
• Target: 151
• Locations: 9 countries
• Sites: 10

Brief Summary

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.

Conditions

Presbyopia

Keywords

Presbyopia; Accommodation; Near visual acuity; LASIK

Outcome Measures

Primary Outcomes (1)

• Uncorrected Near Visual Acuity 20/32 or Better

  12 months

Secondary Outcomes (1)

• Subjective Rating of Near Visual Acuity at 12 Months as Measured by Subjective Questionnaire

  12 months

Study Arms (1)

AcuFocus Corneal Inlay

EXPERIMENTAL

The AcuFocus Corneal Inlay ACI 7000PDT, which is a small medical device, will be surgically implanted in one eye of each subject.

Device: AcuFocus Corneal Inlay ACI 7000PDT

Interventions

AcuFocus Corneal Inlay ACI 7000PDT DEVICE

corneal inlay

Also known as: 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 sign and be given a copy of the written Informed Consent form.
• Subjects must be emmetropes needing a magnitude of +1.00D to +2.50D of reading add.
• Subjects must have distance corrected near visual acuity worse than 20/40 and better than 20/100 in the eye to be implanted.
• Subjects 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 Plano to -0.75D with no more than 0.75D of refractive cylinder as determined by cycloplegic refraction in the eye to be implanted.
• Subjects must have a stable refraction twelve months prior to ACI implantation: i.e. MRSE within 0.50D over prior twelve months as determined by subject history.
• Subjects who are soft contact lens wearers must discontinue their contact lenses for at least one week prior to ACI pre-operative examination.
• Subjects must have a minimum central corneal thickness of ≥ 500 microns in the eye to be implanted.
• Subjects must have a corneal power of ≥ 41.00D and ≤ 47.00D in all meridians in the eye to be implanted.
• Subjects must be ≥ 45 years and ≤ 60 years of age at the time of subject eligibility visit.
• Subjects must have an endothelial cell count ≥ 2000 cells/mm2 in the eye to be implanted.
• Subjects must be willing and able to return for scheduled follow-up examinations for 12 months after surgery.
• Subjects must demonstrate tolerance to monovision blur in the eye to be implanted as determined by loose lens blur tolerance or monovision contact lens trial.

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 abnormality (including endothelial dystrophy, guttata, recurrent corneal erosion, etc.) in the eye to be implanted.
• Subjects with ophthalmoscopic or topographic signs of keratoconus (or keratoconus suspect) or keratoectasia in the eye to be implanted.
• Subjects with dry eye as determined by objective testing; anesthetized Schirmer's test result \<10 mm or a tear break-up time (TBUT) less than 10 seconds are excluded.
• Subjects with distorted or unclear corneal mires on topography maps of 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 worn RGP or PMMA contact lenses within the last 6 months.
• Subjects who have undergone previous intraocular or corneal surgery, including PRK, LASIK, CK, LASEK, and cataract surgery in the eye to be implanted.
• 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, ocular hypertension, or are glaucoma suspects.
• Subjects with an abnormal threshold visual field.
• Subjects with a history of diagnosed diabetes, diagnosed 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.

Sponsors & Collaborators

• AcuFocus, Inc.: lead

Study Sites (11)

Vision Eye Institute

Bondi Junction, New South Wales, 2022, Australia

Location

Univ. Klinik fur Agugenheilkunde und Optometrie, Paracelsus Medzinishe Privatuniversitat Salzburg

Salzburg, A-5020, Austria

Location

Fondation Rothchild

Paris, 75019, France

Location

Shinagawa Lasik Center

Tokyo, Japan

Location

Maastricht University Medical Center

Maastricht, 6229, Netherlands

Location

The Fendalton Eye Clinic

Fendalton, Christchurch, New Zealand

Location

Auckland Eye

Auckland, New Zealand

Location

Asian Eye Institute

Makati City, 1200, Philippines

Location

Singapore National Eye Centre

Singapore, 168751, Singapore

Location

CEIC Vissum Corporación Oftalmológica

Alicante, 03016, Spain

Location

Beyoğlu Goz Training and Research Hospital

Istanbul, Turkey (Türkiye)

Location

Related Links

• Sponsor website

MeSH Terms

Conditions

Presbyopia

Condition Hierarchy (Ancestors)

Refractive Errors; Eye Diseases

Results Point of Contact

• Title: Eugenia Thomas, OD
• Organization: AcuFocus, Inc.

ethomas@acufocus.com

949-585-9511

Study Officials

• Perry Binder, MD

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

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: May 10, 2011
• First Posted: May 11, 2011
• Study Start: May 1, 2011
• Primary Completion: March 1, 2014
• Study Completion: March 1, 2014
• Last Updated: March 28, 2017
• Results First Posted: September 18, 2015

Record last verified: 2017-02

Data Sharing

• IPD Sharing: Will not share

Locations

AU (1); JP (1); NL (1); NZ (2); PH (1); ES (1); TU (1); SG (1); FR (1)