Safety and Effectiveness of the AcuFocus Corneal Inlay ACI7000PDT in Presbyopes

Sponsor
AcuFocus, Inc. (Industry)
Overall Status
Completed
CT.gov ID
NCT01352442
Collaborator
(none)
151
11
1
34
13.7
0.4

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Device: AcuFocus Corneal Inlay ACI 7000PDT
N/A

Detailed Description

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.

Study Design

Study Type:
Interventional
Actual Enrollment :
151 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (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
Study Start Date :
May 1, 2011
Actual Primary Completion Date :
Mar 1, 2014
Actual Study Completion Date :
Mar 1, 2014

Arms and Interventions

Arm Intervention/Treatment
Experimental: AcuFocus Corneal Inlay

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
corneal inlay
Other Names:
  • AcuFocus KAMRA inlay
  • Outcome Measures

    Primary Outcome Measures

    1. Uncorrected Near Visual Acuity 20/32 or Better [12 months]

    Secondary Outcome Measures

    1. Subjective Rating of Near Visual Acuity at 12 Months as Measured by Subjective Questionnaire [12 months]

      Mean subjective rating via questionnaire on 1 to 7 rating scale (1= very dissatisfied and 7 = very satisfied).

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    45 Years to 60 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    Inclusion Criteria:
    1. Subjects must sign and be given a copy of the written Informed Consent form.

    2. Subjects must be emmetropes needing a magnitude of +1.00D to +2.50D of reading add.

    3. Subjects must have distance corrected near visual acuity worse than 20/40 and better than 20/100 in the eye to be implanted.

    4. Subjects must have distance visual acuity correctable to at least 20/20 in both eyes.

    5. 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.

    6. 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.

    7. Subjects who are soft contact lens wearers must discontinue their contact lenses for at least one week prior to ACI pre-operative examination.

    8. Subjects must have a minimum central corneal thickness of ≥ 500 microns in the eye to be implanted.

    9. Subjects must have a corneal power of ≥ 41.00D and ≤ 47.00D in all meridians in the eye to be implanted.

    10. Subjects must be ≥ 45 years and ≤ 60 years of age at the time of subject eligibility visit.

    11. Subjects must have an endothelial cell count ≥ 2000 cells/mm2 in the eye to be implanted.

    12. Subjects must be willing and able to return for scheduled follow-up examinations for 12 months after surgery.

    13. 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.

    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 abnormality (including endothelial dystrophy, guttata, recurrent corneal erosion, etc.) in the eye to be implanted.

    4. Subjects with ophthalmoscopic or topographic signs of keratoconus (or keratoconus suspect) or keratoectasia in the eye to be implanted.

    5. 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.

    6. Subjects taking chronic systemic medications known to exacerbate or induce moderate to severe dry eye in so far as measures of TBUT and Schirmers are decreased or borderline per Exclusion Criterion #5. Subjects taking the following classes of medications should be evaluated: anti-depressants, anti-histamines, beta-blockers, phenothiazines, atropine and atropine derivatives, oral contraceptives, anxiolytics, diuretics, anti-cholinergics, and anti-arrhythmics.

    7. Subjects with distorted or unclear corneal mires on topography maps of 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 worn RGP or PMMA contact lenses within the last 6 months.

    10. Subjects who have undergone previous intraocular or corneal surgery, including PRK, LASIK, CK, LASEK, and cataract surgery in the eye to be implanted.

    11. Subjects with a history of herpes zoster or herpes simplex keratitis.

    12. Subjects who have a history of steroid-responsive rise in intraocular pressure, preoperative IOP > 21 mmHg, glaucoma, ocular hypertension, or are glaucoma suspects.

    13. Subjects with an abnormal threshold visual field.

    14. Subjects with a history of diagnosed diabetes, diagnosed autoimmune disease, connective tissue disease, or clinically significant atopic syndrome.

    15. Subjects on chronic systemic corticosteroids or other immunosuppressive therapy that may affect wound healing, and any immunocompromised subjects.

    16. Subjects who are using ophthalmic medication(s) other than artificial tears for treatment of any ocular pathology including ocular allergy.

    17. Subjects using systemic medications with significant ocular side effects.

    18. Subjects who are pregnant, lactating, or of child-bearing potential and not practicing a medically approved method of birth control.

    19. Subjects with known sensitivity to planned study concomitant medications.

    20. Subjects who are participating in any other ophthalmic drug or device clinical trial during the time of this clinical investigation.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Vision Eye Institute Bondi Junction New South Wales Australia 2022
    2 Univ. Klinik fur Agugenheilkunde und Optometrie, Paracelsus Medzinishe Privatuniversitat Salzburg Salzburg Austria A-5020
    3 Fondation Rothchild Paris France 75019
    4 Shinagawa Lasik Center Tokyo Japan
    5 Maastricht University Medical Center Maastricht Netherlands 6229
    6 The Fendalton Eye Clinic Fendalton Christchurch New Zealand
    7 Auckland Eye Auckland New Zealand
    8 Asian Eye Institute Makati City Philippines 1200
    9 Singapore National Eye Centre Singapore Singapore 168751
    10 CEIC Vissum Corporación Oftalmológica Alicante Spain 03016
    11 Beyoğlu Goz Training and Research Hospital Istanbul Turkey

    Sponsors and Collaborators

    • AcuFocus, Inc.

    Investigators

    • Study Director: Perry Binder, MD,

    Study Documents (Full-Text)

    None provided.

    More Information

    Additional Information:

    Publications

    None provided.
    Responsible Party:
    AcuFocus, Inc.
    ClinicalTrials.gov Identifier:
    NCT01352442
    Other Study ID Numbers:
    • ACU-P10-020B
    First Posted:
    May 11, 2011
    Last Update Posted:
    Mar 28, 2017
    Last Verified:
    Feb 1, 2017
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Keywords provided by AcuFocus, Inc.
    Additional relevant MeSH terms:

    Study Results

    Participant Flow

    Recruitment Details
    Pre-assignment Detail
    Arm/Group Title AcuFocus Corneal Inlay
    Arm/Group Description The AcuFocus Corneal Inlay ACI 7000PDT, which is a small medical device, will be surgically implanted in one eye of each subject. AcuFocus Corneal Inlay ACI 7000PDT: corneal inlay
    Period Title: Overall Study
    STARTED 151
    COMPLETED 139
    NOT COMPLETED 12

    Baseline Characteristics

    Arm/Group Title AcuFocus Corneal Inlay
    Arm/Group Description The AcuFocus Corneal Inlay ACI 7000PDT, which is a small medical device, will be surgically implanted in one eye of each subject. AcuFocus Corneal Inlay ACI 7000PDT: corneal inlay
    Overall Participants 151
    Age (Count of Participants)
    <=18 years
    0
    0%
    Between 18 and 65 years
    151
    100%
    >=65 years
    0
    0%
    Age (years) [Mean (Standard Deviation) ]
    Mean (Standard Deviation) [years]
    51
    (4)
    Sex: Female, Male (Count of Participants)
    Female
    71
    47%
    Male
    80
    53%
    Region of Enrollment (participants) [Number]
    Austria
    9
    6%
    Japan
    9
    6%
    Singapore
    8
    5.3%
    Philippines
    26
    17.2%
    Turkey
    36
    23.8%
    New Zealand
    16
    10.6%
    Australia
    26
    17.2%
    Spain
    3
    2%
    Netherlands
    6
    4%
    France
    12
    7.9%

    Outcome Measures

    1. Primary Outcome
    Title Uncorrected Near Visual Acuity 20/32 or Better
    Description
    Time Frame 12 months

    Outcome Measure Data

    Analysis Population Description
    [Not Specified]
    Arm/Group Title AcuFocus Corneal Inlay
    Arm/Group Description The AcuFocus Corneal Inlay ACI 7000PDT, which is a small medical device, will be surgically implanted in one eye of each subject. AcuFocus Corneal Inlay ACI 7000PDT: corneal inlay
    Measure Participants 139
    Number [percentage of subjects]
    73.8
    2. Secondary Outcome
    Title Subjective Rating of Near Visual Acuity at 12 Months as Measured by Subjective Questionnaire
    Description Mean subjective rating via questionnaire on 1 to 7 rating scale (1= very dissatisfied and 7 = very satisfied).
    Time Frame 12 months

    Outcome Measure Data

    Analysis Population Description
    [Not Specified]
    Arm/Group Title AcuFocus Corneal Inlay
    Arm/Group Description The AcuFocus Corneal Inlay ACI 7000PDT, which is a small medical device, will be surgically implanted in one eye of each subject. AcuFocus Corneal Inlay ACI 7000PDT: corneal inlay
    Measure Participants 139
    Mean (95% Confidence Interval) [Scores on a scale]
    5.4

    Adverse Events

    Time Frame 3 months, 6 months, 1 year, 2 years, 3 years
    Adverse Event Reporting Description
    Arm/Group Title AcuFocus Corneal Inlay
    Arm/Group Description The AcuFocus Corneal Inlay ACI 7000PDT, which is a small medical device, will be surgically implanted in one eye of each subject. AcuFocus Corneal Inlay ACI 7000PDT: corneal inlay
    All Cause Mortality
    AcuFocus Corneal Inlay
    Affected / at Risk (%) # Events
    Total / (NaN)
    Serious Adverse Events
    AcuFocus Corneal Inlay
    Affected / at Risk (%) # Events
    Total 7/151 (4.6%)
    Cardiac disorders
    Hospitalization for Atrial Fibrilation 1/151 (0.7%)
    Investigations
    Hospitalization for investigation of bladder. Suspected cancer. Planned event. 1/151 (0.7%)
    Musculoskeletal and connective tissue disorders
    Complete division of left Achilles tendon 1/151 (0.7%)
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Brain and Lung cancer requiring extended hospitalization 1/151 (0.7%)
    Hospitalization for laser treatment of bladder cancer. Planned event 1/151 (0.7%)
    Pancreatic Cancer 1/151 (0.7%)
    Skin and subcutaneous tissue disorders
    Hospitalisation for Systemic Cellulitis 1/151 (0.7%)
    Other (Not Including Serious) Adverse Events
    AcuFocus Corneal Inlay
    Affected / at Risk (%) # Events
    Total 34/151 (22.5%)
    Cardiac disorders
    Atrial Fibrilation 1/151 (0.7%)
    Eye disorders
    Corneal Edema with grade of greater than or equal to 2+ (at one month or later) 2/151 (1.3%)
    Epithelial Ingrowth 2/151 (1.3%)
    Intraocular pressure 7/151 (4.6%)
    Allergic reaction to study medication (lids) 1/151 (0.7%)
    Blepharitis 1/151 (0.7%)
    AcuFocus Corneal Inlay re-centration or replacement 9/151 (6%)
    Dry eye 1/151 (0.7%)
    Decrease in Best Corrected Distance Visual Acuity greater than 2 lines at Month 3 or later 6/151 (4%)
    Adenoviral Conjunctivitis 1/151 (0.7%)
    Flap complication 1/151 (0.7%)
    Injury, poisoning and procedural complications
    Bone fracture 2/151 (1.3%)

    Limitations/Caveats

    [Not Specified]

    More Information

    Certain Agreements

    Principal Investigators are NOT employed by the organization sponsoring the study.

    There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

    Results Point of Contact

    Name/Title Eugenia Thomas, OD
    Organization AcuFocus, Inc.
    Phone 949-585-9511
    Email ethomas@acufocus.com
    Responsible Party:
    AcuFocus, Inc.
    ClinicalTrials.gov Identifier:
    NCT01352442
    Other Study ID Numbers:
    • ACU-P10-020B
    First Posted:
    May 11, 2011
    Last Update Posted:
    Mar 28, 2017
    Last Verified:
    Feb 1, 2017