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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT01352442




Registration number
NCT01352442
Ethics application status
Date submitted
10/05/2011
Date registered
11/05/2011

Titles & IDs
Public title
Safety and Effectiveness of the AcuFocus Corneal Inlay ACI7000PDT in Presbyopes
Scientific 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
Secondary ID [1] 0 0
ACU-P10-020B
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Presbyopia 0 0
Condition category
Condition code
Eye 0 0 0 0
Diseases / disorders of the eye

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Devices - AcuFocus Corneal Inlay ACI 7000PDT

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.


Treatment: Devices: AcuFocus Corneal Inlay ACI 7000PDT
corneal inlay
Intervention code [1] 0 0
Treatment: Devices
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Uncorrected Near Visual Acuity 20/32 or Better
Timepoint [1] 0 0
12 months
Secondary outcome [1] 0 0
Subjective Rating of Near Visual Acuity at 12 Months as Measured by Subjective Questionnaire
Timepoint [1] 0 0
12 months

Eligibility
Key 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.
Minimum age
45 Years
Maximum age
60 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key 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.

Study design
Purpose of the study
Treatment
Allocation to intervention
NA
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
NA
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/05/2011
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/03/2014
Sample size
Target
Accrual to date
Final
151
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 0 0
Vision Eye Institute - Bondi Junction
Recruitment postcode(s) [1] 0 0
2022 - Bondi Junction
Recruitment outside Australia
Country [1] 0 0
Austria
State/province [1] 0 0
Salzburg
Country [2] 0 0
France
State/province [2] 0 0
Paris
Country [3] 0 0
Japan
State/province [3] 0 0
Tokyo
Country [4] 0 0
Netherlands
State/province [4] 0 0
Maastricht
Country [5] 0 0
New Zealand
State/province [5] 0 0
Christchurch
Country [6] 0 0
New Zealand
State/province [6] 0 0
Auckland
Country [7] 0 0
Philippines
State/province [7] 0 0
Makati City
Country [8] 0 0
Singapore
State/province [8] 0 0
Singapore
Country [9] 0 0
Spain
State/province [9] 0 0
Alicante
Country [10] 0 0
Turkey
State/province [10] 0 0
Istanbul

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
AcuFocus, Inc.
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Perry Binder, MD
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results are available at https://clinicaltrials.gov/study/NCT01352442