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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT00850031




Registration number
NCT00850031
Ethics application status
Date submitted
20/02/2009
Date registered
24/02/2009

Titles & IDs
Public title
Safety and Effectiveness Study of the AcuFocus Corneal Inlay ACI 7000PDT in Presbyopes
Scientific title
A Prospective, Multicenter Clinical Trial to Evaluate the Safety and Effectiveness of the AcuFocus Corneal Inlay (ACI)™ ACI 7000PDT in Presbyopic Subjects (OUS Study)
Secondary ID [1] 0 0
ACU-P08-020A
Universal Trial Number (UTN)
Trial acronym
ACI
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

Experimental: AcuFocus Corneal Inlay - Implantation of the AcuFocus Corneal Inlay in emmetropic presbyopic patients.


Treatment: Devices: AcuFocus Corneal Inlay
Inlay implanted in cornea for improvement of near vision
Intervention code [1] 0 0
Treatment: Devices
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Improvement in Uncorrected Near Visual Acuity
Timepoint [1] 0 0
12 months
Secondary outcome [1] 0 0
Improvement of Near Uncorrected Visual Acuity
Timepoint [1] 0 0
12 months

Eligibility
Key inclusion criteria
1. Subjects must be natural emmetropes needing a minimum magnitude of +1.00D to +2.50D of reading add.
2. Subjects must have uncorrected near visual acuity worse than 20/40 and better than 20/100 in the eye to be implanted.
3. Subject must have distance visual acuity correctable to at least 20/20 in both eyes.
4. 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.
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 abnormalities (including endothelial dystrophy, guttata, recurrent corneal erosion, etc.) in the eye to be implanted.
4. Subjects with ophthalmoscopic signs of keratoconus (or keratoconus suspect) in the eye to be implanted.
5. Subjects with a history of chronic dry eye not responding to therapy.
6. Subjects with distorted or unclear corneal mires on topography maps of the eye to be implanted.
7. Subjects who require canthotomy to generate a corneal flap in 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 undergone previous intraocular or corneal surgery including cataract and LASIK surgery.
10. Subjects with a history of herpes zoster or herpes simplex keratitis.
11. Subjects who have a history of steroid-responsive rise in intraocular pressure, preoperative IOP > 21 mmHg, glaucoma, or is a glaucoma suspect.
12. Subjects with a history of diagnosed diabetes, autoimmune disease, connective tissue disease, or clinically significant atopic syndrome.
13. Subjects on chronic systemic corticosteroids or other immunosuppressive therapy that may affect wound healing, and any immunocompromised subjects.
14. Subjects who are using ophthalmic medication(s) other than artificial tears for treatment of any ocular pathology including ocular allergy.
15. Subjects using systemic medications with significant ocular side effects.
16. Subjects who are pregnant, lactating, or of child-bearing potential and not practicing a medically approved method of birth control.
17. Subjects with known sensitivity to planned study concomitant medications.
18. 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
1/01/2009
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/10/2013
Sample size
Target
Accrual to date
Final
119
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 0 0
Vista Laser Eye Clinics - Melbourne
Recruitment hospital [2] 0 0
The Eye Institute - Bondi Junction
Recruitment postcode(s) [1] 0 0
3185 - Melbourne
Recruitment postcode(s) [2] 0 0
2022 - Bondi Junction
Recruitment outside Australia
Country [1] 0 0
Austria
State/province [1] 0 0
Salzburg
Country [2] 0 0
Germany
State/province [2] 0 0
Bochum
Country [3] 0 0
New Zealand
State/province [3] 0 0
Christchurch
Country [4] 0 0
New Zealand
State/province [4] 0 0
Auckland
Country [5] 0 0
Singapore
State/province [5] 0 0
Singapore
Country [6] 0 0
United Kingdom
State/province [6] 0 0
London

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/NCT00850031