PresbyopiaNCT01352442
Safety and Effectiveness of the AcuFocus Corneal Inlay ACI7000PDT in Presbyopes
A study testing AcuFocus Corneal Inlay ACI 7000PDT in people with Presbyopia, run by AcuFocus, Inc. at 11 sites in 10 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 45 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Presbyopia
- What is being tested?
- AcuFocus Corneal Inlay ACI 7000PDT
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 151 participants
- Where
- 11 sitesin 10 countries
- Study dates
- May 2011to Mar 2014
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 45 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Show all 13Show fewer
- 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.
Who cannot join
- 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 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.
Show all 20Show fewer
- 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.
- Subjects using systemic medications with significant ocular side effects.
- Subjects who are pregnant, lactating, or of child-bearing potential and not practicing a medically approved method of birth control.
- Subjects with known sensitivity to planned study concomitant medications.
- Subjects who are participating in any other ophthalmic drug or device clinical trial during the time of this clinical investigation.
Trial locations and contacts
11 sites in 10 countries.
11 sites in 10 countries
New Zealand2 sites
Auckland Eye
Auckland
The Fendalton Eye Clinic
Fendalton, Christchurch
Austria1 site
Univ. Klinik fur Agugenheilkunde und Optometrie, Paracelsus Medzinishe Privatuniversitat Salzburg
Salzburg, A-5020
Turkey (Türkiye)1 site
Beyoğlu Goz Training and Research Hospital
Istanbul
About this study
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
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.
Read the 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.
- Conditions
- Presbyopia
- Being tested
- AcuFocus Corneal Inlay ACI 7000PDT
- Keywords
- Presbyopia, Accommodation, Near visual acuity, LASIK
- Medical subject headings
- Presbyopia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AcuFocus Corneal Inlay ACI 7000PDTDevice
Also called AcuFocus KAMRA inlay
corneal inlay
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: AcuFocus Corneal Inlay ACI 7000PDT |
What is being measured
The primary outcome is the main question the study is designed to answer.
Uncorrected Near Visual Acuity 20/32 or Better
Measured: 12 months
Secondary outcomes (1)
Subjective Rating of Near Visual Acuity at 12 Months as Measured by Subjective Questionnaire
Mean subjective rating via questionnaire on 1 to 7 rating scale (1= very dissatisfied and 7 = very satisfied).
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 May 2011 (estimated)
- Study startMay 2011
- Primary completionMar 2014
- Study completionMar 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for PresbyopiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 151 participants (actual)
Sponsor and investigators
- Lead sponsor
- AcuFocus, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Perry Binder, MD, Study director
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01352442
- Sponsor's protocol ID
- ACU-P10-020B
- Status last verified
- Feb 2017
- First submitted
- 10 May 2011
- Last updated
- 28 Mar 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01352442
- Acronym / sponsor ID
- ACU-P10-020B
- Conditions
- Presbyopia
- Keywords
- Presbyopia, Accommodation, Near visual acuity, LASIK
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 151 participants (actual)
- Lead sponsor
- AcuFocus, Inc.Industry (pharma, biotech, devices)
- Study start
- May 2011
- Primary completion
- Mar 2014 (actual)
- Study completion
- Mar 2014 (actual)
- First posted
- 11 May 2011 (estimated)
- Results
- Posted 18 Sep 2015
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| AcuFocus Corneal Inlay | Experimental | Device: AcuFocus Corneal Inlay ACI 7000PDTThe AcuFocus Corneal Inlay ACI 7000PDT, which is a small medical device, will be surgically implanted in one eye of each subject. |
Who may qualify
- Ages
- 45 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (13 listed)
- 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.
Key exclusion criteria (20 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AcuFocus Corneal Inlay ACI 7000PDTAlso: AcuFocus KAMRA inlaycorneal inlay | Device | AcuFocus Corneal Inlay |
Primary outcome
Uncorrected Near Visual Acuity 20/32 or Better
Time frame: 12 months
1 secondary outcome
Subjective Rating of Near Visual Acuity at 12 Months as Measured by Subjective Questionnaire
Time frame: 12 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Mar 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Sponsor websiteLink provided by the sponsor.
- Individual participant dataSharing planned: No
Related trials for Presbyopia
Recruiting
Evaluation of Functional Superiority of the Morrow eProgressive
Presbyopia
Active, not recruiting
Clinical Trial With Artiflex Presbyopic (Artiplus)
Presbyopia, Ametropia
Recruiting
VisDura VisAbility™ Micro Insert System Pre-market Clinical Trial
Presbyopia
Recruiting
Volumetric Visual Fields at Intermediate and Near Distances in Presbyopic Patients Using Occupational and General-Purpose Progressive Addition Lenses
Presbyopia
Recruiting
Volumetric Visual Fields at Different Distances in Presbyopic Patients Using Occupational (PC-133 and PC-200) and General-Purpose Progressive Addition Lenses
Presbyopia
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Perry Binder, MD study director
11 sites in 10 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing AcuFocus Corneal Inlay ACI 7000PDT in people with Presbyopia, run by AcuFocus, Inc. at 11 sites in 10 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 13 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Mar 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 11 sites in New Zealand, Australia, Austria, France, Japan and 5 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 18 Sep 2015). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Uncorrected Near Visual Acuity 20/32 or Better (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Mar 2017.