AphakiaNCT01547429
Artisan Aphakia Lens for the Correction of Aphakia (Secondary) in Adults
A study testing Artisan Aphakia Intraocular Lens in people with Aphakia, run by Ophtec USA at 18 sites in 2 countries.
Trial summary
This study will determine the safety and effectiveness of the Artisan Aphakia Lens when used as a secondary implant to correct aphakia in adults. Read more about this study
- Who is it for?
- Ages 22 years and olderHealthy volunteers can take part
- Conditions the study is for
- Aphakia
- What is being tested?
- Artisan Aphakia Intraocular Lens
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 300 participants
- Where
- 18 sitesin 2 countries
- Study dates
- Jan 2012to Dec 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 22 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Patients 22 years of age and over at baseline visit of either sex and of any race where the natural lens has been removed or will be removed and a posterior chamber IOL is not indicated.
- Patient must agree to comply with the visit schedule and other requirements of the study
Who cannot join
- Patients that are not able to meet the extensive postoperative evaluation requirements
- Mentally retarded patients
- When the patient has no useful vision or vision potential in the fellow eye
- History of corneal disease (e.g., herpes simplex, herpes zoster keratitis, etc.), corneal dystrophy, degeneration, opacities or abnormalities that may affect vision.
- Abnormality of the iris or ocular structure which would preclude fixation, such as aniridia, hemiiridectomy, severe iris atrophy, rubeosis iridis, or other compromising iris pathology
- Patients with uncontrolled glaucoma
Show all 13Show fewer
- High preoperative intraocular pressure, >25 mmHg
- Chronic or recurrent uveitis or history of the same
- Preexisting macular pathology that may complicate the ability to assess the benefit or lack of benefit obtained by the lens
- Patients with a retinal detachment or a family history of retinal detachment
- Retinal disease that may limit the visual potential of the eye such as retinopathy of prematurity or Stargardt's retinopathy Optic nerve disease that may limit the visual potential of the eye
- Diabetes mellitus
- Pregnant, lactating, or plans to become pregnant during the course of this study
Trial locations and contacts
18 sites in 2 countries.
18 sites in 2 countries
United States17 sites
Valley Eye Associates
Appleton, Wisconsin, 54914
Nevyas Eye Associates
Bala-Cynwyd, Pennsylvania, 19004
Assil Eye Institute
Beverly Hills, California, 90210
Boston Children's Hospital
Boston, Massachusetts, 02115
UF Health Eye Center
Gainesville, Florida, 32605
Rosenthal Eye and Facial Plastic Surgery
Great Neck, New York, 11023
Price Vision Group
Indianapolis, Indiana, 46260
John Kenyon Eye Center
Jeffersonville, Indiana, 47130
Advanced Vision Care
Los Angeles, California, 90067
University of Tennessee, Hamilton Eye Clinic
Memphis, Tennessee, 38163
Pamel Vision and Laser Group
New York, New York, 10065
Sight MD
Rockville Centre, New York, 11570
Moran Eye Center
Salt Lake City, Utah, 84132
Focal Point Vision
San Antonio, Texas, 78229
Vance Thompson Vision
Sioux Falls, South Dakota, 57108
Yale Medicine Ophthalmology
Stratford, Connecticut, 06614
New York Medical College, Westchester Medical Center
Valhalla, New York, 10595
About this study
Official title: Artisan Aphakia Lens for the Correction of Aphakia in Adults
This study will determine the safety and effectiveness of the Artisan Aphakia Lens when used as a secondary implant to correct aphakia in adults.
Read the detailed description
Not desired
- Conditions
- Aphakia
- Being tested
- Artisan Aphakia Intraocular Lens
- Keywords
- aphakia, secondary intraocular lens
- Medical subject headings
- Aphakia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Artisan Aphakia Intraocular LensDevice
Implantation of lens to correct refractive error in aphakic eye
| Study group | Role | What they receive |
|---|---|---|
| Intraocular Lens Implantation for the Treatment for Aphakia | Experimental | Implantation of an Artisan intraocular lens to correct aphakia in Adults. No other information is needed to describe this section Receives: Device: Artisan Aphakia Intraocular Lens |
What is being measured
The primary outcome is the main question the study is designed to answer.
Improvement in best corrected visual acuity
Measured: 3 year follow up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Mar 2012 (estimated)
- Study startJan 2012
- Primary completionDec 2025 (estimated)
- Study completionDec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AphakiaStudies 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
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ophtec USA
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Abraham Farhan, Study director, Sponsor GmbH
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01547429
- Sponsor's protocol ID
- Artisan Adult Aphakia
- Status last verified
- Aug 2024
- First submitted
- 27 Feb 2012
- Last updated
- 7 Aug 2024
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Artisan Aphakia Lens for the Correction of Aphakia in Adults
- ClinicalTrials.gov ID
- NCT01547429
- Acronym / sponsor ID
- Artisan Adult Aphakia
- Conditions
- Aphakia
- Keywords
- aphakia, secondary intraocular lens
- Study type
- Interventional
- Recruitment status
- Suspended
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Ophtec USAIndustry (pharma, biotech, devices)
- Study start
- Jan 2012
- Primary completion
- Dec 2025 (estimated)
- Study completion
- Dec 2025 (estimated)
- First posted
- 7 Mar 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study will determine the safety and effectiveness of the Artisan Aphakia Lens when used as a secondary implant to correct aphakia in adults.
Detailed description
Not desired
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Intraocular Lens Implantation for the Treatment for Aphakia | Experimental | Device: Artisan Aphakia Intraocular LensImplantation of an Artisan intraocular lens to correct aphakia in Adults. No other information is needed to describe this section |
Who may qualify
- Ages
- 22 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patients 22 years of age and over at baseline visit of either sex and of any race where the natural lens has been removed or will be removed and a posterior chamber IOL is not indicated.
- Patient must agree to comply with the visit schedule and other requirements of the study
Key exclusion criteria (13 listed)
- Patients that are not able to meet the extensive postoperative evaluation requirements
- Mentally retarded patients
- When the patient has no useful vision or vision potential in the fellow eye
- History of corneal disease (e.g., herpes simplex, herpes zoster keratitis, etc.), corneal dystrophy, degeneration, opacities or abnormalities that may affect vision.
- Abnormality of the iris or ocular structure which would preclude fixation, such as aniridia, hemiiridectomy, severe iris atrophy, rubeosis iridis, or other compromising iris pathology
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 |
|---|---|---|
| Artisan Aphakia Intraocular LensImplantation of lens to correct refractive error in aphakic eye | Device | Intraocular Lens Implantation for the Treatment for Aphakia |
Primary outcome
Improvement in best corrected visual acuity
Time frame: 3 year follow up
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Aug 2024.
Related trials for Aphakia
Not yet recruiting
Trial to Investigate the Safety and Effectiveness of the KI-362-US1 (YP2.2VM) Intraocular Lens (IOL) in Adult Participants for Correction of Aphakia Following Cataract Extraction
Aphakia, Postcataract
Recruiting
Clareon TruPlus Study
Aphakia, Astigmatism
Recruiting
Clinical Evaluation of a Novel Trifocal IOL
Aphakia, Cataract
Active, not recruiting
Contralateral Claims Study of Clareon Vivity Pro
Aphakia, Presbyopia
Recruiting
Bicentric Clinical Investigation to Assess Safety and Performance of LuxBoost IOL
Aphakia
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.
Abraham Farhan study director
Sponsor GmbH
18 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Artisan Aphakia Intraocular Lens in people with Aphakia, run by Ophtec USA at 18 sites in 2 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 2 inclusion and 13 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: paused, as of the sponsor's last update on 7 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 18 sites in United States, Canada. 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?
Results are not available in the source record.
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?
Improvement in best corrected visual acuity (time frame: 3 year follow up). 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 7 Aug 2024.