AphakiaNCT01547442
Artisan Aphakia Lens for the Correction of Aphakia in Children
A study testing Artisan Aphakia Intraocular Lens in people with Aphakia, run by Ophtec USA at 19 sites in 2 countries.
Trial summary
The purpose of this study is to determine the safety and effectiveness of the Artisan Aphakia Lens in the treatment of aphakia in children. Read more about this study
- Who is it for?
- Ages 2 to 21 yearsHealthy 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
- 19 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 2 to 21 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- 2 to 21 years of age
- Have a visually significant cataract or need IOL replacement surgery
- Compromised capsular bag prohibiting implantation of standard posterior IOL
- Subject or parent/guardian must be able to comply with visit schedule and study requirements
- Subject's legal representative must be able to sign the Informed Consent
Who cannot join
- Under 2 years of age
- Unable to meet Postoperative evaluation requirements
- No useful vision or vision potential in fellow eye
- Mentally retarded patients
- History of corneal disease
- Abnormality of the iris or ocular structure
Show all 16Show fewer
- ACD less than 3.2 mm
- Uncontrolled glaucoma
- IOP > 25 mmHg
- Chronic or recurrent uveitis
- Preexisting macular pathology that may complicate the ability to assess the benefit of this lens
- Retinal detachment or family history
- Retinal disease that may limit visual potential
- Optic nerve disease that may limit visual potential
- Diabetes mellitus
- Pregnant, lactating or plan to become pregnant
Trial locations and contacts
19 sites in 2 countries.
19 sites in 2 countries
United States18 sites
Harvard University, Boston Children's Hospital
Boston, Massachusetts, 02115
Medical University of South Carolina, Storm Eye Institute
Charleston, South Carolina, 29425
Nationwide Children's Hospital, Pediatric Ophthalmology Associates
Columbus, Ohio, 43205
University of Texas, Southwestern Medical Center
Dallas, Texas, 75390
Rosenthal Eye and Facial Plastic Surgery
Great Neck, New York, 11023
University of Texas, Robert Cizik Eye Clinic
Houston, Texas, 77030
Indiana University, Riley Hospital for Children
Indianapolis, Indiana, 46202
Children's Mercy Hospital and Clinics
Kansas City, Missouri, 64111
The Vision Center
Los Angeles, California, 90027
University Hospitals Case Medical Center, Rainbow Babies and Children's Hospital
Mayfield Heights, Ohio, 44124
University of Minnesota, MN Lions Children's Eye Clinic
Minneapolis, Minnesota, 55454
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, 19104
Phoenix Children's Hospital
Phoenix, Arizona, 35016
University of Pittsburgh Medical Center, Children's Hospital of Pittsburgh
Pittsburgh, Pennsylvania, 15224
Mayo Clinic
Rochester, Minnesota, 55905
Moran Eye Center
Salt Lake City, Utah, 84132
Washington University, St. Louis Children's Hospital
St Louis, Missouri, 63110
New York Medical College, Westchester Medical Center
Valhalla, New York, 10595
About this study
The purpose of this study is to determine the safety and effectiveness of the Artisan Aphakia Lens in the treatment of aphakia in children.
- Conditions
- Aphakia
- Being tested
- Artisan Aphakia Intraocular Lens
- Keywords
- aphakia, secondary intraocular lens, congenital cataract, marfan syndrome, pediatric cataract, ectopia lentis, subluxated lens
- Medical subject headings
- Aphakia, Marfan Syndrome, Ectopia Lentis
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 an intraocular lens
| Study group | Role | What they receive |
|---|---|---|
| Artisan Aphakia Intraocular Lens | Experimental | Implantation of an Artisan intraocular lens to correct aphakia in children Receives: Device: Artisan Aphakia Intraocular Lens |
What is being measured
The primary outcome is the main question the study is designed to answer.
Best corrected distance visual acuity at 12 months postoperative
Determination of the ability of the lens to correct refractive error caused by aphakia
Measured: 5 years 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
- NCT01547442
- Sponsor's protocol ID
- Artisan Pediatric Aphakia
- Status last verified
- Aug 2024
- First submitted
- 27 Feb 2012
- Last updated
- 28 Aug 2024
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 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 Children
- ClinicalTrials.gov ID
- NCT01547442
- Acronym / sponsor ID
- Artisan Pediatric Aphakia
- Conditions
- Aphakia
- Keywords
- aphakia, secondary intraocular lens, congenital cataract, marfan syndrome, pediatric cataract, ectopia lentis, subluxated 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.
The purpose of this study is to determine the safety and effectiveness of the Artisan Aphakia Lens in the treatment of aphakia in children.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Artisan Aphakia Intraocular Lens | Experimental | Device: Artisan Aphakia Intraocular LensImplantation of an Artisan intraocular lens to correct aphakia in children |
Who may qualify
- Ages
- 2 to 21 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (5 listed)
- 2 to 21 years of age
- Have a visually significant cataract or need IOL replacement surgery
- Compromised capsular bag prohibiting implantation of standard posterior IOL
- Subject or parent/guardian must be able to comply with visit schedule and study requirements
- Subject's legal representative must be able to sign the Informed Consent
Key exclusion criteria (16 listed)
- Under 2 years of age
- Unable to meet Postoperative evaluation requirements
- No useful vision or vision potential in fellow eye
- Mentally retarded patients
- History of corneal disease
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 an intraocular lens | Device | Artisan Aphakia Intraocular Lens |
Primary outcome
Best corrected distance visual acuity at 12 months postoperative
Time frame: 5 years follow up
Determination of the ability of the lens to correct refractive error caused by aphakia
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Aug 2024.
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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
19 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 19 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 5 inclusion and 16 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 28 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 19 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?
Best corrected distance visual acuity at 12 months postoperative (time frame: 5 years 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 28 Aug 2024.