CataractNCT00963742
Lenstec Softec HD Posterior Chamber Intraocular Lens Clinical Investigational Protocol
A study testing Lenstec Softec HD IOL implantation in people with Cataract, run by Lenstec Incorporated.
Trial summary
The objectives of this multi-center clinical investigation are to determine the safety and effectiveness of the Lenstec Softec HD Posterior Chamber intraocular lens (IOL) following one year of post-operative assessment. Read more about this study
- Who is it for?
- Ages 21 years and olderHealthy volunteers can take part
- Conditions the study is for
- Cataract
- What is being tested?
- Lenstec Softec HD IOL implantation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 390 participants
- Where
- No sites listed yet
- Study dates
- Dec 2006to Apr 2010
- 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 21 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Cataract requiring cataract extraction
- Study IOL to only be implanted in 1 eye
- Distance BCVA 20/40 or worse or glare acuity worse than 20/30
- Ability to comply with study follow-up requirements
Who cannot join
- Patients with serious corneal disease, previous surgery or serious systemic disease
- Ocular condition that could impact vision after cataract surgery
- Pregnant or lactating women
- Use of ocular or systemic medications that could impact vision
About this study
Official title: Lenstec Softec HD Posterior Chamber Intraocular Lens (PCIOL) Clinical Investigational Protocol
The objectives of this multi-center clinical investigation are to determine the safety and effectiveness of the Lenstec Softec HD Posterior Chamber intraocular lens (IOL) following one year of post-operative assessment.
Read the detailed description
The Softec HD Posterior Chamber IOL is designed for the treatment of aphakia. The lens is indicated for primary implantation when a cataractous lens has been removed by phacoemulsification with circular tear capsulotomy and the posterior capsule intact. The intended benefit of the Softec HD Posterior Chamber IOL is to provide enhanced vision.
- Conditions
- Cataract
- Being tested
- Lenstec Softec HD IOL implantation
- Keywords
- cataract surgery, IOL, Intraocular lens
- Medical subject headings
- Cataract
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lenstec Softec HD IOL implantationDevice
Also called Softec HD PCIOL, Softec HD Posterior Chamber IOL, Softec HD Posterior Chamber Intraocular Lens
surgical removal of cataract and implantation of Softec HD PCIOL
| Study group | Role | What they receive |
|---|---|---|
| Lenstec Softec HD IOL implantation | Experimental | 390 eyes of 390 study subjects all receiving the investigational IOL; IOL implanted after surgical removal of cataract Receives: Device: Lenstec Softec HD IOL implantation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Distance Best Corrected Visual Acuity
Measured: 1 year
Secondary outcomes (1)
FDA IOL Grid Adverse Events
Measured: through 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Aug 2009 (estimated)
- Study startDec 2006
- Primary completionJul 2009
- Study completionApr 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CataractStudies 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
- 390 participants (actual)
Sponsor and investigators
- Lead sponsor
- Lenstec Incorporated
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Donald R Sanders, M.D. Ph.D, Study director, Center for Clinical Research
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00963742
- Sponsor's protocol ID
- IDE G060058
- Status last verified
- Mar 2014
- First submitted
- 20 Aug 2009
- Last updated
- 18 Mar 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Mar 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Lenstec Softec HD Posterior Chamber Intraocular Lens (PCIOL) Clinical Investigational Protocol
- ClinicalTrials.gov ID
- NCT00963742
- Acronym / sponsor ID
- IDE G060058
- Conditions
- Cataract
- Keywords
- cataract surgery, IOL, Intraocular lens
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 390 participants (actual)
- Lead sponsor
- Lenstec IncorporatedIndustry (pharma, biotech, devices)
- Study start
- Dec 2006
- Primary completion
- Jul 2009 (actual)
- Study completion
- Apr 2010 (actual)
- First posted
- 21 Aug 2009 (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 objectives of this multi-center clinical investigation are to determine the safety and effectiveness of the Lenstec Softec HD Posterior Chamber intraocular lens (IOL) following one year of post-operative assessment.
Detailed description
The Softec HD Posterior Chamber IOL is designed for the treatment of aphakia. The lens is indicated for primary implantation when a cataractous lens has been removed by phacoemulsification with circular tear capsulotomy and the posterior capsule intact. The intended benefit of the Softec HD Posterior Chamber IOL is to provide enhanced vision.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Lenstec Softec HD IOL implantation | Experimental | Device: Lenstec Softec HD IOL implantation390 eyes of 390 study subjects all receiving the investigational IOL; IOL implanted after surgical removal of cataract |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Cataract requiring cataract extraction
- Study IOL to only be implanted in 1 eye
- Distance BCVA 20/40 or worse or glare acuity worse than 20/30
- Ability to comply with study follow-up requirements
Key exclusion criteria (4 listed)
- Patients with serious corneal disease, previous surgery or serious systemic disease
- Ocular condition that could impact vision after cataract surgery
- Pregnant or lactating women
- Use of ocular or systemic medications that could impact vision
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 |
|---|---|---|
| Lenstec Softec HD IOL implantationAlso: Softec HD PCIOL, Softec HD Posterior Chamber IOL, Softec HD Posterior Chamber Intraocular Lenssurgical removal of cataract and implantation of Softec HD PCIOL | Device | Lenstec Softec HD IOL implantation |
Primary outcome
Distance Best Corrected Visual Acuity
Time frame: 1 year
1 secondary outcome
FDA IOL Grid Adverse Events
Time frame: through 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Mar 2014.
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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.
Donald R Sanders, M.D. Ph.D study director
Center for Clinical Research
Questions about this trial
What is this clinical trial studying?
A study testing Lenstec Softec HD IOL implantation in people with Cataract, run by Lenstec Incorporated.
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 4 inclusion and 4 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 18 Mar 2014. Status can change between updates, so confirm with the study contact before making plans.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Distance Best Corrected Visual Acuity (time frame: 1 year). 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 18 Mar 2014.