CataractNCT00969371
Lenstec Tetraflex Accommodating Posterior Chamber Intraocular Lens (IOL) Clinical Investigation
A study testing posterior chamber IOL implantation and Experimental TetraFlex Study IOL in people with Cataract, run by Lenstec Incorporated.
Trial summary
The purpose of the following clinical protocol is to evaluate the safety and effectiveness of the Lenstec Tetraflex Accommodating Posterior Chamber Intraocular Lens (IOL) for the protocol inclusion/exclusion criteria. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Cataract
- What is being tested?
- posterior chamber IOL implantation and Experimental TetraFlex Study IOL
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 470 participants
- Where
- No sites listed yet
- Study dates
- Sep 2005to Jun 2009
- 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Male or Female
- Any race
- Patients age at time of surgery to be 18 years or older.
- Presence of bilateral cataract requiring cataract extraction. If only one eye is being implanted with the study lens, the other eye may have had cataract extraction with IOL implantation.
- Clear intraocular media other than cataract.
- Patients with BSCVA < 20/40 or cataract with glare acuity worse than 20/30
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- Corneal Astigmatism less than 1 Diopter.
- Good Visual Potential: Best corrected visual acuity (BCVA) projected by PAM or Pinhole 20/25 or better if other pathology is suspected.
- Patient is able and willing to comply with follow-up.
- Able to provide written informed consent.
Who cannot join
- Patients who are monocular.
- Presence of an ocular infection.
- Greater than or equal to 1 Diopter of pre-operative corneal astigmatism.
- Patients who are on anti-psychotic and antidepressant medication that could potentially effect accommodation
- Patients who chronically take any medication that may affect accommodation, including first generation antihistamines, and anticholinergic agents.
- Previous intraocular surgery in either eye.
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- Previous serious corneal disease.
- Diagnosis of any of the following ocular conditions: active scleral disease, glaucoma, retinal disease potentially affecting central vision, macular disease or uveitis, severe dry eyes and dysthyroid eye disease
- Subjects who may be expected to require retinal laser treatment.
- Subjects with diagnosed degenerative visual disorders (e.g. macular degeneration or other retinal disorders) that are predicted to cause future acuity losses to a level of 20/30 or worse).
- Patients requiring administration of topical ophthalmic medications other than the study medications. Use of systemic corticosteroids or anti-metabolites or other medications that could affect wound healing is specifically contraindicated.
- Allergy to anesthetics or other postoperative medications.
- Presence of any uncontrolled systemic disease (e.g. diabetes, hypertension, cardiovascular disease).
- Pregnant or lactating women
- Persons who, in the determination of the investigator, are not competent to understand the procedure, the actions asked of them as research subjects, or capable of completing the patient satisfaction questionnaire.
- Participation in a previous clinical trial within the 30 days prior to the start of the study.
- Persons who may not be able to complete the requirements of returning to the investigator's clinic over the period of the study, or who may be difficult to locate or contact on short notice. This does not preclude vacations or travel.
About this study
Official title: Lenstec TetraFlex Accommodating Posterior Chamber Intraocular Lens (IOL)Clinical Investigation
The purpose of the following clinical protocol is to evaluate the safety and effectiveness of the Lenstec Tetraflex Accommodating Posterior Chamber Intraocular Lens (IOL) for the protocol inclusion/exclusion criteria.
Read the detailed description
The Lenstec TetraFlex Accommodating Posterior Chamber Intraocular Lens (IOL) is an ultraviolet absorbing optical implant designed for the replacement of the human crystalline lens following phacoemulsification cataract removal. The TetraFlex Accommodating Posterior Chamber IOL is designed for 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 TetraFlex Accommodating Posterior Chamber IOL is to provide enhanced distance and near vision with an increased independence from corrective lens wear.
- Conditions
- Cataract
- Being tested
- posterior chamber IOL implantation, Experimental TetraFlex Study IOL
- Keywords
- posterior chamber intraocular lens, PCIOL, IOL
- Medical subject headings
- Cataract
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
posterior chamber IOL implantationDevice
Experimental TetraFlex Study IOLDevice
TetraFlex IOL implanted
| Study group | Role | What they receive |
|---|---|---|
| Lenstec Tetraflex IOL implantation | Experimental | patients in Study arm received TetraFlex Lens Receives: Device: Experimental TetraFlex Study IOL |
| Control IOL | Active comparator | commercially approved PCIOL implanted Receives: Device: posterior chamber IOL implantation |
What is being measured
The primary outcome is the main question the study is designed to answer.
The primary efficacy outcome is the assessment of the % of eyes obtaining 20/40 or better distance best corrected visual acuity.
Measured: 1 year
The primary safety outcome is the incidence/severity of adverse events and complications.
Measured: 1 year
Secondary outcomes (1)
Patient's functional reading ability, and other distance, near and intermediate vision testing including subjective patient survey outcomes on dependence on corrective eyewear and patient symptoms.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Sep 2009 (estimated)
- Study startSep 2005
- Primary completionJun 2009
- Study completionJun 2009
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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 470 participants (actual)
Sponsor and investigators
- Lead sponsor
- Lenstec Incorporated
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Donald R Sanders, MD, PhD, Study director, Center for Clinical Research
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00969371
- Sponsor's protocol ID
- IDE G050048
- Status last verified
- Oct 2018
- First submitted
- 31 Aug 2009
- Last updated
- 18 Oct 2018
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Lenstec TetraFlex Accommodating Posterior Chamber Intraocular Lens (IOL)Clinical Investigation
- ClinicalTrials.gov ID
- NCT00969371
- Acronym / sponsor ID
- IDE G050048
- Conditions
- Cataract
- Keywords
- posterior chamber intraocular lens, PCIOL, IOL
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 470 participants (actual)
- Lead sponsor
- Lenstec IncorporatedIndustry (pharma, biotech, devices)
- Study start
- Sep 2005
- Primary completion
- Jun 2009 (actual)
- Study completion
- Jun 2009 (actual)
- First posted
- 1 Sep 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 purpose of the following clinical protocol is to evaluate the safety and effectiveness of the Lenstec Tetraflex Accommodating Posterior Chamber Intraocular Lens (IOL) for the protocol inclusion/exclusion criteria.
Detailed description
The Lenstec TetraFlex Accommodating Posterior Chamber Intraocular Lens (IOL) is an ultraviolet absorbing optical implant designed for the replacement of the human crystalline lens following phacoemulsification cataract removal. The TetraFlex Accommodating Posterior Chamber IOL is designed for 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 TetraFlex Accommodating Posterior Chamber IOL is to provide enhanced distance and near vision with an increased independence from corrective lens wear.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Lenstec Tetraflex IOL implantation | Experimental | Device: Experimental TetraFlex Study IOLpatients in Study arm received TetraFlex Lens |
| Control IOL | Active comparator | Device: posterior chamber IOL implantationcommercially approved PCIOL implanted |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Male or Female
- Any race
- Patients age at time of surgery to be 18 years or older.
- Presence of bilateral cataract requiring cataract extraction. If only one eye is being implanted with the study lens, the other eye may have had cataract extraction with IOL implantation.
- Clear intraocular media other than cataract.
Key exclusion criteria (17 listed)
- Patients who are monocular.
- Presence of an ocular infection.
- Greater than or equal to 1 Diopter of pre-operative corneal astigmatism.
- Patients who are on anti-psychotic and antidepressant medication that could potentially effect accommodation
- Patients who chronically take any medication that may affect accommodation, including first generation antihistamines, and anticholinergic agents.
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 |
|---|---|---|
| posterior chamber IOL implantation | Device | Control IOL |
| Experimental TetraFlex Study IOLTetraFlex IOL implanted | Device | Lenstec Tetraflex IOL implantation |
Primary outcome
The primary efficacy outcome is the assessment of the % of eyes obtaining 20/40 or better distance best corrected visual acuity.
Time frame: 1 year
The primary safety outcome is the incidence/severity of adverse events and complications.
Time frame: 1 year
1 secondary outcome
Patient's functional reading ability, and other distance, near and intermediate vision testing including subjective patient survey outcomes on dependence on corrective eyewear and patient symptoms.
Time frame: 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 Oct 2018.
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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, MD, PhD study director
Center for Clinical Research
Questions about this trial
What is this clinical trial studying?
A study testing posterior chamber IOL implantation and Experimental TetraFlex Study IOL 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 10 inclusion and 17 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 Oct 2018. 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?
The primary efficacy outcome is the assessment of the % of eyes obtaining 20/40 or better distance best corrected visual acuity. (time frame: 1 year). The study lists 2 primary outcomes in all. 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 Oct 2018.