To Collect Information About Visual Outcomes and Participant SatisfactionPhase 4NCT01191229
Prospective Evaluation of Visual Outcomes With Tecnis One-Piece Multifocal Intraocular Lenses Compared With Patients Previously Implanted With Crystalens Aspheric Optic (AO)
A Phase 4 study testing Tecnis one-piece MF IOL and Crystalens AO in people with To Collect Information About Visual Outcomes and Participant Satisfaction, run by Innovative Medical at 1 site in United States.
Trial summary
The study is being conducted to collect information about visual outcomes and participant satisfaction with the Tecnis One-Piece Multifocal (MF) Intraocular Lenses (IOLs) compared with participants previously implanted with Crystalens Aspheric Optic (AO) IOLs. The U.S. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- To Collect Information About Visual Outcomes and Participant Satisfaction
- What is being tested?
- Tecnis one-piece MF IOL and Crystalens AO
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2010to Jun 2012
- Phase
- Phase 4
- 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
- Age 18 or greater
- Bilateral cataracts for which phacoemulsification extraction and posterior IOL implantation has been planned for both eyes
- Visual potential of 20/30 or better in each eye after cataract removal and IOL implantation
- Preoperative best-corrected distance visual acuity (BCDVA) worse than 20/40 Snellen
- Naturally dilated pupil size (in dim light) > 3.5 mm (with no dilation medications) for both eyes
- Preoperative corneal astigmatism of 1.5 D or less
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- Clear intraocular media other than cataract
- Availability, willingness, and sufficient cognitive awareness to comply with examination procedures
- At least 18 years of age
- Underwent bilateral implantation with Crystalens AO at least 6 months previously
- Visual potential of 20/30 or better in each eye after cataract removal and IOL implantation
- Preoperative best-corrected distance visual acuity (BCDVA) worse than 20/40 Snellen
- Naturally dilated pupil size (in dim light) > 3.5 mm (with no dilation medications) for both eyes
- Preoperative corneal astigmatism of 1.5 D or less
- Clear intraocular media other than cataract
- Availability, willingness, and sufficient cognitive awareness to comply with examination procedures
Who cannot join
- Use of systemic or ocular medications that may affect vision
- Acute or chronic disease or illness that would increase risk or confound study results (e.g. diabetes mellitus, immunocompromised, etc.)
- Subjects with diabetes mellitus
- Uncontrolled systemic or ocular disease
- History of ocular trauma or prior ocular surgery
- Amblyopia or strabismus
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- Known pathology that may affect visual acuity; particularly retinal changes that affect vision (macular degeneration, cystoid macular edema, proliferative diabetic retinopathy, etc.)
- 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 with forme fruste keratoconus or keratoconus
- Subjects who may be expected to require retinal laser treatment or other surgical intervention
- Capsule or zonular abnormalities that may affect postoperative centration or tilt of the lens (e.g. pseudoexfoliation syndrome)
- Pupil abnormalities (non-reactive, tonic pupils, abnormally shaped pupils, or pupils that do not dilate at least 4.0 mm under mesopic/scotopic conditions)
- Contact lens usage within 6 months for PMMA contacts lenses, 1 month for gas permeable lenses or 1 week for extended-wear and daily-wear soft contact lenses
- Requiring an intraocular lens <15.0 or >26.0 diopters
- 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 with forme fruste keratoconus or keratoconus
- Subjects who may be expected to require retinal laser treatment or other surgical intervention
- Capsule or zonular abnormalities that may affect postoperative centration or tilt of the lens (e.g. pseudoexfoliation syndrome)
- Pupil abnormalities (non-reactive, tonic pupils, abnormally shaped pupils, or pupils that do not dilate at least 4.0 mm under mesopic/scotopic conditions)
- Requiring an intraocular lens <15.0 or >26.0 diopters Exclusion Criteria for Part 2
- 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 with forme fruste keratoconus or keratoconus
- Subjects who may be expected to require retinal laser treatment or other surgical intervention
- Capsule or zonular abnormalities that may affect postoperative centration or tilt of the lens (e.g. pseudoexfoliation syndrome)
- Pupil abnormalities (non-reactive, tonic pupils, abnormally shaped pupils, or pupils that do not dilate at least 4.0 mm under mesopic/scotopic conditions)
- Requiring an intraocular lens <15.0 or >26.0 diopters
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Prospective Evaluation of Visual Outcomes With Tecnis One-Piece Multifocal Intraocular Lenses Compared With Patients Previously Implanted With Crystalens AO
The study is being conducted to collect information about visual outcomes and participant satisfaction with the Tecnis One-Piece Multifocal (MF) Intraocular Lenses (IOLs) compared with participants previously implanted with Crystalens Aspheric Optic (AO) IOLs. The U.S. Food and Drug Administration (FDA) has cleared the Tecnis One-Piece MF IOL for visual correction of aphakia (replacing a removed lens in the eye) in adults.
- Being tested
- Tecnis one-piece MF IOL, Crystalens AO
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tecnis one-piece MF IOLDevice
25 patients to be implanted after cataract surgery
Crystalens AODevice
25 patients that are previously implanted
| Study group | Role | What they receive |
|---|---|---|
| Tecnis One-Piece MF IOL | No intervention | It is planned that about 25 people who are at least 18 years old who are scheduled to have the Tecnis One-Piece Multifocal Intraocular Lenses placed into their eyes after cataract surgery Receives: Device: Tecnis one-piece MF IOL |
| Crystalens AO | No intervention | It is planned that about 25 people who are at least 18 years old and have been implanted with Crystalens AO Receives: Device: Crystalens AO |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incision size
Part 1 Only:
The primary outcome measure is incision size at three points:
Immediately after application of the keratome blade Post phacoemulsification Post Tecnis IOL implantation Target refraction vs. achieved
Part 1 and 2:
UCVA data at distance, intermediate, and near Near vision will be measured in mesopic and photopic conditions standardized with light meter BCVA at distance and near Enhancement rates Spectacle independence questionnaire and patient satisfaction Incidence of adverse events
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 posted30 Aug 2010 (estimated)
- Study startJul 2010
- Primary completionJun 2012
- Study completionJun 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for To Collect Information About Visual Outcomes and Participant SatisfactionStudies 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 4
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Innovative Medical
- Sponsor type
- Industry (pharma, biotech, devices)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01191229
- Sponsor's protocol ID
- Tecnis One-Piece MF IOL
- Status last verified
- Jun 2012
- First submitted
- 19 Aug 2010
- Last updated
- 14 Jun 2012
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Jun 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Evaluation of Visual Outcomes With Tecnis One-Piece Multifocal Intraocular Lenses Compared With Patients Previously Implanted With Crystalens AO
- ClinicalTrials.gov ID
- NCT01191229
- Acronym / sponsor ID
- Tecnis One-Piece MF IOL
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Innovative MedicalIndustry (pharma, biotech, devices)
- Study start
- Jul 2010
- Primary completion
- Jun 2012 (actual)
- Study completion
- Jun 2012 (actual)
- First posted
- 30 Aug 2010 (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 study is being conducted to collect information about visual outcomes and participant satisfaction with the Tecnis One-Piece Multifocal (MF) Intraocular Lenses (IOLs) compared with participants previously implanted with Crystalens Aspheric Optic (AO) IOLs. The U.S. Food and Drug Administration (FDA) has cleared the Tecnis One-Piece MF IOL for visual correction of aphakia (replacing a removed lens in the eye) in adults.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Tecnis One-Piece MF IOL | No intervention | Device: Tecnis one-piece MF IOLIt is planned that about 25 people who are at least 18 years old who are scheduled to have the Tecnis One-Piece Multifocal Intraocular Lenses placed into their eyes after cataract surgery |
| Crystalens AO | No intervention | Device: Crystalens AOIt is planned that about 25 people who are at least 18 years old and have been implanted with Crystalens AO |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (16 listed)
- At least 18 years of age
- Underwent bilateral implantation with Crystalens AO at least 6 months previously
- Visual potential of 20/30 or better in each eye after cataract removal and IOL implantation
- Preoperative best-corrected distance visual acuity (BCDVA) worse than 20/40 Snellen
- Naturally dilated pupil size (in dim light) > 3.5 mm (with no dilation medications) for both eyes
Key exclusion criteria (26 listed)
- 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 with forme fruste keratoconus or keratoconus
- Subjects who may be expected to require retinal laser treatment or other surgical intervention
- Capsule or zonular abnormalities that may affect postoperative centration or tilt of the lens (e.g. pseudoexfoliation syndrome)
- Pupil abnormalities (non-reactive, tonic pupils, abnormally shaped pupils, or pupils that do not dilate at least 4.0 mm under mesopic/scotopic conditions)
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 |
|---|---|---|
| Tecnis one-piece MF IOL25 patients to be implanted after cataract surgery | Device | Tecnis One-Piece MF IOL |
| Crystalens AO25 patients that are previously implanted | Device | Crystalens AO |
Primary outcome
Incision size
Time frame: 1 year
Part 1 Only: The primary outcome measure is incision size at three points: Immediately after application of the keratome blade Post phacoemulsification Post Tecnis IOL implantation Target refraction vs. achieved Part 1 and 2: UCVA data at distance, intermediate, and near Near vision will be measured in mesopic and photopic conditions standardized with light meter BCVA at distance and near Enhancement rates Spectacle independence questionnaire and patient satisfaction Incidence of adverse events
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 14 Jun 2012.
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Tecnis one-piece MF IOL and Crystalens AO in people with To Collect Information About Visual Outcomes and Participant Satisfaction, run by Innovative Medical at 1 site in United States.
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 16 inclusion and 26 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 14 Jun 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Incision size (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 14 Jun 2012.