CataractNCT01140477
Toric Intraocular Lens Following Cataract Surgery
A study testing Toric Accommodating Lens and Accommodating Lens in people with Cataract and Astigmatism, run by Bausch & Lomb Incorporated at 1 site in United States.
Trial summary
The objective of this clinical trial is to evaluate the safety and effectiveness of the Bausch + Lomb Toric Accommodating Posterior Chamber Silicone Intraocular Lens used to provide near, intermediate, and distance vision and a reduction of the effects of preoperative corneal astigmatism in presbyopic patients… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cataract, Astigmatism
- What is being tested?
- Toric Accommodating Lens and Accommodating Lens
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 229 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2010to Oct 2012
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subjects must have a clinically documented diagnosis of age-related cataract
- Subjects must require a lens power from 16 to 27 diopters
- Subjects must have predicted post-operative corneal astigmatism between 0.83D and 2.50D, as determined by the Toric Calculator
Who cannot join
- Subjects with any anterior segment pathology for which extracapsular/ phacoemulsification cataract surgery would be contraindicated.
- Subjects with diagnoses of degenerative visual disorders.
- Subjects with conditions associated with increased risk of zonular rupture.
- Subjects who have had previous corneal surgery in the planned operative eye.
- Subjects with irregular corneal astigmatism.
- Subjects with clinically significant retinal pigment or epithelium/macular changes.
Show all 9Show fewer
- Subjects with chronic use of systemic steroids or immunosuppressive medications.
- Subjects either concurrently participating in another clinical trial or have participated in another clinical trial within 60 days prior to enrollment in this study.
- Subjects with a difference in corneal astigmatism measured with the IOL Master and the topographer greater than 0.5 D using vector analysis.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Prospective Multicenter Clinical Trial To Evaluate the Effectiveness of A Toric Accommodating Posterior Chamber Silicone Intraocular Lens Designed To Provide Near, Intermediate, And Distance Vision And Reduce The Effects Of Preoperative Corneal Astigmatism On Postoperative Refraction Following Cataract Surgery
The objective of this clinical trial is to evaluate the safety and effectiveness of the Bausch + Lomb Toric Accommodating Posterior Chamber Silicone Intraocular Lens used to provide near, intermediate, and distance vision and a reduction of the effects of preoperative corneal astigmatism in presbyopic patients undergoing cataract extraction and intraocular lens (IOL) placement.
- Conditions
- Cataract, Astigmatism
- Being tested
- Toric Accommodating Lens, Accommodating Lens
- Medical subject headings
- Cataract, Astigmatism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Toric Accommodating LensDevice
Toric accommodating lens implanted after cataract extraction
Accommodating LensDevice
Accommodating lens implanted after cataract extraction
| Study group | Role | What they receive |
|---|---|---|
| Crystalens toric IOL | Experimental | Toric Accommodating Lens Crystalens toric silicone multi-piece accommodating IOL (Models AT-50T/AT-52T) Receives: Device: Toric Accommodating Lens |
| Crystalens IOL | Active comparator | Accommodating Lens Crystalens silicone multi-piece accommodating IOL (Models AT-50SE/AT-52SE) Receives: Device: Accommodating Lens |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percent Reduction in Absolute Cylinder
Percent reduction in absolute cylinder expressed as a percentage of the intended reduction in cylinder. Cylinder reduction is the measurement for astigmatism reduction. Astigmatism is a form of refractive error that can affect uncorrected visual acuity (at all distances). Reducing cylinder should improve UCVA, but other elements of refractive error, such as myopia or hyperopia, can also affect UCVA. Best corrected visual acuity (BCVA) is not affected by refractive error.
Measured: 120 - 180 day postoperative visit
Secondary outcomes (2)
Lens Misalignment
This Outcome Measure was evaluated for Crystalens Toric IOL arm only - Toric IOLs require precise alignment to correct astigmatism; control IOLs do not.
Measured: 120 - 180 day postoperative visit
Visual Acuity
Best-Corrected Distance Visual Acuity (BCDVA) without Glare (logMAR)
Measured: 120 - 180 day postoperative visit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jun 2010 (estimated)
- Study startJun 2010
- Primary completionDec 2011
- Study completionOct 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 229 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bausch & Lomb Incorporated
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Jay Pepose, MD, PhD, Study director, Pepose Vision Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01140477
- Sponsor's protocol ID
- 650
- Status last verified
- Aug 2014
- First submitted
- 8 Jun 2010
- Last updated
- 8 Sep 2014
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Sep 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Multicenter Clinical Trial To Evaluate the Effectiveness of A Toric Accommodating Posterior Chamber Silicone Intraocular Lens Designed To Provide Near, Intermediate, And Distance Vision And Reduce The Effects Of Preoperative Corneal Astigmatism On Postoperative Refraction Following Cataract Surgery
- ClinicalTrials.gov ID
- NCT01140477
- Acronym / sponsor ID
- 650
- Conditions
- Cataract, Astigmatism
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 229 participants (actual)
- Lead sponsor
- Bausch & Lomb IncorporatedIndustry (pharma, biotech, devices)
- Study start
- Jun 2010
- Primary completion
- Dec 2011 (actual)
- Study completion
- Oct 2012 (actual)
- First posted
- 9 Jun 2010 (estimated)
- Results
- Posted 22 Aug 2014
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The objective of this clinical trial is to evaluate the safety and effectiveness of the Bausch + Lomb Toric Accommodating Posterior Chamber Silicone Intraocular Lens used to provide near, intermediate, and distance vision and a reduction of the effects of preoperative corneal astigmatism in presbyopic patients undergoing cataract extraction and intraocular lens (IOL) placement.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Crystalens toric IOL | Experimental | Device: Toric Accommodating LensToric Accommodating Lens Crystalens toric silicone multi-piece accommodating IOL (Models AT-50T/AT-52T) |
| Crystalens IOL | Active comparator | Device: Accommodating LensAccommodating Lens Crystalens silicone multi-piece accommodating IOL (Models AT-50SE/AT-52SE) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Subjects must have a clinically documented diagnosis of age-related cataract
- Subjects must require a lens power from 16 to 27 diopters
- Subjects must have predicted post-operative corneal astigmatism between 0.83D and 2.50D, as determined by the Toric Calculator
Key exclusion criteria (9 listed)
- Subjects with any anterior segment pathology for which extracapsular/ phacoemulsification cataract surgery would be contraindicated.
- Subjects with diagnoses of degenerative visual disorders.
- Subjects with conditions associated with increased risk of zonular rupture.
- Subjects who have had previous corneal surgery in the planned operative eye.
- Subjects with irregular corneal astigmatism.
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 |
|---|---|---|
| Toric Accommodating LensToric accommodating lens implanted after cataract extraction | Device | Crystalens toric IOL |
| Accommodating LensAccommodating lens implanted after cataract extraction | Device | Crystalens IOL |
Primary outcome
Percent Reduction in Absolute Cylinder
Time frame: 120 - 180 day postoperative visit
Percent reduction in absolute cylinder expressed as a percentage of the intended reduction in cylinder. Cylinder reduction is the measurement for astigmatism reduction. Astigmatism is a form of refractive error that can affect uncorrected visual acuity (at all distances). Reducing cylinder should improve UCVA, but other elements of refractive error, such as myopia or hyperopia, can also affect UCVA. Best corrected visual acuity (BCVA) is not affected by refractive error.
2 secondary outcomes
Lens Misalignment
Time frame: 120 - 180 day postoperative visit
Visual Acuity
Time frame: 120 - 180 day postoperative visit
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Sep 2014.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Jay Pepose, MD, PhD study director
Pepose Vision Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Toric Accommodating Lens and Accommodating Lens in people with Cataract and Astigmatism, run by Bausch & Lomb Incorporated 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 3 inclusion and 9 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 8 Sep 2014. 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.
Are results available for this study?
Yes. Results are posted in the registry (first posted 22 Aug 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Percent Reduction in Absolute Cylinder (time frame: 120 - 180 day postoperative visit). 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 8 Sep 2014.