CataractNCT01045733
A Comparison of Corneal Aberrations in Subjects With Contralateral AcrySof IQ Toric Intraocular Lens (IOL) and AcrySof IQ IOL With Limbal Relaxing Incision (LRI)
A study testing AcrySof IQ Toric IOL, AcrySof IQ Aspheric IOL and Limbal Relaxing Incision (LRI) in people with Cataract and Astigmatism, run by Alcon Research at 1 site in United States.
Trial summary
The purpose of this study was to evaluate and compare postoperative corneal aberrations and visual parameters in patients contralaterally implanted with an AcrySof IQ Toric intraocular lens (IOL) and AcrySof IQ Aspheric IOL with concomitant limbal relaxing incision. Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- Cataract, Astigmatism
- What is being tested?
- AcrySof IQ Toric IOL, AcrySof IQ Aspheric IOL and Limbal Relaxing Incision (LRI)
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2009to May 2011
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Ocular criteria must be met in both eyes.
- Willing and able to understand and sign an informed consent;
- Willing and able to attend postoperative examinations per protocol schedule;
- Have cataracts that require extraction followed by implantation of a posterior chamber intraocular lens and used as an on-label procedure;
- Free of disease(s)/condition(s) listed in the "Caution" section of the AcrySof IQ and AcrySof IQ Toric package inserts;
- Have regular, bowtie shaped corneal astigmatism and qualify for an SN6AT3, SN6AT4 or SN6AT5 Intraocular Lens (IOL) in both eyes;
- Have the second surgery at least one week following the first eye implant but not later than one month after the first implant.
- Other protocol-defined inclusion criteria may apply.
Who cannot join
- Previous corneal surgery;
- Planned multiple procedures during cataract/IOL implantation surgery;
- Ocular disease and/or condition that may compromise study results;
- Pregnant or planning pregnancy during course of study;
- Other protocol-defined exclusion criteria may apply.
Trial locations and contacts
1 site in 1 country.
United States1 site
Contact Alcon Call Center for Trial Locations
Fort Worth, Texas, 76134
About this study
Official title: A Prospective Contralateral Comparison of Corneal Aberrations in Subjects Undergoing Aspheric Lens Implantation With Concomitant LRI and Aspheric Toric IOL Implantation
The purpose of this study was to evaluate and compare postoperative corneal aberrations and visual parameters in patients contralaterally implanted with an AcrySof IQ Toric intraocular lens (IOL) and AcrySof IQ Aspheric IOL with concomitant limbal relaxing incision.
- Conditions
- Cataract, Astigmatism
- Being tested
- AcrySof IQ Toric IOL, AcrySof IQ Aspheric IOL, Limbal Relaxing Incision (LRI)
- Keywords
- Cataract, Toric, IOL, AcrySof, LRI, Astigmatism
- Medical subject headings
- Cataract, Astigmatism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AcrySof IQ Toric IOLDevice
Also called AcrySof IQ Toric IOL Model SN6AT3, AcrySof IQ Toric IOL Model SN6AT4, AcrySof IQ Toric IOL Model SN6AT5
AcrySof IQ Toric intraocular lens implanted in the capsular bag of the eye during cataract surgery. The IOL is intended for the lifetime of the patient.
AcrySof IQ Aspheric IOLDevice
Also called AcrySof IQ Aspheric IOL Model SN60WF
AcrySof IQ aspheric intraocular lens implanted in the capsular bag of the eye during cataract surgery. The IOL is intended for the lifetime of the patient.
Limbal Relaxing Incision (LRI)Procedure or surgery
An incision was made at the corneal-limbal junction during cataract surgery for the purpose of relaxing corneal curvature, ie., correcting astigmatism.
| Study group | Role | What they receive |
|---|---|---|
| IQ Toric IOL | Experimental | AcrySof IQ Toric intraocular lens (IOL) randomly assigned to one eye, with AcrySof IQ Aspheric IOL with Limbal Relaxing Incision (LRI) procedure in the fellow eye for contralateral implantation. Receives: Device: AcrySof IQ Toric IOL |
| IQ Aspheric IOL + LRI | Active comparator | AcrySof IQ Aspheric intraocular lens (IOL) with Limbal Relaxing Incision (LRI) procedure randomly assigned to one eye, with AcrySof IQ Toric IOL in the fellow eye for contralateral implantation Receives: Device: AcrySof IQ Aspheric IOL; Procedure: Limbal Relaxing Incision (LRI) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Corneal Aberration
Measured: Month 6 postoperative
Secondary outcomes (2)
Visual Acuity
Measured: Month 6 postoperative
Corneal Cylinder
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jan 2010 (estimated)
- Study startDec 2009
- Primary completionMay 2011
- Study completionMay 2011
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
- Randomised
- Intervention model
- Single group
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- Alcon Research
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01045733
- Sponsor's protocol ID
- M-09-045
- Status last verified
- Nov 2012
- First submitted
- 8 Jan 2010
- Last updated
- 29 Nov 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Nov 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Contralateral Comparison of Corneal Aberrations in Subjects Undergoing Aspheric Lens Implantation With Concomitant LRI and Aspheric Toric IOL Implantation
- ClinicalTrials.gov ID
- NCT01045733
- Acronym / sponsor ID
- M-09-045
- Conditions
- Cataract, Astigmatism
- Keywords
- Cataract, Toric, IOL, AcrySof, LRI, Astigmatism
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- Alcon ResearchIndustry (pharma, biotech, devices)
- Study start
- Dec 2009
- Primary completion
- May 2011 (actual)
- Study completion
- May 2011 (actual)
- First posted
- 11 Jan 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 purpose of this study was to evaluate and compare postoperative corneal aberrations and visual parameters in patients contralaterally implanted with an AcrySof IQ Toric intraocular lens (IOL) and AcrySof IQ Aspheric IOL with concomitant limbal relaxing incision.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| IQ Toric IOL | Experimental | Device: AcrySof IQ Toric IOLAcrySof IQ Toric intraocular lens (IOL) randomly assigned to one eye, with AcrySof IQ Aspheric IOL with Limbal Relaxing Incision (LRI) procedure in the fellow eye for contralateral implantation. |
| IQ Aspheric IOL + LRI | Active comparator | Device: AcrySof IQ Aspheric IOL, Procedure: Limbal Relaxing Incision (LRI)AcrySof IQ Aspheric intraocular lens (IOL) with Limbal Relaxing Incision (LRI) procedure randomly assigned to one eye, with AcrySof IQ Toric IOL in the fellow eye for contralateral implantation |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Ocular criteria must be met in both eyes.
- Willing and able to understand and sign an informed consent;
- Willing and able to attend postoperative examinations per protocol schedule;
- Have cataracts that require extraction followed by implantation of a posterior chamber intraocular lens and used as an on-label procedure;
- Free of disease(s)/condition(s) listed in the "Caution" section of the AcrySof IQ and AcrySof IQ Toric package inserts;
Key exclusion criteria (5 listed)
- Previous corneal surgery;
- Planned multiple procedures during cataract/IOL implantation surgery;
- Ocular disease and/or condition that may compromise study results;
- Pregnant or planning pregnancy during course of study;
- Other protocol-defined exclusion criteria may apply.
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 |
|---|---|---|
| AcrySof IQ Toric IOLAlso: AcrySof IQ Toric IOL Model SN6AT3, AcrySof IQ Toric IOL Model SN6AT4, AcrySof IQ Toric IOL Model SN6AT5AcrySof IQ Toric intraocular lens implanted in the capsular bag of the eye during cataract surgery. The IOL is intended for the lifetime of the patient. | Device | IQ Toric IOL |
| AcrySof IQ Aspheric IOLAlso: AcrySof IQ Aspheric IOL Model SN60WFAcrySof IQ aspheric intraocular lens implanted in the capsular bag of the eye during cataract surgery. The IOL is intended for the lifetime of the patient. | Device | IQ Aspheric IOL + LRI |
| Limbal Relaxing Incision (LRI)An incision was made at the corneal-limbal junction during cataract surgery for the purpose of relaxing corneal curvature, ie., correcting astigmatism. | Procedure or surgery | IQ Aspheric IOL + LRI |
Primary outcome
Corneal Aberration
Time frame: Month 6 postoperative
2 secondary outcomes
Visual Acuity
Time frame: Month 6 postoperative
Corneal Cylinder
Time frame: 6 months
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 29 Nov 2012.
Related trials for Cataract
RecruitingObservational study
Capella Scientia Development Study
Cataract
Recruiting
Clareon TruPlus Study
Aphakia, Astigmatism
RecruitingObservational study
Anterior Segment Anatomy Assessed by Swept-Source OCT in Ocular Surgery Patients
Cataract, Primary Angle-Closure Glaucoma
Active, not recruitingObservational study
Age-Related Eye Disease Study (AREDS) Follow-Up
Age-Related Macular Degeneration, Cataract
RecruitingObservational study
Rare Disease Patient Registry & Natural History Study - Coordination of Rare Diseases at Sanford
Rare Disorders, Undiagnosed Disorders
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 study testing AcrySof IQ Toric IOL, AcrySof IQ Aspheric IOL and Limbal Relaxing Incision (LRI) in people with Cataract and Astigmatism, run by Alcon Research 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 8 inclusion and 5 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 29 Nov 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.
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?
Corneal Aberration (time frame: Month 6 postoperative). 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 29 Nov 2012.