CataractsPhase 4NCT00929747
Comparison of Corneal Aberrations and Visual Outcomes in AcrySof IQ Toric Patients Versus Limbal Relaxing Incision (LRI) Patients
A Phase 4 study testing Toric and Limbal Relaxing Incision in people with Cataracts, run by Alcon Research at 1 site in United States.
Trial summary
A prospective evaluation of postoperative corneal aberrations and visual parameters in patients assigned to either an AcrySof IQ Toric intraocular lens (IOL) group or a group implanted with a SN60WF IOL and having concomitant limbal relaxing incision. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Cataracts
- What is being tested?
- Toric and Limbal Relaxing Incision
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2009to Oct 2009
- 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 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- operable cataracts
- good ocular health
- 0.5 D to 2.0 D of corneal astigmatism
Who cannot join
- > 2.0 D astigmatism
- irregular astigmatism
- prior or ongoing corneal disease or scarring
- history of ocular disease
Trial locations and contacts
1 site in 1 country.
United States1 site
Alcon Call Center for Trial Locations
Fort Worth, Texas, 76134
About this study
Official title: Comparison of Corneal Aberrations and Visual Outcomes in AcrySof IQ Toric Patients Versus LRI Patients
A prospective evaluation of postoperative corneal aberrations and visual parameters in patients assigned to either an AcrySof IQ Toric intraocular lens (IOL) group or a group implanted with a SN60WF IOL and having concomitant limbal relaxing incision.
- Conditions
- Cataracts
- Being tested
- Toric, Limbal Relaxing Incision
- Keywords
- Cataract, Toric, IOL, AcrySof, LRI
- Medical subject headings
- Cataract
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ToricDevice
Unilateral implantation of the AcrySof IQ Toric IOL
Limbal Relaxing IncisionProcedure or surgery
Unilateral implantation of a AcrySof IQ (SN60WF) IOL with concomitant LRI at the time of surgery
| Study group | Role | What they receive |
|---|---|---|
| Toric IOL | Active comparator | AcrySof IQ Toric IOL Receives: Device: Toric |
| Limbal Relaxing Incision | Active comparator | AcrySof IQ with Limbal Relaxing Incision Receives: Procedure: Limbal Relaxing Incision |
What is being measured
The primary outcome is the main question the study is designed to answer.
Corneal aberration
Measured: 3 months
Secondary outcomes (1)
Visual acuity
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jun 2009 (estimated)
- Study startJun 2009
- Primary completionOct 2009
- Study completionOct 2009
Why it stopped: Management Decision
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CataractsStudies of the same condition, open and under way.
- More trials run by Alcon ResearchThe sponsor's other registered studies.
- 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 0 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
- NCT00929747
- Sponsor's protocol ID
- M08-008
- Status last verified
- Oct 2009
- First submitted
- 25 Jun 2009
- Last updated
- 12 Apr 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Apr 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Corneal Aberrations and Visual Outcomes in AcrySof IQ Toric Patients Versus LRI Patients
- ClinicalTrials.gov ID
- NCT00929747
- Acronym / sponsor ID
- M08-008
- Conditions
- Cataracts
- Keywords
- Cataract, Toric, IOL, AcrySof, LRI
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Management Decision
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Alcon ResearchIndustry (pharma, biotech, devices)
- Study start
- Jun 2009
- Primary completion
- Oct 2009 (actual)
- Study completion
- Oct 2009 (actual)
- First posted
- 29 Jun 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.
A prospective evaluation of postoperative corneal aberrations and visual parameters in patients assigned to either an AcrySof IQ Toric intraocular lens (IOL) group or a group implanted with a SN60WF IOL and having concomitant limbal relaxing incision.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Toric IOL | Active comparator | Device: ToricAcrySof IQ Toric IOL |
| Limbal Relaxing Incision | Active comparator | Procedure: Limbal Relaxing IncisionAcrySof IQ with Limbal Relaxing Incision |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- operable cataracts
- good ocular health
- 0.5 D to 2.0 D of corneal astigmatism
Key exclusion criteria (4 listed)
- > 2.0 D astigmatism
- irregular astigmatism
- prior or ongoing corneal disease or scarring
- history of ocular disease
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 |
|---|---|---|
| ToricUnilateral implantation of the AcrySof IQ Toric IOL | Device | Toric IOL |
| Limbal Relaxing IncisionUnilateral implantation of a AcrySof IQ (SN60WF) IOL with concomitant LRI at the time of surgery | Procedure or surgery | Limbal Relaxing Incision |
Primary outcome
Corneal aberration
Time frame: 3 months
1 secondary outcome
Visual acuity
Time frame: 3 months
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Apr 2012.
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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.
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 Toric and Limbal Relaxing Incision in people with Cataracts, 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 3 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: withdrawn, as of the sponsor's last update on 12 Apr 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 was withdrawn before enrolling participants, so there are no results.
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: 3 months). 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 12 Apr 2012.