Visual FunctionPhase 4NCT00758550
Visual Function After Bilateral Implantation of AcrySof® Toric
A Phase 4 study testing AcrySof® Toric IOL and AcrySof Natural in people with Visual Function, run by Alcon Research at 1 site in United States.
Trial summary
The objective of this study was to evaluate visual function of AcrySof Toric and AcrySof Natural Intraocular Lenses (IOLs) following implant for replacement of cataract. Read more about this study
- Who is it for?
- Ages 40 to 80 years
- Conditions the study is for
- Visual Function
- What is being tested?
- AcrySof® Toric IOL and AcrySof Natural
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2007to Jun 2008
- Phase
- Phase 4
- 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 40 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Bilateral cataracts
- 40~80 years of age
- 4 Days - 1 Week interval between a single patient's surgery
- dilated pupil size (in dim light) ≥ 4.0 mm
- Anticipated correction with an IOL of +10 Diopters ~ +25 Diopters
- 0.75 - 2.0 Diopters of astigmatism preoperatively as measured by Keratometry readings
Who cannot join
- Preoperative ocular pathology
- Previous intraocular or corneal surgery
- An increased risk for complications which could require vitreoretinal surgery
- Corneal irregularities
- Corneal opacities
- Current contact lens usage(within 6 months prior to first surgery)
Trial locations and contacts
1 site in 1 country.
About this study
The objective of this study was to evaluate visual function of AcrySof Toric and AcrySof Natural Intraocular Lenses (IOLs) following implant for replacement of cataract.
- Conditions
- Visual Function
- Being tested
- AcrySof® Toric IOL, AcrySof Natural
- Keywords
- Visual function;, Refractive cylinder;, AcrySof® Toric;, AcrySof® Natural
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AcrySof® Toric IOLDevice
AcrySof® Toric Intraocular Lens (IOL) implanted into the study eye following cataract extraction surgery
AcrySof NaturalDevice
AcrySof Natural Intraocular Lens (IOL) implanted into the study eye following cataract extraction surgery
| Study group | Role | What they receive |
|---|---|---|
| AcrySof Toric IOL | Experimental | AcrySof Toric Intraocular Lens (IOL) Receives: Device: AcrySof® Toric IOL |
| AcrySof Natural IOL | Active comparator | AcrySof Natural Intraocular Lens (IOL) Receives: Device: AcrySof Natural |
What is being measured
The primary outcome is the main question the study is designed to answer.
Uncorrected Visual Acuity (UCVA)
Uncorrected Visual Acuity (UCVA) from surgery measured in logMAR. LogMAR is the "logarithm of the minimum angle of resolution". A lower logMAR value indicates better visual acuity.
Measured: 6 Months after surgery
Secondary outcomes (1)
Questionnaire Results
Results of questionnaire rating the quality of distance vision without glasses or contact lenses. Measured on a scale of 0 to 6 (0 = worst, 6 = best).
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 posted25 Sep 2008 (estimated)
- Study startApr 2007
- Primary completionJun 2008
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 Visual FunctionStudies 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Alcon Research
- Sponsor type
- Industry (pharma, biotech, devices)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00758550
- Sponsor's protocol ID
- CM-06-17
- Status last verified
- Mar 2010
- First submitted
- 23 Sep 2008
- Last updated
- 16 Mar 2010
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Mar 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Visual Function After Bilateral Implantation of AcrySof® Toric
- ClinicalTrials.gov ID
- NCT00758550
- Acronym / sponsor ID
- CM-06-17
- Conditions
- Visual Function
- Keywords
- Visual function;, Refractive cylinder;, AcrySof® Toric;, AcrySof® Natural
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Alcon ResearchIndustry (pharma, biotech, devices)
- Study start
- Apr 2007
- Primary completion
- Jun 2008 (actual)
- First posted
- 25 Sep 2008 (estimated)
- Results
- Posted 16 Mar 2010
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 study was to evaluate visual function of AcrySof Toric and AcrySof Natural Intraocular Lenses (IOLs) following implant for replacement of cataract.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| AcrySof Toric IOL | Experimental | Device: AcrySof® Toric IOLAcrySof Toric Intraocular Lens (IOL) |
| AcrySof Natural IOL | Active comparator | Device: AcrySof NaturalAcrySof Natural Intraocular Lens (IOL) |
Who may qualify
- Ages
- 40 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Bilateral cataracts
- 40~80 years of age
- 4 Days - 1 Week interval between a single patient's surgery
- dilated pupil size (in dim light) ≥ 4.0 mm
- Anticipated correction with an IOL of +10 Diopters ~ +25 Diopters
Key exclusion criteria (6 listed)
- Preoperative ocular pathology
- Previous intraocular or corneal surgery
- An increased risk for complications which could require vitreoretinal surgery
- Corneal irregularities
- Corneal opacities
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® Toric IOLAcrySof® Toric Intraocular Lens (IOL) implanted into the study eye following cataract extraction surgery | Device | AcrySof Toric IOL |
| AcrySof NaturalAcrySof Natural Intraocular Lens (IOL) implanted into the study eye following cataract extraction surgery | Device | AcrySof Natural IOL |
Primary outcome
Uncorrected Visual Acuity (UCVA)
Time frame: 6 Months after surgery
Uncorrected Visual Acuity (UCVA) from surgery measured in logMAR. LogMAR is the "logarithm of the minimum angle of resolution". A lower logMAR value indicates better visual acuity.
1 secondary outcome
Questionnaire Results
Time frame: 6 Months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Mar 2010.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Related trials for Visual Function
Active, not recruitingObservational study
Impact of Glaucoma and Visual Field Loss on Life Space
Primary Open-angle Glaucoma
Recruiting
Trial Comparing miLOOP Device Assisted Phacoemulsification vs Standard Surgery for Dense Cataracts: Effects on Endothelial Cell Loss, Energy Use, and Vision Recovery
Cataract, Endothelial Cell Density
Active, not recruitingObservational study
Long-Term Follow-up Study of ADVM-022 in DME (INFINITY-EXT)
Diabetic Macular Edema, Diabetic Retinopathy
RecruitingPhase 2
The Progressive Supranuclear Palsy Clinical Trial Platform
Progressive Supranuclear Palsy(PSP)
RecruitingObservational study
Early Risk Stratification of Thyroid Eye Disease in Newly Diagnosed Graves' Disease
Graves' Orbitopathy, Thyroid Eye Disease, TED
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 AcrySof® Toric IOL and AcrySof Natural in people with Visual Function, 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 6 inclusion and 6 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 16 Mar 2010. 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?
Yes. Results are posted in the registry (first posted 16 Mar 2010). 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?
Uncorrected Visual Acuity (UCVA) (time frame: 6 Months after surgery). 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 16 Mar 2010.