CataractPhase 4NCT00963560
Presbyopia-Correcting Intraocular Lenses (IOLs)
A Phase 4 study testing ReSTOR +3, Crystalens HD and Crystalens AO in people with Cataract, run by Alcon Research at 1 site in United States.
Trial summary
The purpose of this study is to prospectively evaluate postoperative visual and refractive parameters in a series of subjects bilaterally implanted with Presbyopia-Correcting Intraocular Lenses (IOLs). Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- Cataract
- What is being tested?
- ReSTOR +3, Crystalens HD and Crystalens AO
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 132 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2009to Mar 2011
- 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 21 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- diagnosed with bilateral cataracts
- candidate for presbyopic lens
Who cannot join
- > 1 Diopter preoperative astigmatism by Keratometry readings
- pre-existing conditions that could skew the results
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 Randomized, Subject-masked Comparison of Visual Function After Bilateral Implantation of Presbyopia-correcting IOLs
The purpose of this study is to prospectively evaluate postoperative visual and refractive parameters in a series of subjects bilaterally implanted with Presbyopia-Correcting Intraocular Lenses (IOLs).
- Conditions
- Cataract
- Being tested
- ReSTOR +3, Crystalens HD, Crystalens AO
- Keywords
- ReSTOR +3
- Medical subject headings
- Cataract
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ReSTOR +3Device
Bilateral implantation of the AcrySof ReSTOR Aspheric +3 Model SN6AD1 Intraocular lens (IOL) for the treatment of cataract.
Crystalens HDDevice
Bilateral implantation of the Crystalens HD intraocular lens (IOL) for the treatment of cataract.
Crystalens AODevice
Bilateral implantation of the Crystalens AO intraocular lens (IOL) for the treatment of cataract.
| Study group | Role | What they receive |
|---|---|---|
| ReSTOR +3 | Experimental | Bilateral implantation of ReSTOR +3 Intraocular Lens (IOL) Receives: Device: ReSTOR +3 |
| Crystalens HD | Active comparator | Bilateral implantation of Crystalens HD Intraocular Lens (IOL) Receives: Device: Crystalens HD |
| Crystalens AO | Active comparator | Bilateral implantation of Crystalens AO Intraocular Lens (IOL) Receives: Device: Crystalens AO |
What is being measured
The primary outcome is the main question the study is designed to answer.
Best Corrected Visual Acuity
Best corrected vision was tested at 4 meters (m), 60 centimeters (cm), 40cm and at preferred distance (distance chosen by each subject) with a standard ETDRS chart for distance and a hand held chart for near. Scores were calculated using logMAR values. LogMAR is the "logarithm of the minimum angle of resolution". A lower logMAR value indicates better visual acuity. Preferred distance for each study group was as follows: ReSTOR +3 = 38.7 +/- 6.8 cm, Crystalens HD = 49.9 +/- 9.8 cm, Crystalens AO = 53.1 +/- 9.8 cm.
Measured: 6 Months after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Aug 2009 (estimated)
- Study startAug 2009
- Primary completionMar 2011
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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 132 participants (actual)
Sponsor and investigators
- Lead sponsor
- Alcon Research
- Sponsor type
- Industry (pharma, biotech, devices)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00963560
- Sponsor's protocol ID
- M09-008
- Status last verified
- Jul 2011
- First submitted
- 19 Aug 2009
- Last updated
- 9 Aug 2011
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Aug 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Subject-masked Comparison of Visual Function After Bilateral Implantation of Presbyopia-correcting IOLs
- ClinicalTrials.gov ID
- NCT00963560
- Acronym / sponsor ID
- M09-008
- Conditions
- Cataract
- Keywords
- ReSTOR +3
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 132 participants (actual)
- Lead sponsor
- Alcon ResearchIndustry (pharma, biotech, devices)
- Study start
- Aug 2009
- Primary completion
- Mar 2011 (actual)
- First posted
- 21 Aug 2009 (estimated)
- Results
- Posted 9 Aug 2011
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 is to prospectively evaluate postoperative visual and refractive parameters in a series of subjects bilaterally implanted with Presbyopia-Correcting Intraocular Lenses (IOLs).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| ReSTOR +3 | Experimental | Device: ReSTOR +3Bilateral implantation of ReSTOR +3 Intraocular Lens (IOL) |
| Crystalens HD | Active comparator | Device: Crystalens HDBilateral implantation of Crystalens HD Intraocular Lens (IOL) |
| Crystalens AO | Active comparator | Device: Crystalens AOBilateral implantation of Crystalens AO Intraocular Lens (IOL) |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- diagnosed with bilateral cataracts
- candidate for presbyopic lens
Key exclusion criteria (2 listed)
- > 1 Diopter preoperative astigmatism by Keratometry readings
- pre-existing conditions that could skew the results
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 |
|---|---|---|
| ReSTOR +3Bilateral implantation of the AcrySof ReSTOR Aspheric +3 Model SN6AD1 Intraocular lens (IOL) for the treatment of cataract. | Device | ReSTOR +3 |
| Crystalens HDBilateral implantation of the Crystalens HD intraocular lens (IOL) for the treatment of cataract. | Device | Crystalens HD |
| Crystalens AOBilateral implantation of the Crystalens AO intraocular lens (IOL) for the treatment of cataract. | Device | Crystalens AO |
Primary outcome
Best Corrected Visual Acuity
Time frame: 6 Months after surgery
Best corrected vision was tested at 4 meters (m), 60 centimeters (cm), 40cm and at preferred distance (distance chosen by each subject) with a standard ETDRS chart for distance and a hand held chart for near. Scores were calculated using logMAR values. LogMAR is the "logarithm of the minimum angle of resolution". A lower logMAR value indicates better visual acuity. Preferred distance for each study group was as follows: ReSTOR +3 = 38.7 +/- 6.8 cm, Crystalens HD = 49.9 +/- 9.8 cm, Crystalens AO = 53.1 +/- 9.8 cm.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Aug 2011.
- 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.
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 ReSTOR +3, Crystalens HD and Crystalens AO in people with Cataract, 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 2 inclusion and 2 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 9 Aug 2011. 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 9 Aug 2011). 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?
Best Corrected Visual Acuity (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 9 Aug 2011.