CataractNCT01299155
A Comparison of Visual Function After Bilateral Implantation of Presbyopia Correcting Intraocular Lenses
A study testing ReSTOR +3 and LENTIS MPlus in people with Cataract, run by Alcon Research at 1 site in Spain.
Trial summary
To prospectively evaluate postoperative visual and refractive parameters in a series of subjects bilaterally implanted with AcrySof ReSTOR +3 vs. those bilaterally implanted with LENTIS MPlus Intraocular Lens (IOL). 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 and LENTIS MPlus
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteSpain
- Study dates
- Mar 2011to Sep 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
- are willing and able to understand and sign an informed consent
- <= 1.0 Diopters of regular corneal astigmatism in both eyes. NOTE: look for consistency between manual keratometry, auto-keratometry and simulated keratometry measures to ensure "regular" astigmatism prior to enrollment. Subjects who wear contact lenses must discontinue its use for at least 2 weeks (soft contact lens) and at least 3 weeks (gas permeable contact lens) and until corneal topography shows stability prior to preoperative study measurements.
- are willing and able to attend postoperative examinations per protocol schedule
- are more than 21 years of age, of either gender and any race:
- require bilateral cataract extraction followed by posterior intraocular lens (IOL) implantation used as on-label procedure
- be willing to have second eye surgery within one month of first eye surgery
Show all 9Show fewer
- are in good ocular health, with the exception of cataracts
- are free of disease(s)/condition(s) listed in the "Precautions" section of the AcrySof IQ ReSTOR +3 and LENTIS Mplus package inserts
- are able to read and understand one of the following languages: Dutch or Spanish
Who cannot join
- Planned multiple procedures, including limbal relaxing incision (LRI), during cataract/IOL implantation surgery
- An ocular disease and/or condition that may compromise visual acuity levels (i.e. glaucoma, diabetic retinopathy, macular degeneration, amblyopia, pupil abnormality such as corectopia, etc.)
- Previous corneal surgery and/or reshaping
- Clinically significant corneal endothelial dystrophy (e.g. Fuchs' dystrophy)
- History of corneal disease (eg. herpes simplex, herpes zoster keratitis, etc.)
- History of retinal detachment
- Subjects that have an acute or chronic disease or illness that would increase the operative risk or confound the results of this investigation (eg, immunocompromised, connective tissue disease, clinically significant atopic disease, diabetes, and any other such disease or illness).
- suturing of incision required at time of surgery
Trial locations and contacts
1 site in 1 country.
Spain1 site
Contact Alcon Call Center for Trial Locations
Oviedo, Principality of Asturias, 33012
About this study
Official title: A Randomized, Pilot Study, Subject Masked Comparison of Visual Function After Bilateral Implantation of Presbyopia Correcting Intraocular Lenses (IOLs)
To prospectively evaluate postoperative visual and refractive parameters in a series of subjects bilaterally implanted with AcrySof ReSTOR +3 vs. those bilaterally implanted with LENTIS MPlus Intraocular Lens (IOL).
- Conditions
- Cataract
- Being tested
- ReSTOR +3, LENTIS MPlus
- Keywords
- Intraocular Lens, Presbyopia Correcting IOL
- 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 an Alcon AcrySof ReSTOR +3 Intraocular Lens (IOL) Model SN6AD1 following cataract extraction.
LENTIS MPlusDevice
Bilateral implantation of a LENTIS MPlus Intraocular Lens (IOL) following cataract extraction.
| Study group | Role | What they receive |
|---|---|---|
| ReSTOR +3 | Experimental | Bilateral implantation of a ReSTOR +3 Intraocular Lens (IOL) Model SN6AD1 Receives: Device: ReSTOR +3 |
| LENTIS MPlus | Active comparator | Bilateral implantation of a LENTIS MPlus Intraocular Lens (IOL) Model Receives: Device: LENTIS MPlus |
What is being measured
The primary outcome is the main question the study is designed to answer.
Unilateral Uncorrected Near Visual Acuity
Measured: 3 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 posted18 Feb 2011 (estimated)
- Study startMar 2011
- Primary completionSep 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.
- 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 24 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
- NCT01299155
- Sponsor's protocol ID
- M10-070
- Status last verified
- Oct 2011
- First submitted
- 17 Feb 2011
- Last updated
- 23 Oct 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Oct 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Pilot Study, Subject Masked Comparison of Visual Function After Bilateral Implantation of Presbyopia Correcting Intraocular Lenses (IOLs)
- ClinicalTrials.gov ID
- NCT01299155
- Acronym / sponsor ID
- M10-070
- Conditions
- Cataract
- Keywords
- Intraocular Lens, Presbyopia Correcting IOL
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Alcon ResearchIndustry (pharma, biotech, devices)
- Study start
- Mar 2011
- Primary completion
- Sep 2011 (actual)
- First posted
- 18 Feb 2011 (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.
To prospectively evaluate postoperative visual and refractive parameters in a series of subjects bilaterally implanted with AcrySof ReSTOR +3 vs. those bilaterally implanted with LENTIS MPlus Intraocular Lens (IOL).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ReSTOR +3 | Experimental | Device: ReSTOR +3Bilateral implantation of a ReSTOR +3 Intraocular Lens (IOL) Model SN6AD1 |
| LENTIS MPlus | Active comparator | Device: LENTIS MPlusBilateral implantation of a LENTIS MPlus Intraocular Lens (IOL) Model |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- are willing and able to understand and sign an informed consent
- <= 1.0 Diopters of regular corneal astigmatism in both eyes. NOTE: look for consistency between manual keratometry, auto-keratometry and simulated keratometry measures to ensure "regular" astigmatism prior to enrollment. Subjects who wear contact lenses must discontinue its use for at least 2 weeks (soft contact lens) and at least 3 weeks (gas permeable contact lens) and until corneal topography shows stability prior to preoperative study measurements.
- are willing and able to attend postoperative examinations per protocol schedule
- are more than 21 years of age, of either gender and any race:
- require bilateral cataract extraction followed by posterior intraocular lens (IOL) implantation used as on-label procedure
Key exclusion criteria (8 listed)
- Planned multiple procedures, including limbal relaxing incision (LRI), during cataract/IOL implantation surgery
- An ocular disease and/or condition that may compromise visual acuity levels (i.e. glaucoma, diabetic retinopathy, macular degeneration, amblyopia, pupil abnormality such as corectopia, etc.)
- Previous corneal surgery and/or reshaping
- Clinically significant corneal endothelial dystrophy (e.g. Fuchs' dystrophy)
- History of corneal disease (eg. herpes simplex, herpes zoster keratitis, etc.)
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 an Alcon AcrySof ReSTOR +3 Intraocular Lens (IOL) Model SN6AD1 following cataract extraction. | Device | ReSTOR +3 |
| LENTIS MPlusBilateral implantation of a LENTIS MPlus Intraocular Lens (IOL) following cataract extraction. | Device | LENTIS MPlus |
Primary outcome
Unilateral Uncorrected Near Visual Acuity
Time frame: 3 months after surgery
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 23 Oct 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 study testing ReSTOR +3 and LENTIS MPlus in people with Cataract, run by Alcon Research at 1 site in Spain.
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 9 inclusion and 8 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 23 Oct 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 Spain. 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?
Unilateral Uncorrected Near Visual Acuity (time frame: 3 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 23 Oct 2012.