CataractsNCT01190631
An Assessment of Residual Spherical Aberration, Postoperative Total High Order Aberrations, and Functional Vision Correlation Following Intraocular Lens (IOL) Implantation
A study testing Acrysof IQ (SN60WF) IOL in people with Cataracts, run by Alcon Research at 1 site in United States.
Trial summary
The purpose of this study was to evaluate total residual spherical aberration (TSA) post-IOL implantation, and to determine if an association exists between TSA, postoperative high order aberrations (HOA), and functional vision following IOL implantation in patients grouped by pre-operative corneal spherical… Read more about this study
- Who is it for?
- Ages 40 to 80 years
- Conditions the study is for
- Cataracts
- What is being tested?
- Acrysof IQ (SN60WF) IOL
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2010to Nov 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 40 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age-related cataract grade 3 or lower in at least one eye;
- Planned cataract removal via phacoemulsification with an implantation of an aspheric IOL;
- Able to have an operation within 30 days of preoperative evaluation;
- Good ocular health, with the exception of cataracts;
- ≤ 1.50 diopter (D) of preoperative astigmatism by keratometry;
- Willing and able to understand and sign an informed consent;
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- Willing and able to attend postoperative examinations per protocol schedule;
- Able to achieve 6.5mm dilated pupil;
- Other protocol-defined inclusion criteria may apply.
Who cannot join
- Preoperative ocular pathology as specified in protocol;
- Preoperative corneal pathology as specified in protocol;
- Keratometric astigmatism exceeding 1.50 diopter;
- Planned postoperative refraction for mono-vision;
- Uncontrolled diabetes;
- Use of any systemic or topical drug known to interfere with visual performance;
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- Contact lens use during the active treatment portion of the trial;
- Any concurrent infectious/non infectious conjunctivitis, keratitis or uveitis;
- Any clinically significant, serious or severe medical or psychiatric condition that may increase the risk associated with study participation or study device implantation or may interfere with the interpretation of study results;
- Participation in (or current participation) any investigational drug or device trial within the previous 30 days prior to the start date of this trial;
- Intraocular conventional surgery within the past three months or intraocular laser surgery within one month in the operated eye;
- Pregnant or nursing mothers and females of childbearing potential not practicing a reliable and medically acceptable method of birth control;
- 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: An Assessment of Residual Spherical Aberration, Postoperative Total High Order Aberrations, and Functional Vision Correlation After SN60WF IOL Implantation
The purpose of this study was to evaluate total residual spherical aberration (TSA) post-IOL implantation, and to determine if an association exists between TSA, postoperative high order aberrations (HOA), and functional vision following IOL implantation in patients grouped by pre-operative corneal spherical aberration (CSA).
Read the detailed description
Patients will be grouped by pre-operative corneal spherical aberration (CSA) measures, i.e., ≤0.230 micron and ≥0.270 micron.
- Conditions
- Cataracts
- Being tested
- Acrysof IQ (SN60WF) IOL
- Keywords
- intraocular lens, cataracts, total residual spherical aberration, high order aberrations
- Medical subject headings
- Cataract
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Acrysof IQ (SN60WF) IOLDevice
Also called Acrysof® IQ Model SN60WF
Acrysof IQ (SN60WF) intraocular lens implanted in the capsular bag of the eye during cataract surgery. The IOL is intended for the lifetime of the patient. Unilateral (one eye only) implantation is planned.
| Study group | Role | What they receive |
|---|---|---|
| Acrysof IQ (SN60WF) IOL | Experimental | AcrySof IQ SN60WF intraocular lens (IOL) implanted in one eye only during cataract surgery. Receives: Device: Acrysof IQ (SN60WF) IOL |
What is being measured
The primary outcome is the main question the study is designed to answer.
Contrast Sensitivity
Contrast sensitivity is the measurement of one's ability to detect slight changes in luminance before it becomes indistinguishable. It is measured in logarithmic units by means of an illuminated box, the CSV 1000 by Vector Vision. A higher value for the logarithmic units translates to better contrast sensitivity.
Measured: Day 90 postoperative
Secondary outcomes (6)
Total Higher Order Aberrations
A higher order aberration is a distortion acquired by a wavefront light when it passes through an eye with irregularities of its refractive components (tear film, cornea, aqueous humor, crystalline lens and vitreous humor). It is measured via wavefront measurements according to manufacturer's instructions with a LADARWave (Alcon Laboratories, Inc., Ft. Worth TX).
Measured: Day 90 postoperative
Corneal Spherical Aberration
Corneal spherical aberration is the blurring of an image that occurs when light from the margin of a lens or mirror with a spherical surface comes to a shorter focus than light from the central portion. The changing focal length is caused by deviations in the lens or mirror surface from a true sphere and is measured by corneal topography with a commercially available topographer in accordance with manufacturer's guidelines.
Measured: Day 90 postoperative
Uncorrected Visual Acuity (UCVA)
Uncorrected visual acuity, i.e., visual acuity without any type of corrective lenses, is measured in logMAR. LogMAR is the "logarithm of the minimum angle of resolution," and a lower logMAR value indicates better visual acuity.
Measured: Day 90 postoperative
Best Corrected Visual Acuity (BCVA)
Best corrected visual acuity, i.e., visual correction utilizing a phoropter or trial frames, is measured in logMAR. LogMAR is the "logarithm of the minimum angle of resolution," and a lower logMAR value indicates better visual acuity.
Measured: Day 90 postoperative
Low Contrast (10%) Visual Acuity
Visual acuity is tested using 10% contrast ETDRS (Early Treatment Diabetic Retinopathy Study) charts under photopic conditions. Testing is performed using the correction from the manifest refraction at a distance calibrated for the chart. Visual acuity (VA) is measured in logMAR. LogMAR is the "logarithm of the minimum angle of resolution," and a lower logMAR value indicates better visual acuity.
Measured: Day 90 postoperative
Quality of Vision Questionnaire
As completed by the participant.
Measured: Day 90 postoperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Aug 2010 (estimated)
- Study startJul 2010
- Primary completionNov 2011
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 N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 100 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
- NCT01190631
- Sponsor's protocol ID
- M-10-008
- Status last verified
- Nov 2012
- First submitted
- 26 Aug 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
- An Assessment of Residual Spherical Aberration, Postoperative Total High Order Aberrations, and Functional Vision Correlation After SN60WF IOL Implantation
- ClinicalTrials.gov ID
- NCT01190631
- Acronym / sponsor ID
- M-10-008
- Conditions
- Cataracts
- Keywords
- intraocular lens, cataracts, total residual spherical aberration, high order aberrations
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Alcon ResearchIndustry (pharma, biotech, devices)
- Study start
- Jul 2010
- Primary completion
- Nov 2011 (actual)
- First posted
- 27 Aug 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 total residual spherical aberration (TSA) post-IOL implantation, and to determine if an association exists between TSA, postoperative high order aberrations (HOA), and functional vision following IOL implantation in patients grouped by pre-operative corneal spherical aberration (CSA).
Detailed description
Patients will be grouped by pre-operative corneal spherical aberration (CSA) measures, i.e., ≤0.230 micron and ≥0.270 micron.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- Double blind (participant, care provider)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Acrysof IQ (SN60WF) IOL | Experimental | Device: Acrysof IQ (SN60WF) IOLAcrySof IQ SN60WF intraocular lens (IOL) implanted in one eye only during cataract surgery. |
Who may qualify
- Ages
- 40 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Age-related cataract grade 3 or lower in at least one eye;
- Planned cataract removal via phacoemulsification with an implantation of an aspheric IOL;
- Able to have an operation within 30 days of preoperative evaluation;
- Good ocular health, with the exception of cataracts;
- ≤ 1.50 diopter (D) of preoperative astigmatism by keratometry;
Key exclusion criteria (13 listed)
- Preoperative ocular pathology as specified in protocol;
- Preoperative corneal pathology as specified in protocol;
- Keratometric astigmatism exceeding 1.50 diopter;
- Planned postoperative refraction for mono-vision;
- Uncontrolled diabetes;
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 (SN60WF) IOLAlso: Acrysof® IQ Model SN60WFAcrysof IQ (SN60WF) intraocular lens implanted in the capsular bag of the eye during cataract surgery. The IOL is intended for the lifetime of the patient. Unilateral (one eye only) implantation is planned. | Device | Acrysof IQ (SN60WF) IOL |
Primary outcome
Contrast Sensitivity
Time frame: Day 90 postoperative
Contrast sensitivity is the measurement of one's ability to detect slight changes in luminance before it becomes indistinguishable. It is measured in logarithmic units by means of an illuminated box, the CSV 1000 by Vector Vision. A higher value for the logarithmic units translates to better contrast sensitivity.
6 secondary outcomes
Total Higher Order Aberrations
Time frame: Day 90 postoperative
Corneal Spherical Aberration
Time frame: Day 90 postoperative
Uncorrected Visual Acuity (UCVA)
Time frame: Day 90 postoperative
Best Corrected Visual Acuity (BCVA)
Time frame: Day 90 postoperative
Low Contrast (10%) Visual Acuity
Time frame: Day 90 postoperative
Quality of Vision Questionnaire
Time frame: Day 90 postoperative
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.
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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 Acrysof IQ (SN60WF) IOL 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 9 inclusion and 13 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?
Contrast Sensitivity (time frame: Day 90 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.