Bilateral CataractNCT00967473
ACRYSOF® Toric NATURAL T9 Intraocular Lens (IOL)
A study testing ACRYSOF® Single-Piece NATURAL Toric IOL Model SN60T9 and Model SN60T8. in people with Bilateral Cataract, run by Alcon Research at 1 site in United States.
Trial summary
The purpose of this study is to describe rates of spatial distortions related to intraocular lens (IOL) misalignment for ACRYSOF® Single-Piece Toric NATURAL IOL Model SN60T9 when implanted bilaterally into the capsular bag following phacoemulsification in adult patients with bilateral cataract and regular corneal… Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- Bilateral Cataract
- What is being tested?
- ACRYSOF® Single-Piece NATURAL Toric IOL Model SN60T9 and Model SN60T8.
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2009to May 2010
- Phase
- Interventional
- 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
- Adults, 21 years of age or older at the time of surgery, of either gender or any race, diagnosed with bilateral cataracts;
- Calculated lens power is within the available range;
- Willing and able to complete all required postoperative visits;
- Planned cataract removal by phacoemulsification;
- Potential postoperative visual acuity of 0.2 logMAR or better in study eyes;
- Preoperative astigmatism of 4.11 - 4.62 Diopter (D) of predicted crossed cylinder as calculated by the study specific web-based Alcon® Toric IOL Calculator in the first operative eye. Corneal incisions made to reduce astigmatism will not be allowed during the course of the study;
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- Preoperative astigmatism of 3.60 - 4.62 D of predicted crossed cylinder as calculated by study specific web-based Alcon® Toric IOL Calculator in the second operative eye;
- Clear intraocular media other than cataract;
- Able to comprehend and sign a statement of informed consent;
- Preoperative Best Corrected Distance Visual Acuity (BCDVA) worse than 0.2 logMAR;
- Pupil size greater than or equal to 6 mm after dilation;
- The subject must be able to undergo second eye surgery within 30 days of first eye surgery.
Who cannot join
- Irregular corneal astigmatism;
- Keratopathy/Keratectasia - any corneal abnormality, other than regular corneal astigmatism, including but not limited to the following; keratoconus, keratoglobus, keratolysis, keratomalacia, keratomycosis, and corneal plana;
- Any inflammation or edema (swelling) of the cornea, including but not limited to the following; keratitis, keratoconjunctivitis, and keratouveitis;
- Previous corneal refractive surgery;
- Subjects with diagnosed degenerative visual disorders (e.g., macular degeneration or other retinal disorders) that are predicted to cause future acuity losses to a level worse than 0.2 logMAR;
- Amblyopia;
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- Clinically severe corneal dystrophy (e.g., epithelial, stromal, or endothelial dystrophy);
- Diabetic retinopathy;
- Extremely shallow anterior chamber, not due to swollen cataract;
- Microphthalmos;
- Previous retinal detachment;
- Previous corneal transplant;
- Recurrent severe anterior or posterior segment inflammation of unknown etiology;
- Rubella or traumatic cataract;
- Iris neovascularization;
- Uncontrolled glaucoma;
- Aniridia;
- Optic nerve atrophy;
- Pregnancy;
- Any subject currently participating in another investigational drug or device study that may confound the results of this investigation.
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
The purpose of this study is to describe rates of spatial distortions related to intraocular lens (IOL) misalignment for ACRYSOF® Single-Piece Toric NATURAL IOL Model SN60T9 when implanted bilaterally into the capsular bag following phacoemulsification in adult patients with bilateral cataract and regular corneal astigmatism. Subjects were implanted with the Model SN60T9 in the first operative (study) eye and either Model SN60T9 or Model SN60T8 in the second operative eye.
- Conditions
- Bilateral Cataract
- Being tested
- ACRYSOF® Single-Piece NATURAL Toric IOL Model SN60T9 and Model SN60T8.
- Keywords
- Astigmatism, cataract, corneal astigmatism, IOL, AcrySof
- Medical subject headings
- Cataract, Astigmatism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ACRYSOF® Single-Piece NATURAL Toric IOL Model SN60T9 and Model SN60T8.Device
ACRYSOF® Single-Piece Toric NATURAL Intraocular Lens (IOL) Model SN60T9 in the first eye and either the ACRYSOF® Single-Piece Toric NATURAL IOL Model SN60T9 or Model SN60T8 in the second eye.
| Study group | Role | What they receive |
|---|---|---|
| Toric Intraocular Lens | Experimental | ACRYSOF® Single-Piece Toric NATURAL Intraocular Lens (IOL) Models SN60T9/SN60T8 Receives: Device: ACRYSOF® Single-Piece NATURAL Toric IOL Model SN60T9 and Model SN60T8. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Subjects Reporting Spatial Distortions Related to Intraocular Lens (IOL) Misalignment
Rates of spatial distortions were evaluated by use of the Visual Distortion Questionnaire (VDQ). The VDQ evaluates the rate \& frequency of subjects' experiences with potential visual distortions. The fewer the patients that report visual distortions, the better. The VDQ is a binocular assessment, therfore the subject will use both eyes to evaluate visual distortions.
Measured: Before Surgery and 180 days after second eye implant
Reduction of Cylinder
Percentage of subjects with reduction in post-operative refractive cylinder (amount of astigmatism) compared to pre-operative keratometric cylinder in the study eye. The post-operative refractive cylinder should be significantly lower than it was pre-operatively.
Measured: 6 months after surgery on second eye
Lens Axis Misalignment
Comparison of where the surgeon intended to place the lens axis versus final placement of the lens during the surgical procedure, measured in degrees. This number should be close to zero as there should be minimal difference between the two numbers. This assessment is only for the study eye.
Measured: Time of surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Aug 2009 (estimated)
- Study startAug 2009
- Primary completionMay 2010
- Study completionMay 2010
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 Bilateral 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 N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 15 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
- NCT00967473
- Sponsor's protocol ID
- C-08-062
- Status last verified
- Jun 2011
- First submitted
- 25 Aug 2009
- Last updated
- 9 Jan 2017
- 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 Jan 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- ACRYSOF® Toric NATURAL T9 Intraocular Lens (IOL)
- ClinicalTrials.gov ID
- NCT00967473
- Acronym / sponsor ID
- C-08-062
- Conditions
- Bilateral Cataract
- Keywords
- Astigmatism, cataract, corneal astigmatism, IOL, AcrySof
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- Alcon ResearchIndustry (pharma, biotech, devices)
- Study start
- Aug 2009
- Primary completion
- May 2010 (actual)
- Study completion
- May 2010 (actual)
- First posted
- 27 Aug 2009 (estimated)
- Results
- Posted 22 Jul 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 describe rates of spatial distortions related to intraocular lens (IOL) misalignment for ACRYSOF® Single-Piece Toric NATURAL IOL Model SN60T9 when implanted bilaterally into the capsular bag following phacoemulsification in adult patients with bilateral cataract and regular corneal astigmatism. Subjects were implanted with the Model SN60T9 in the first operative (study) eye and either Model SN60T9 or Model SN60T8 in the second operative eye.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Toric Intraocular Lens | Experimental | Device: ACRYSOF® Single-Piece NATURAL Toric IOL Model SN60T9 and Model SN60T8.ACRYSOF® Single-Piece Toric NATURAL Intraocular Lens (IOL) Models SN60T9/SN60T8 |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- Adults, 21 years of age or older at the time of surgery, of either gender or any race, diagnosed with bilateral cataracts;
- Calculated lens power is within the available range;
- Willing and able to complete all required postoperative visits;
- Planned cataract removal by phacoemulsification;
- Potential postoperative visual acuity of 0.2 logMAR or better in study eyes;
Key exclusion criteria (20 listed)
- Irregular corneal astigmatism;
- Keratopathy/Keratectasia - any corneal abnormality, other than regular corneal astigmatism, including but not limited to the following; keratoconus, keratoglobus, keratolysis, keratomalacia, keratomycosis, and corneal plana;
- Any inflammation or edema (swelling) of the cornea, including but not limited to the following; keratitis, keratoconjunctivitis, and keratouveitis;
- Previous corneal refractive surgery;
- Subjects with diagnosed degenerative visual disorders (e.g., macular degeneration or other retinal disorders) that are predicted to cause future acuity losses to a level worse than 0.2 logMAR;
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® Single-Piece NATURAL Toric IOL Model SN60T9 and Model SN60T8.ACRYSOF® Single-Piece Toric NATURAL Intraocular Lens (IOL) Model SN60T9 in the first eye and either the ACRYSOF® Single-Piece Toric NATURAL IOL Model SN60T9 or Model SN60T8 in the second eye. | Device | Toric Intraocular Lens |
Primary outcome
Number of Subjects Reporting Spatial Distortions Related to Intraocular Lens (IOL) Misalignment
Time frame: Before Surgery and 180 days after second eye implant
Rates of spatial distortions were evaluated by use of the Visual Distortion Questionnaire (VDQ). The VDQ evaluates the rate \& frequency of subjects' experiences with potential visual distortions. The fewer the patients that report visual distortions, the better. The VDQ is a binocular assessment, therfore the subject will use both eyes to evaluate visual distortions.
Reduction of Cylinder
Time frame: 6 months after surgery on second eye
Percentage of subjects with reduction in post-operative refractive cylinder (amount of astigmatism) compared to pre-operative keratometric cylinder in the study eye. The post-operative refractive cylinder should be significantly lower than it was pre-operatively.
Lens Axis Misalignment
Time frame: Time of surgery
Comparison of where the surgeon intended to place the lens axis versus final placement of the lens during the surgical procedure, measured in degrees. This number should be close to zero as there should be minimal difference between the two numbers. This assessment is only for the study eye.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jan 2017.
- 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 study testing ACRYSOF® Single-Piece NATURAL Toric IOL Model SN60T9 and Model SN60T8. in people with Bilateral 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 12 inclusion and 20 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 Jan 2017. 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?
Yes. Results are posted in the registry (first posted 22 Jul 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?
Number of Subjects Reporting Spatial Distortions Related to Intraocular Lens (IOL) Misalignment (time frame: Before Surgery and 180 days after second eye implant). The study lists 3 primary outcomes in all. 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 Jan 2017.