CataractNCT00886249
Depth of Focus Comparison Between Acrysof IQ and Acrysof Natural IOLs
An observational study of Cataract and Vision, run by Medical University of South Carolina at 1 site in United States.
Trial summary
The purpose of this study is to evaluate and compare the depth of focus and visual outcomes after implantation of the Acrysof IQ SN60WF aspheric intraocular lens (IOL) and the Acrysof Natural SN60AT spherical IOL. Read more about this study
- Who is it for?
- Ages 40 years and olderHealthy volunteers can take part
- What is being tested?
- Acrysof IQ and Acrysof Natural IOL
- Type of treatment
- Medical device
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2009to Oct 2009
- Phase
- Observational
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: A total of 50 patients of both sexes and any race undergoing routine bilateral phacoemulsification and intraocular lens implantation will be included.
Who may be able to join
- Patient Inclusion Criteria:
- Subject must have an age-related cataract in both eyes;
- Subject must be 40 years of age or older;
- Subject must desire cataract extraction;
- Expected maximum of 2 weeks and minimum of 1 week interval between the first and second eye surgeries; AND
- Subject must be willing and able to comply with scheduled visits and other study procedures.
Show all 30Show fewer
- Patient Exclusion Criteria:
- Preoperative ocular pathology: amblyopia, shallow anterior chamber, aniridia, history of iritis, iris neovascularization or iris atrophy, uveitis, medically uncontrolled glaucoma or advanced glaucomatous damage, rubella cataract, diabetic retinopathy, macular edema, retinal detachment, microphtalmus or macrophtalmus, optic nerve atrophy, macular degeneration (with anticipated best postoperative visual acuity less than 20/30), etc.;
- Keratometric astigmatism exceeding 1.5 diopters;
- Uncontrolled diabetes;
- Use of any systemic or topical drug known to interfere with visual performance;
- Contact lens use during the active treatment portion of the trial;
- Any concurrent infectious/non infectious conjunctivitis, keratitis or uveitis;
- Pregnant or nursing mothers and females of childbearing potential not practicing a reliable and medically acceptable method of birth control;
- 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.
- Prior history of eye surgery;
- Other ocular surgery at the time of the cataract extraction (except limbal relaxing incisions, LRI); OR
- History of trauma.
- Surgical Exclusion Criteria:
- The study lens should not be implanted and the patient should be excluded from the study if any of the following complications are encountered during surgery:
- Significant anterior chamber bleeding;
- Detached Descemet's membrane;
- Iris damage;
- Inability to achieve secure, symmetric, "in the bag" position of the IOL: posterior capsule rupture, radial tear in capsulorhexis, vitreous loss, zonular rupture; OR
- Use of corneal sutures for more than 1 week.
- Post-implantation Exclusion Criteria:
- Haptic not in the capsular bag;
- Decentration of the IOL of more than 1.0 mm; OR
- Ocular pathologies potentially affecting visual acuity that were not evident prior to surgery.
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
United States1 site
Medical University of South Carolina, Storm Eye Institute
Charleston, South Carolina, 29425
About this study
The purpose of this study is to evaluate and compare the depth of focus and visual outcomes after implantation of the Acrysof IQ SN60WF aspheric intraocular lens (IOL) and the Acrysof Natural SN60AT spherical IOL.
Read the detailed description
Cataract is prevalent throughout the world and IOLs are routinely implanted after the extraction of the cataractous lens. It is the most frequently performed surgery in the United States with an estimated 2-3 million procedures performed annually. With the aging population on the rise, as well as the increasing popularity of refractive intraocular lenses, the number of intraocular surgeries continues to rise.
Over the years, evolution of IOLs has broadened surgeon's armamentarium following cataract extraction. Traditionally spherical IOLs have been routinely implanted following cataract extraction for the correction of aphakia. Even though these IOLs improved the patient vision to 20/20 in most of the times, they did nott address the spherical aberration of the optical system.
Normally the cornea has a positive spherical aberration. Spherical aberration means that the light rays falling on the eye's periphery are either more (positive spherical aberration) or less (negative spherical aberration) refracted than the axial rays. Such aberration usually affects the functional vision of the patient such as contrast sensitivity, depth of focus (ability to see far, near and intermediate) and the perception of glare and haloes. Corneal spherical aberration is adequately neutralized by the negative spherical aberration of the crystalline lens until the age of 40. (1) When the cataractous lens is removed, the corneal spherical aberration is no longer neutralized and the optical system will have now a net positive spherical aberration.
Conventional IOLs implanted after phacoemulsification result in a spherical aberration of approximately 0.08 µm adding to the already positive corneal aberration of the eye. (2, 3) In order for the patient to reach the optimal functional vision, efforts have led to the development of the aspheric IOLs. Aspheric IOLs compensate for the positive spherical aberration of the cornea. They have been shown to improve the functional vision and optical quality in pseudophakic patients. (4, 5)
Acrysof IQ, an aspheric IOL was introduced after gaining FDA approval in May 2006. Its shares the basic design features of the Acrysof Natural IOL with the modifications of its optic design to acquire a posterior prolate surface reducing its central thickness. Unlike the cornea, it introduces negative spherical aberration (0.2 µm) that lowers the spherical aberration of the eye.(6) It has been reported to provide better contrast sensitivity, quality of vision and fewer aberration with the aspheric IOL compared to the conventional (spherical) IOL.(6,7,8) However, some studies have found that conventional (spherical) IOLs have better depth of focus than aspheric IOLs allowing the patient to achieve better intermediate and near vision.(5) Conversely, Mester et al found no difference in depth of focus between both IOLs.(7)
The purpose of this study is to evaluate and compare depth of focus and visual outcomes in eyes receiving the aspheric Acrysof IQ and those receiving the spherical Acrysof Natural IOL after routine cataract extraction.
- Being tested
- Acrysof IQ, Acrysof Natural IOL
- Keywords
- Vision, Eye, Cataract
- Medical subject headings
- Cataract
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Acrysof IQDevice
Also called Acrysof IQ SN60WF aspheric intraocular lens
Intraocular lens
Acrysof Natural IOLDevice
Also called Acrysof Natural SN60AT spherical IOL
Intraocular Lens
What is being measured
The primary outcome is the main question the study is designed to answer.
The purpose of this study is to evaluate and compare depth of focus and visual outcomes in eyes receiving the aspheric Acrysof IQ and those receiving the spherical Acrysof Natural IOL after routine cataract extraction.
Measured: six months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Apr 2009 (estimated)
- Study startMar 2009
- Primary completionOct 2009
- Study completionOct 2009
Why it stopped: The PI has determined not to continue the study.
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.
- 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
- Observational
- Observational model
- Case only
- Time perspective
- Retrospective
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medical University of South Carolina
- Sponsor type
- University, hospital or other
- Investigators
- Helga P Sandoval, MD, Principal investigator, Associate Professor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00886249
- Sponsor's protocol ID
- HR#29924
- Status last verified
- Oct 2009
- First submitted
- 21 Apr 2009
- Last updated
- 7 Jun 2018
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Jun 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Depth of Focus Comparison Between Acrysof IQ and Acrysof Natural IOLs
- ClinicalTrials.gov ID
- NCT00886249
- Acronym / sponsor ID
- HR#29924
- Keywords
- Vision, Eye, Cataract
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: The PI has determined not to continue the study.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Medical University of South CarolinaUniversity, hospital or other
- Study start
- Mar 2009
- Primary completion
- Oct 2009 (actual)
- Study completion
- Oct 2009 (actual)
- First posted
- 22 Apr 2009 (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 is to evaluate and compare the depth of focus and visual outcomes after implantation of the Acrysof IQ SN60WF aspheric intraocular lens (IOL) and the Acrysof Natural SN60AT spherical IOL.
Detailed description
Cataract is prevalent throughout the world and IOLs are routinely implanted after the extraction of the cataractous lens. It is the most frequently performed surgery in the United States with an estimated 2-3 million procedures performed annually. With the aging population on the rise, as well as the increasing popularity of refractive intraocular lenses, the number of intraocular surgeries continues to rise.
Over the years, evolution of IOLs has broadened surgeon's armamentarium following cataract extraction. Traditionally spherical IOLs have been routinely implanted following cataract extraction for the correction of aphakia. Even though these IOLs improved the patient vision to 20/20 in most of the times, they did nott address the spherical aberration of the optical system.
Normally the cornea has a positive spherical aberration. Spherical aberration means that the light rays falling on the eye's periphery are either more (positive spherical aberration) or less (negative spherical aberration) refracted than the axial rays. Such aberration usually affects the functional vision of the patient such as contrast sensitivity, depth of focus (ability to see far, near and intermediate) and the perception of glare and haloes. Corneal spherical aberration is adequately neutralized by the negative spherical aberration of the crystalline lens until the age of 40. (1) When the cataractous lens is removed, the corneal spherical aberration is no longer neutralized and the optical system will have now a net positive spherical aberration.
Conventional IOLs implanted after phacoemulsification result in a spherical aberration of approximately 0.08 µm adding to the already positive corneal aberration of the eye. (2, 3) In order for the patient to reach the optimal functional vision, efforts have led to the development of the aspheric IOLs. Aspheric IOLs compensate for the positive spherical aberration of the cornea. They have been shown to improve the functional vision and optical quality in pseudophakic patients. (4, 5)
Acrysof IQ, an aspheric IOL was introduced after gaining FDA approval in May 2006. Its shares the basic design features of the Acrysof Natural IOL with the modifications of its optic design to acquire a posterior prolate surface reducing its central thickness. Unlike the cornea, it introduces negative spherical aberration (0.2 µm) that lowers the spherical aberration of the eye.(6) It has been reported to provide better contrast sensitivity, quality of vision and fewer aberration with the aspheric IOL compared to the conventional (spherical) IOL.(6,7,8) However, some studies have found that conventional (spherical) IOLs have better depth of focus than aspheric IOLs allowing the patient to achieve better intermediate and near vision.(5) Conversely, Mester et al found no difference in depth of focus between both IOLs.(7)
The purpose of this study is to evaluate and compare depth of focus and visual outcomes in eyes receiving the aspheric Acrysof IQ and those receiving the spherical Acrysof Natural IOL after routine cataract extraction.
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- A total of 50 patients of both sexes and any race undergoing routine bilateral phacoemulsification and intraocular lens implantation will be included.
Key inclusion criteria (30 listed)
- Subject must have an age-related cataract in both eyes;
- Subject must be 40 years of age or older;
- Subject must desire cataract extraction;
- Expected maximum of 2 weeks and minimum of 1 week interval between the first and second eye surgeries; AND
- Subject must be willing and able to comply with scheduled visits and other study procedures.
Key exclusion criteria (0 listed)
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 IQAlso: Acrysof IQ SN60WF aspheric intraocular lensIntraocular lens | Device | – |
| Acrysof Natural IOLAlso: Acrysof Natural SN60AT spherical IOLIntraocular Lens | Device | – |
Primary outcome
The purpose of this study is to evaluate and compare depth of focus and visual outcomes in eyes receiving the aspheric Acrysof IQ and those receiving the spherical Acrysof Natural IOL after routine cataract extraction.
Time frame: six months
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jun 2018.
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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.
Helga P Sandoval, MD principal investigator
Associate Professor
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cataract and Vision, run by Medical University of South Carolina 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 30 inclusion and 0 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: withdrawn, as of the sponsor's last update on 7 Jun 2018. 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 was withdrawn before enrolling participants, so there are no results.
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?
The purpose of this study is to evaluate and compare depth of focus and visual outcomes in eyes receiving the aspheric Acrysof IQ and those receiving the spherical Acrysof Natural IOL after routine cataract extraction. (time frame: six months). 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 7 Jun 2018.