Cataract ExtractionNCT00366496
Surgical Outcomes After Routine Cataract Extraction & Implantation of a Conventional or Spheric Intraocular Lens
A study testing Acrysof single piece (SA60AT) and Acrysof IQ (SN60WF) in people with Cataract Extraction, run by Medical University of South Carolina.
Trial summary
To determine quality of vision post cataract extraction and intraocular lens (IOL) implantation of 2 different acrylic intraocular lenses: Acrysof® Single-Piece IOL and Acrysof® WF, through evaluation of contrast sensitivity, glare testing, visual outcomes, wavefront, corneal topography, and patient satisfaction. Read more about this study
- Who is it for?
- Ages 50 to 80 years
- Conditions the study is for
- Cataract Extraction
- What is being tested?
- Acrysof single piece (SA60AT) and Acrysof IQ (SN60WF)
- Type of treatment
- Medical device
- How many people
- 30 participants
- Where
- No sites listed yet
- Study dates
- Jul 2004to May 2005
- 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 50 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Unilateral or bilateral cataract
- Eligible for phacoemulsification with primary implantation of a posterior chamber IOL. If bilateral, patient will receive the same IOL than the fellow eye.
- Expected maximum of 4 weeks and minimum of 1 week interval between primary and second eye surgeries when bilateral.
- Best corrected visual acuity (BCVA) should be no better than 20/40 in the presence of a glare source using Snellen visual acuity. In the Snellen visual acuity chart, better than 20/40 will be at least 3 letters read correctly in the 20/30 line.
- Naturally dilated pupil (in dim light) ≥ 4.0 mm in both eyes.
Who cannot join
- Preoperative ocular pathology potentially affecting visual acuity
- Previous intraocular or corneal surgery.
- Keratometric astigmatism exceeding 1.5 diopters.
- Planned postoperative refraction for mono-vision.
- Current contact lens usage.
- Other ocular surgery at the time of the cataract extraction.
Show all 24Show fewer
- Uncontrolled diabetes.
- Any neurological condition that might interfere with performance of required test.
- Auto-immune deficiency disease.
- Other severe acute or chronic 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.
- Use of any systemic or topical drug known to interfere with visual performance.
- Surgical Exclusion Criteria
- Significant anterior chamber bleeding.
- Detached Descemet's membrane
- Iris damage
- Posterior capsule rupture
- Radial tear in capsulorhexis
- Vitreous loss
- Zonular rupture.
- Use of corneal sutures for more than 1 week.
- Post-implantation Exclusion Criteria
- Haptic not in the capsular bag.
- Descentration of the IOL of more than 1.0 mm
- Ocular pathologies potentially affecting visual acuity that were not evident prior to surgery.
About this study
Official title: Comparison of Visual Outcomes, Wavefront Analysis, Contrast Sensitivity and Glare Testing Following Cataract Extraction Between Acrysof Single-Piece IOL and Acrysof WF
To determine quality of vision post cataract extraction and intraocular lens (IOL) implantation of 2 different acrylic intraocular lenses: Acrysof® Single-Piece IOL and Acrysof® WF, through evaluation of contrast sensitivity, glare testing, visual outcomes, wavefront, corneal topography, and patient satisfaction.
- Conditions
- Cataract Extraction
- Being tested
- Acrysof single piece (SA60AT), Acrysof IQ (SN60WF)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Acrysof single piece (SA60AT)Device
Acrysof IQ (SN60WF)Device
What is being measured
The primary outcome is the main question the study is designed to answer.
Contrast sensitivity
Visual acuity
Secondary outcomes (3)
Induction of hight order aberrations
Corneal topography
Patient satisfaction
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Aug 2006 (estimated)
- Study startJul 2004
- Study completionMay 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cataract ExtractionStudies of the same condition, open and under way.
- More trials run by Medical University of South CarolinaThe 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
- Double blind
- Enrolment
- 30 participants
Sponsor and investigators
- Lead sponsor
- Medical University of South Carolina
- Sponsor type
- University, hospital or other
- Investigators
- Kerry D. Solomon, MD, Principal investigator, Medical University of South Carolina
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00366496
- Sponsor's protocol ID
- MRC-05-004
- Status last verified
- Jul 2005
- First submitted
- 17 Aug 2006
- Last updated
- 21 Aug 2006
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Aug 2006. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Visual Outcomes, Wavefront Analysis, Contrast Sensitivity and Glare Testing Following Cataract Extraction Between Acrysof Single-Piece IOL and Acrysof WF
- ClinicalTrials.gov ID
- NCT00366496
- Acronym / sponsor ID
- MRC-05-004
- Conditions
- Cataract Extraction
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants
- Lead sponsor
- Medical University of South CarolinaUniversity, hospital or other
- Study start
- Jul 2004
- Study completion
- May 2005
- First posted
- 21 Aug 2006 (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 determine quality of vision post cataract extraction and intraocular lens (IOL) implantation of 2 different acrylic intraocular lenses: Acrysof® Single-Piece IOL and Acrysof® WF, through evaluation of contrast sensitivity, glare testing, visual outcomes, wavefront, corneal topography, and patient satisfaction.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Who may qualify
- Ages
- 50 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Unilateral or bilateral cataract
- Eligible for phacoemulsification with primary implantation of a posterior chamber IOL. If bilateral, patient will receive the same IOL than the fellow eye.
- Expected maximum of 4 weeks and minimum of 1 week interval between primary and second eye surgeries when bilateral.
- Best corrected visual acuity (BCVA) should be no better than 20/40 in the presence of a glare source using Snellen visual acuity. In the Snellen visual acuity chart, better than 20/40 will be at least 3 letters read correctly in the 20/30 line.
- Naturally dilated pupil (in dim light) ≥ 4.0 mm in both eyes.
Key exclusion criteria (24 listed)
- Preoperative ocular pathology potentially affecting visual acuity
- Previous intraocular or corneal surgery.
- Keratometric astigmatism exceeding 1.5 diopters.
- Planned postoperative refraction for mono-vision.
- Current contact lens usage.
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 (SA60AT) | Device | – |
| Acrysof IQ (SN60WF) | Device | – |
Primary outcome
Contrast sensitivity
Visual acuity
3 secondary outcomes
Induction of hight order aberrations
Corneal topography
Patient satisfaction
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 21 Aug 2006.
Related trials for Cataract Extraction
Enrolling by invitation
Effectiveness of a Large Language Model-Based Educational Tool on Intraocular Lens Options
Eye Disorders, Cataract Extraction
RecruitingPhase 3
PRO-232 in Patients Subjected to Cataract Surgery
Cataract Extraction
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.
Kerry D. Solomon, MD principal investigator
Medical University of South Carolina
Questions about this trial
What is this clinical trial studying?
A study testing Acrysof single piece (SA60AT) and Acrysof IQ (SN60WF) in people with Cataract Extraction, run by Medical University of South Carolina.
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 5 inclusion and 24 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 21 Aug 2006. Status can change between updates, so confirm with the study contact before making plans.
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. The study lists 2 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 21 Aug 2006; AzTrials last refreshed its copy on 8 Nov 2026.