CataractNCT00720005
Evaluation of the Aspheric ReSTOR IOL After Routine Cataract Extraction
An observational study of Cataract, run by Medical University of South Carolina at 1 site in United States.
Trial summary
The purpose of this study is to evaluate the visual outcomes and patient satisfaction after bilateral implantation of the aspheric ReSTOR multifocal intraocular lens (IOL) and compare it to a historical control group of patients implanted bilaterally with the spherical ReSTOR multifocal Read more about this study
- Who is it for?
- Ages 40 to 90 years
- Conditions the study is for
- Cataract
- What is being tested?
- Aspheric Acrysof ReSTOR intraocular lens
- Type of treatment
- Medical device
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2007to Dec 2008
- 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 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Subjects 18 years or older who had cataract surgery.
Who may be able to join
- Subject must have an age-related cataract in both eyes.
- 40 years of age or older.
- Patient must desire cataract extraction.
- Expected maximum of 2 weeks and minimum of 1-week interval between first and second eye surgeries.
- Willing and able to comply with scheduled visits and other study procedures
Who cannot join
- Preoperative ocular pathology potentially affecting visual acuity.
- Keratometric astigmatism exceeding 1.50 diopters.
- Planned postoperative refraction for mono-vision.
- 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.
Show all 12Show fewer
- 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.
- Intraocular conventional surgery within the past three months or intraocular laser surgery within one month in the operated eye.
- Other ocular surgery at the time of the cataract extraction.
Trial locations and contacts
1 site in 1 country.
United States1 site
Storm Eye Institute, Medical University of South Carolina
Charleston, South Carolina, 29425
About this study
The purpose of this study is to evaluate the visual outcomes and patient satisfaction after bilateral implantation of the aspheric ReSTOR multifocal intraocular lens (IOL) and compare it to a historical control group of patients implanted bilaterally with the spherical ReSTOR multifocal
Read the detailed description
The purpose of this study is to evaluate the visual outcomes and patient satisfaction after bilateral implantation of the aspheric ReSTOR multifocal intraocular lens (IOL) and compare it to a historical control group of patients implanted bilaterally with the spherical ReSTOR multifocal.
- Conditions
- Cataract
- Being tested
- Aspheric Acrysof ReSTOR intraocular lens
- Keywords
- Cataract, cataract extraction, intraocular lens, age related
- Medical subject headings
- Cataract
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Aspheric Acrysof ReSTOR intraocular lensDevice
Also called Acrysof ReSTOR
Bilateral implantation of Aspheric Acrysof ReSTOR
| Study group | Role | What they receive |
|---|---|---|
| Aspheric Acrysof ResTOR Lens | Implantation of Aspheric Acrysof ResTOR Receives: Device: Aspheric Acrysof ReSTOR intraocular lens |
What is being measured
The primary outcome is the main question the study is designed to answer.
ETDRS uncorrected and best corrected visual acuity at distance, intermediate, and near, manifest refraction, distance corrected near visual acuity (DCNVA), and best near point (optimal reading distance).
Measured: Preoperatively, 1, 3 and 6 months postoperatively
Secondary outcomes (1)
pupil size and contrast sensitivity under photopic and mesopic conditions wearing the best distance correction (the latter per eye and both eyes. Slit-lamp exam, eye dominance, reading speed test, and a quality of vision questionnaire.
Measured: preoperatively, 1, 3, 6 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jul 2008 (estimated)
- Study startSep 2007
- Primary completionDec 2008
- Study completionDec 2008
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 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
- Observational
- Observational model
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medical University of South Carolina
- Sponsor type
- University, hospital or other
- Investigators
- Kerry D. Solomon, MD, Principal investigator, Assistant Professor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00720005
- Sponsor's protocol ID
- MRC-07-002
- Status last verified
- Oct 2010
- First submitted
- 18 Jul 2008
- Last updated
- 4 Oct 2010
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Oct 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Aspheric ReSTOR IOL After Routine Cataract Extraction
- ClinicalTrials.gov ID
- NCT00720005
- Acronym / sponsor ID
- MRC-07-002
- Conditions
- Cataract
- Keywords
- Cataract, cataract extraction, intraocular lens, age related
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Medical University of South CarolinaUniversity, hospital or other
- Study start
- Sep 2007
- Primary completion
- Dec 2008 (actual)
- Study completion
- Dec 2008 (actual)
- First posted
- 22 Jul 2008 (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 the visual outcomes and patient satisfaction after bilateral implantation of the aspheric ReSTOR multifocal intraocular lens (IOL) and compare it to a historical control group of patients implanted bilaterally with the spherical ReSTOR multifocal
Detailed description
The purpose of this study is to evaluate the visual outcomes and patient satisfaction after bilateral implantation of the aspheric ReSTOR multifocal intraocular lens (IOL) and compare it to a historical control group of patients implanted bilaterally with the spherical ReSTOR multifocal.
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Aspheric Acrysof ResTOR Lens | – | Device: Aspheric Acrysof ReSTOR intraocular lensImplantation of Aspheric Acrysof ResTOR |
Who may qualify
- Ages
- 40 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Subjects 18 years or older who had cataract surgery.
Key inclusion criteria (5 listed)
- Subject must have an age-related cataract in both eyes.
- 40 years of age or older.
- Patient must desire cataract extraction.
- Expected maximum of 2 weeks and minimum of 1-week interval between first and second eye surgeries.
- Willing and able to comply with scheduled visits and other study procedures
Key exclusion criteria (12 listed)
- Preoperative ocular pathology potentially affecting visual acuity.
- Keratometric astigmatism exceeding 1.50 diopters.
- Planned postoperative refraction for mono-vision.
- Uncontrolled diabetes.
- Use of any systemic or topical drug known to interfere with visual performance.
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 |
|---|---|---|
| Aspheric Acrysof ReSTOR intraocular lensAlso: Acrysof ReSTORBilateral implantation of Aspheric Acrysof ReSTOR | Device | Aspheric Acrysof ResTOR Lens |
Primary outcome
ETDRS uncorrected and best corrected visual acuity at distance, intermediate, and near, manifest refraction, distance corrected near visual acuity (DCNVA), and best near point (optimal reading distance).
Time frame: Preoperatively, 1, 3 and 6 months postoperatively
1 secondary outcome
pupil size and contrast sensitivity under photopic and mesopic conditions wearing the best distance correction (the latter per eye and both eyes. Slit-lamp exam, eye dominance, reading speed test, and a quality of vision questionnaire.
Time frame: preoperatively, 1, 3, 6 month
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 4 Oct 2010.
Related trials for Cataract
Recruiting
Implementing AI-based Glaucoma Screening Within Federally Qualified Health Centers
Glaucoma, Ocular Hypertension
Not yet recruiting
Trial to Investigate the Safety and Effectiveness of the KI-362-US1 (YP2.2VM) Intraocular Lens (IOL) in Adult Participants for Correction of Aphakia Following Cataract Extraction
Aphakia, Postcataract
Not yet recruiting
Effects of Oxygen Cage Support During Cataract Surgery
Cataract
Active, not recruitingObservational study
Age-Related Eye Disease Study (AREDS) Follow-Up
Age-Related Macular Degeneration, Cataract
RecruitingObservational study
Objective Depth-of-Focus Changes During Light Adjustable Lens UV Adjustments
Light Adjustable Lens, Objective Depth of Focus
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
Assistant 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, 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 5 inclusion and 12 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 4 Oct 2010. 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?
ETDRS uncorrected and best corrected visual acuity at distance, intermediate, and near, manifest refraction, distance corrected near visual acuity (DCNVA), and best near point (optimal reading distance). (time frame: Preoperatively, 1, 3 and 6 months postoperatively). 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 4 Oct 2010.