Outcomes Following Restor IOL Lens ImplantNCT00344578
Clinical Outcomes After AcrySof® ReStor IOL Surgery in Faculty Practice at UTSW Medical Center at Dallas: A Retrospective Review
An observational study of Outcomes Following Restor IOL Lens Implant, run by University of Texas Southwestern Medical Center at 2 sites in United States.
Trial summary
To evaluate the clinical outcomes of AcrySof® ReSTOR® IOL for the Faculty Practice at UTSW Medical Center at Dallas Read more about this study
- Who is it for?
- Ages 18 to 90 yearsHealthy volunteers can take part
- Conditions the study is for
- Outcomes Following Restor IOL Lens Implant
- What is being tested?
- Restor IOL
- Type of treatment
- Medical device
- How many people
- 120 participants
- Where
- 2 sitesUnited States
- Study dates
- Mar 2006to Jul 2007
- 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 18 to 90 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: All patients of any race and sex between the ages of 18-90 years of age who have undergone ReSTOR® IOL cataract surgery will be recruited in this retrospective project.
Who may be able to join
- All patients of any race and sex between the ages of 18-90 years of age who have undergone ReSTOR® IOL cataract surgery will be recruited in this retrospective project.
Who cannot join
- Patients who underwent conventional IOL cataract extraction surgery
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Aston Ambulatory Care Center
Dallas, Texas, 75390-8866
UTSW Medical Center at Dallas
Dallas, Texas, 75390
About this study
To evaluate the clinical outcomes of AcrySof® ReSTOR® IOL for the Faculty Practice at UTSW Medical Center at Dallas
Read the detailed description
The AcrySof® ReSTOR® intraocular lens (IOL) is the latest advance in vision surgery. This IOL has been uniquely designed to improve vision throughout the entire visual spectrum, up close, far away and everything in-between. Thus, giving cataract patients their best chance ever to function free of glasses.
The pre-operative and post-operative data from ReSTOR® IOL implant cataract surgeries will be analyzed to determine whether the desired outcome was achieved, i.e. excellent vision with no correction. Variables to be studied include patient age, gender, number of ReSTOR® IOL implants, ocular comorbidities, preoperative and postoperative corrected and uncorrected visual acuities, keratometry readings, and corneal topography readings. A patient survey will also be sent to patients having undergone the surgery to measure their level of satisfaction.
Project Goals: The ultimate outcome of this project is to learn more insight on the following:
- Visual acuity with and without correction of distance and near at 3-6 months
- Percent of patients requiring keratorefractive surgery
- Ocular comorbidity subgroup analysis
- Monocular implantation subanalysis (prior to LASIK)
- Comparison of post-op spherical equivalent to target refraction
- Posterior capsule opacity that may be treated with laser procedure known as a YAG laser capsulotomy?
- Subjective patient satisfaction
- Validated questionnaire assessing visual function and quality of life
- Being tested
- Restor IOL
- Keywords
- Higher Order Abberations
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Restor IOLDevice
What is being measured
The primary outcome is the main question the study is designed to answer.
1)Visual acuity with and without correction of distance and near at 3-6 months
Secondary outcomes (7)
Percent of patients requiring keratorefractive surgery
Ocular comorbidity subgroup analysis
Monocular implantation subanalysis (prior to LASIK)
Comparison of post-op spherical equivalent to target refraction
Posterior capsule opacity that may be treated with laser procedure known as a YAG laser capsulotomy?
Subjective patient satisfaction
Validated questionnaire assessing visual function and quality of life
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jun 2006 (estimated)
- Study startMar 2006
- Primary completionJul 2007
- Study completionJul 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Outcomes Following Restor IOL Lens ImplantStudies of the same condition, open and under way.
- More trials run by University of Texas Southwestern Medical CenterThe 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
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Texas Southwestern Medical Center
- Sponsor type
- University, hospital or other
- Investigators
- Adam Fedyk, MD, Principal investigator, UTSW Medical Center at DallasVinod Mootha, MD, Study director, UTSW Medical Center at DallasJames McCulley, MD, Study chair, UTSW Medical Center at Dallas
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00344578
- Sponsor's protocol ID
- Fedyk001
- Status last verified
- Jun 2006
- First submitted
- 23 Jun 2006
- Last updated
- 23 Mar 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Mar 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Outcomes After AcrySof® ReStor IOL Surgery in Faculty Practice at UTSW Medical Center at Dallas: A Retrospective Review
- ClinicalTrials.gov ID
- NCT00344578
- Acronym / sponsor ID
- Fedyk001
- Keywords
- Higher Order Abberations
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- University of Texas Southwestern Medical CenterUniversity, hospital or other
- Study start
- Mar 2006
- Primary completion
- Jul 2007 (actual)
- Study completion
- Jul 2007 (actual)
- First posted
- 27 Jun 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 evaluate the clinical outcomes of AcrySof® ReSTOR® IOL for the Faculty Practice at UTSW Medical Center at Dallas
Detailed description
The AcrySof® ReSTOR® intraocular lens (IOL) is the latest advance in vision surgery. This IOL has been uniquely designed to improve vision throughout the entire visual spectrum, up close, far away and everything in-between. Thus, giving cataract patients their best chance ever to function free of glasses.
The pre-operative and post-operative data from ReSTOR® IOL implant cataract surgeries will be analyzed to determine whether the desired outcome was achieved, i.e. excellent vision with no correction. Variables to be studied include patient age, gender, number of ReSTOR® IOL implants, ocular comorbidities, preoperative and postoperative corrected and uncorrected visual acuities, keratometry readings, and corneal topography readings. A patient survey will also be sent to patients having undergone the surgery to measure their level of satisfaction.
Project Goals: The ultimate outcome of this project is to learn more insight on the following:
- Visual acuity with and without correction of distance and near at 3-6 months
- Percent of patients requiring keratorefractive surgery
- Ocular comorbidity subgroup analysis
- Monocular implantation subanalysis (prior to LASIK)
- Comparison of post-op spherical equivalent to target refraction
- Posterior capsule opacity that may be treated with laser procedure known as a YAG laser capsulotomy?
- Subjective patient satisfaction
- Validated questionnaire assessing visual function and quality of life
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- All patients of any race and sex between the ages of 18-90 years of age who have undergone ReSTOR® IOL cataract surgery will be recruited in this retrospective project.
Key inclusion criteria (1 listed)
- All patients of any race and sex between the ages of 18-90 years of age who have undergone ReSTOR® IOL cataract surgery will be recruited in this retrospective project.
Key exclusion criteria (1 listed)
- Patients who underwent conventional IOL cataract extraction surgery
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 |
|---|---|---|
| Restor IOL | Device | – |
Primary outcome
1)Visual acuity with and without correction of distance and near at 3-6 months
7 secondary outcomes
Percent of patients requiring keratorefractive surgery
Ocular comorbidity subgroup analysis
Monocular implantation subanalysis (prior to LASIK)
Comparison of post-op spherical equivalent to target refraction
Posterior capsule opacity that may be treated with laser procedure known as a YAG laser capsulotomy?
Subjective patient satisfaction
Validated questionnaire assessing visual function and quality of life
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 23 Mar 2011.
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.
Adam Fedyk, MD principal investigator
UTSW Medical Center at Dallas
Vinod Mootha, MD study director
UTSW Medical Center at Dallas
James McCulley, MD study chair
UTSW Medical Center at Dallas
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Outcomes Following Restor IOL Lens Implant, run by University of Texas Southwestern Medical Center at 2 sites 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 1 inclusion and 1 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 23 Mar 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
1)Visual acuity with and without correction of distance and near at 3-6 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 23 Mar 2011.