Refractive AssessmentPhase 4NCT00345111
ACRYSOF® Restor Apodized Diffractive IOL Postmarket Evaluation of Clinical Outcomes and Life-Style Visual Performance RESTOR IOL SN60WF IOL (Control Group)
A Phase 4 study testing Clinical visual outcomes of bilateral implantation of Restore Intra Ocular Lens. in people with Refractive Assessment, run by University of Texas Southwestern Medical Center at 1 site in United States.
Trial summary
The objective of the research on the Restore Intra Ocular Lens Implant (IOL) is to determine the clinical visual outcomes following bilateral implantation of the IOL compared to a control IOL and to demonstrate what percentage of the subjects obtain spectacle freedom. Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Refractive Assessment
- What is being tested?
- Clinical visual outcomes of bilateral implantation of Restore Intra Ocular Lens.
- Type of treatment
- Surgery or procedure
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2005to Dec 2007
- Phase
- Phase 4
- 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 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Inclusion Criteria: 70 years of age or younger; any race; either gender; diagnosis of cataracts both eyes; pre-existing physical conditions that could skew visual results, such as Diabetes, Retinal detachment, Macular degeneration, or Cancer; subjects must have < 1.00 diopter of astigmatism; biometry results for the Restore patients should target emmetropia or +0.25.
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Exclusion Criteria: Over 70 years old; other procedures needed at the time of surgery besides cataract extraction; Sulcus-Sulcus or Bag-Sulcus fixation during surgery; Capsulothexis edge not covering optic edge 360 degrees around; Capsular Rupture; vitreous loss; capsularhexis tear; significant anterior chamber hyphema; Zonular rupture.
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Trial locations and contacts
1 site in 1 country.
United States1 site
University of Texas Southwestern Medical Center at Dallas
Dallas, Texas, 75390-8866
About this study
Official title: ACRYSOF® Restor Apodized Diffractive IOL Postmarket Evaluation of Clinical Outcomes and Life-Style Visual Performance With RESTOR IOL Compared With SN60WF IOL (Control Group)
The objective of the research on the Restore Intra Ocular Lens Implant (IOL) is to determine the clinical visual outcomes following bilateral implantation of the IOL compared to a control IOL and to demonstrate what percentage of the subjects obtain spectacle freedom.
Read the detailed description
The Acusof Restor IOL has recently been FDA approved. This research will be an indicator by comparison to a conventional implant lens used for catract surgery. The standard of care for cataract surgery is to implant an IOL to allow the patient distant vision only. As a result, the patient is forced to wear reading glasses or magnifying glasses for near work. With the Restore IOL implant, the patient will have the ability to be corrected for not only distance vision but for near and intermediate visual needs. With FDA approval, the statistical indications demonstate 80% of patients tested in clinical trials did not have the need for use of glasses after cataract surgery. This research will further confirm and quantify the data already submitted by comparing the control group with the Restore Group in this Phase IV project.
The control group of subjects will be patients who have already had cataract surgery in both eyes approximately 6 months prior to entering the study. These individuals will be tested only for the 6 month evaluation in both eyes, including the following tests (manifest refraction, which determines the best vision correction possible, the near, intermediate and distant visual acuity will be assessed at the respective ranges of distance. contrast sensitivity will be determined by choosing the circles that have lines in them opposed to the ones that don't (further assessing visual acuity), stereopsis which indicates whether both eyes are functioning together, pupilometry which measures the pupil diameter, the life style questionaire and the life style vision evaluation form as well.
The Restore IOl group of subjects' post operative visual acuity data will be compared to the control subjects' post operative visual data results at the distance, near, and intermediate ranges, as well as all the other testing required at the sixxth month time frame listed above. The testing will require approximately 2 hours for the 6 month visit for both control and Restore groups.
The Restore group of subjects will have 4 other visits. The pre operative visit will take avout 2 hours and include the following tests: Manifest refraction, near, inermediate, and distance visual acuity testing, life style questionnaire, and obtaining informed consent. The 1 week and 1 month post-operative visit will include manifest refraction, near, intermediate, and distance visual acuity assessment.
- Conditions
- Refractive Assessment
- Being tested
- Clinical visual outcomes of bilateral implantation of Restore Intra Ocular Lens.
- Keywords
- Restor IOL versus Conventional IOL
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Clinical visual outcomes of bilateral implantation of Restore Intra Ocular Lens.Procedure or surgery
What is being measured
The primary outcome is the main question the study is designed to answer.
manifest refraction, contrast sensitivity, stereopsis.
Secondary outcomes (1)
near, intermediate and distant visual acuity, life style questionaire and the life style vision evaluation
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 startJul 2005
- Primary completionDec 2007
- Study completionDec 2007
Why it stopped: Verified with former investigator that recruitment activity did not take place
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Refractive AssessmentStudies 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
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Texas Southwestern Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- R. Wayne Bowman, M.D., Principal investigator, University of Texas, Southwestern Medical Center at Dallas
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00345111
- Sponsor's protocol ID
- 062005-060
- Status last verified
- Aug 2018
- First submitted
- 23 Jun 2006
- Last updated
- 16 Aug 2018
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- ACRYSOF® Restor Apodized Diffractive IOL Postmarket Evaluation of Clinical Outcomes and Life-Style Visual Performance With RESTOR IOL Compared With SN60WF IOL (Control Group)
- ClinicalTrials.gov ID
- NCT00345111
- Acronym / sponsor ID
- 062005-060
- Conditions
- Refractive Assessment
- Keywords
- Restor IOL versus Conventional IOL
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Verified with former investigator that recruitment activity did not take place
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of Texas Southwestern Medical CenterUniversity, hospital or other
- Study start
- Jul 2005
- Primary completion
- Dec 2007 (actual)
- Study completion
- Dec 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.
The objective of the research on the Restore Intra Ocular Lens Implant (IOL) is to determine the clinical visual outcomes following bilateral implantation of the IOL compared to a control IOL and to demonstrate what percentage of the subjects obtain spectacle freedom.
Detailed description
The Acusof Restor IOL has recently been FDA approved. This research will be an indicator by comparison to a conventional implant lens used for catract surgery. The standard of care for cataract surgery is to implant an IOL to allow the patient distant vision only. As a result, the patient is forced to wear reading glasses or magnifying glasses for near work. With the Restore IOL implant, the patient will have the ability to be corrected for not only distance vision but for near and intermediate visual needs. With FDA approval, the statistical indications demonstate 80% of patients tested in clinical trials did not have the need for use of glasses after cataract surgery. This research will further confirm and quantify the data already submitted by comparing the control group with the Restore Group in this Phase IV project.
The control group of subjects will be patients who have already had cataract surgery in both eyes approximately 6 months prior to entering the study. These individuals will be tested only for the 6 month evaluation in both eyes, including the following tests (manifest refraction, which determines the best vision correction possible, the near, intermediate and distant visual acuity will be assessed at the respective ranges of distance. contrast sensitivity will be determined by choosing the circles that have lines in them opposed to the ones that don't (further assessing visual acuity), stereopsis which indicates whether both eyes are functioning together, pupilometry which measures the pupil diameter, the life style questionaire and the life style vision evaluation form as well.
The Restore IOl group of subjects' post operative visual acuity data will be compared to the control subjects' post operative visual data results at the distance, near, and intermediate ranges, as well as all the other testing required at the sixxth month time frame listed above. The testing will require approximately 2 hours for the 6 month visit for both control and Restore groups.
The Restore group of subjects will have 4 other visits. The pre operative visit will take avout 2 hours and include the following tests: Manifest refraction, near, inermediate, and distance visual acuity testing, life style questionnaire, and obtaining informed consent. The 1 week and 1 month post-operative visit will include manifest refraction, near, intermediate, and distance visual acuity assessment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
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 |
|---|---|---|
| Clinical visual outcomes of bilateral implantation of Restore Intra Ocular Lens. | Procedure or surgery | – |
Primary outcome
manifest refraction, contrast sensitivity, stereopsis.
1 secondary outcome
near, intermediate and distant visual acuity, life style questionaire and the life style vision evaluation
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 16 Aug 2018.
Related trials for Refractive Assessment
Recruiting
Algorithm-assisted Subjective Refraction Program Dedicated to Children
Refractive Assessment, Refractive Disorders
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.
R. Wayne Bowman, M.D. principal investigator
University of Texas, Southwestern Medical Center at Dallas
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Clinical visual outcomes of bilateral implantation of Restore Intra Ocular Lens. in people with Refractive Assessment, run by University of Texas Southwestern Medical Center 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?
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 16 Aug 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
manifest refraction, contrast sensitivity, stereopsis.. 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 16 Aug 2018; AzTrials last refreshed its copy on 1 Nov 2026.