- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01946581
Retrospective Patient Satisfaction Survey in Subjects With Tecnis Intra Ocular Lenses and Cataracts Surgery
September 16, 2013 updated by: MDbackline, LLC
Retrospective Patient Satisfaction Survey in Subjects With Tecnis Intra Ocular Lenses Cataracts Surgery
Define what factors correlate with higher degrees of patient satisfaction and dissatisfaction among patients who have recently undergone cataract surgery.
Study Overview
Study Type
Observational
Enrollment (Anticipated)
200
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
California
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Laguna Hills, California, United States, 92653
- Recruiting
- Harvard Eye Associates
-
Principal Investigator:
- John Hovanesian, MD
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 90 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
Patients that have had Cataract Surgery.
Description
Inclusion Criteria:
- Patients with uncomplicated bilateral cataract surgery with a Tecnis Multifocal or monofocal implant completed at least 60 days before the survey date.
- Patient with and without astigmatic keratotomy will be included.
Exclusion Criteria:
- Patients with visually significant co-morbidities (corneal, retina, optic nerve disease) that could affect their satisfaction with surgery
- Patients with surgical complications either during or after surgery (capsule tears, iris trauma, decentered IOL, cystoid macular edema, etc.)
- Patients with ≥ grade 1 posterior capsule opacity at their last visit
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
Cataract Surgery
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Patient overall satisfaction post Cataract surgery
Time Frame: 60 plus days Post surgery
|
Patient will be given a satisfaction survey based on overall satisfaction:
|
60 plus days Post surgery
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: John Hovanesian, MD, MD Backline
- Study Director: John Hovanesian, MD, MD Backline
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
May 1, 2013
Primary Completion (Anticipated)
May 1, 2014
Study Registration Dates
First Submitted
September 12, 2013
First Submitted That Met QC Criteria
September 16, 2013
First Posted (Estimate)
September 19, 2013
Study Record Updates
Last Update Posted (Estimate)
September 19, 2013
Last Update Submitted That Met QC Criteria
September 16, 2013
Last Verified
September 1, 2013
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- JH SAT 2013
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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-
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-
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-
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-
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-
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