- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01731743
Evaluation of Visual Acuity and Patient Satisfaction With AT LISA TRI 839MP Intraocular Lenses
January 25, 2018 updated by: Carl Zeiss Meditec AG
The purpose of the study is to evaluate the far, intermediate and near visual acuities with a trifocal IOL.
Study Overview
Detailed Description
After bilateral cataract surgery, monocular and binocular uncorrected (UCVA) and best distance corrected visual acuity (BCVA) will be measured at far (4m), intermediate (80 cm) and near (40 cm) distance as well as the subjective refraction.
A patient questionnaire will be used to assess the patient satisfaction and spectacle independence.
Study Type
Interventional
Enrollment (Actual)
107
Phase
- Not Applicable
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
-
-
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Berlin, Germany, 10589
- Carl Zeiss Meditec AG
-
-
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
50 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Man or woman, over 50 years of age
- Bilateral implantation of a trifocal intraocular lens
- Capsular bag implantation
Exclusion Criteria:
- Existing ocular pathology
- Surgical complications
- Corneal astigmatism ≥ 1.0D
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
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Other: implantation of a trifocal IOL (AT LISA tri 839MP)
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Intermediate visual acuity
Time Frame: up to 3 months postoperatively
|
Monocular and binocular uncorrected and best distance corrected
|
up to 3 months postoperatively
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
near and far visual acuity
Time Frame: 1 and 3 month postoperatively
|
Monocular and binocular uncorrected and best distance corrected
|
1 and 3 month postoperatively
|
Other Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Patient satisfaction and spectacle independence
Time Frame: 1 and 3 month postoperatively
|
1 and 3 month postoperatively
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
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
January 1, 2012
Primary Completion (Actual)
July 1, 2013
Study Completion (Actual)
July 1, 2013
Study Registration Dates
First Submitted
November 19, 2012
First Submitted That Met QC Criteria
November 21, 2012
First Posted (Estimate)
November 22, 2012
Study Record Updates
Last Update Posted (Actual)
January 29, 2018
Last Update Submitted That Met QC Criteria
January 25, 2018
Last Verified
January 1, 2018
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 839 MP HEN 402-11
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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