- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01605058
Visual Performance With a Trifocal Intraocular Lens
Visual Performance Adn Quality of Vision Evaluation After Implantation of a Trifocal Intraocular Lens
The purpose of this study is to evaluate the visual performance of a trifocal intraocular lens at distance, near and intermediate viewing, by way of visual acuity measurement, contrast sensitivity.
Patient satisfaction and quality of vision will also be assessed by way of a questionnaire.
Study Overview
Status
Conditions
Detailed Description
Monocular and Binocular Unaided (UCVA) and Best Corrected Visual Acuity (BCVA) will be measured at 6m in LogMAR units under photopic conditions (85cd/m2).
Subjective Refraction will be performed to establish any residual refractive error will for distance, intermediate and near.
Defocus Profiles (visual acuity over imposed defocus) are measured for each patient. The patient observes the 6m LogMAR chart through best distance correction, then defocusing is achieved by the addition of pairs of lenses from +2.00D to -4.00D in 0.50D steps.. The LogMAR acuity will be recorded and the data plotted.
Contrast Sensitivity will be evaluated monocularly under photopic (85cd/m2) conditions and mesopic (4cd/m2) using the Pelli-Robson Contrast Sensitivity Chart.
Near and intermediate performance will be evaluated using the Radner Reading Charts to assess acuity (LogRAD units) and reading speed in photopic conditions 85cd/m2
Study Type
Enrollment (Anticipated)
Contacts and Locations
Study Locations
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Essex
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Westclifff-on-Sea, Essex, United Kingdom, SS0 9AG
- BMI Southend Hospital
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- Age 40-70yrs
- Bilateral implantation of a trifocal intraocular lens
Exclusion Criteria:
- existing ocular pathology
- surgical complications
- corneal astigmatism > 1.50DC
Study Plan
How is the study designed?
Design Details
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Elizabeth M Agrippa, BSc, BMI Southend
Study record dates
Study Major Dates
Study Start
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- TRI 1.1
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