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Visual Performance With a Trifocal Intraocular Lens

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified May 2012 by Elizabeth Agrippa, BMI Southend Hospital.
Recruitment status was:  Not yet recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT01605058
First Posted: May 24, 2012
Last Update Posted: May 30, 2012
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Elizabeth Agrippa, BMI Southend Hospital
  Purpose

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.


Condition
Cataract

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Visual Performance Adn Quality of Vision Evaluation After Implantation of a Trifocal Intraocular Lens

Further study details as provided by Elizabeth Agrippa, BMI Southend Hospital:

Estimated Enrollment: 30
Study Start Date: June 2012
Estimated Study Completion Date: August 2013
Estimated Primary Completion Date: July 2013 (Final data collection date for primary outcome measure)
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

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   40 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population
Patients from a private ophthalmology clinic
Criteria

Inclusion Criteria:

  • Age 40-70yrs
  • Bilateral implantation of a trifocal intraocular lens

Exclusion Criteria:

  • existing ocular pathology
  • surgical complications
  • corneal astigmatism > 1.50DC
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01605058


Locations
United Kingdom
BMI Southend Hospital Not yet recruiting
Westclifff-on-Sea, Essex, United Kingdom, SS0 9AG
Contact: Elizabeth Agrippa    07795176257    elizabeth.agrippa@gmail.com   
Sponsors and Collaborators
BMI Southend Hospital
Investigators
Principal Investigator: Elizabeth M Agrippa, BSc BMI Southend
  More Information

Responsible Party: Elizabeth Agrippa, Optometrist, BMI Southend Hospital
ClinicalTrials.gov Identifier: NCT01605058     History of Changes
Other Study ID Numbers: TRI 1.1
First Submitted: May 22, 2012
First Posted: May 24, 2012
Last Update Posted: May 30, 2012
Last Verified: May 2012

Additional relevant MeSH terms:
Cataract
Lens Diseases
Eye Diseases