Visual Performance With a Trifocal Intraocular Lens

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. Identifier: NCT01605058
Recruitment Status : Unknown
Verified May 2012 by Elizabeth Agrippa, BMI Southend Hospital.
Recruitment status was:  Not yet recruiting
First Posted : May 24, 2012
Last Update Posted : May 30, 2012
Information provided by (Responsible Party):
Elizabeth Agrippa, BMI Southend Hospital

Brief Summary:

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 or disease

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 : Observational
Estimated Enrollment : 30 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Visual Performance Adn Quality of Vision Evaluation After Implantation of a Trifocal Intraocular Lens
Study Start Date : June 2012
Estimated Primary Completion Date : July 2013
Estimated Study Completion Date : August 2013

Information from the National Library of Medicine

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

Inclusion Criteria:

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

Exclusion Criteria:

  • existing ocular pathology
  • surgical complications
  • corneal astigmatism > 1.50DC

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 identifier (NCT number): NCT01605058

United Kingdom
BMI Southend Hospital Not yet recruiting
Westclifff-on-Sea, Essex, United Kingdom, SS0 9AG
Contact: Elizabeth Agrippa    07795176257   
Sponsors and Collaborators
BMI Southend Hospital
Principal Investigator: Elizabeth M Agrippa, BSc BMI Southend

Responsible Party: Elizabeth Agrippa, Optometrist, BMI Southend Hospital Identifier: NCT01605058     History of Changes
Other Study ID Numbers: TRI 1.1
First Posted: May 24, 2012    Key Record Dates
Last Update Posted: May 30, 2012
Last Verified: May 2012

Additional relevant MeSH terms:
Lens Diseases
Eye Diseases