Visual Performance With a Trifocal Intraocular Lens

Cataract Clinical Trial

Official title:

Visual Performance Adn Quality of Vision Evaluation After Implantation of a Trifocal Intraocular Lens

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT01605058
• Other study ID #: TRI 1.1
• Status: Not yet recruiting
• Phase: N/A
• First received: May 22, 2012
• Last updated: May 25, 2012
• Start date: June 2012
• Est. completion date: August 2013

Study information

• Verified date: May 2012
• Source: BMI Southend Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: United Kingdom: National Health Service
• Study type: Observational

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 30
• Est. completion date: August 2013
• Est. primary completion date: July 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 40 Years to 70 Years

Eligibility

Inclusion Criteria:

• Age 40-70yrs

• Bilateral implantation of a trifocal intraocular lens

Exclusion Criteria:

• existing ocular pathology

• surgical complications

• corneal astigmatism > 1.50DC

Study Design

Observational Model: Cohort, Time Perspective: Retrospective

Related Conditions & MeSH terms

• Cataract

Locations

Country	Name	City	State
United Kingdom	BMI Southend Hospital	Westclifff-on-Sea	Essex

Sponsors (1)

Lead Sponsor	Collaborator
BMI Southend Hospital

Country where clinical trial is conducted

United Kingdom,