Visual Performance With a Trifocal Intraocular Lens

NCT ID: NCT01605058

Last Updated: 2012-05-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

30 participants

Study Classification

OBSERVATIONAL

Study Start Date

2012-06-30

Study Completion Date

2013-08-31

Brief Summary

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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.

Detailed Description

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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

Conditions

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Cataract

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

* existing ocular pathology
* surgical complications
* corneal astigmatism \> 1.50DC
Minimum Eligible Age

40 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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BMI Southend Hospital

OTHER

Sponsor Role lead

Responsible Party

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Elizabeth Agrippa

Optometrist

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Elizabeth M Agrippa, BSc

Role: PRINCIPAL_INVESTIGATOR

BMI Southend

Locations

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BMI Southend Hospital

Westclifff-on-Sea, Essex, United Kingdom

Site Status

Countries

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United Kingdom

Facility Contacts

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Elizabeth Agrippa

Role: primary

07795176257

Other Identifiers

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TRI 1.1

Identifier Type: -

Identifier Source: org_study_id

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