NCT01605058

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
30

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Jun 2012

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 22, 2012

Completed
2 days until next milestone

First Posted

Study publicly available on registry

May 24, 2012

Completed
8 days until next milestone

Study Start

First participant enrolled

June 1, 2012

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2013

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2013

Completed
Last Updated

May 30, 2012

Status Verified

May 1, 2012

Enrollment Period

1.1 years

First QC Date

May 22, 2012

Last Update Submit

May 25, 2012

Conditions

Cataract

Eligibility Criteria

Age40 Years - 70 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Patients from a private ophthalmology clinic

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

BMI Southend Hospital

Westclifff-on-Sea, Essex, SS0 9AG, United Kingdom

Location

MeSH Terms

Conditions

Cataract

Condition Hierarchy (Ancestors)

Lens DiseasesEye Diseases

Study Officials

  • Elizabeth M Agrippa, BSc

    BMI Southend

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Optometrist

Study Record Dates

First Submitted

May 22, 2012

First Posted

May 24, 2012

Study Start

June 1, 2012

Primary Completion

July 1, 2013

Study Completion

August 1, 2013

Last Updated

May 30, 2012

Record last verified: 2012-05

Locations

GB(1)