NCT02847572

Brief Summary

This will be a single center, non comparison clinical trial. Fifty study patients will have the Symfony IOL implanted in their dominant eye and a +3,25D Tecnis Multifocal in their non-dominant eye. The investigators will be evaluated vision at distance, intermediate and near as well as assessing patient satisfaction and spectacle independence.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2016

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2016

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

March 1, 2016

Completed
5 months until next milestone

First Posted

Study publicly available on registry

July 28, 2016

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2016

Completed
Last Updated

July 21, 2017

Status Verified

July 1, 2017

Enrollment Period

11 months

First QC Date

March 1, 2016

Last Update Submit

July 18, 2017

Conditions

Cataract

Outcome Measures

Primary Outcomes (1)

  • Visual Acuity

    Vision will be measured at distance, intermediate and near with and without correction.

    3 months

Secondary Outcomes (1)

  • Patient Satisfaction

    3 months

Study Arms (1)

Surgery Patient

OTHER

All patients to be implanted bilaterally with a Tecnis Extended Range Lens in the Dominant eye and a Low Add Multifocal in the non dominant

Procedure: Cataract Surgery

Interventions

Cataract SurgeryPROCEDURE

All patients wil be having intraocular lens surgery

Surgery Patient

Eligibility Criteria

Age21 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • good general health,
  • willing to comply with study instructions,
  • Visual potential of 20/30 or better,
  • less than 1.5D of corneal astigmatism,
  • normal macula,
  • clear lens or cataract,
  • pupil size greater than 3.5mm

You may not qualify if:

  • known pathology to affect visual outcome,
  • amblyopia or strabismus,
  • pupil abnormalities,
  • zonule problems,
  • keratoconus,
  • no prior ocular surgery,use of medication that could affect vision,
  • uncontrolled systemic disease

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Crystal Clear Vision

Toronto, Ontario, M5R 2E3, Canada

Location

MeSH Terms

Conditions

Cataract

Interventions

Cataract Extraction

Condition Hierarchy (Ancestors)

Lens DiseasesEye Diseases

Intervention Hierarchy (Ancestors)

Refractive Surgical ProceduresOphthalmologic Surgical ProceduresSurgical Procedures, Operative

Study Officials

  • Sondra Black, OD

    Crystal Clear Vision

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 1, 2016

First Posted

July 28, 2016

Study Start

January 1, 2016

Primary Completion

December 1, 2016

Study Completion

December 1, 2016

Last Updated

July 21, 2017

Record last verified: 2017-07

Data Sharing

IPD Sharing
Will not share

Locations

CA(1)