NCT02394379

Brief Summary

To evaluate the incidence of IOL vaulting (ie, position change) of the Trulign™ Toric IOL following cataract surgery.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
600

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Mar 2015

Longer than P75 for all trials

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 9, 2015

Completed
10 days until next milestone

Study Start

First participant enrolled

March 19, 2015

Completed
1 day until next milestone

First Posted

Study publicly available on registry

March 20, 2015

Completed
4.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 5, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 5, 2019

Completed
Last Updated

November 13, 2019

Status Verified

November 1, 2019

Enrollment Period

4.4 years

First QC Date

March 9, 2015

Last Update Submit

November 12, 2019

Conditions

Cataract

Outcome Measures

Primary Outcomes (1)

  • Incidence of clinically significant IOL vaulting

    IOL vaulting is position change such as clinically significant anterior vaulting, clinically significant tilt, and secondary surgical intervention related to such vaulting. The proportion of study eyes experiencing vaulting will be estimated by Kaplan-Meier method.

    Up to 3 years

Study Arms (1)

Trulign™ Toric IOL

Trulign™ Toric Posterior Chamber IOL is a modified plate haptic lens

Device: Trulign™ Toric IOL

Interventions

Trulign™ Toric IOLDEVICE

Trulign™ Toric Posterior Chamber IOL is a modified plate haptic lens

Trulign™ Toric IOL

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Subjects will be chosen from 30-50 clinical sites in the US. All subjects who meet Eligibility Criteria (below) will be consecutively offered enrollment until the site meets the maximum number of enrollees.

You may qualify if:

  • Subjects who are able and willing to comply with the follow-up schedule
  • Subjects must have a clinically documented diagnosis of age-related cataract that is considered amenable to treatment with standard phacoemulsification/extracapsular cataract extraction
  • Subjects must require a lens power from 4 to 33 D
  • Subjects must have a Best Corrected Visual Acuity (BCVA) equal to or worse than 20/40, with or without a glare source

You may not qualify if:

  • Subjects with any anterior segment pathology in the study eye likely to increase the risk of complications from phacoemulsification cataract surgery
  • Subjects with associated ocular conditions which could affect the stability of the IOL
  • Subjects with clinically significant irregular corneal astigmatism in the study eye

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Bausch & Lomb Incorporated

Rochester, New York, 14609, United States

Location

MeSH Terms

Conditions

Cataract

Condition Hierarchy (Ancestors)

Lens DiseasesEye Diseases

Study Officials

  • Anya Loncaric

    Valeant Pharmaceuticals NA / Bausch & Lomb

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 9, 2015

First Posted

March 20, 2015

Study Start

March 19, 2015

Primary Completion

August 5, 2019

Study Completion

August 5, 2019

Last Updated

November 13, 2019

Record last verified: 2019-11

Locations

US(1)