NCT01140477

Brief Summary

The objective of this clinical trial is to evaluate the safety and effectiveness of the Bausch + Lomb Toric Accommodating Posterior Chamber Silicone Intraocular Lens used to provide near, intermediate, and distance vision and a reduction of the effects of preoperative corneal astigmatism in presbyopic patients undergoing cataract extraction and intraocular lens (IOL) placement.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
229

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jun 2010

Typical duration for not_applicable

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

June 1, 2010

Completed
7 days until next milestone

First Submitted

Initial submission to the registry

June 8, 2010

Completed
1 day until next milestone

First Posted

Study publicly available on registry

June 9, 2010

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2011

Completed
10 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2012

Completed
1.9 years until next milestone

Results Posted

Study results publicly available

August 22, 2014

Completed
Last Updated

September 8, 2014

Status Verified

August 1, 2014

Enrollment Period

1.5 years

First QC Date

June 8, 2010

Results QC Date

August 7, 2014

Last Update Submit

August 29, 2014

Conditions

CataractAstigmatism

Outcome Measures

Primary Outcomes (1)

  • Percent Reduction in Absolute Cylinder

    Percent reduction in absolute cylinder expressed as a percentage of the intended reduction in cylinder. Cylinder reduction is the measurement for astigmatism reduction. Astigmatism is a form of refractive error that can affect uncorrected visual acuity (at all distances). Reducing cylinder should improve UCVA, but other elements of refractive error, such as myopia or hyperopia, can also affect UCVA. Best corrected visual acuity (BCVA) is not affected by refractive error.

    120 - 180 day postoperative visit

Secondary Outcomes (2)

  • Lens Misalignment

    120 - 180 day postoperative visit

  • Visual Acuity

    120 - 180 day postoperative visit

Study Arms (2)

Crystalens toric IOL

EXPERIMENTAL

Toric Accommodating Lens Crystalens toric silicone multi-piece accommodating IOL (Models AT-50T/AT-52T)

Device: Toric Accommodating Lens

Crystalens IOL

ACTIVE COMPARATOR

Accommodating Lens Crystalens silicone multi-piece accommodating IOL (Models AT-50SE/AT-52SE)

Device: Accommodating Lens

Interventions

Toric Accommodating LensDEVICE

Toric accommodating lens implanted after cataract extraction

Crystalens toric IOL
Accommodating LensDEVICE

Accommodating lens implanted after cataract extraction

Crystalens IOL

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Subjects must have a clinically documented diagnosis of age-related cataract
  • Subjects must require a lens power from 16 to 27 diopters
  • Subjects must have predicted post-operative corneal astigmatism between 0.83D and 2.50D, as determined by the Toric Calculator

You may not qualify if:

  • Subjects with any anterior segment pathology for which extracapsular/ phacoemulsification cataract surgery would be contraindicated.
  • Subjects with diagnoses of degenerative visual disorders.
  • Subjects with conditions associated with increased risk of zonular rupture.
  • Subjects who have had previous corneal surgery in the planned operative eye.
  • Subjects with irregular corneal astigmatism.
  • Subjects with clinically significant retinal pigment or epithelium/macular changes.
  • Subjects with chronic use of systemic steroids or immunosuppressive medications.
  • Subjects either concurrently participating in another clinical trial or have participated in another clinical trial within 60 days prior to enrollment in this study.
  • Subjects with a difference in corneal astigmatism measured with the IOL Master and the topographer greater than 0.5 D using vector analysis.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

B&L Surgical

Bridgewater, New Jersey, 08807, United States

Location

MeSH Terms

Conditions

CataractAstigmatism

Interventions

Multifocal Intraocular Lenses

Condition Hierarchy (Ancestors)

Lens DiseasesEye DiseasesRefractive Errors

Intervention Hierarchy (Ancestors)

Lenses, IntraocularLensesOptical DevicesEquipment and SuppliesProstheses and Implants

Results Point of Contact

Title
Johnson Varughese
Organization
Bausch & Lomb, a division of Valeant Corporation
Johnson.Varughese@valeant.com
908-541-2179

Study Officials

  • Jay Pepose, MD, PhD

    Pepose Vision Institute

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
OTHER
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 8, 2010

First Posted

June 9, 2010

Study Start

June 1, 2010

Primary Completion

December 1, 2011

Study Completion

October 1, 2012

Last Updated

September 8, 2014

Results First Posted

August 22, 2014

Record last verified: 2014-08

Locations

US(1)