NCT00786565

Brief Summary

This study evaluates the visual performance and occurrence of posterior capsular opacification after implantation of a new aspherical intraocular lens compared with a control spherical lens of otherwise identical design.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
75

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started Jan 2004

Longer than P75 for phase_4

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, 2004

Completed
4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2008

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

November 3, 2008

Completed
3 days until next milestone

First Posted

Study publicly available on registry

November 6, 2008

Completed
2.2 years until next milestone

Results Posted

Study results publicly available

January 5, 2011

Completed
Last Updated

December 12, 2011

Status Verified

December 1, 2011

Enrollment Period

4 years

First QC Date

November 3, 2008

Results QC Date

February 20, 2009

Last Update Submit

December 7, 2011

Conditions

Cataract

Outcome Measures

Primary Outcomes (5)

  • Low Contrast Best Corrected Visual Acuity Following Cataract Surgery

    Low contrast best corrected visual acuity (ability to distinguish objects on a similarly colored or shaded background) 3 months following cataract surgery.

    3 months

  • Low Contrast Uncorrected Visual Acuity Following Cataract Surgery

    Low contrast uncorrected visual acuity 3 months post cataract surgery

    3 months

  • Photopic Contrast Sensitivity

    The mean photopic (day light) contrast sensitivity for each spatial frequency (cycle per degree-CPD) (1.5, 3.0, 6.0, 12.0 and 18 cpd)

    3 months

  • Mesoptic Contrast Sensitivity

    The mean mesoptic (low light) contrast sensitivity for each spatial frequency (cycle per degree-CPD) (1.5, 3.0, 6.0, 12.0 and 18 cpd)

    3 Months

  • Posterior Capsule Opacification Score

    Posterior Capsule Opacification Score (PCO), Density of opacification measured from 0-4 (1=minimal and 4=severe) and area of opacification measured from 0-1 (0=no opacification and 1=posterior capsule opacification required a treatment). Results (EPCO) were computer calculated by multiplying density by area of opacification.

    24 months

Secondary Outcomes (12)

  • High Contrast Visual Acuity

    1 month

  • High Contrast Visual Acuity Uncorrected

    3 months

  • High Contrast Visual Acuity Best Corrected

    3 months

  • High Contrast Visual Acuity

    12 months

  • High Contrast Visual Acuity Uncorrected

    24 Months

  • +7 more secondary outcomes

Study Arms (2)

Advanced Akreos Adapt

EXPERIMENTAL

Advanced Akreos Adapt Aspheric Intraocular Lens (IOL).

Device: Advanced Akreos Adapt in one operated eye.

Akreos Adapt

EXPERIMENTAL

Akreos Adapt Spherical Intraocular Lens (IOL).

Device: Akreos Adapt in fellow operated eye.

Interventions

Advanced Akreos Adapt in one operated eye.DEVICE

Cataract surgery to implant the assigned IOL according to randomized schedule.

Advanced Akreos Adapt
Akreos Adapt in fellow operated eye.DEVICE

Cataract surgery to implant the assigned IOL according to randomized schedule.

Akreos Adapt

Eligibility Criteria

Age50 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients must have a clinically documented diagnosis of bilateral cataract (either cortical, nuclear, subcapsular or a combination) liable to benefit from standard cataract surgery.
  • Patients must be undergoing primary cataract surgery with IOL in-the-bag implantation, requiring a IOL power from 10 to 30 diopters.

You may not qualify if:

  • Patients with corneal damage.
  • Patients with any anterior segment pathology for which extracapsular phacoemulsification cataract surgery would be contraindicated.
  • Patients with any ocular pathology, other than the cataract, having repercussions on visual function:

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Cataract

Condition Hierarchy (Ancestors)

Lens DiseasesEye Diseases

Results Point of Contact

Title
Jon Hayashida
Organization
Bausch & Lomb
jon.hayashida@bausch.com
(585) 338-6370

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
LTE60
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 3, 2008

First Posted

November 6, 2008

Study Start

January 1, 2004

Primary Completion

January 1, 2008

Study Completion

January 1, 2008

Last Updated

December 12, 2011

Results First Posted

January 5, 2011

Record last verified: 2011-12