Clinical Evaluation of a New Aspheric Intraocular Lens.

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Bausch & Lomb Incorporated
ClinicalTrials.gov Identifier:
NCT00786565
First received: November 3, 2008
Last updated: December 7, 2011
Last verified: December 2011
  Purpose

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.


Condition Intervention Phase
Cataract
Device: Advanced Akreos Adapt in one operated eye.
Device: Akreos Adapt in fellow operated eye.
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Official Title: Clinical Evaluation of a New Aspheric Intraocular Lens. A Prospective, Multi-Center, Comparative Study.

Resource links provided by NLM:


Further study details as provided by Bausch & Lomb Incorporated:

Primary Outcome Measures:
  • Low Contrast Best Corrected Visual Acuity Following Cataract Surgery [ Time Frame: 3 months ] [ Designated as safety issue: No ]
    Low contrast best corrected visual acuity (ability to distinguish objects on a similarly colored or shaded background) 3 months following cataract surgery.

  • Low Contrast Uncorrected Visual Acuity Following Cataract Surgery [ Time Frame: 3 months ] [ Designated as safety issue: No ]
    Low contrast uncorrected visual acuity 3 months post cataract surgery

  • Photopic Contrast Sensitivity [ Time Frame: 3 months ] [ Designated as safety issue: No ]
    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)

  • Mesoptic Contrast Sensitivity [ Time Frame: 3 Months ] [ Designated as safety issue: No ]
    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)

  • Posterior Capsule Opacification Score [ Time Frame: 24 months ] [ Designated as safety issue: No ]
    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.


Secondary Outcome Measures:
  • High Contrast Visual Acuity [ Time Frame: 1 month ] [ Designated as safety issue: No ]
    High contrast visual acuity (ability to distinguish objects of contrasting color such as black on white) uncorrected and best corrected visual acuity.

  • High Contrast Visual Acuity Uncorrected [ Time Frame: 3 months ] [ Designated as safety issue: No ]
  • High Contrast Visual Acuity Best Corrected [ Time Frame: 3 months ] [ Designated as safety issue: No ]
  • High Contrast Visual Acuity [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • High Contrast Visual Acuity Uncorrected [ Time Frame: 24 Months ] [ Designated as safety issue: No ]
  • High Contrast Visual Acuity Best Corrected [ Time Frame: 24 Months ] [ Designated as safety issue: No ]
  • Low Contrast Visual Acuity [ Time Frame: 1 month ] [ Designated as safety issue: No ]
    Uncorrected Low contrast visual acuity - LogMar visual acuity value

  • Contrast Sensitivity Photopic 1.5cpd [ Time Frame: 1 month ] [ Designated as safety issue: No ]
    The mean photopic (day light) contrast sensitivity were to be compared between both IOLs for each special frequency (1.5, 3.0, 6.0, 12.0 and 18 cpd)

  • Contrast Sensitivity Photopic [ Time Frame: 1 month ] [ Designated as safety issue: No ]
    The mean photopic (day light) contrast sensitivity were to be compared between both IOLs for each special frequency (1.5, 3.0, 6.0, 12.0 and 18 cpd)

  • Contrast Sensitivity Mesoptic 1.5 Cpd [ Time Frame: 1 month ] [ Designated as safety issue: No ]
    The mean mesopic (dim light) contrast sensitivity were to be compared between both IOLs for each special frequency (1.5, 3.0, 6.0, 12.0 and 18 cpd)

  • Contrast Sensitivity Mesoptic [ Time Frame: 1 month ] [ Designated as safety issue: No ]
    The mean mesopic (dim light) contrast sensitivity were to be compared between both IOLs for each special frequency (1.5, 3.0, 6.0, 12.0 and 18 cpd)

  • Posterior Capsule Opacification [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    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.


Enrollment: 75
Study Start Date: January 2004
Study Completion Date: January 2008
Primary Completion Date: January 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Advanced Akreos Adapt
Advanced Akreos Adapt Aspheric Intraocular Lens (IOL).
Device: Advanced Akreos Adapt in one operated eye.
Cataract surgery to implant the assigned IOL according to randomized schedule.
Experimental: Akreos Adapt
Akreos Adapt Spherical Intraocular Lens (IOL).
Device: Akreos Adapt in fellow operated eye.
Cataract surgery to implant the assigned IOL according to randomized schedule.

  Eligibility

Ages Eligible for Study:   50 Years to 85 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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:
  Contacts and Locations
No Contacts or Locations Provided
  More Information

No publications provided

Responsible Party: Bausch & Lomb Incorporated
ClinicalTrials.gov Identifier: NCT00786565     History of Changes
Other Study ID Numbers: 001/04
Study First Received: November 3, 2008
Results First Received: February 20, 2009
Last Updated: December 7, 2011
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Additional relevant MeSH terms:
Cataract
Lens Diseases
Eye Diseases

ClinicalTrials.gov processed this record on April 23, 2014