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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 August 21, 2014