Evaluation of 3 Intraocular Lenses Following Lens Extraction

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Bausch & Lomb Incorporated
ClinicalTrials.gov Identifier:
NCT01122576
First received: May 11, 2010
Last updated: February 12, 2014
Last verified: February 2014
  Purpose

The objective of this study is to evaluate the efficacy and subject satisfaction with three different FDA approved lenses for adults over 40 years of age who desire a reduction in spectacle dependence.


Condition Intervention Phase
Cataract
Device: Crystalens AO
Device: ReSTOR
Device: Tecnis Multifocal IOL
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Three Arm Prospective Clinical Evaluation of Three FDA Approved Intraocular Lenses Designed to Improve Distance, Intermediate and Near Vision Following Lens Extraction.

Resource links provided by NLM:


Further study details as provided by Bausch & Lomb Incorporated:

Primary Outcome Measures:
  • Mesopic Monocular Contrast Sensitivity Without Glare 1.5 and 3 Cycles/Degree [ Time Frame: Postoperative visit 3 (2-3 months) ] [ Designated as safety issue: No ]
    Logarithm of the mesopic (low light) contrast sensitivity (ability to detect detail with subtle gradations of grayness between test target and background) without glare at five spatial frequencies (number of light and dark bars per cycle). A higher mean indicates improved contrast sensitivity

  • Mesopic Monocular Contrast Sensitivity Without Glare 6 Cycles/Degree [ Time Frame: Postoperative visit 3 (2-3 months) ] [ Designated as safety issue: No ]
    Logarithm of the mesopic (low light) contrast sensitivity (ability to detect detail with subtle gradations of grayness between test target and background) without glare at five spatial frequencies (number of light and dark bars per cycle). A higher mean indicates improved contrast sensitivity

  • Mesopic Monocular Contrast Sensitivity Without Glare 12 Cycles/Degree [ Time Frame: Postoperative visit 3 (2-3 months) ] [ Designated as safety issue: No ]
    Logarithm of the mesopic (low light) contrast sensitivity (ability to detect detail with subtle gradations of grayness between test target and background) without glare at five spatial frequencies (number of light and dark bars per cycle). A higher mean indicates improved contrast sensitivity

  • Mesopic Monocular Contrast Sensitivity Without Glare 18 Cycles/Degree [ Time Frame: Postoperative visit 3 (2-3 months) ] [ Designated as safety issue: No ]
    Logarithm of the mesopic (low light) contrast sensitivity (ability to detect detail with subtle gradations of grayness between test target and background) without glare at five spatial frequencies (number of light and dark bars per cycle). A higher mean indicates improved contrast sensitivity

  • Mesopic Monocular Contrast Sensitivity Without Glare 1.5 Cycles/Degree [ Time Frame: Postoperative visit 4 ( 4-6 months) ] [ Designated as safety issue: No ]
    Logarithm of the mesopic (low light) contrast sensitivity (ability to detect detail with subtle gradations of grayness between test target and background) without glare at five spatial frequencies (number of light and dark bars per cycle). A higher mean indicates improved contrast sensitivity

  • Mesopic Monocular Contrast Sensitivity Without Glare 3 Cycles/Degree [ Time Frame: Postoperative visit 4 ( 4-6 months) ] [ Designated as safety issue: No ]
    Logarithm of the mesopic (low light) contrast sensitivity (ability to detect detail with subtle gradations of grayness between test target and background) without glare at five spatial frequencies (number of light and dark bars per cycle). A higher mean indicates improved contrast sensitivity

  • Mesopic Monocular Contrast Sensitivity Without Glare 6 Cycles/Degree [ Time Frame: Postoperative visit 4 ( 4-6 months) ] [ Designated as safety issue: No ]
    Logarithm of the mesopic (low light) contrast sensitivity (ability to detect detail with subtle gradations of grayness between test target and background) without glare at five spatial frequencies (number of light and dark bars per cycle). A higher mean indicates improved contrast sensitivity

  • Mesopic Monocular Contrast Sensitivity Without Glare 12 Cycles/Degree [ Time Frame: Postoperative visit 4 ( 4-6 months) ] [ Designated as safety issue: No ]
    Logarithm of the mesopic (low light) contrast sensitivity (ability to detect detail with subtle gradations of grayness between test target and background) without glare at five spatial frequencies (number of light and dark bars per cycle). A higher mean indicates improved contrast sensitivity

  • Mesopic Monocular Contrast Sensitivity Without Glare 18 Cycles/Degree [ Time Frame: Postoperative visit 4 ( 4-6 months) ] [ Designated as safety issue: No ]
    Logarithm of the mesopic (low light) contrast sensitivity (ability to detect detail with subtle gradations of grayness between test target and background) without glare at five spatial frequencies (number of light and dark bars per cycle). A higher mean indicates improved contrast sensitivity


Secondary Outcome Measures:
  • Binocular Mesopic Contrast Sensitivity Without Glare 1.5 & 3 Cycles/Degree [ Time Frame: Visit 3 (2-3 months) ] [ Designated as safety issue: No ]
    Logarithm of the mesopic (low light) contrast sensitivity (ability to detect detail with subtle gradations of grayness between test target and background) without glare at five spatial frequencies (number of light and dark bars per cycle). A higher mean indicates improved contrast sensitivity

  • Binocular Mesopic Contrast Sensitivity Without Glare 6 Cycles/Degree [ Time Frame: Visit 3 (2-3 months) ] [ Designated as safety issue: No ]
    Logarithm of the mesopic (low light) contrast sensitivity (ability to detect detail with subtle gradations of grayness between test target and background) without glare at five spatial frequencies (number of light and dark bars per cycle). A higher mean indicates improved contrast sensitivity

  • Binocular Mesopic Contrast Sensitivity Without Glare 12 Cycles/Degree [ Time Frame: Visit 3 (2-3 months) ] [ Designated as safety issue: No ]
    Logarithm of the mesopic (low light) contrast sensitivity (ability to detect detail with subtle gradations of grayness between test target and background) without glare at five spatial frequencies (number of light and dark bars per cycle). A higher mean indicates improved contrast sensitivity

  • Binocular Mesopic Contrast Sensitivity Without Glare 18 Cycles/Degree [ Time Frame: Visit 3 (2-3 months) ] [ Designated as safety issue: No ]
    Logarithm of the mesopic (low light) contrast sensitivity (ability to detect detail with subtle gradations of grayness between test target and background) without glare at five spatial frequencies (number of light and dark bars per cycle). A higher mean indicates improved contrast sensitivity

  • Binocular Mesopic Contrast Sensitivity Without Glare 1.5, 3, 6 Cycles/Degree [ Time Frame: Visit 4 (4-6 months) ] [ Designated as safety issue: No ]
    Logarithm of the mesopic (low light) contrast sensitivity (ability to detect detail with subtle gradations of grayness between test target and background) without glare at five spatial frequencies (number of light and dark bars per cycle). A higher mean indicates improved contrast sensitivity

  • Binocular Mesopic Contrast Sensitivity Without Glare 12 Cycles/Degree [ Time Frame: Visit 4 (4-6 months) ] [ Designated as safety issue: No ]
    Logarithm of the mesopic (low light) contrast sensitivity (ability to detect detail with subtle gradations of grayness between test target and background) without glare at five spatial frequencies (number of light and dark bars per cycle). A higher mean indicates improved contrast sensitivity

  • Binocular Mesopic Contrast Sensitivity Without Glare 18 Cycles/Degree [ Time Frame: Visit 4 (4-6 months) ] [ Designated as safety issue: No ]
    Logarithm of the mesopic (low light) contrast sensitivity (ability to detect detail with subtle gradations of grayness between test target and background) without glare at five spatial frequencies (number of light and dark bars per cycle). A higher mean indicates improved contrast sensitivity

  • Mesopic Monocular Contrast Sensitivity With Glare 1.5 Cycles/Degree [ Time Frame: Visit 3 (2-3 months) ] [ Designated as safety issue: No ]
    Logarithm of the mesopic (low light) contrast sensitivity (ability to detect detail with subtle gradations of grayness between test target and background) with glare at five spatial frequencies (number of light and dark bars per cycle). A higher mean indicates improved contrast sensitivity

  • Mesopic Monocular Contrast Sensitivity With Glare 3 Cycles/Degree [ Time Frame: Visit 3 (2-3 months) ] [ Designated as safety issue: No ]
    Logarithm of the mesopic (low light) contrast sensitivity (ability to detect detail with subtle gradations of grayness between test target and background) with glare at five spatial frequencies (number of light and dark bars per cycle). A higher mean indicates improved contrast sensitivity

  • Mesopic Monocular Contrast Sensitivity With Glare 6 Cycles/Degree [ Time Frame: Visit 3 (2-3 months) ] [ Designated as safety issue: No ]
    Logarithm of the mesopic (low light) contrast sensitivity (ability to detect detail with subtle gradations of grayness between test target and background) with glare at five spatial frequencies (number of light and dark bars per cycle). A higher mean indicates improved contrast sensitivity

  • Mesopic Monocular Contrast Sensitivity With Glare 12 Cycles/Degree [ Time Frame: Visit 3 (2-3 months) ] [ Designated as safety issue: No ]
    Logarithm of the mesopic (low light) contrast sensitivity (ability to detect detail with subtle gradations of grayness between test target and background) with glare at five spatial frequencies (number of light and dark bars per cycle). A higher mean indicates improved contrast sensitivity

  • Mesopic Monocular Contrast Sensitivity With Glare 18 Cycles/Degree [ Time Frame: Visit 3 (2-3 months) ] [ Designated as safety issue: No ]
    Logarithm of the mesopic (low light) contrast sensitivity (ability to detect detail with subtle gradations of grayness between test target and background) with glare at five spatial frequencies (number of light and dark bars per cycle). A higher mean indicates improved contrast sensitivity

  • Mesopic Monocular Contrast Sensitivity With Glare 1.5 Cycles/Degree [ Time Frame: Visit 4 (4-6 months) ] [ Designated as safety issue: No ]
    Logarithm of the mesopic (low light) contrast sensitivity (ability to detect detail with subtle gradations of grayness between test target and background) with glare at five spatial frequencies (number of light and dark bars per cycle). A higher mean indicates improved contrast sensitivity

  • Mesopic Monocular Contrast Sensitivity With Glare 3 Cycles/Degree [ Time Frame: Visit 4 (4-6 months) ] [ Designated as safety issue: No ]
    Logarithm of the mesopic (low light) contrast sensitivity (ability to detect detail with subtle gradations of grayness between test target and background) with glare at five spatial frequencies (number of light and dark bars per cycle). A higher mean indicates improved contrast sensitivity

  • Mesopic Monocular Contrast Sensitivity With Glare 6 Cycles/Degree [ Time Frame: Visit 4 (4-6 months) ] [ Designated as safety issue: No ]
    Logarithm of the mesopic (low light) contrast sensitivity (ability to detect detail with subtle gradations of grayness between test target and background) with glare at five spatial frequencies (number of light and dark bars per cycle). A higher mean indicates improved contrast sensitivity

  • Mesopic Monocular Contrast Sensitivity With Glare 12 Cycles/Degree [ Time Frame: Visit 4 (4-6 months) ] [ Designated as safety issue: No ]
    Logarithm of the mesopic (low light) contrast sensitivity (ability to detect detail with subtle gradations of grayness between test target and background) with glare at five spatial frequencies (number of light and dark bars per cycle). A higher mean indicates improved contrast sensitivity

  • Mesopic Monocular Contrast Sensitivity With Glare 18 Cycles/Degree [ Time Frame: Visit 4 (4-6 months) ] [ Designated as safety issue: No ]
    Logarithm of the mesopic (low light) contrast sensitivity (ability to detect detail with subtle gradations of grayness between test target and background) with glare at five spatial frequencies (number of light and dark bars per cycle). A higher mean indicates improved contrast sensitivity

  • Mesopic Binocular Contrast Sensitivity With Glare 1.5, 3 Cycles/Degree [ Time Frame: Visit 3 (2-3 months) ] [ Designated as safety issue: No ]
    Logarithm of the mesopic (low light) contrast sensitivity (ability to detect detail with subtle gradations of grayness between test target and background) with glare at five spatial frequencies (number of light and dark bars per cycle). A higher mean indicates improved contrast sensitivity

  • Mesopic Binocular Contrast Sensitivity With Glare 6 Cycles/Degree [ Time Frame: Visit 3 (2-3 months) ] [ Designated as safety issue: No ]
    Logarithm of the mesopic (low light) contrast sensitivity (ability to detect detail with subtle gradations of grayness between test target and background) with glare at five spatial frequencies (number of light and dark bars per cycle). A higher mean indicates improved contrast sensitivity

  • Mesopic Binocular Contrast Sensitivity With Glare 12 Cycles/Degree [ Time Frame: Visit 3 (2-3 months) ] [ Designated as safety issue: No ]
    Logarithm of the mesopic (low light) contrast sensitivity (ability to detect detail with subtle gradations of grayness between test target and background) with glare at five spatial frequencies (number of light and dark bars per cycle). A higher mean indicates improved contrast sensitivity

  • Mesopic Binocular Contrast Sensitivity With Glare 18 Cycles/Degree [ Time Frame: Visit 3 (2-3 months) ] [ Designated as safety issue: No ]
    Logarithm of the mesopic (low light) contrast sensitivity (ability to detect detail with subtle gradations of grayness between test target and background) with glare at five spatial frequencies (number of light and dark bars per cycle). A higher mean indicates improved contrast sensitivity

  • Mesopic Binocular Contrast Sensitivity With Glare 1.5, 3 Cycles/Degree [ Time Frame: Visit 4 (4-6 months) ] [ Designated as safety issue: No ]
    Logarithm of the mesopic (low light) contrast sensitivity (ability to detect detail with subtle gradations of grayness between test target and background) with glare at five spatial frequencies (number of light and dark bars per cycle). A higher mean indicates improved contrast sensitivity

  • Mesopic Binocular Contrast Sensitivity With Glare 6 Cycles/Degree [ Time Frame: Visit 4 (4-6 months) ] [ Designated as safety issue: No ]
    Logarithm of the mesopic (low light) contrast sensitivity (ability to detect detail with subtle gradations of grayness between test target and background) with glare at five spatial frequencies (number of light and dark bars per cycle). A higher mean indicates improved contrast sensitivity

  • Mesopic Binocular Contrast Sensitivity With Glare 12 Cycles/Degree [ Time Frame: Visit 4 (4-6 months) ] [ Designated as safety issue: No ]
    Logarithm of the mesopic (low light) contrast sensitivity (ability to detect detail with subtle gradations of grayness between test target and background) with glare at five spatial frequencies (number of light and dark bars per cycle). A higher mean indicates improved contrast sensitivity

  • Mesopic Binocular Contrast Sensitivity With Glare 18 Cycles/Degree [ Time Frame: Visit 4 (4-6 months) ] [ Designated as safety issue: No ]
    Logarithm of the mesopic (low light) contrast sensitivity (ability to detect detail with subtle gradations of grayness between test target and background) with glare at five spatial frequencies (number of light and dark bars per cycle). A higher mean indicates improved contrast sensitivity

  • Optical Scatter [ Time Frame: Visit 3 (2-3 months) ] [ Designated as safety issue: No ]
    Objective scatter index (OSI) was assessed using the Optical Quality Analysis System(OQAS) and summarized as a continuous variable. For this assessment, an OSI score of 1 or less represents good quality vision, 1-2 indicates some degradation but otherwise normal vision, 2-3 significant light scatter possibly requiring treatment, and scores over 4 severely compromised vision requiring intervention.

  • Optical Scatter [ Time Frame: Visit 4 (4-6 months) ] [ Designated as safety issue: No ]
    Objective scatter index (OSI) was assessed using the Optical Quality Analysis System(OQAS) and summarized as a continuous variable. For this assessment, an OSI score of 1 or less represents good quality vision, 1-2 indicates some degradation but otherwise normal vision, 2-3 significant light scatter possibly requiring treatment, and scores over 4 severely compromised vision requiring intervention.

  • Monocular Halo and Starburst [ Time Frame: Visit 3 (2-3 months) ] [ Designated as safety issue: No ]
    Halo and starburst (both monocular and binocular) were measured using a glarometer on integer scales of 1-5, where the smaller the number the better the outcome.

  • Monocular Halo and Starburst [ Time Frame: Visit 4 (4-6 months) ] [ Designated as safety issue: No ]
    Halo and starburst (both monocular and binocular) were measured using a glarometer on integer scales of 1-5, where the smaller the number the better the outcome.

  • Binocular Halo and Starburst [ Time Frame: Visit 3 (2-3 months) ] [ Designated as safety issue: No ]
    Halo and starburst (both monocular and binocular) were measured using a glarometer on integer scales of 1-5, where the smaller the number the better the outcome.

  • Binocular Halo and Starburst [ Time Frame: Visit 4 (4-6 months) ] [ Designated as safety issue: No ]
    Halo and starburst (both monocular and binocular) were measured using a glarometer on integer scales of 1-5, where the smaller the number the better the outcome.

  • Manifest Refraction [ Time Frame: Visit 3 (2-3 Months) ] [ Designated as safety issue: No ]
    Manifest refraction spherical equivalent (MRSE) was calculated as the value of the sphere plus one-half of the value of the cylinder.

  • Manifest Refraction [ Time Frame: Visit 4 (4-6 Months) ] [ Designated as safety issue: No ]
    Manifest refraction spherical equivalent (MRSE) was calculated as the value of the sphere plus one-half of the value of the cylinder.

  • Uncorrected Distance Visual Acuity [ Time Frame: Visit 3 (2-3 months) Visit 4 (4-6 months) ] [ Designated as safety issue: No ]
    High Contrast Uncorrected Distance (UCDVA) measured at 32 inches, Intermediate (UCIVA) at 32 inches, and Near Visual Acuity (UCNVA) at 16 inches

  • Best-corrected Distance Visual Acuity [ Time Frame: Visit 3 (2-3 months) Visit 4 (4-6 months) ] [ Designated as safety issue: No ]
    High Contrast Distance-Corrected Distance,(BCDVA), Intermediate (DCIVA), and Near Visual Acuity (DCNVA)


Enrollment: 78
Study Start Date: June 2010
Study Completion Date: September 2012
Primary Completion Date: June 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Crystalens AO
Eligible subjects to undergo small incision cataract surgery and were implanted with the Crystalens AO bilaterally.
Device: Crystalens AO
Crystalens AO surgically implanted bilaterally. Study observation up to 180 days.
Active Comparator: ReSTOR
Eligible subjects to undergo small incision cataract surgery and were implanted with the ReSTOR IOL bilaterally.
Device: ReSTOR
ReSTOR surgically implanted bilaterally. Study observation up to 180 days.
Active Comparator: Tecnis Multifocal IOL
Eligible subjects to undergo small incision cataract surgery and were implanted with the Tecnis Multifocal IOL bilaterally.
Device: Tecnis Multifocal IOL
Tecnis surgically implanted bilaterally. Study observation up to 180 days.

  Eligibility

Ages Eligible for Study:   40 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Subjects must have a clinically documented diagnosis of age-related bilateral cataracts that are considered amenable to treatment with standard phacoemulsification cataract extraction.
  • Subjects must require a spherical lens power from 10.00 D to 33.00 D
  • Subjects must have the potential for corrected distance visual acuity (CDVA) of 20/32 or better in both eyes, as documented by a Potential Acuity Meter

Exclusion Criteria:

  • Subjects with conditions with increased risk of zonular rupture, such as pseudoexfoliation syndrome. Zonular rupture during cataract surgery may affect postoperative centration, tilt, and stability of the lens.
  • Subjects who have any active inflammation or edema (swelling) of the cornea, including but not limited to the following: keratitis, keratoconjunctivitis, and keratouveitis.
  • Subjects with visually significant diabetic retinopathy (proliferative or non-proliferative) which reduces potential acuity to 20/32 or worse.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01122576

Locations
United States, California
Bausch & Lomb, Inc
Aliso Viejo, California, United States, 92656
Sponsors and Collaborators
Bausch & Lomb Incorporated
Investigators
Study Director: Omid Khodai, OD, RAC Bausch & Lomb Incorporated
  More Information

No publications provided

Responsible Party: Bausch & Lomb Incorporated
ClinicalTrials.gov Identifier: NCT01122576     History of Changes
Other Study ID Numbers: 651
Study First Received: May 11, 2010
Results First Received: September 13, 2013
Last Updated: February 12, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Bausch & Lomb Incorporated:
Intra Ocular Lens
Ocular surgery
Phacoemulsification

Additional relevant MeSH terms:
Cataract
Lens Diseases
Eye Diseases

ClinicalTrials.gov processed this record on April 22, 2014