Skip to main content
OpenTrials
Completed

NCT Number: NCT01122576

Evaluation of 3 Intraocular Lenses Following Lens Extraction

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Cataract Eye Diseases Lens Diseases

Age range

40 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Bausch & Lomb, Inc

Aliso Viejo, California, 92656, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Crystalens AO

Device

Crystalens AO surgically implanted bilaterally. Study observation up to 180 days.

ReSTOR

Device

ReSTOR surgically implanted bilaterally. Study observation up to 180 days.

Tecnis Multifocal IOL

Device

Tecnis surgically implanted bilaterally. Study observation up to 180 days.

Primary outcomes

  1. Mesopic Monocular Contrast Sensitivity Without Glare 1.5 and 3 Cycles/Degree

    Time frame: Postoperative visit 3 (2-3 months)

    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

  2. Mesopic Monocular Contrast Sensitivity Without Glare 6 Cycles/Degree

    Time frame: Postoperative visit 3 (2-3 months)

    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

  3. Mesopic Monocular Contrast Sensitivity Without Glare 12 Cycles/Degree

    Time frame: Postoperative visit 3 (2-3 months)

    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

  4. Mesopic Monocular Contrast Sensitivity Without Glare 18 Cycles/Degree

    Time frame: Postoperative visit 3 (2-3 months)

    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

  5. Mesopic Monocular Contrast Sensitivity Without Glare 1.5 Cycles/Degree

    Time frame: Postoperative visit 4 ( 4-6 months)

    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

  6. Mesopic Monocular Contrast Sensitivity Without Glare 3 Cycles/Degree

    Time frame: Postoperative visit 4 ( 4-6 months)

    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

  7. Mesopic Monocular Contrast Sensitivity Without Glare 6 Cycles/Degree

    Time frame: Postoperative visit 4 ( 4-6 months)

    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

  8. Mesopic Monocular Contrast Sensitivity Without Glare 12 Cycles/Degree

    Time frame: Postoperative visit 4 ( 4-6 months)

    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

  9. Mesopic Monocular Contrast Sensitivity Without Glare 18 Cycles/Degree

    Time frame: Postoperative visit 4 ( 4-6 months)

    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 outcomes

  1. Binocular Mesopic Contrast Sensitivity Without Glare 1.5 & 3 Cycles/Degree

    Time frame: Visit 3 (2-3 months)

    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

  2. Binocular Mesopic Contrast Sensitivity Without Glare 6 Cycles/Degree

    Time frame: Visit 3 (2-3 months)

    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

  3. Binocular Mesopic Contrast Sensitivity Without Glare 12 Cycles/Degree

    Time frame: Visit 3 (2-3 months)

    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

  4. Binocular Mesopic Contrast Sensitivity Without Glare 18 Cycles/Degree

    Time frame: Visit 3 (2-3 months)

    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

  5. Binocular Mesopic Contrast Sensitivity Without Glare 1.5, 3, 6 Cycles/Degree

    Time frame: Visit 4 (4-6 months)

    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

  6. Binocular Mesopic Contrast Sensitivity Without Glare 12 Cycles/Degree

    Time frame: Visit 4 (4-6 months)

    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

  7. Binocular Mesopic Contrast Sensitivity Without Glare 18 Cycles/Degree

    Time frame: Visit 4 (4-6 months)

    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

  8. Mesopic Monocular Contrast Sensitivity With Glare 1.5 Cycles/Degree

    Time frame: Visit 3 (2-3 months)

    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

  9. Mesopic Monocular Contrast Sensitivity With Glare 3 Cycles/Degree

    Time frame: Visit 3 (2-3 months)

    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

  10. Mesopic Monocular Contrast Sensitivity With Glare 6 Cycles/Degree

    Time frame: Visit 3 (2-3 months)

    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

  11. Mesopic Monocular Contrast Sensitivity With Glare 12 Cycles/Degree

    Time frame: Visit 3 (2-3 months)

    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

  12. Mesopic Monocular Contrast Sensitivity With Glare 18 Cycles/Degree

    Time frame: Visit 3 (2-3 months)

    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

  13. Mesopic Monocular Contrast Sensitivity With Glare 1.5 Cycles/Degree

    Time frame: Visit 4 (4-6 months)

    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

  14. Mesopic Monocular Contrast Sensitivity With Glare 3 Cycles/Degree

    Time frame: Visit 4 (4-6 months)

    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

  15. Mesopic Monocular Contrast Sensitivity With Glare 6 Cycles/Degree

    Time frame: Visit 4 (4-6 months)

    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

  16. Mesopic Monocular Contrast Sensitivity With Glare 12 Cycles/Degree

    Time frame: Visit 4 (4-6 months)

    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

  17. Mesopic Monocular Contrast Sensitivity With Glare 18 Cycles/Degree

    Time frame: Visit 4 (4-6 months)

    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

  18. Mesopic Binocular Contrast Sensitivity With Glare 1.5, 3 Cycles/Degree

    Time frame: Visit 3 (2-3 months)

    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

  19. Mesopic Binocular Contrast Sensitivity With Glare 6 Cycles/Degree

    Time frame: Visit 3 (2-3 months)

    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

  20. Mesopic Binocular Contrast Sensitivity With Glare 12 Cycles/Degree

    Time frame: Visit 3 (2-3 months)

    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

  21. Mesopic Binocular Contrast Sensitivity With Glare 18 Cycles/Degree

    Time frame: Visit 3 (2-3 months)

    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

  22. Mesopic Binocular Contrast Sensitivity With Glare 1.5, 3 Cycles/Degree

    Time frame: Visit 4 (4-6 months)

    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

  23. Mesopic Binocular Contrast Sensitivity With Glare 6 Cycles/Degree

    Time frame: Visit 4 (4-6 months)

    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

  24. Mesopic Binocular Contrast Sensitivity With Glare 12 Cycles/Degree

    Time frame: Visit 4 (4-6 months)

    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

  25. Mesopic Binocular Contrast Sensitivity With Glare 18 Cycles/Degree

    Time frame: Visit 4 (4-6 months)

    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

  26. Optical Scatter

    Time frame: Visit 3 (2-3 months)

    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.

  27. Optical Scatter

    Time frame: Visit 4 (4-6 months)

    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.

  28. Monocular Halo and Starburst

    Time frame: Visit 3 (2-3 months)

    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.

  29. Monocular Halo and Starburst

    Time frame: Visit 4 (4-6 months)

    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.

  30. Binocular Halo and Starburst

    Time frame: Visit 3 (2-3 months)

    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.

  31. Binocular Halo and Starburst

    Time frame: Visit 4 (4-6 months)

    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.

  32. Manifest Refraction

    Time frame: Visit 3 (2-3 Months)

    Manifest refraction spherical equivalent (MRSE) was calculated as the value of the sphere plus one-half of the value of the cylinder.

  33. Manifest Refraction

    Time frame: Visit 4 (4-6 Months)

    Manifest refraction spherical equivalent (MRSE) was calculated as the value of the sphere plus one-half of the value of the cylinder.

  34. Uncorrected Distance Visual Acuity

    Time frame: Visit 3 (2-3 months) Visit 4 (4-6 months)

    High Contrast Uncorrected Distance (UCDVA) measured at 32 inches, Intermediate (UCIVA) at 32 inches, and Near Visual Acuity (UCNVA) at 16 inches

  35. Best-corrected Distance Visual Acuity

    Time frame: Visit 3 (2-3 months) Visit 4 (4-6 months)

    High Contrast Distance-Corrected Distance,(BCDVA), Intermediate (DCIVA), and Near Visual Acuity (DCNVA)

Sponsors and collaborators

Lead sponsor

Bausch & Lomb Incorporated

Industry

Registry information

Official study title

A Three Arm Prospective Clinical Evaluation of Three FDA Approved Intraocular Lenses Designed to Improve Distance, Intermediate and Near Vision Following Lens Extraction.

Important dates

Study start
2010
Primary completion
2012
Study completion
2012
First posted
May 13, 2010
Registry last updated
Mar 28, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.