Evaluation of 3 Intraocular Lenses Following Lens Extraction

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

Study Overview

• Status: Completed
• Conditions: Cataract
• Intervention / Treatment: Device: Crystalens AO; Device: ReSTOR; Device: Tecnis Multifocal IOL

• Study Type: Interventional
• Enrollment (Actual): 78
• Phase: Phase 4

Contacts and Locations

Study Locations

• United States
  • California
    • Aliso Viejo, California, United States, 92656
      • Bausch & Lomb, Inc

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: DOUBLE

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mesopic Monocular Contrast Sensitivity Without Glare 1.5 and 3 Cycles/Degree	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	Postoperative visit 3 (2-3 months)
Mesopic Monocular Contrast Sensitivity Without Glare 6 Cycles/Degree	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	Postoperative visit 3 (2-3 months)
Mesopic Monocular Contrast Sensitivity Without Glare 12 Cycles/Degree	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	Postoperative visit 3 (2-3 months)
Mesopic Monocular Contrast Sensitivity Without Glare 18 Cycles/Degree	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	Postoperative visit 3 (2-3 months)
Mesopic Monocular Contrast Sensitivity Without Glare 1.5 Cycles/Degree	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	Postoperative visit 4 ( 4-6 months)
Mesopic Monocular Contrast Sensitivity Without Glare 3 Cycles/Degree	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	Postoperative visit 4 ( 4-6 months)
Mesopic Monocular Contrast Sensitivity Without Glare 6 Cycles/Degree	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	Postoperative visit 4 ( 4-6 months)
Mesopic Monocular Contrast Sensitivity Without Glare 12 Cycles/Degree	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	Postoperative visit 4 ( 4-6 months)
Mesopic Monocular Contrast Sensitivity Without Glare 18 Cycles/Degree	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	Postoperative visit 4 ( 4-6 months)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Binocular Mesopic Contrast Sensitivity Without Glare 1.5 & 3 Cycles/Degree	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	Visit 3 (2-3 months)
Binocular Mesopic Contrast Sensitivity Without Glare 6 Cycles/Degree	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	Visit 3 (2-3 months)
Binocular Mesopic Contrast Sensitivity Without Glare 12 Cycles/Degree	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	Visit 3 (2-3 months)
Binocular Mesopic Contrast Sensitivity Without Glare 18 Cycles/Degree	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	Visit 3 (2-3 months)
Binocular Mesopic Contrast Sensitivity Without Glare 1.5, 3, 6 Cycles/Degree	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	Visit 4 (4-6 months)
Binocular Mesopic Contrast Sensitivity Without Glare 12 Cycles/Degree	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	Visit 4 (4-6 months)
Binocular Mesopic Contrast Sensitivity Without Glare 18 Cycles/Degree	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	Visit 4 (4-6 months)
Mesopic Monocular Contrast Sensitivity With Glare 1.5 Cycles/Degree	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	Visit 3 (2-3 months)
Mesopic Monocular Contrast Sensitivity With Glare 3 Cycles/Degree	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	Visit 3 (2-3 months)
Mesopic Monocular Contrast Sensitivity With Glare 6 Cycles/Degree	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	Visit 3 (2-3 months)
Mesopic Monocular Contrast Sensitivity With Glare 12 Cycles/Degree	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	Visit 3 (2-3 months)
Mesopic Monocular Contrast Sensitivity With Glare 18 Cycles/Degree	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	Visit 3 (2-3 months)
Mesopic Monocular Contrast Sensitivity With Glare 1.5 Cycles/Degree	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	Visit 4 (4-6 months)
Mesopic Monocular Contrast Sensitivity With Glare 3 Cycles/Degree	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	Visit 4 (4-6 months)
Mesopic Monocular Contrast Sensitivity With Glare 6 Cycles/Degree	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	Visit 4 (4-6 months)
Mesopic Monocular Contrast Sensitivity With Glare 12 Cycles/Degree	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	Visit 4 (4-6 months)
Mesopic Monocular Contrast Sensitivity With Glare 18 Cycles/Degree	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	Visit 4 (4-6 months)
Mesopic Binocular Contrast Sensitivity With Glare 1.5, 3 Cycles/Degree	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	Visit 3 (2-3 months)
Mesopic Binocular Contrast Sensitivity With Glare 6 Cycles/Degree	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	Visit 3 (2-3 months)
Mesopic Binocular Contrast Sensitivity With Glare 12 Cycles/Degree	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	Visit 3 (2-3 months)
Mesopic Binocular Contrast Sensitivity With Glare 18 Cycles/Degree	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	Visit 3 (2-3 months)
Mesopic Binocular Contrast Sensitivity With Glare 1.5, 3 Cycles/Degree	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	Visit 4 (4-6 months)
Mesopic Binocular Contrast Sensitivity With Glare 6 Cycles/Degree	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	Visit 4 (4-6 months)
Mesopic Binocular Contrast Sensitivity With Glare 12 Cycles/Degree	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	Visit 4 (4-6 months)
Mesopic Binocular Contrast Sensitivity With Glare 18 Cycles/Degree	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	Visit 4 (4-6 months)
Optical Scatter	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.	Visit 3 (2-3 months)
Optical Scatter	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.	Visit 4 (4-6 months)
Monocular Halo and Starburst	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.	Visit 3 (2-3 months)
Monocular Halo and Starburst	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.	Visit 4 (4-6 months)
Binocular Halo and Starburst	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.	Visit 3 (2-3 months)
Binocular Halo and Starburst	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.	Visit 4 (4-6 months)
Manifest Refraction	Manifest refraction spherical equivalent (MRSE) was calculated as the value of the sphere plus one-half of the value of the cylinder.	Visit 3 (2-3 Months)
Manifest Refraction	Manifest refraction spherical equivalent (MRSE) was calculated as the value of the sphere plus one-half of the value of the cylinder.	Visit 4 (4-6 Months)
Uncorrected Distance Visual Acuity	High Contrast Uncorrected Distance (UCDVA) measured at 32 inches, Intermediate (UCIVA) at 32 inches, and Near Visual Acuity (UCNVA) at 16 inches	Visit 3 (2-3 months) Visit 4 (4-6 months)
Best-corrected Distance Visual Acuity	High Contrast Distance-Corrected Distance,(BCDVA), Intermediate (DCIVA), and Near Visual Acuity (DCNVA)	Visit 3 (2-3 months) Visit 4 (4-6 months)

Collaborators and Investigators

• Sponsor: Bausch & Lomb Incorporated
• Investigators: Study Director: Omid Khodai, OD, RAC, Bausch & Lomb Incorporated

Study record dates

Study Major Dates

• Study Start: June 1, 2010
• Primary Completion (ACTUAL): June 1, 2012
• Study Completion (ACTUAL): September 1, 2012

Study Registration Dates

• First Submitted: May 11, 2010
• First Submitted That Met QC Criteria: May 12, 2010
• First Posted (ESTIMATE): May 13, 2010

Study Record Updates

• Last Update Posted (ESTIMATE): March 28, 2014
• Last Update Submitted That Met QC Criteria: February 12, 2014
• Last Verified: February 1, 2014

More Information

Terms related to this study

• Keywords: Phacoemulsification; Intra Ocular Lens; Ocular surgery
• Additional Relevant MeSH Terms: Eye Diseases; Lens Diseases; Cataract
• Other Study ID Numbers: 651 (CHM)