Evaluation of 3 Intraocular Lenses Following Lens Extraction

Cataract Clinical Trial

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01122576
• Other study ID #: 651
• Status: Completed
• Phase: Phase 4
• First received: May 11, 2010
• Last updated: February 12, 2014
• Start date: June 2010
• Est. completion date: September 2012

Study information

• Verified date: February 2014
• Source: Bausch & Lomb Incorporated
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 78
• Est. completion date: September 2012
• Est. primary completion date: June 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 40 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Cataract

Intervention

Device:
• Crystalens AO
Crystalens AO surgically implanted bilaterally. Study observation up to 180 days.
• ReSTOR
ReSTOR surgically implanted bilaterally. Study observation up to 180 days.
• Tecnis Multifocal IOL
Tecnis surgically implanted bilaterally. Study observation up to 180 days.

Locations

Country	Name	City	State
United States	Bausch & Lomb, Inc	Aliso Viejo	California

Sponsors (1)

Lead Sponsor	Collaborator
Bausch & Lomb Incorporated

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)	No
Primary	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)	No
Primary	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)	No
Primary	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)	No
Primary	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)	No
Primary	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)	No
Primary	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)	No
Primary	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)	No
Primary	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)	No
Secondary	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)	No
Secondary	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)	No
Secondary	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)	No
Secondary	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)	No
Secondary	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)	No
Secondary	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)	No
Secondary	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)	No
Secondary	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)	No
Secondary	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)	No
Secondary	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)	No
Secondary	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)	No
Secondary	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)	No
Secondary	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)	No
Secondary	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)	No
Secondary	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)	No
Secondary	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)	No
Secondary	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)	No
Secondary	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)	No
Secondary	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)	No
Secondary	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)	No
Secondary	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)	No
Secondary	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)	No
Secondary	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)	No
Secondary	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)	No
Secondary	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)	No
Secondary	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)	No
Secondary	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)	No
Secondary	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)	No
Secondary	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)	No
Secondary	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)	No
Secondary	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)	No
Secondary	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)	No
Secondary	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)	No
Secondary	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)	No
Secondary	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)	No