Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

Three Intraocular Lenses Designed to Improve Distance, Intermediate and Near Vision Following Lens Extraction

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Bausch & Lomb Incorporated
ClinicalTrials.gov Identifier:
NCT01225952
First received: October 19, 2010
Last updated: December 11, 2012
Last verified: December 2012

October 19, 2010
December 11, 2012
July 2010
June 2011   (final data collection date for primary outcome measure)
  • Monocular Mesopic Contrast Sensitivity Without Glare (1.5, 3 Cycles/Degree) [ Time Frame: Postoperative visit 3 (day 30-60) ] [ Designated as safety issue: No ]
    A single eye (monocular) in dim light (mesopic) measuring contrast sensitivity; The participant is presented with a sine-wave grating target of a given spatial frequency (cycles/degree of visual angle) where the smaller the number of cycles/degree the wider apart the gradations (vertical lines of grayness). The participant's ability to detect changes in contrast is determined. Higher mean indicates improved contrast sensitivity.
  • Monocular Mesopic Contrast Sensitivity Without Glare(6 Cycles/Degree) [ Time Frame: Postoperative visit 3 (day 30-60) ] [ Designated as safety issue: No ]
    A single eye (monocular) in dim light (mesopic) measuring contrast sensitivity; The participant is presented with a sine-wave grating target of a given spatial frequency (cycles/degree of visual angle) where the smaller the number of cycles/degree the wider apart the gradations (vertical lines of grayness). The participant's ability to detect changes in contrast is determined. Higher mean indicates improved contrast sensitivity.
  • Monocular Mesopic Contrast Sensitivity Without Glare(12 Cycles/Degree) [ Time Frame: Postoperative visit 3 (day 30-60) ] [ Designated as safety issue: No ]
    A single eye (monocular) in dim light (mesopic) measuring contrast sensitivity; The participant is presented with a sine-wave grating target of a given spatial frequency (cycles/degree of visual angle) where the smaller the number of cycles/degree the wider apart the gradations (vertical lines of grayness). The participant's ability to detect changes in contrast is determined. Higher mean indicates improved contrast sensitivity.
  • Monocular Mesopic Contrast Sensitivity Without Glare(18 Cycles/Degree) [ Time Frame: Postoperative visit 3 (day 30-60) ] [ Designated as safety issue: No ]
    A single eye (monocular) in dim light (mesopic) measuring contrast sensitivity; The participant is presented with a sine-wave grating target of a given spatial frequency (cycles/degree of visual angle) where the smaller the number of cycles/degree the wider apart the gradations (vertical lines of grayness). The participant's ability to detect changes in contrast is determined. Higher mean indicates improved contrast sensitivity.
  • Monocular Mesopic Contrast Sensitivity Without Glare(1.5, 3 Cycles/Degree) [ Time Frame: Postoperative visit 4 (day 120-180) ] [ Designated as safety issue: No ]
    A single eye (monocular) in dim light (mesopic) measuring contrast sensitivity; The participant is presented with a sine-wave grating target of a given spatial frequency (cycles/degree of visual angle) where the smaller the number of cycles/degree the wider apart the gradations (vertical lines of grayness). The participant's ability to detect changes in contrast is determined. Higher mean indicates improved contrast sensitivity.
  • Monocular Mesopic Contrast Sensitivity Without Glare(6 Cycles/Degree) [ Time Frame: Postoperative visit 4 (day 120-180) ] [ Designated as safety issue: No ]
    A single eye (monocular) in dim light (mesopic) measuring contrast sensitivity; The participant is presented with a sine-wave grating target of a given spatial frequency (cycles/degree of visual angle) where the smaller the number of cycles/degree the wider apart the gradations (vertical lines of grayness). The participant's ability to detect changes in contrast is determined. Higher mean indicates improved contrast sensitivity.
  • Monocular Mesopic Contrast Sensitivity Without Glare(12 Cycles/Degree) [ Time Frame: Postoperative visit 4 (day 120-180) ] [ Designated as safety issue: No ]
    A single eye (monocular) in dim light (mesopic) measuring contrast sensitivity; The participant is presented with a sine-wave grating target of a given spatial frequency (cycles/degree of visual angle) where the smaller the number of cycles/degree the wider apart the gradations (vertical lines of grayness). The participant's ability to detect changes in contrast is determined. Higher mean indicates improved contrast sensitivity.
  • Monocular Mesopic Contrast Sensitivity Without Glare(18 Cycles/Degree) [ Time Frame: Postoperative visit 4 (day 120-180) ] [ Designated as safety issue: No ]
    A single eye (monocular) in dim light (mesopic) measuring contrast sensitivity; The participant is presented with a sine-wave grating target of a given spatial frequency (cycles/degree of visual angle) where the smaller the number of cycles/degree the wider apart the gradations (vertical lines of grayness). The participant's ability to detect changes in contrast is determined. Higher mean indicates improved contrast sensitivity.
  • Mesopic contrast sensitivity without glare [ Time Frame: Postoperative visit 3 (day 30-60) ] [ Designated as safety issue: No ]
    Mesopic contrast sensitivity without glare at five spatial frequencies (1.5, 3, 6, 12, and 18 cycles/degree)
  • Mesopic contrast sensitivity without glare [ Time Frame: Postoperative visit 4 (day 120-180) ] [ Designated as safety issue: No ]
    Mesopic contrast sensitivity without glare at five spatial frequencies (1.5, 3, 6, 12, and 18 cycles/degree)
Complete list of historical versions of study NCT01225952 on ClinicalTrials.gov Archive Site
  • Binocular Mesopic Contrast Sensitivity Without Glare(1.5, 3 Cycles/Degree) [ Time Frame: Postoperative visit 3 (day 30-60) ] [ Designated as safety issue: No ]
    In two eye (Binocular) in dim light (mesopic) measuring contrast sensitivity; The participant is presented with a sine-wave grating target of a given spatial frequency (cycles/degree of visual angle) where the smaller the number of cycles/degree the wider apart the gradations (vertical lines of grayness). The participant's ability to detect changes in contrast is determined. Higher mean indicates improved contrast sensitivity.
  • Binocular Mesopic Contrast Sensitivity Without Glare(6 Cycles/Degree) [ Time Frame: Postoperative visit 3 (day 30-60) ] [ Designated as safety issue: No ]
    In two eyes (binocular) in dim light (mesopic) measuring contrast sensitivity; The participant is presented with a sine-wave grating target of a given spatial frequency (cycles/degree of visual angle) where the smaller the number of cycles/degree the wider apart the gradations (vertical lines of grayness). The participant's ability to detect changes in contrast is determined. Higher mean indicates improved contrast sensitivity.
  • Binocular Mesopic Contrast Sensitivity Without Glare(12 Cycles/Degree) [ Time Frame: Postoperative visit 3 (day 30-60) ] [ Designated as safety issue: No ]
    In two eyes (binocular) in dim light (mesopic) measuring contrast sensitivity; The participant is presented with a sine-wave grating target of a given spatial frequency (cycles/degree of visual angle) where the smaller the number of cycles/degree the wider apart the gradations (vertical lines of grayness). The participant's ability to detect changes in contrast is determined. Higher mean indicates improved contrast sensitivity.
  • Binocular Mesopic Contrast Sensitivity Without Glare(18 Cycles/Degree) [ Time Frame: Postoperative visit 3 (day 30-60) ] [ Designated as safety issue: No ]
    In two eyes (binocular) in dim light (mesopic) measuring contrast sensitivity; The participant is presented with a sine-wave grating target of a given spatial frequency (cycles/degree of visual angle) where the smaller the number of cycles/degree the wider apart the gradations (vertical lines of grayness). The participant's ability to detect changes in contrast is determined. Higher mean indicates improved contrast sensitivity.
  • Binocular Mesopic Contrast Sensitivity Without Glare(1.5, 3 Cycles/Degree) [ Time Frame: Postoperative visit 4 (day 120-180) ] [ Designated as safety issue: No ]
    In two eyes (binocular) in dim light (mesopic) measuring contrast sensitivity; The participant is presented with a sine-wave grating target of a given spatial frequency (cycles/degree of visual angle) where the smaller the number of cycles/degree the wider apart the gradations (vertical lines of grayness). The participant's ability to detect changes in contrast is determined. Higher mean indicates improved contrast sensitivity.
  • Binocular Mesopic Contrast Sensitivity Without Glare(6 Cycles/Degree) [ Time Frame: Postoperative visit 4 (day 120-180) ] [ Designated as safety issue: No ]
    In two eyes (binocular) in dim light (mesopic) measuring contrast sensitivity; The participant is presented with a sine-wave grating target of a given spatial frequency (cycles/degree of visual angle) where the smaller the number of cycles/degree the wider apart the gradations (vertical lines of grayness). The participant's ability to detect changes in contrast is determined. Higher mean indicates improved contrast sensitivity.
  • Binocular Mesopic Contrast Sensitivity Without Glare(12 Cycles/Degree) [ Time Frame: Postoperative visit 4 (day 120-180) ] [ Designated as safety issue: No ]
    In two eyes (binocular) in dim light (mesopic) measuring contrast sensitivity; The participant is presented with a sine-wave grating target of a given spatial frequency (cycles/degree of visual angle) where the smaller the number of cycles/degree the wider apart the gradations (vertical lines of grayness). The participant's ability to detect changes in contrast is determined. Higher mean indicates improved contrast sensitivity.
  • Binocular Mesopic Contrast Sensitivity Without Glare(18 Cycles/Degree) [ Time Frame: Postoperative visit 4 (day 120-180) ] [ Designated as safety issue: No ]
    In two eyes (binocular) in dim light (mesopic) measuring contrast sensitivity; The participant is presented with a sine-wave grating target of a given spatial frequency (cycles/degree of visual angle) where the smaller the number of cycles/degree the wider apart the gradations (vertical lines of grayness). The participant's ability to detect changes in contrast is determined. Higher mean indicates improved contrast sensitivity.
  • Monocular Mesopic Contrast Sensitivity With Glare(1.5 Cycles/Degree) [ Time Frame: Postoperative visit 3 (day 30-60) ] [ Designated as safety issue: No ]
    In one eye (monocular) in dim light (mesopic) measuring contrast sensitivity; The participant is presented with a sine-wave grating target of a given spatial frequency (cycles/degree of visual angle) where the smaller the number of cycles/degree the wider apart the gradations (vertical lines of grayness). The participant's ability to detect changes in contrast is determined. Higher mean indicates improved contrast sensitivity.
  • Monocular Mesopic Contrast Sensitivity With Glare (3 Cycles/Degree) [ Time Frame: Postoperative visit 3 (day 30-60) ] [ Designated as safety issue: No ]
    In one eye (monocular) in dim light (mesopic) measuring contrast sensitivity; The participant is presented with a sine-wave grating target of a given spatial frequency (cycles/degree of visual angle) where the smaller the number of cycles/degree the wider apart the gradations (vertical lines of grayness). The participant's ability to detect changes in contrast is determined. Higher mean indicates improved contrast sensitivity.
  • Monocular Mesopic Contrast Sensitivity With Glare(6 Cycles/Degree) [ Time Frame: Postoperative visit 3 (day 30-60) ] [ Designated as safety issue: No ]
    In one eye (monocular) in dim light (mesopic) measuring contrast sensitivity; The participant is presented with a sine-wave grating target of a given spatial frequency (cycles/degree of visual angle) where the smaller the number of cycles/degree the wider apart the gradations (vertical lines of grayness). The participant's ability to detect changes in contrast is determined. Higher mean indicates improved contrast sensitivity.
  • Monocular Mesopic Contrast Sensitivity With Glare(12 Cycles/Degree) [ Time Frame: Postoperative visit 3 (day 30-60) ] [ Designated as safety issue: No ]
    In one eye (monocular) in dim light (mesopic) measuring contrast sensitivity; The participant is presented with a sine-wave grating target of a given spatial frequency (cycles/degree of visual angle) where the smaller the number of cycles/degree the wider apart the gradations (vertical lines of grayness). The participant's ability to detect changes in contrast is determined. Higher mean indicates improved contrast sensitivity.
  • Monocular Mesopic Contrast Sensitivity With Glare(18 Cycles/Degree) [ Time Frame: Postoperative visit 3 (day 30-60) ] [ Designated as safety issue: No ]
    In one eye (monocular) in dim light (mesopic) measuring contrast sensitivity; The participant is presented with a sine-wave grating target of a given spatial frequency (cycles/degree of visual angle) where the smaller the number of cycles/degree the wider apart the gradations (vertical lines of grayness). The participant's ability to detect changes in contrast is determined. Higher mean indicates improved contrast sensitivity.
  • Monocular Mesopic Contrast Sensitivity With Glare(1.5 Cycles/Degree) [ Time Frame: Postoperative visit 4 (day 120-180) ] [ Designated as safety issue: No ]
    In one eye (monocular) in dim light (mesopic) measuring contrast sensitivity; The participant is presented with a sine-wave grating target of a given spatial frequency (cycles/degree of visual angle) where the smaller the number of cycles/degree the wider apart the gradations (vertical lines of grayness). The participant's ability to detect changes in contrast is determined. Higher mean indicates improved contrast sensitivity.
  • Monocular Mesopic Contrast Sensitivity With Glare(3 Cycles/Degree) [ Time Frame: Postoperative visit 4 (day 120-180) ] [ Designated as safety issue: No ]
    In one eye (monocular) in dim light (mesopic) measuring contrast sensitivity; The participant is presented with a sine-wave grating target of a given spatial frequency (cycles/degree of visual angle) where the smaller the number of cycles/degree the wider apart the gradations (vertical lines of grayness). The participant's ability to detect changes in contrast is determined. Higher mean indicates improved contrast sensitivity.
  • Monocular Mesopic Contrast Sensitivity With Glare(6 Cycles/Degree) [ Time Frame: Postoperative visit 4 (day 120-180) ] [ Designated as safety issue: No ]
    In one eye (monocular) in dim light (mesopic) measuring contrast sensitivity; The participant is presented with a sine-wave grating target of a given spatial frequency (cycles/degree of visual angle) where the smaller the number of cycles/degree the wider apart the gradations (vertical lines of grayness). The participant's ability to detect changes in contrast is determined. Higher mean indicates improved contrast sensitivity.
  • Monocular Mesopic Contrast Sensitivity With Glare(12 Cycles/Degree) [ Time Frame: Postoperative visit 4 (day 120-180) ] [ Designated as safety issue: No ]
    In one eye (monocular) in dim light (mesopic) measuring contrast sensitivity; The participant is presented with a sine-wave grating target of a given spatial frequency (cycles/degree of visual angle) where the smaller the number of cycles/degree the wider apart the gradations (vertical lines of grayness). The participant's ability to detect changes in contrast is determined. Higher mean indicates improved contrast sensitivity.
  • Monocular Mesopic Contrast Sensitivity With Glare(18 Cycles/Degree) [ Time Frame: Postoperative visit 4 (day 120-180) ] [ Designated as safety issue: No ]
    In one eye (monocular) in dim light (mesopic) measuring contrast sensitivity; The participant is presented with a sine-wave grating target of a given spatial frequency (cycles/degree of visual angle) where the smaller the number of cycles/degree the wider apart the gradations (vertical lines of grayness). The participant's ability to detect changes in contrast is determined. Higher mean indicates improved contrast sensitivity.
  • Mesopic contrast sensitivity with glare [ Time Frame: Postoperative visit 3 (day 30-60) ] [ Designated as safety issue: No ]
    Mesopic contrast sensitivity with glare at five spatial frequencies (1.5, 3, 6, 12, and 18 cycles/degree)
  • Mesopic contrast sensitivity with glare [ Time Frame: Postoperative visit 4 (day 120-180) ] [ Designated as safety issue: No ]
    Mesopic contrast sensitivity with glare at five spatial frequencies (1.5, 3, 6, 12, and 18 cycles/degree)
Not Provided
Not Provided
 
Three Intraocular Lenses Designed to Improve Distance, Intermediate and Near Vision 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 compare the contrast sensitivity, high and low contrast visual acuity (VA), glare meter outcomes, and subject satisfaction with three different FDA-approved intraocular lenses (IOLs) designed to improve distance, intermediate, and near vision following lens extraction in adults at least 40 years of age.

Not Provided
Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Outcomes Assessor)
Primary Purpose: Treatment
Cataract
  • Device: Crystalens AO
    Bausch & Lomb model silicone multi-piece accommodating IOL.
  • Device: ReSTOR 3.0
    An aspheric multifocal IOL (Alcon Laboratories) combines the functions of an apodized diffractive region and a refractive region.
  • Device: AMO Tecnis Multifocal
    The Tecnis Multifocal foldable hydrophobic acrylic IOL, Model ZMA00 (Abbott Medical Optics), is an ultraviolet light-absorbing posterior chamber IOL.
  • Experimental: Crystalens AO
    Bausch & Lomb silicone multi-piece accommodating IOL is a modified plate haptic lens
    Intervention: Device: Crystalens AO
  • Active Comparator: ReSTOR 3.0
    An aspheric multifocal IOL (Alcon Laboratories) combines the functions of an apodized diffractive region and a refractive region.
    Intervention: Device: ReSTOR 3.0
  • Active Comparator: AMO Tecnis Multifocal
    A foldable hydrophobic acrylic IOL,(Abbott Medical Optics), is an ultraviolet light-absorbing posterior chamber IOL
    Intervention: Device: AMO Tecnis Multifocal
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
93
July 2011
June 2011   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Subjects must be undergoing primary IOL implantation for the correction of aphakia following continuous curvilinear anterior capsulotomy and phacoemulsification cataract extraction.
  • Subjects must require a spherical lens power from 10.00 diopters (D) to 33.00 D.
  • Subjects must have the potential for corrected distance visual acuity (CDVA) of 20/32 or better in both eyes.
  • Subjects must have stopped contact lens wear for at least two weeks for soft lens wearers or three weeks for gas permeable lens wearers prior to biometry and surgery.
  • At the time of surgery, subjects must have an intact centered capsulorhexis, intact posterior capsule, and no zonular rupture.
  • Subjects must have ≤ 1.25 D of preoperative corneal astigmatism in both eyes.

Exclusion Criteria:

  • Subjects with diagnoses of degenerative visual disorders (eg, macular degeneration, or other retinal disorders) that cause potential acuity losses to a level of 20/32 or worse.
  • Subjects with conditions with increased risk of zonular rupture, such as pseudoexfoliation syndrome.
  • 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 uncontrolled glaucoma.
  • Subjects with previous retinal detachment.
  • Subjects with visually significant diabetic retinopathy (proliferative or nonproliferative) which reduces potential acuity to 20/32 or worse.
  • Subjects with rubella, bilateral congenital, traumatic, complicated or polar cataract.
  • Subjects with marked microphthalmos or aniridia.
  • Subjects who have had previous corneal surgery.
  • Subjects with irregular corneal astigmatism.
  • Subjects with amblyopia which reduces potential acuity to 20/32 or worse.
  • Subjects with optic atrophy.
  • Subjects with iris neovascularization.
  • Subjects with clinically significant retinal pigment epithelium/macular changes which reduces potential acuity to 20/32 or worse.
  • Subjects with chronic use of systemic steroids or immunosuppressive medications.
Both
40 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Philippines
 
NCT01225952
656
No
Bausch & Lomb Incorporated
Bausch & Lomb Incorporated
Not Provided
Study Director: Tes Ignacio, MD Bausch & Lomb Incorporated
Bausch & Lomb Incorporated
December 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP