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
  Purpose

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.


Condition Intervention Phase
Cataract
Device: Crystalens AO
Device: ReSTOR 3.0
Device: AMO Tecnis Multifocal
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/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

Further study details as provided by Bausch & Lomb Incorporated:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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.


Enrollment: 93
Study Start Date: July 2010
Study Completion Date: July 2011
Primary Completion Date: June 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Crystalens AO
Bausch & Lomb silicone multi-piece accommodating IOL is a modified plate haptic lens
Device: Crystalens AO
Bausch & Lomb model silicone multi-piece accommodating IOL.
Active Comparator: ReSTOR 3.0
An aspheric multifocal IOL (Alcon Laboratories) combines the functions of an apodized diffractive region and a refractive region.
Device: ReSTOR 3.0
An aspheric multifocal IOL (Alcon Laboratories) combines the functions of an apodized diffractive region and a refractive region.
Active Comparator: AMO Tecnis Multifocal
A foldable hydrophobic acrylic IOL,(Abbott Medical Optics), is an ultraviolet light-absorbing posterior chamber IOL
Device: AMO Tecnis Multifocal
The Tecnis Multifocal foldable hydrophobic acrylic IOL, Model ZMA00 (Abbott Medical Optics), is an ultraviolet light-absorbing posterior chamber IOL.

  Eligibility

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

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01225952

Locations
Philippines
Asian Eye Institute
Makati City, Philippines, 1200
Sponsors and Collaborators
Bausch & Lomb Incorporated
Investigators
Study Director: Tes Ignacio, MD Bausch & Lomb Incorporated
  More Information

No publications provided

Responsible Party: Bausch & Lomb Incorporated
ClinicalTrials.gov Identifier: NCT01225952     History of Changes
Other Study ID Numbers: 656
Study First Received: October 19, 2010
Results First Received: August 31, 2012
Last Updated: December 11, 2012
Health Authority: United States: Food and Drug Administration
Philippines: Bureau of Food and Drugs

Keywords provided by Bausch & Lomb Incorporated:
phacoemulsification
intraocular lens

ClinicalTrials.gov processed this record on November 20, 2014