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

Primary Purpose

Cataract

Status
Completed
Phase
Phase 4
Locations
Philippines
Study Type
Interventional
Intervention
Crystalens AO
ReSTOR 3.0
AMO Tecnis Multifocal
Sponsored by
Bausch & Lomb Incorporated
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cataract focused on measuring phacoemulsification, intraocular lens

Eligibility Criteria

40 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Asian Eye Institute

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Active Comparator

Active Comparator

Arm Label

Crystalens AO

ReSTOR 3.0

AMO Tecnis Multifocal

Arm Description

Bausch & Lomb silicone multi-piece accommodating IOL is a modified plate haptic lens

An aspheric multifocal IOL (Alcon Laboratories) combines the functions of an apodized diffractive region and a refractive region.

A foldable hydrophobic acrylic IOL,(Abbott Medical Optics), is an ultraviolet light-absorbing posterior chamber IOL

Outcomes

Primary Outcome Measures

Monocular Mesopic Contrast Sensitivity Without Glare (1.5, 3 Cycles/Degree)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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.

Full Information

First Posted
October 19, 2010
Last Updated
December 11, 2012
Sponsor
Bausch & Lomb Incorporated
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1. Study Identification

Unique Protocol Identification Number
NCT01225952
Brief Title
Three Intraocular Lenses Designed to Improve Distance, Intermediate and Near Vision Following Lens Extraction
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
Study Type
Interventional

2. Study Status

Record Verification Date
December 2012
Overall Recruitment Status
Completed
Study Start Date
July 2010 (undefined)
Primary Completion Date
June 2011 (Actual)
Study Completion Date
July 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Bausch & Lomb Incorporated

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cataract
Keywords
phacoemulsification, intraocular lens

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
93 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Crystalens AO
Arm Type
Experimental
Arm Description
Bausch & Lomb silicone multi-piece accommodating IOL is a modified plate haptic lens
Arm Title
ReSTOR 3.0
Arm Type
Active Comparator
Arm Description
An aspheric multifocal IOL (Alcon Laboratories) combines the functions of an apodized diffractive region and a refractive region.
Arm Title
AMO Tecnis Multifocal
Arm Type
Active Comparator
Arm Description
A foldable hydrophobic acrylic IOL,(Abbott Medical Optics), is an ultraviolet light-absorbing posterior chamber IOL
Intervention Type
Device
Intervention Name(s)
Crystalens AO
Intervention Description
Bausch & Lomb model silicone multi-piece accommodating IOL.
Intervention Type
Device
Intervention Name(s)
ReSTOR 3.0
Intervention Description
An aspheric multifocal IOL (Alcon Laboratories) combines the functions of an apodized diffractive region and a refractive region.
Intervention Type
Device
Intervention Name(s)
AMO Tecnis Multifocal
Intervention Description
The Tecnis Multifocal foldable hydrophobic acrylic IOL, Model ZMA00 (Abbott Medical Optics), is an ultraviolet light-absorbing posterior chamber IOL.
Primary Outcome Measure Information:
Title
Monocular Mesopic Contrast Sensitivity Without Glare (1.5, 3 Cycles/Degree)
Description
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.
Time Frame
Postoperative visit 3 (day 30-60)
Title
Monocular Mesopic Contrast Sensitivity Without Glare(6 Cycles/Degree)
Description
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.
Time Frame
Postoperative visit 3 (day 30-60)
Title
Monocular Mesopic Contrast Sensitivity Without Glare(12 Cycles/Degree)
Description
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.
Time Frame
Postoperative visit 3 (day 30-60)
Title
Monocular Mesopic Contrast Sensitivity Without Glare(18 Cycles/Degree)
Description
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.
Time Frame
Postoperative visit 3 (day 30-60)
Title
Monocular Mesopic Contrast Sensitivity Without Glare(1.5, 3 Cycles/Degree)
Description
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.
Time Frame
Postoperative visit 4 (day 120-180)
Title
Monocular Mesopic Contrast Sensitivity Without Glare(6 Cycles/Degree)
Description
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.
Time Frame
Postoperative visit 4 (day 120-180)
Title
Monocular Mesopic Contrast Sensitivity Without Glare(12 Cycles/Degree)
Description
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.
Time Frame
Postoperative visit 4 (day 120-180)
Title
Monocular Mesopic Contrast Sensitivity Without Glare(18 Cycles/Degree)
Description
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.
Time Frame
Postoperative visit 4 (day 120-180)
Secondary Outcome Measure Information:
Title
Binocular Mesopic Contrast Sensitivity Without Glare(1.5, 3 Cycles/Degree)
Description
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.
Time Frame
Postoperative visit 3 (day 30-60)
Title
Binocular Mesopic Contrast Sensitivity Without Glare(6 Cycles/Degree)
Description
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.
Time Frame
Postoperative visit 3 (day 30-60)
Title
Binocular Mesopic Contrast Sensitivity Without Glare(12 Cycles/Degree)
Description
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.
Time Frame
Postoperative visit 3 (day 30-60)
Title
Binocular Mesopic Contrast Sensitivity Without Glare(18 Cycles/Degree)
Description
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.
Time Frame
Postoperative visit 3 (day 30-60)
Title
Binocular Mesopic Contrast Sensitivity Without Glare(1.5, 3 Cycles/Degree)
Description
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.
Time Frame
Postoperative visit 4 (day 120-180)
Title
Binocular Mesopic Contrast Sensitivity Without Glare(6 Cycles/Degree)
Description
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.
Time Frame
Postoperative visit 4 (day 120-180)
Title
Binocular Mesopic Contrast Sensitivity Without Glare(12 Cycles/Degree)
Description
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.
Time Frame
Postoperative visit 4 (day 120-180)
Title
Binocular Mesopic Contrast Sensitivity Without Glare(18 Cycles/Degree)
Description
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.
Time Frame
Postoperative visit 4 (day 120-180)
Title
Monocular Mesopic Contrast Sensitivity With Glare(1.5 Cycles/Degree)
Description
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.
Time Frame
Postoperative visit 3 (day 30-60)
Title
Monocular Mesopic Contrast Sensitivity With Glare (3 Cycles/Degree)
Description
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.
Time Frame
Postoperative visit 3 (day 30-60)
Title
Monocular Mesopic Contrast Sensitivity With Glare(6 Cycles/Degree)
Description
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.
Time Frame
Postoperative visit 3 (day 30-60)
Title
Monocular Mesopic Contrast Sensitivity With Glare(12 Cycles/Degree)
Description
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.
Time Frame
Postoperative visit 3 (day 30-60)
Title
Monocular Mesopic Contrast Sensitivity With Glare(18 Cycles/Degree)
Description
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.
Time Frame
Postoperative visit 3 (day 30-60)
Title
Monocular Mesopic Contrast Sensitivity With Glare(1.5 Cycles/Degree)
Description
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.
Time Frame
Postoperative visit 4 (day 120-180)
Title
Monocular Mesopic Contrast Sensitivity With Glare(3 Cycles/Degree)
Description
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.
Time Frame
Postoperative visit 4 (day 120-180)
Title
Monocular Mesopic Contrast Sensitivity With Glare(6 Cycles/Degree)
Description
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.
Time Frame
Postoperative visit 4 (day 120-180)
Title
Monocular Mesopic Contrast Sensitivity With Glare(12 Cycles/Degree)
Description
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.
Time Frame
Postoperative visit 4 (day 120-180)
Title
Monocular Mesopic Contrast Sensitivity With Glare(18 Cycles/Degree)
Description
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.
Time Frame
Postoperative visit 4 (day 120-180)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Tes Ignacio, MD
Organizational Affiliation
Bausch & Lomb Incorporated
Official's Role
Study Director
Facility Information:
Facility Name
Asian Eye Institute
City
Makati City
ZIP/Postal Code
1200
Country
Philippines

12. IPD Sharing Statement

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

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