Three Intraocular Lenses Designed to Improve Distance, Intermediate and Near Vision Following Lens Extraction
This study has been completed.
Sponsor:
Bausch & Lomb Incorporated
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
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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 |
Resource links provided by NLM:
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 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 |
Additional relevant MeSH terms:
|
Myopia Cataract Refractive Errors Eye Diseases Lens Diseases |
ClinicalTrials.gov processed this record on May 16, 2013