| 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 |
| |
| 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 |