CataractPhase 4NCT01225952
Three Intraocular Lenses Designed to Improve Distance, Intermediate and Near Vision Following Lens Extraction
A Phase 4 study testing Crystalens AO, ReSTOR 3.0 and AMO Tecnis Multifocal in people with Cataract, run by Bausch & Lomb Incorporated at 1 site in Philippines.
Trial 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… Read more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- Cataract
- What is being tested?
- Crystalens AO, ReSTOR 3.0 and AMO Tecnis Multifocal
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 93 participants
- Where
- 1 sitePhilippines
- Study dates
- Jul 2010to Jul 2011
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Show all 15Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
- Conditions
- Cataract
- Being tested
- Crystalens AO, ReSTOR 3.0, AMO Tecnis Multifocal
- Keywords
- phacoemulsification, intraocular lens
- Medical subject headings
- Cataract
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Crystalens AODevice
Bausch \& Lomb model silicone multi-piece accommodating IOL.
ReSTOR 3.0Device
An aspheric multifocal IOL (Alcon Laboratories) combines the functions of an apodized diffractive region and a refractive region.
AMO Tecnis MultifocalDevice
The Tecnis Multifocal foldable hydrophobic acrylic IOL, Model ZMA00 (Abbott Medical Optics), is an ultraviolet light-absorbing posterior chamber IOL.
| Study group | Role | What they receive |
|---|---|---|
| Crystalens AO | Experimental | Bausch \& Lomb silicone multi-piece accommodating IOL is a modified plate haptic lens Receives: Device: Crystalens AO |
| ReSTOR 3.0 | Active comparator | An aspheric multifocal IOL (Alcon Laboratories) combines the functions of an apodized diffractive region and a refractive region. Receives: Device: ReSTOR 3.0 |
| AMO Tecnis Multifocal | Active comparator | A foldable hydrophobic acrylic IOL,(Abbott Medical Optics), is an ultraviolet light-absorbing posterior chamber IOL Receives: Device: AMO Tecnis Multifocal |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Postoperative visit 3 (day 30-60)
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.
Measured: Postoperative visit 3 (day 30-60)
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.
Measured: Postoperative visit 3 (day 30-60)
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.
Measured: Postoperative visit 3 (day 30-60)
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.
Measured: Postoperative visit 4 (day 120-180)
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.
Measured: Postoperative visit 4 (day 120-180)
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.
Measured: Postoperative visit 4 (day 120-180)
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.
Measured: Postoperative visit 4 (day 120-180)
Secondary outcomes (18)
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.
Measured: Postoperative visit 3 (day 30-60)
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.
Measured: Postoperative visit 3 (day 30-60)
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.
Measured: Postoperative visit 3 (day 30-60)
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.
Measured: Postoperative visit 3 (day 30-60)
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.
Measured: Postoperative visit 4 (day 120-180)
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.
Measured: Postoperative visit 4 (day 120-180)
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.
Measured: Postoperative visit 4 (day 120-180)
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.
Measured: Postoperative visit 4 (day 120-180)
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.
Measured: Postoperative visit 3 (day 30-60)
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.
Measured: Postoperative visit 3 (day 30-60)
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.
Measured: Postoperative visit 3 (day 30-60)
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.
Measured: Postoperative visit 3 (day 30-60)
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.
Measured: Postoperative visit 3 (day 30-60)
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.
Measured: Postoperative visit 4 (day 120-180)
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.
Measured: Postoperative visit 4 (day 120-180)
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.
Measured: Postoperative visit 4 (day 120-180)
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.
Measured: Postoperative visit 4 (day 120-180)
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.
Measured: Postoperative visit 4 (day 120-180)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Oct 2010 (estimated)
- Study startJul 2010
- Primary completionJun 2011
- Study completionJul 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for CataractStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 93 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bausch & Lomb Incorporated
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Tes Ignacio, MD, Study director, Bausch & Lomb Incorporated
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01225952
- Sponsor's protocol ID
- 656
- Status last verified
- Dec 2012
- First submitted
- 19 Oct 2010
- Last updated
- 18 Jan 2013
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Jan 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01225952
- Acronym / sponsor ID
- 656
- Conditions
- Cataract
- Keywords
- phacoemulsification, intraocular lens
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 93 participants (actual)
- Lead sponsor
- Bausch & Lomb IncorporatedIndustry (pharma, biotech, devices)
- Study start
- Jul 2010
- Primary completion
- Jun 2011 (actual)
- Study completion
- Jul 2011 (actual)
- First posted
- 21 Oct 2010 (estimated)
- Results
- Posted 18 Jan 2013
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Crystalens AO | Experimental | Device: Crystalens AOBausch \& Lomb silicone multi-piece accommodating IOL is a modified plate haptic lens |
| ReSTOR 3.0 | Active comparator | Device: ReSTOR 3.0An aspheric multifocal IOL (Alcon Laboratories) combines the functions of an apodized diffractive region and a refractive region. |
| AMO Tecnis Multifocal | Active comparator | Device: AMO Tecnis MultifocalA foldable hydrophobic acrylic IOL,(Abbott Medical Optics), is an ultraviolet light-absorbing posterior chamber IOL |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (15 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Crystalens AOBausch \& Lomb model silicone multi-piece accommodating IOL. | Device | Crystalens AO |
| ReSTOR 3.0An aspheric multifocal IOL (Alcon Laboratories) combines the functions of an apodized diffractive region and a refractive region. | Device | ReSTOR 3.0 |
| AMO Tecnis MultifocalThe Tecnis Multifocal foldable hydrophobic acrylic IOL, Model ZMA00 (Abbott Medical Optics), is an ultraviolet light-absorbing posterior chamber IOL. | Device | AMO Tecnis Multifocal |
Primary outcome
Monocular Mesopic Contrast Sensitivity Without Glare (1.5, 3 Cycles/Degree)
Time frame: Postoperative visit 3 (day 30-60)
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)
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)
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)
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)
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)
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)
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)
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.
18 secondary outcomes
Binocular Mesopic Contrast Sensitivity Without Glare(1.5, 3 Cycles/Degree)
Time frame: Postoperative visit 3 (day 30-60)
Binocular Mesopic Contrast Sensitivity Without Glare(6 Cycles/Degree)
Time frame: Postoperative visit 3 (day 30-60)
Binocular Mesopic Contrast Sensitivity Without Glare(12 Cycles/Degree)
Time frame: Postoperative visit 3 (day 30-60)
Binocular Mesopic Contrast Sensitivity Without Glare(18 Cycles/Degree)
Time frame: Postoperative visit 3 (day 30-60)
Binocular Mesopic Contrast Sensitivity Without Glare(1.5, 3 Cycles/Degree)
Time frame: Postoperative visit 4 (day 120-180)
Binocular Mesopic Contrast Sensitivity Without Glare(6 Cycles/Degree)
Time frame: Postoperative visit 4 (day 120-180)
Binocular Mesopic Contrast Sensitivity Without Glare(12 Cycles/Degree)
Time frame: Postoperative visit 4 (day 120-180)
Binocular Mesopic Contrast Sensitivity Without Glare(18 Cycles/Degree)
Time frame: Postoperative visit 4 (day 120-180)
Monocular Mesopic Contrast Sensitivity With Glare(1.5 Cycles/Degree)
Time frame: Postoperative visit 3 (day 30-60)
Monocular Mesopic Contrast Sensitivity With Glare (3 Cycles/Degree)
Time frame: Postoperative visit 3 (day 30-60)
Monocular Mesopic Contrast Sensitivity With Glare(6 Cycles/Degree)
Time frame: Postoperative visit 3 (day 30-60)
Monocular Mesopic Contrast Sensitivity With Glare(12 Cycles/Degree)
Time frame: Postoperative visit 3 (day 30-60)
Monocular Mesopic Contrast Sensitivity With Glare(18 Cycles/Degree)
Time frame: Postoperative visit 3 (day 30-60)
Monocular Mesopic Contrast Sensitivity With Glare(1.5 Cycles/Degree)
Time frame: Postoperative visit 4 (day 120-180)
Monocular Mesopic Contrast Sensitivity With Glare(3 Cycles/Degree)
Time frame: Postoperative visit 4 (day 120-180)
Monocular Mesopic Contrast Sensitivity With Glare(6 Cycles/Degree)
Time frame: Postoperative visit 4 (day 120-180)
Monocular Mesopic Contrast Sensitivity With Glare(12 Cycles/Degree)
Time frame: Postoperative visit 4 (day 120-180)
Monocular Mesopic Contrast Sensitivity With Glare(18 Cycles/Degree)
Time frame: Postoperative visit 4 (day 120-180)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jan 2013.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Tes Ignacio, MD study director
Bausch & Lomb Incorporated
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Crystalens AO, ReSTOR 3.0 and AMO Tecnis Multifocal in people with Cataract, run by Bausch & Lomb Incorporated at 1 site in Philippines.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Jan 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Philippines. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 18 Jan 2013). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Monocular Mesopic Contrast Sensitivity Without Glare (1.5, 3 Cycles/Degree) (time frame: Postoperative visit 3 (day 30-60)). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Jan 2013.