CataractPhase 4NCT01122576
Evaluation of 3 Intraocular Lenses Following Lens Extraction
A Phase 4 study testing Crystalens AO, ReSTOR and Tecnis Multifocal IOL in people with Cataract, run by Bausch & Lomb Incorporated at 1 site in United States.
Trial summary
The objective of this study is to evaluate the efficacy and subject satisfaction with three different FDA approved lenses for adults over 40 years of age who desire a reduction in spectacle dependence. 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 and Tecnis Multifocal IOL
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 78 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2010to Sep 2012
- 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 have a clinically documented diagnosis of age-related bilateral cataracts that are considered amenable to treatment with standard phacoemulsification cataract extraction.
- Subjects must require a spherical lens power from 10.00 D to 33.00 D
- Subjects must have the potential for corrected distance visual acuity (CDVA) of 20/32 or better in both eyes, as documented by a Potential Acuity Meter
Who cannot join
- Subjects with conditions with increased risk of zonular rupture, such as pseudoexfoliation syndrome. Zonular rupture during cataract surgery may affect postoperative centration, tilt, and stability of the lens.
- 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 visually significant diabetic retinopathy (proliferative or non-proliferative) which reduces potential acuity to 20/32 or worse.
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 evaluate the efficacy and subject satisfaction with three different FDA approved lenses for adults over 40 years of age who desire a reduction in spectacle dependence.
- Conditions
- Cataract
- Being tested
- Crystalens AO, ReSTOR, Tecnis Multifocal IOL
- Keywords
- Intra Ocular Lens, Ocular surgery, Phacoemulsification
- 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
Crystalens AO surgically implanted bilaterally. Study observation up to 180 days.
ReSTORDevice
ReSTOR surgically implanted bilaterally. Study observation up to 180 days.
Tecnis Multifocal IOLDevice
Tecnis surgically implanted bilaterally. Study observation up to 180 days.
| Study group | Role | What they receive |
|---|---|---|
| Crystalens AO | Experimental | Eligible subjects to undergo small incision cataract surgery and were implanted with the Crystalens AO bilaterally. Receives: Device: Crystalens AO |
| ReSTOR | Active comparator | Eligible subjects to undergo small incision cataract surgery and were implanted with the ReSTOR IOL bilaterally. Receives: Device: ReSTOR |
| Tecnis Multifocal IOL | Active comparator | Eligible subjects to undergo small incision cataract surgery and were implanted with the Tecnis Multifocal IOL bilaterally. Receives: Device: Tecnis Multifocal IOL |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mesopic Monocular Contrast Sensitivity Without Glare 1.5 and 3 Cycles/Degree
Logarithm of the mesopic (low light) contrast sensitivity (ability to detect detail with subtle gradations of grayness between test target and background) without glare at five spatial frequencies (number of light and dark bars per cycle). A higher mean indicates improved contrast sensitivity
Measured: Postoperative visit 3 (2-3 months)
Mesopic Monocular Contrast Sensitivity Without Glare 6 Cycles/Degree
Logarithm of the mesopic (low light) contrast sensitivity (ability to detect detail with subtle gradations of grayness between test target and background) without glare at five spatial frequencies (number of light and dark bars per cycle). A higher mean indicates improved contrast sensitivity
Measured: Postoperative visit 3 (2-3 months)
Mesopic Monocular Contrast Sensitivity Without Glare 12 Cycles/Degree
Logarithm of the mesopic (low light) contrast sensitivity (ability to detect detail with subtle gradations of grayness between test target and background) without glare at five spatial frequencies (number of light and dark bars per cycle). A higher mean indicates improved contrast sensitivity
Measured: Postoperative visit 3 (2-3 months)
Mesopic Monocular Contrast Sensitivity Without Glare 18 Cycles/Degree
Logarithm of the mesopic (low light) contrast sensitivity (ability to detect detail with subtle gradations of grayness between test target and background) without glare at five spatial frequencies (number of light and dark bars per cycle). A higher mean indicates improved contrast sensitivity
Measured: Postoperative visit 3 (2-3 months)
Mesopic Monocular Contrast Sensitivity Without Glare 1.5 Cycles/Degree
Logarithm of the mesopic (low light) contrast sensitivity (ability to detect detail with subtle gradations of grayness between test target and background) without glare at five spatial frequencies (number of light and dark bars per cycle). A higher mean indicates improved contrast sensitivity
Measured: Postoperative visit 4 ( 4-6 months)
Mesopic Monocular Contrast Sensitivity Without Glare 3 Cycles/Degree
Logarithm of the mesopic (low light) contrast sensitivity (ability to detect detail with subtle gradations of grayness between test target and background) without glare at five spatial frequencies (number of light and dark bars per cycle). A higher mean indicates improved contrast sensitivity
Measured: Postoperative visit 4 ( 4-6 months)
Mesopic Monocular Contrast Sensitivity Without Glare 6 Cycles/Degree
Logarithm of the mesopic (low light) contrast sensitivity (ability to detect detail with subtle gradations of grayness between test target and background) without glare at five spatial frequencies (number of light and dark bars per cycle). A higher mean indicates improved contrast sensitivity
Measured: Postoperative visit 4 ( 4-6 months)
Mesopic Monocular Contrast Sensitivity Without Glare 12 Cycles/Degree
Logarithm of the mesopic (low light) contrast sensitivity (ability to detect detail with subtle gradations of grayness between test target and background) without glare at five spatial frequencies (number of light and dark bars per cycle). A higher mean indicates improved contrast sensitivity
Measured: Postoperative visit 4 ( 4-6 months)
Mesopic Monocular Contrast Sensitivity Without Glare 18 Cycles/Degree
Logarithm of the mesopic (low light) contrast sensitivity (ability to detect detail with subtle gradations of grayness between test target and background) without glare at five spatial frequencies (number of light and dark bars per cycle). A higher mean indicates improved contrast sensitivity
Measured: Postoperative visit 4 ( 4-6 months)
Secondary outcomes (35)
Binocular Mesopic Contrast Sensitivity Without Glare 1.5 & 3 Cycles/Degree
Logarithm of the mesopic (low light) contrast sensitivity (ability to detect detail with subtle gradations of grayness between test target and background) without glare at five spatial frequencies (number of light and dark bars per cycle). A higher mean indicates improved contrast sensitivity
Measured: Visit 3 (2-3 months)
Binocular Mesopic Contrast Sensitivity Without Glare 6 Cycles/Degree
Logarithm of the mesopic (low light) contrast sensitivity (ability to detect detail with subtle gradations of grayness between test target and background) without glare at five spatial frequencies (number of light and dark bars per cycle). A higher mean indicates improved contrast sensitivity
Measured: Visit 3 (2-3 months)
Binocular Mesopic Contrast Sensitivity Without Glare 12 Cycles/Degree
Logarithm of the mesopic (low light) contrast sensitivity (ability to detect detail with subtle gradations of grayness between test target and background) without glare at five spatial frequencies (number of light and dark bars per cycle). A higher mean indicates improved contrast sensitivity
Measured: Visit 3 (2-3 months)
Binocular Mesopic Contrast Sensitivity Without Glare 18 Cycles/Degree
Logarithm of the mesopic (low light) contrast sensitivity (ability to detect detail with subtle gradations of grayness between test target and background) without glare at five spatial frequencies (number of light and dark bars per cycle). A higher mean indicates improved contrast sensitivity
Measured: Visit 3 (2-3 months)
Binocular Mesopic Contrast Sensitivity Without Glare 1.5, 3, 6 Cycles/Degree
Logarithm of the mesopic (low light) contrast sensitivity (ability to detect detail with subtle gradations of grayness between test target and background) without glare at five spatial frequencies (number of light and dark bars per cycle). A higher mean indicates improved contrast sensitivity
Measured: Visit 4 (4-6 months)
Binocular Mesopic Contrast Sensitivity Without Glare 12 Cycles/Degree
Logarithm of the mesopic (low light) contrast sensitivity (ability to detect detail with subtle gradations of grayness between test target and background) without glare at five spatial frequencies (number of light and dark bars per cycle). A higher mean indicates improved contrast sensitivity
Measured: Visit 4 (4-6 months)
Binocular Mesopic Contrast Sensitivity Without Glare 18 Cycles/Degree
Logarithm of the mesopic (low light) contrast sensitivity (ability to detect detail with subtle gradations of grayness between test target and background) without glare at five spatial frequencies (number of light and dark bars per cycle). A higher mean indicates improved contrast sensitivity
Measured: Visit 4 (4-6 months)
Mesopic Monocular Contrast Sensitivity With Glare 1.5 Cycles/Degree
Logarithm of the mesopic (low light) contrast sensitivity (ability to detect detail with subtle gradations of grayness between test target and background) with glare at five spatial frequencies (number of light and dark bars per cycle). A higher mean indicates improved contrast sensitivity
Measured: Visit 3 (2-3 months)
Mesopic Monocular Contrast Sensitivity With Glare 3 Cycles/Degree
Logarithm of the mesopic (low light) contrast sensitivity (ability to detect detail with subtle gradations of grayness between test target and background) with glare at five spatial frequencies (number of light and dark bars per cycle). A higher mean indicates improved contrast sensitivity
Measured: Visit 3 (2-3 months)
Mesopic Monocular Contrast Sensitivity With Glare 6 Cycles/Degree
Logarithm of the mesopic (low light) contrast sensitivity (ability to detect detail with subtle gradations of grayness between test target and background) with glare at five spatial frequencies (number of light and dark bars per cycle). A higher mean indicates improved contrast sensitivity
Measured: Visit 3 (2-3 months)
Mesopic Monocular Contrast Sensitivity With Glare 12 Cycles/Degree
Logarithm of the mesopic (low light) contrast sensitivity (ability to detect detail with subtle gradations of grayness between test target and background) with glare at five spatial frequencies (number of light and dark bars per cycle). A higher mean indicates improved contrast sensitivity
Measured: Visit 3 (2-3 months)
Mesopic Monocular Contrast Sensitivity With Glare 18 Cycles/Degree
Logarithm of the mesopic (low light) contrast sensitivity (ability to detect detail with subtle gradations of grayness between test target and background) with glare at five spatial frequencies (number of light and dark bars per cycle). A higher mean indicates improved contrast sensitivity
Measured: Visit 3 (2-3 months)
Mesopic Monocular Contrast Sensitivity With Glare 1.5 Cycles/Degree
Logarithm of the mesopic (low light) contrast sensitivity (ability to detect detail with subtle gradations of grayness between test target and background) with glare at five spatial frequencies (number of light and dark bars per cycle). A higher mean indicates improved contrast sensitivity
Measured: Visit 4 (4-6 months)
Mesopic Monocular Contrast Sensitivity With Glare 3 Cycles/Degree
Logarithm of the mesopic (low light) contrast sensitivity (ability to detect detail with subtle gradations of grayness between test target and background) with glare at five spatial frequencies (number of light and dark bars per cycle). A higher mean indicates improved contrast sensitivity
Measured: Visit 4 (4-6 months)
Mesopic Monocular Contrast Sensitivity With Glare 6 Cycles/Degree
Logarithm of the mesopic (low light) contrast sensitivity (ability to detect detail with subtle gradations of grayness between test target and background) with glare at five spatial frequencies (number of light and dark bars per cycle). A higher mean indicates improved contrast sensitivity
Measured: Visit 4 (4-6 months)
Mesopic Monocular Contrast Sensitivity With Glare 12 Cycles/Degree
Logarithm of the mesopic (low light) contrast sensitivity (ability to detect detail with subtle gradations of grayness between test target and background) with glare at five spatial frequencies (number of light and dark bars per cycle). A higher mean indicates improved contrast sensitivity
Measured: Visit 4 (4-6 months)
Mesopic Monocular Contrast Sensitivity With Glare 18 Cycles/Degree
Logarithm of the mesopic (low light) contrast sensitivity (ability to detect detail with subtle gradations of grayness between test target and background) with glare at five spatial frequencies (number of light and dark bars per cycle). A higher mean indicates improved contrast sensitivity
Measured: Visit 4 (4-6 months)
Mesopic Binocular Contrast Sensitivity With Glare 1.5, 3 Cycles/Degree
Logarithm of the mesopic (low light) contrast sensitivity (ability to detect detail with subtle gradations of grayness between test target and background) with glare at five spatial frequencies (number of light and dark bars per cycle). A higher mean indicates improved contrast sensitivity
Measured: Visit 3 (2-3 months)
Mesopic Binocular Contrast Sensitivity With Glare 6 Cycles/Degree
Logarithm of the mesopic (low light) contrast sensitivity (ability to detect detail with subtle gradations of grayness between test target and background) with glare at five spatial frequencies (number of light and dark bars per cycle). A higher mean indicates improved contrast sensitivity
Measured: Visit 3 (2-3 months)
Mesopic Binocular Contrast Sensitivity With Glare 12 Cycles/Degree
Logarithm of the mesopic (low light) contrast sensitivity (ability to detect detail with subtle gradations of grayness between test target and background) with glare at five spatial frequencies (number of light and dark bars per cycle). A higher mean indicates improved contrast sensitivity
Measured: Visit 3 (2-3 months)
Mesopic Binocular Contrast Sensitivity With Glare 18 Cycles/Degree
Logarithm of the mesopic (low light) contrast sensitivity (ability to detect detail with subtle gradations of grayness between test target and background) with glare at five spatial frequencies (number of light and dark bars per cycle). A higher mean indicates improved contrast sensitivity
Measured: Visit 3 (2-3 months)
Mesopic Binocular Contrast Sensitivity With Glare 1.5, 3 Cycles/Degree
Logarithm of the mesopic (low light) contrast sensitivity (ability to detect detail with subtle gradations of grayness between test target and background) with glare at five spatial frequencies (number of light and dark bars per cycle). A higher mean indicates improved contrast sensitivity
Measured: Visit 4 (4-6 months)
Mesopic Binocular Contrast Sensitivity With Glare 6 Cycles/Degree
Logarithm of the mesopic (low light) contrast sensitivity (ability to detect detail with subtle gradations of grayness between test target and background) with glare at five spatial frequencies (number of light and dark bars per cycle). A higher mean indicates improved contrast sensitivity
Measured: Visit 4 (4-6 months)
Mesopic Binocular Contrast Sensitivity With Glare 12 Cycles/Degree
Logarithm of the mesopic (low light) contrast sensitivity (ability to detect detail with subtle gradations of grayness between test target and background) with glare at five spatial frequencies (number of light and dark bars per cycle). A higher mean indicates improved contrast sensitivity
Measured: Visit 4 (4-6 months)
Mesopic Binocular Contrast Sensitivity With Glare 18 Cycles/Degree
Logarithm of the mesopic (low light) contrast sensitivity (ability to detect detail with subtle gradations of grayness between test target and background) with glare at five spatial frequencies (number of light and dark bars per cycle). A higher mean indicates improved contrast sensitivity
Measured: Visit 4 (4-6 months)
Optical Scatter
Objective scatter index (OSI) was assessed using the Optical Quality Analysis System(OQAS) and summarized as a continuous variable. For this assessment, an OSI score of 1 or less represents good quality vision, 1-2 indicates some degradation but otherwise normal vision, 2-3 significant light scatter possibly requiring treatment, and scores over 4 severely compromised vision requiring intervention.
Measured: Visit 3 (2-3 months)
Optical Scatter
Objective scatter index (OSI) was assessed using the Optical Quality Analysis System(OQAS) and summarized as a continuous variable. For this assessment, an OSI score of 1 or less represents good quality vision, 1-2 indicates some degradation but otherwise normal vision, 2-3 significant light scatter possibly requiring treatment, and scores over 4 severely compromised vision requiring intervention.
Measured: Visit 4 (4-6 months)
Monocular Halo and Starburst
Halo and starburst (both monocular and binocular) were measured using a glarometer on integer scales of 1-5, where the smaller the number the better the outcome.
Measured: Visit 3 (2-3 months)
Monocular Halo and Starburst
Halo and starburst (both monocular and binocular) were measured using a glarometer on integer scales of 1-5, where the smaller the number the better the outcome.
Measured: Visit 4 (4-6 months)
Binocular Halo and Starburst
Halo and starburst (both monocular and binocular) were measured using a glarometer on integer scales of 1-5, where the smaller the number the better the outcome.
Measured: Visit 3 (2-3 months)
Binocular Halo and Starburst
Halo and starburst (both monocular and binocular) were measured using a glarometer on integer scales of 1-5, where the smaller the number the better the outcome.
Measured: Visit 4 (4-6 months)
Manifest Refraction
Manifest refraction spherical equivalent (MRSE) was calculated as the value of the sphere plus one-half of the value of the cylinder.
Measured: Visit 3 (2-3 Months)
Manifest Refraction
Manifest refraction spherical equivalent (MRSE) was calculated as the value of the sphere plus one-half of the value of the cylinder.
Measured: Visit 4 (4-6 Months)
Uncorrected Distance Visual Acuity
High Contrast Uncorrected Distance (UCDVA) measured at 32 inches, Intermediate (UCIVA) at 32 inches, and Near Visual Acuity (UCNVA) at 16 inches
Measured: Visit 3 (2-3 months) Visit 4 (4-6 months)
Best-corrected Distance Visual Acuity
High Contrast Distance-Corrected Distance,(BCDVA), Intermediate (DCIVA), and Near Visual Acuity (DCNVA)
Measured: Visit 3 (2-3 months) Visit 4 (4-6 months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 May 2010 (estimated)
- Study startJun 2010
- Primary completionJun 2012
- Study completionSep 2012
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
- 78 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bausch & Lomb Incorporated
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Omid Khodai, OD, RAC, Study director, Bausch & Lomb Incorporated
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01122576
- Sponsor's protocol ID
- 651
- Status last verified
- Feb 2014
- First submitted
- 11 May 2010
- Last updated
- 28 Mar 2014
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Mar 2014. 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
- NCT01122576
- Acronym / sponsor ID
- 651
- Conditions
- Cataract
- Keywords
- Intra Ocular Lens, Ocular surgery, Phacoemulsification
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 78 participants (actual)
- Lead sponsor
- Bausch & Lomb IncorporatedIndustry (pharma, biotech, devices)
- Study start
- Jun 2010
- Primary completion
- Jun 2012 (actual)
- Study completion
- Sep 2012 (actual)
- First posted
- 13 May 2010 (estimated)
- Results
- Posted 28 Mar 2014
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 evaluate the efficacy and subject satisfaction with three different FDA approved lenses for adults over 40 years of age who desire a reduction in spectacle dependence.
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 AOEligible subjects to undergo small incision cataract surgery and were implanted with the Crystalens AO bilaterally. |
| ReSTOR | Active comparator | Device: ReSTOREligible subjects to undergo small incision cataract surgery and were implanted with the ReSTOR IOL bilaterally. |
| Tecnis Multifocal IOL | Active comparator | Device: Tecnis Multifocal IOLEligible subjects to undergo small incision cataract surgery and were implanted with the Tecnis Multifocal IOL bilaterally. |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Subjects must have a clinically documented diagnosis of age-related bilateral cataracts that are considered amenable to treatment with standard phacoemulsification cataract extraction.
- Subjects must require a spherical lens power from 10.00 D to 33.00 D
- Subjects must have the potential for corrected distance visual acuity (CDVA) of 20/32 or better in both eyes, as documented by a Potential Acuity Meter
Key exclusion criteria (3 listed)
- Subjects with conditions with increased risk of zonular rupture, such as pseudoexfoliation syndrome. Zonular rupture during cataract surgery may affect postoperative centration, tilt, and stability of the lens.
- 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 visually significant diabetic retinopathy (proliferative or non-proliferative) which reduces potential acuity to 20/32 or worse.
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 AOCrystalens AO surgically implanted bilaterally. Study observation up to 180 days. | Device | Crystalens AO |
| ReSTORReSTOR surgically implanted bilaterally. Study observation up to 180 days. | Device | ReSTOR |
| Tecnis Multifocal IOLTecnis surgically implanted bilaterally. Study observation up to 180 days. | Device | Tecnis Multifocal IOL |
Primary outcome
Mesopic Monocular Contrast Sensitivity Without Glare 1.5 and 3 Cycles/Degree
Time frame: Postoperative visit 3 (2-3 months)
Logarithm of the mesopic (low light) contrast sensitivity (ability to detect detail with subtle gradations of grayness between test target and background) without glare at five spatial frequencies (number of light and dark bars per cycle). A higher mean indicates improved contrast sensitivity
Mesopic Monocular Contrast Sensitivity Without Glare 6 Cycles/Degree
Time frame: Postoperative visit 3 (2-3 months)
Logarithm of the mesopic (low light) contrast sensitivity (ability to detect detail with subtle gradations of grayness between test target and background) without glare at five spatial frequencies (number of light and dark bars per cycle). A higher mean indicates improved contrast sensitivity
Mesopic Monocular Contrast Sensitivity Without Glare 12 Cycles/Degree
Time frame: Postoperative visit 3 (2-3 months)
Logarithm of the mesopic (low light) contrast sensitivity (ability to detect detail with subtle gradations of grayness between test target and background) without glare at five spatial frequencies (number of light and dark bars per cycle). A higher mean indicates improved contrast sensitivity
Mesopic Monocular Contrast Sensitivity Without Glare 18 Cycles/Degree
Time frame: Postoperative visit 3 (2-3 months)
Logarithm of the mesopic (low light) contrast sensitivity (ability to detect detail with subtle gradations of grayness between test target and background) without glare at five spatial frequencies (number of light and dark bars per cycle). A higher mean indicates improved contrast sensitivity
Mesopic Monocular Contrast Sensitivity Without Glare 1.5 Cycles/Degree
Time frame: Postoperative visit 4 ( 4-6 months)
Logarithm of the mesopic (low light) contrast sensitivity (ability to detect detail with subtle gradations of grayness between test target and background) without glare at five spatial frequencies (number of light and dark bars per cycle). A higher mean indicates improved contrast sensitivity
Mesopic Monocular Contrast Sensitivity Without Glare 3 Cycles/Degree
Time frame: Postoperative visit 4 ( 4-6 months)
Logarithm of the mesopic (low light) contrast sensitivity (ability to detect detail with subtle gradations of grayness between test target and background) without glare at five spatial frequencies (number of light and dark bars per cycle). A higher mean indicates improved contrast sensitivity
Mesopic Monocular Contrast Sensitivity Without Glare 6 Cycles/Degree
Time frame: Postoperative visit 4 ( 4-6 months)
Logarithm of the mesopic (low light) contrast sensitivity (ability to detect detail with subtle gradations of grayness between test target and background) without glare at five spatial frequencies (number of light and dark bars per cycle). A higher mean indicates improved contrast sensitivity
Mesopic Monocular Contrast Sensitivity Without Glare 12 Cycles/Degree
Time frame: Postoperative visit 4 ( 4-6 months)
Logarithm of the mesopic (low light) contrast sensitivity (ability to detect detail with subtle gradations of grayness between test target and background) without glare at five spatial frequencies (number of light and dark bars per cycle). A higher mean indicates improved contrast sensitivity
Mesopic Monocular Contrast Sensitivity Without Glare 18 Cycles/Degree
Time frame: Postoperative visit 4 ( 4-6 months)
Logarithm of the mesopic (low light) contrast sensitivity (ability to detect detail with subtle gradations of grayness between test target and background) without glare at five spatial frequencies (number of light and dark bars per cycle). A higher mean indicates improved contrast sensitivity
35 secondary outcomes
Binocular Mesopic Contrast Sensitivity Without Glare 1.5 & 3 Cycles/Degree
Time frame: Visit 3 (2-3 months)
Binocular Mesopic Contrast Sensitivity Without Glare 6 Cycles/Degree
Time frame: Visit 3 (2-3 months)
Binocular Mesopic Contrast Sensitivity Without Glare 12 Cycles/Degree
Time frame: Visit 3 (2-3 months)
Binocular Mesopic Contrast Sensitivity Without Glare 18 Cycles/Degree
Time frame: Visit 3 (2-3 months)
Binocular Mesopic Contrast Sensitivity Without Glare 1.5, 3, 6 Cycles/Degree
Time frame: Visit 4 (4-6 months)
Binocular Mesopic Contrast Sensitivity Without Glare 12 Cycles/Degree
Time frame: Visit 4 (4-6 months)
Binocular Mesopic Contrast Sensitivity Without Glare 18 Cycles/Degree
Time frame: Visit 4 (4-6 months)
Mesopic Monocular Contrast Sensitivity With Glare 1.5 Cycles/Degree
Time frame: Visit 3 (2-3 months)
Mesopic Monocular Contrast Sensitivity With Glare 3 Cycles/Degree
Time frame: Visit 3 (2-3 months)
Mesopic Monocular Contrast Sensitivity With Glare 6 Cycles/Degree
Time frame: Visit 3 (2-3 months)
Mesopic Monocular Contrast Sensitivity With Glare 12 Cycles/Degree
Time frame: Visit 3 (2-3 months)
Mesopic Monocular Contrast Sensitivity With Glare 18 Cycles/Degree
Time frame: Visit 3 (2-3 months)
Mesopic Monocular Contrast Sensitivity With Glare 1.5 Cycles/Degree
Time frame: Visit 4 (4-6 months)
Mesopic Monocular Contrast Sensitivity With Glare 3 Cycles/Degree
Time frame: Visit 4 (4-6 months)
Mesopic Monocular Contrast Sensitivity With Glare 6 Cycles/Degree
Time frame: Visit 4 (4-6 months)
Mesopic Monocular Contrast Sensitivity With Glare 12 Cycles/Degree
Time frame: Visit 4 (4-6 months)
Mesopic Monocular Contrast Sensitivity With Glare 18 Cycles/Degree
Time frame: Visit 4 (4-6 months)
Mesopic Binocular Contrast Sensitivity With Glare 1.5, 3 Cycles/Degree
Time frame: Visit 3 (2-3 months)
Mesopic Binocular Contrast Sensitivity With Glare 6 Cycles/Degree
Time frame: Visit 3 (2-3 months)
Mesopic Binocular Contrast Sensitivity With Glare 12 Cycles/Degree
Time frame: Visit 3 (2-3 months)
Mesopic Binocular Contrast Sensitivity With Glare 18 Cycles/Degree
Time frame: Visit 3 (2-3 months)
Mesopic Binocular Contrast Sensitivity With Glare 1.5, 3 Cycles/Degree
Time frame: Visit 4 (4-6 months)
Mesopic Binocular Contrast Sensitivity With Glare 6 Cycles/Degree
Time frame: Visit 4 (4-6 months)
Mesopic Binocular Contrast Sensitivity With Glare 12 Cycles/Degree
Time frame: Visit 4 (4-6 months)
Mesopic Binocular Contrast Sensitivity With Glare 18 Cycles/Degree
Time frame: Visit 4 (4-6 months)
Optical Scatter
Time frame: Visit 3 (2-3 months)
Optical Scatter
Time frame: Visit 4 (4-6 months)
Monocular Halo and Starburst
Time frame: Visit 3 (2-3 months)
Monocular Halo and Starburst
Time frame: Visit 4 (4-6 months)
Binocular Halo and Starburst
Time frame: Visit 3 (2-3 months)
Binocular Halo and Starburst
Time frame: Visit 4 (4-6 months)
Manifest Refraction
Time frame: Visit 3 (2-3 Months)
Manifest Refraction
Time frame: Visit 4 (4-6 Months)
Uncorrected Distance Visual Acuity
Time frame: Visit 3 (2-3 months) Visit 4 (4-6 months)
Best-corrected Distance Visual Acuity
Time frame: Visit 3 (2-3 months) Visit 4 (4-6 months)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Mar 2014.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Effects of Oxygen Cage Support During Cataract Surgery
Cataract
Active, not recruitingObservational study
Age-Related Eye Disease Study (AREDS) Follow-Up
Age-Related Macular Degeneration, Cataract
RecruitingObservational study
Objective Depth-of-Focus Changes During Light Adjustable Lens UV Adjustments
Light Adjustable Lens, Objective Depth of Focus
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.
Omid Khodai, OD, RAC 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 and Tecnis Multifocal IOL in people with Cataract, run by Bausch & Lomb Incorporated at 1 site in United States.
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 3 inclusion and 3 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 28 Mar 2014. 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 United States. 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 28 Mar 2014). 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?
Mesopic Monocular Contrast Sensitivity Without Glare 1.5 and 3 Cycles/Degree (time frame: Postoperative visit 3 (2-3 months)). The study lists 9 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 28 Mar 2014.