CataractPhase 3NCT00747227
Safety and Efficacy of a Violet Visible Light Blocking Intraocular Lens (IOL)
A Phase 3 study testing modified light transmission intraocular lens and monofocal acrylic intraocular lens in people with Cataract, run by Abbott Medical Optics at 11 sites in United States.
Trial summary
The purpose of this study is to evaluate the safety and effectiveness of a new investigational modified light transmission monofocal intraocular lens compared to a conventional intraocular lens (IOL). Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Cataract
- What is being tested?
- modified light transmission intraocular lens and monofocal acrylic intraocular lens
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 250 participants
- Where
- 11 sitesUnited States
- Study dates
- Dec 2006to Jun 2009
- Phase
- Phase 3
- 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Age 18 years of age or older
- Bilateral cataracts for which phacoemulsification extraction and posterior IOL implantation has been planned
- Visual potential in both eyes of 20/30 Snellen or better after cataract removal and IOL implantation
- Preoperative corneal astigmatism of 1.5 diopters or less
Who cannot join
- Use of systemic or ocular medications that may affect vision
- Uncontrolled systemic or recurrent ocular disease
- Requiring an intraocular lens <15.0 or >26.0 diopters
- Abnormal results with the Farnsworth-Munsell D-15 and/or Ishihara color plates
- History of ocular trauma or prior ocular surgery
- Known pathology that may affect visual acuity or visual field
Show all 9Show fewer
- Corneal abnormalities
- Pupil abnormalities
- Capsule or zonular abnormalities
Trial locations and contacts
11 sites in 1 country.
11 sites in 1 country
United States11 sites
Y. Ralph Chu, M.D.
Bloomington, Minnesota, 55420
William Christie, M.D.
Cranberry Township, Pennsylvania, 16066
Steven Silverstein, M.D.
Kansas City, Missouri, 64133
Jay Rudd, M.D.
Lacey, Washington, 98503
Aron Rose, M.D.
New Haven, Connecticut, 06510
Mark Blecher, M.D.
Philadelphia, Pennsylvania, 19148
Robert L. Bahr, M.D.
Providence, Rhode Island, 02906
Randall E. Cole, M.D.
Rogers, Arkansas, 72756
Jon-Marc Weston, M.D.
Roseburg, Oregon, 97470
Patrick Aiello, M.D.
Scottsdale, Arizona, 85054
Vance Thompson, M.D.
Sioux Falls, South Dakota, 57105
About this study
Official title: Clinical Evaluation of a Modified Light Transmission IOL
The purpose of this study is to evaluate the safety and effectiveness of a new investigational modified light transmission monofocal intraocular lens compared to a conventional intraocular lens (IOL).
Read the detailed description
The investigational IOL will be found to be safe and effective with respect to visual acuity, color vision, contrast sensitivity and complications and will be similar to results for the ZA9003 control eyes. Complication rates and adverse event rates will be within the FDA grid for posterior chamber IOLs.
- Conditions
- Cataract
- Being tested
- modified light transmission intraocular lens, monofocal acrylic intraocular lens
- Keywords
- cataract, monofocal, intraocular lens, acrylic
- Medical subject headings
- Cataract
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
modified light transmission intraocular lensDevice
Also called ZV9003
violet visible light blocking acrylic intraocular lens
monofocal acrylic intraocular lensDevice
Also called ZA9003
conventional hydrophobic acrylic intraocular lens
| Study group | Role | What they receive |
|---|---|---|
| ZV9003 | Experimental | modified light transmission intraocular lens Receives: Device: modified light transmission intraocular lens |
| ZA9003 | Active comparator | monofocal acrylic intraocular lens Receives: Device: monofocal acrylic intraocular lens |
What is being measured
The primary outcome is the main question the study is designed to answer.
Best Corrected Distance Visual Acuity
Snellen Equivalent visual acuity of 20/40 or better
Measured: One year
Uncorrected Distance Visual Acuity
Snellen Equivalent of 20/40 or better at one year
Measured: One Year
Secondary outcomes (2)
Contrast Sensitivity
Contrast sensitivity is the measurement of how faded an image may become before it can clearly be seen. Contrast sensitivity was measured in photopic and mesopic conditions at the following spatial frequencies: 3.0, 6.0, 12.0, and 18 cpd (cycles per degree). Contrast sensitivity is measured in log units. A higher value for the logarithmic units translates to better contrast sensitivity.
Measured: 4-6 months
Subject Satisfaction - Subjects Satisfied With Overall Eyesight Rated as "Good" or "Excellent".
Subjects indicating a subjective response to a multiple choice question, "At the present time, would you say your eyesight using both eyes (with glasses or contact lenses, if you wear them) is excellent, good, fair, poor, or very poor or are you completely blind?", on a multi-item questionnaire administered by interviewer to determine subject satisfaction with their overall visual outcome at the one year visit.
Measured: One Year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Sep 2008 (estimated)
- Study startDec 2006
- Primary completionMar 2009
- Study completionJun 2009
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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 250 participants (actual)
Sponsor and investigators
- Lead sponsor
- Abbott Medical Optics
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Roger F. Steinert, M.D., Principal investigator, University of California, Irvine, Dept. of Ophthalmology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00747227
- Sponsor's protocol ID
- BBLK-102-PRSM
- Status last verified
- Oct 2011
- First submitted
- 3 Sep 2008
- Last updated
- 11 Nov 2011
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Nov 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Evaluation of a Modified Light Transmission IOL
- ClinicalTrials.gov ID
- NCT00747227
- Acronym / sponsor ID
- BBLK-102-PRSM
- Conditions
- Cataract
- Keywords
- cataract, monofocal, intraocular lens, acrylic
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 250 participants (actual)
- Lead sponsor
- Abbott Medical OpticsIndustry (pharma, biotech, devices)
- Study start
- Dec 2006
- Primary completion
- Mar 2009 (actual)
- Study completion
- Jun 2009 (actual)
- First posted
- 5 Sep 2008 (estimated)
- Results
- Posted 11 Nov 2011
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to evaluate the safety and effectiveness of a new investigational modified light transmission monofocal intraocular lens compared to a conventional intraocular lens (IOL).
Detailed description
The investigational IOL will be found to be safe and effective with respect to visual acuity, color vision, contrast sensitivity and complications and will be similar to results for the ZA9003 control eyes. Complication rates and adverse event rates will be within the FDA grid for posterior chamber IOLs.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ZV9003 | Experimental | Device: modified light transmission intraocular lensmodified light transmission intraocular lens |
| ZA9003 | Active comparator | Device: monofocal acrylic intraocular lensmonofocal acrylic intraocular lens |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age 18 years of age or older
- Bilateral cataracts for which phacoemulsification extraction and posterior IOL implantation has been planned
- Visual potential in both eyes of 20/30 Snellen or better after cataract removal and IOL implantation
- Preoperative corneal astigmatism of 1.5 diopters or less
Key exclusion criteria (9 listed)
- Use of systemic or ocular medications that may affect vision
- Uncontrolled systemic or recurrent ocular disease
- Requiring an intraocular lens <15.0 or >26.0 diopters
- Abnormal results with the Farnsworth-Munsell D-15 and/or Ishihara color plates
- History of ocular trauma or prior ocular surgery
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 |
|---|---|---|
| modified light transmission intraocular lensAlso: ZV9003violet visible light blocking acrylic intraocular lens | Device | ZV9003 |
| monofocal acrylic intraocular lensAlso: ZA9003conventional hydrophobic acrylic intraocular lens | Device | ZA9003 |
Primary outcome
Best Corrected Distance Visual Acuity
Time frame: One year
Snellen Equivalent visual acuity of 20/40 or better
Uncorrected Distance Visual Acuity
Time frame: One Year
Snellen Equivalent of 20/40 or better at one year
2 secondary outcomes
Contrast Sensitivity
Time frame: 4-6 months
Subject Satisfaction - Subjects Satisfied With Overall Eyesight Rated as "Good" or "Excellent".
Time frame: One Year
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Nov 2011.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Related trials for Cataract
Recruiting
Implementing AI-based Glaucoma Screening Within Federally Qualified Health Centers
Glaucoma, Ocular Hypertension
Not yet recruiting
Trial to Investigate the Safety and Effectiveness of the KI-362-US1 (YP2.2VM) Intraocular Lens (IOL) in Adult Participants for Correction of Aphakia Following Cataract Extraction
Aphakia, Postcataract
Not yet recruiting
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.
Roger F. Steinert, M.D. principal investigator
University of California, Irvine, Dept. of Ophthalmology
11 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing modified light transmission intraocular lens and monofocal acrylic intraocular lens in people with Cataract, run by Abbott Medical Optics at 11 sites 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 4 inclusion and 9 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 11 Nov 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 11 sites 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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 11 Nov 2011). 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?
Best Corrected Distance Visual Acuity (time frame: One year). The study lists 2 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 11 Nov 2011.