CataractPhase 4NCT00348270
Comparison of the Quality of Vision Provided by AMO Tecnis Z9000 and Alcon Laboratories MA60 Acrysof Posterior Chamber Intraocular Lenses
A Phase 4 study testing Tecnis Z9000 intraocular lens and MA60 intraocular lens in people with Cataract, run by Singapore National Eye Centre at 1 site in Singapore.
Trial summary
This study is a comparison of the quality of vision provided by AMO Tecnis Z9000 three-piece silicone posterior chamber intraocular lens and Alcon Laboratories MA60 three-piece acrylic posterior chamber intraocular lens. Read more about this study
- Who is it for?
- Ages 50 to 80 years
- Conditions the study is for
- Cataract
- What is being tested?
- Tecnis Z9000 intraocular lens and MA60 intraocular lens
- Type of treatment
- Medical device
- How many people
- 80 participants
- Where
- 1 siteSingapore
- Study dates
- Jul 2005to Oct 2008
- Phase
- Phase 4
- Are there results?
- None posted in the registry
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 50 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Bilateral cataracts, eligible for phacoemulsification with primary implantation of a posterior chamber IOL
- Males and females 50 to 80 years of age
- Expected maximum of 6-weeks and minimum of 3 weeks interval between a single patient's surgeries
- Best corrected visual acuity (BCVA) should be no better than 20/40 in the presence of a glare source. (In the early treatment diabetic retinopathy study [ETDRS] visual acuity chart, better than 20/40 will be at least 3 letters read correctly in the 20/30 line).
- Best corrected visual acuity projected by Potential Acuity Meter (PAM) or other reliable potential acuity test procedure to be 20/30 or better in each eye after cataract removal and IOL implantation.
- Naturally dilated pupil size (in dim light) ≥ 4.0 mm (with no dilation medications) - both eyes
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- Anticipated correction with an IOL of +6 to +30 diopters (both eyes)
- Evidence of a personally signed and dated informed consent document indicating the patient (or a legally acceptable representative) has been informed of all pertinent aspects of the trial
- Willing and able to comply with scheduled visits and other study procedures
Who cannot join
- Preoperative pathology: amblyopia, rubella cataract, proliferative diabetic retinopathy, shallow anterior chamber, macular edema, retinal detachment, aniridia or iris atrophy, uveitis, history of iritis, iris neovascularization, medically uncontrolled glaucoma, microphthalmus or macrophthalmus, optic nerve atrophy
- Previous intraocular or corneal surgery, including refractive surgery, corneal transplant
- Other pathologies potentially affecting visual acuity, e.g., macular degeneration, glaucoma with the presence of visual field defects
- An increased risk for complications which could require vitreoretinal surgery
- Corneal irregularities potentially affecting visual acuity, e.g., keratoconus, corneal dystrophy
- Corneal opacities
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- Keratometric astigmatism exceeding 1.5 diopters
- Patient in whom postoperative refractive error is planned to be different between fellow eyes (anisometropia) such as in cases where postoperative refraction is planned for mono-vision
- Current contact lens usage (within 6 months prior to first surgery and/or during the study)
- Other ocular surgery at time of cataract extraction
- Uncontrolled diabetes
- Any neurological condition that might interfere with performance of required tests
- Immune deficiency disease
- Other severe acute or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with study participation or study device implantation or may interfere with the interpretation of study results and, in the judgment of the investigator, would make the patient inappropriate for entry into this study
- Use of any systemic or topical drug known to interfere with visual performance
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparison of the Quality of Vision Provided by AMO Tecnis Z9000 Three-piece Silicone Posterior Chamber Intraocular Lens and Alcon Laboratories MA60 Acrysof Three-piece Acrylic Posterior Chamber Intraocular Lens
This study is a comparison of the quality of vision provided by AMO Tecnis Z9000 three-piece silicone posterior chamber intraocular lens and Alcon Laboratories MA60 three-piece acrylic posterior chamber intraocular lens.
Read the detailed description
Today, intraocular lenses (IOLs) are routinely implanted after cataract extraction. Cataract surgical techniques are constantly developing due to innovations in surgical implantation and IOL manufacturing processes. Although material development and surgical implantation have advanced extensively during the past several years, there has been little attention paid to the improvement of the optical quality of IOLs.
It has been documented that the vision of an IOL patient is no better than that of a person with healthy eyes of a similar age, i.e., when a 65-year-old patient with cataracts has them removed and implanted with an IOL, the resulting visual outcome is no better than the visual quality of a 65-year-old without cataracts. The fact that the visual quality of the IOL patients is no better than that of their same-age counterparts is surprising because an IOL is optically superior to the natural crystalline lens. This fact may be explained by aberrations.
Aberrations cause incoming light that would otherwise be focused to a point to be blurred, which in turn causes a reduction in visual quality. This reduction in quality is more severe under low luminance conditions because ocular aberrations increase when the pupil size gets larger. The Z9000 is an IOL that is designed to counteract the spherical aberration of the cornea and thus improve the resulting visual quality of IOL patients.
Different materials and lens designs result in different visual quality. The handling of the lens, proper centration in the eye, the postoperative course, and the optical image may vary depending on the design of the lens. Two lenses will be compared: AMO Tecnis Z9000 three-piece silicone lens and Alcon Laboratories MA60 three-piece acrylic lens.
This will be a randomized, evaluator-masked study in bilateral cataract surgery patients. Each patient will be assigned to a AMO Tecnis Z9000 lens in one eye and an Alcon Laboratories MA60 lens in the other eye. All first surgeries will be on the right eye. A randomization list will be used to decide lens allocation.
A total of 80 patients (men and women) from the Singapore National Eye Centre will be enrolled in the study. All patients will undergo wavefront analysis 90-120 days postoperatively.
The two lens models look different, even in the eye, after implantation. It is not possible to mask the individual investigator at the time of surgery or personnel responsible for conducting the clinical ocular examinations (e.g., evaluation of complications, posterior capsule, IOP, pupil size) and optic evaluations (e.g., evaluation of the IOL).
- Conditions
- Cataract
- Being tested
- Tecnis Z9000 intraocular lens, MA60 intraocular lens
- Keywords
- Cataract, Intraocular lens, Aberration, Wavefront
- Medical subject headings
- Cataract
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tecnis Z9000 intraocular lensDevice
MA60 intraocular lensDevice
What is being measured
The primary outcome is the main question the study is designed to answer.
The primary outcome of this comparative study is the best corrected mesopic log contrast sensitivity function of eyes implanted with Z9000 and MA60 lenses at 6 cycles/degree, 90-120 days postoperatively.
Secondary outcomes (5)
The best corrected mesopic log contrast sensitivity function of eyes implanted with Z9000 and MA60 lenses at 1.5, 3, 12, and 18 cycles/degree, 90-120 days postoperatively
The change in best corrected mesopic log contrast sensitivity function after cataract surgery (postoperatively minus preoperatively) at 1.5, 3, 6, 12, and 18 cycles/degree
The residual spherical aberrations of the postoperative eye using wavefront analysis
Logarithm of the minimum angle of resolution (LogMAR) visual acuity
Postoperative ocular complications/adverse events
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jul 2006 (estimated)
- Study startJul 2005
- Primary completionOct 2008
- Study completionOct 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Single blind
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Singapore National Eye Centre
- Sponsor type
- Other government
- Investigators
- Wei-Han Chua, Principal investigator, Singapore National Eye Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00348270
- Sponsor's protocol ID
- R367/25/2004
- Status last verified
- May 2010
- First submitted
- 3 Jul 2006
- Last updated
- 12 May 2010
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 May 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of the Quality of Vision Provided by AMO Tecnis Z9000 Three-piece Silicone Posterior Chamber Intraocular Lens and Alcon Laboratories MA60 Acrysof Three-piece Acrylic Posterior Chamber Intraocular Lens
- ClinicalTrials.gov ID
- NCT00348270
- Acronym / sponsor ID
- R367/25/2004
- Conditions
- Cataract
- Keywords
- Cataract, Intraocular lens, Aberration, Wavefront
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Singapore National Eye CentreOther government
- Study start
- Jul 2005
- Primary completion
- Oct 2008 (actual)
- Study completion
- Oct 2008 (actual)
- First posted
- 4 Jul 2006 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study is a comparison of the quality of vision provided by AMO Tecnis Z9000 three-piece silicone posterior chamber intraocular lens and Alcon Laboratories MA60 three-piece acrylic posterior chamber intraocular lens.
Detailed description
Today, intraocular lenses (IOLs) are routinely implanted after cataract extraction. Cataract surgical techniques are constantly developing due to innovations in surgical implantation and IOL manufacturing processes. Although material development and surgical implantation have advanced extensively during the past several years, there has been little attention paid to the improvement of the optical quality of IOLs.
It has been documented that the vision of an IOL patient is no better than that of a person with healthy eyes of a similar age, i.e., when a 65-year-old patient with cataracts has them removed and implanted with an IOL, the resulting visual outcome is no better than the visual quality of a 65-year-old without cataracts. The fact that the visual quality of the IOL patients is no better than that of their same-age counterparts is surprising because an IOL is optically superior to the natural crystalline lens. This fact may be explained by aberrations.
Aberrations cause incoming light that would otherwise be focused to a point to be blurred, which in turn causes a reduction in visual quality. This reduction in quality is more severe under low luminance conditions because ocular aberrations increase when the pupil size gets larger. The Z9000 is an IOL that is designed to counteract the spherical aberration of the cornea and thus improve the resulting visual quality of IOL patients.
Different materials and lens designs result in different visual quality. The handling of the lens, proper centration in the eye, the postoperative course, and the optical image may vary depending on the design of the lens. Two lenses will be compared: AMO Tecnis Z9000 three-piece silicone lens and Alcon Laboratories MA60 three-piece acrylic lens.
This will be a randomized, evaluator-masked study in bilateral cataract surgery patients. Each patient will be assigned to a AMO Tecnis Z9000 lens in one eye and an Alcon Laboratories MA60 lens in the other eye. All first surgeries will be on the right eye. A randomization list will be used to decide lens allocation.
A total of 80 patients (men and women) from the Singapore National Eye Centre will be enrolled in the study. All patients will undergo wavefront analysis 90-120 days postoperatively.
The two lens models look different, even in the eye, after implantation. It is not possible to mask the individual investigator at the time of surgery or personnel responsible for conducting the clinical ocular examinations (e.g., evaluation of complications, posterior capsule, IOP, pupil size) and optic evaluations (e.g., evaluation of the IOL).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
Who may qualify
- Ages
- 50 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Bilateral cataracts, eligible for phacoemulsification with primary implantation of a posterior chamber IOL
- Males and females 50 to 80 years of age
- Expected maximum of 6-weeks and minimum of 3 weeks interval between a single patient's surgeries
- Best corrected visual acuity (BCVA) should be no better than 20/40 in the presence of a glare source. (In the early treatment diabetic retinopathy study [ETDRS] visual acuity chart, better than 20/40 will be at least 3 letters read correctly in the 20/30 line).
- Best corrected visual acuity projected by Potential Acuity Meter (PAM) or other reliable potential acuity test procedure to be 20/30 or better in each eye after cataract removal and IOL implantation.
Key exclusion criteria (15 listed)
- Preoperative pathology: amblyopia, rubella cataract, proliferative diabetic retinopathy, shallow anterior chamber, macular edema, retinal detachment, aniridia or iris atrophy, uveitis, history of iritis, iris neovascularization, medically uncontrolled glaucoma, microphthalmus or macrophthalmus, optic nerve atrophy
- Previous intraocular or corneal surgery, including refractive surgery, corneal transplant
- Other pathologies potentially affecting visual acuity, e.g., macular degeneration, glaucoma with the presence of visual field defects
- An increased risk for complications which could require vitreoretinal surgery
- Corneal irregularities potentially affecting visual acuity, e.g., keratoconus, corneal dystrophy
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 |
|---|---|---|
| Tecnis Z9000 intraocular lens | Device | – |
| MA60 intraocular lens | Device | – |
Primary outcome
The primary outcome of this comparative study is the best corrected mesopic log contrast sensitivity function of eyes implanted with Z9000 and MA60 lenses at 6 cycles/degree, 90-120 days postoperatively.
5 secondary outcomes
The best corrected mesopic log contrast sensitivity function of eyes implanted with Z9000 and MA60 lenses at 1.5, 3, 12, and 18 cycles/degree, 90-120 days postoperatively
The change in best corrected mesopic log contrast sensitivity function after cataract surgery (postoperatively minus preoperatively) at 1.5, 3, 6, 12, and 18 cycles/degree
The residual spherical aberrations of the postoperative eye using wavefront analysis
Logarithm of the minimum angle of resolution (LogMAR) visual acuity
Postoperative ocular complications/adverse events
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 May 2010.
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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.
Wei-Han Chua principal investigator
Singapore National Eye Center
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 Tecnis Z9000 intraocular lens and MA60 intraocular lens in people with Cataract, run by Singapore National Eye Centre at 1 site in Singapore.
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 9 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 12 May 2010. 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 Singapore. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
The primary outcome of this comparative study is the best corrected mesopic log contrast sensitivity function of eyes implanted with Z9000 and MA60 lenses at 6 cycles/degree, 90-120 days postoperatively.. 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 12 May 2010; AzTrials last refreshed its copy on 8 Nov 2026.