CataractPhase 1/2IOLNCT00876707
Wavefront Analyzes and Visual Performance of Three Multifocal Intra-ocular Lenses
A Phase 1/2 study testing Tecnis implant, ReSTOR implant and ReZoom implant in people with Cataract and Astigmatism, run by University of Sao Paulo at 1 site in Brazil.
Trial summary
The purpose of this study is to determine if differences in the design of multifocal intra-ocular lenses would mean different values of higher-order aberrations and different performance in objective parameters such as modulation transfer function. Read more about this study
- Who is it for?
- Ages 40 to 70 years
- Conditions the study is for
- Cataract, Astigmatism
- What is being tested?
- Tecnis implant, ReSTOR implant and ReZoom implant
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteBrazil
- Study dates
- Mar 2009to Nov 2009
- Phase
- Phase 1/2
- 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 40 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with bilateral visually significant cataract with corneal astigmatism lower than 1.0D
Who cannot join
- Any ocular diseases, such as:
- corneal opacities or irregularity
- dry eye
- amblyopia
- anisometropia
- glaucoma
Show all 11Show fewer
- retinal abnormality
- Surgical complications
- IOL tilt
- IOL decentration greater than 0.4 mm (estimated by retroillumination)
- Incomplete follow-up
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Phase 1 Study of Ocular Aberrations and Visual Performance of Eyes Implanted With Three Multifocal Intra-ocular Lenses
The purpose of this study is to determine if differences in the design of multifocal intra-ocular lenses would mean different values of higher-order aberrations and different performance in objective parameters such as modulation transfer function.
- Conditions
- Cataract, Astigmatism
- Being tested
- Tecnis implant, ReSTOR implant, ReZoom implant
- Keywords
- wavefront, multifocal IOL, modulation transfer function, intraocular lenses, wavefront data, Visual performance
- Medical subject headings
- Cataract, Astigmatism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tecnis implantDevice
Implant of diffractive multifocal IOL Tecnis
ReSTOR implantDevice
Implant of multifocal IOL ReSTOR
ReZoom implantDevice
Implant of multifocal IOL ReZoom
| Study group | Role | What they receive |
|---|---|---|
| Tecnis | Active comparator | Not described Receives: Device: Tecnis implant |
| ReSTOR | Active comparator | Not described Receives: Device: ReSTOR implant |
| ReZoom | Active comparator | Not described Receives: Device: ReZoom implant |
What is being measured
The primary outcome is the main question the study is designed to answer.
visual acuity, wavefront data and modulation transfer function
Measured: 30, 90 and 120 days after surgery
Secondary outcomes (1)
contrast sensitivity
Measured: 90 days after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Apr 2009 (estimated)
- Study startMar 2009
- Primary completionNov 2009
- Study completionNov 2009
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 1/2
- Primary purpose
- Treatment
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Sao Paulo
- Sponsor type
- University, hospital or other
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00876707
- Sponsor's protocol ID
- 0088/09
- Acronym
- IOL
- Status last verified
- Apr 2009
- First submitted
- 3 Apr 2009
- Last updated
- 2 Jul 2010
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Jul 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 1 Study of Ocular Aberrations and Visual Performance of Eyes Implanted With Three Multifocal Intra-ocular Lenses
- ClinicalTrials.gov ID
- NCT00876707
- Acronym / sponsor ID
- IOL / 0088/09
- Conditions
- Cataract, Astigmatism
- Keywords
- wavefront, multifocal IOL, modulation transfer function, intraocular lenses, wavefront data, Visual performance
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- University of Sao PauloUniversity, hospital or other
- Study start
- Mar 2009
- Primary completion
- Nov 2009 (actual)
- Study completion
- Nov 2009 (actual)
- First posted
- 7 Apr 2009 (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.
The purpose of this study is to determine if differences in the design of multifocal intra-ocular lenses would mean different values of higher-order aberrations and different performance in objective parameters such as modulation transfer function.
Study design
- Primary purpose
- Treatment
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Tecnis | Active comparator | Device: Tecnis implant |
| ReSTOR | Active comparator | Device: ReSTOR implant |
| ReZoom | Active comparator | Device: ReZoom implant |
Who may qualify
- Ages
- 40 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients with bilateral visually significant cataract with corneal astigmatism lower than 1.0D
Key exclusion criteria (11 listed)
- Any ocular diseases, such as:
- Surgical complications
- IOL tilt
- IOL decentration greater than 0.4 mm (estimated by retroillumination)
- Incomplete follow-up
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 implantImplant of diffractive multifocal IOL Tecnis | Device | Tecnis |
| ReSTOR implantImplant of multifocal IOL ReSTOR | Device | ReSTOR |
| ReZoom implantImplant of multifocal IOL ReZoom | Device | ReZoom |
Primary outcome
visual acuity, wavefront data and modulation transfer function
Time frame: 30, 90 and 120 days after surgery
1 secondary outcome
contrast sensitivity
Time frame: 90 days after surgery
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 2 Jul 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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Tecnis implant, ReSTOR implant and ReZoom implant in people with Cataract and Astigmatism, run by University of Sao Paulo at 1 site in Brazil.
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 1 inclusion and 11 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 2 Jul 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 Brazil. 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 combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
visual acuity, wavefront data and modulation transfer function (time frame: 30, 90 and 120 days after surgery). 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 2 Jul 2010.