Cataract ExtractionNCT00366665
Comparison of the Performance of the Infiniti Vision and the Series 20000 Legacy Phacoemulsification Systems
A study testing Legacy 20000 and Infinit system in people with Cataract Extraction, run by Medical University of South Carolina.
Trial summary
To compare the efficiency of the Infiniti vision system and the Series 20000 Legacy System phacoemulsification units during routine cataract extraction. Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Cataract Extraction
- What is being tested?
- Legacy 20000 and Infinit system
- Type of treatment
- Medical device
- How many people
- 30 participants
- Where
- No sites listed yet
- Study dates
- Mar 2005to May 2005
- Phase
- Interventional
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Cataract
- Eligible for cataract extraction with primary implantation of a posterior chamber IOL
- 2 to 3+ cataract density
Who cannot join
- Preoperative ocular pathology that can affect visual acuity
- Corneal irregularities such as keratoconus, corneal dystrophy, corneal opacities.
- Previous intraocular or corneal surgery.
- Other ocular surgery at the time of the cataract extraction.
- Surgical Exclusion Criteria:
- Significant intraoperative intraocular bleeding
- Detached Descemet's membrane
- Implantation of the intraocular lens in the anterior chamber or sulcus
About this study
Official title: Comparison of the Infiniti Vision and the Series 20000 Legacy Systems
To compare the efficiency of the Infiniti vision system and the Series 20000 Legacy System phacoemulsification units during routine cataract extraction.
- Conditions
- Cataract Extraction
- Being tested
- Legacy 20000, Infinit system
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Legacy 20000Device
Infinit systemDevice
What is being measured
The primary outcome is the main question the study is designed to answer.
Ultrasound time
Amount of fluid used
Post operative visual acuity.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Aug 2006 (estimated)
- Study startMar 2005
- Study completionMay 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cataract ExtractionStudies of the same condition, open and under way.
- More trials run by Medical University of South CarolinaThe sponsor's other registered studies.
- 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Enrolment
- 30 participants
Sponsor and investigators
- Lead sponsor
- Medical University of South Carolina
- Sponsor type
- University, hospital or other
- Investigators
- Kerry D. Solomon, MD, Principal investigator, Medical University of South Carolina
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00366665
- Sponsor's protocol ID
- MRC-05-002
- Status last verified
- May 2005
- First submitted
- 17 Aug 2006
- Last updated
- 21 Aug 2006
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Aug 2006. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of the Infiniti Vision and the Series 20000 Legacy Systems
- ClinicalTrials.gov ID
- NCT00366665
- Acronym / sponsor ID
- MRC-05-002
- Conditions
- Cataract Extraction
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants
- Lead sponsor
- Medical University of South CarolinaUniversity, hospital or other
- Study start
- Mar 2005
- Study completion
- May 2005
- First posted
- 21 Aug 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.
To compare the efficiency of the Infiniti vision system and the Series 20000 Legacy System phacoemulsification units during routine cataract extraction.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Cataract
- Eligible for cataract extraction with primary implantation of a posterior chamber IOL
- 2 to 3+ cataract density
Key exclusion criteria (8 listed)
- Preoperative ocular pathology that can affect visual acuity
- Corneal irregularities such as keratoconus, corneal dystrophy, corneal opacities.
- Previous intraocular or corneal surgery.
- Other ocular surgery at the time of the cataract extraction.
- Surgical Exclusion Criteria:
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 |
|---|---|---|
| Legacy 20000 | Device | – |
| Infinit system | Device | – |
Primary outcome
Ultrasound time
Amount of fluid used
Post operative visual acuity.
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 21 Aug 2006.
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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.
Kerry D. Solomon, MD principal investigator
Medical University of South Carolina
Questions about this trial
What is this clinical trial studying?
A study testing Legacy 20000 and Infinit system in people with Cataract Extraction, run by Medical University of South Carolina.
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 8 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 21 Aug 2006. Status can change between updates, so confirm with the study contact before making plans.
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.
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?
Ultrasound time. The study lists 3 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 21 Aug 2006.