Cataract SurgeryNCT02910362
Intra-surgical Evaluation of CATS Tonometer Prism and Abbott Medical Optics Versus Alcon Phacoemulsification Machines
A study testing Alcon phacoemulsification equipment and AMO phacoemulsification equipment in people with Cataract Surgery, run by Intuor Technologies, Inc. at 1 site in United States.
Trial summary
This study will measure the dynamic real-time intraocular pressure (IOP) in the anterior chamber during standard phacoemulsification surgery. What is known: Fluidics control is determined to be one of the primary drivers of physician decision making in choosing phacoemulsification equipment. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cataract Surgery
- What is being tested?
- Alcon phacoemulsification equipment and AMO phacoemulsification equipment
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2016to Jan 2017
- Phase
- Interventional
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- • Age 18 or greater
- Bilateral cataracts for which phacoemulsification extraction and posterior IOL implantation has been planned for both eyes
- Subjects able to give informed consent
- Nuclear Sclerotic cataract graded 2+ or 3+
- Naturally dilated pupil size (in dim light) > 4.0 mm (with no dilation medications) for both eyes
- Preoperative corneal astigmatism of 2.5 D or less
- Ages between 55 and 80
- Availability, willingness, and sufficient cognitive awareness to comply with examination procedures
Who cannot join
- • Uncontrolled systemic disease that in the opinion of the Investigator would put the subject's heath at risk
- Intraoperative complications
- Subjects with only one functional eye
- Those with one eye having poor or eccentric fixation
- Mild or severe cataracts, predominantly posterior subcapsular cataracts
- High corneal astigmatism (i.e. those eyes displaying an oval contact image)
Show all 23Show fewer
- Those with corneal scarring or who have had corneal surgery including corneal laser surgery
- Microphthalmos
- Buphthalmos
- Severe Dry eyes
- Blepharospasm
- Nystagmus
- Keratoconus
- Any other corneal or conjunctival pathology or infection.
- Central corneal thickness greater than 0,600 mm or less than 0,500 mm (2 standard deviations about the human mean)
- Acute or chronic disease or illness that would increase risk or confound study results (e.g. diabetes mellitus, immunocompromised, etc.)
- Uncontrolled systemic or ocular disease
- History of ocular trauma or prior ocular surgery
- Fuchs Dystrophy
- Subjects who may be expected to require retinal laser treatment or other surgical intervention, including LRI's
- Capsule or zonular abnormalities that may affect postoperative centration or tilt of the lens (e.g. pseudoexfoliation syndrome)
- Pupil abnormalities (non-reactive, tonic pupils, abnormally shaped pupils, or pupils that do not dilate at least 4.0 mm under mesopic/scotopic conditions)
- Contact lens usage within 6 months for PMMA contacts lenses, 1 month for gas permeable lenses or 1 week for extended-wear and daily-wear soft contact lens
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Intra-surgical Evaluation of CATS Tonometer Prism and AMO Versus Alcon Phacoemulsification Machines
This study will measure the dynamic real-time intraocular pressure (IOP) in the anterior chamber during standard phacoemulsification surgery.
What is known:
- Fluidics control is determined to be one of the primary drivers of physician decision making in choosing phacoemulsification equipment.
- Active pressure system fluidic control has a perceived and possibly real (based upon recent literature) improvement in intra-cameral IOP stability and reduced pressure fluctuations.
- Improved fluidics can allow for reduced dynamic IOP fluctuations, in-the-bag positioned phaco tip, and intra-cameral fluid flow all of which will likely improve corneal health post-operatively.
- Conditions
- Cataract Surgery
- Being tested
- Alcon phacoemulsification equipment, AMO phacoemulsification equipment
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Alcon phacoemulsification equipmentDevice
cataract surgery with Alcon phacoemulsification equipment.
AMO phacoemulsification equipmentDevice
cataract surgery with AMO phacoemulsification equipment.
| Study group | Role | What they receive |
|---|---|---|
| Alcon phacoemulsification equipment | Experimental | cataract surgery performed with the Alcon phacoemulsification equipment Receives: Device: Alcon phacoemulsification equipment |
| AMO phacoemulsification equipment | Active comparator | cataract surgery with the AMO phacoemulsification equipment Receives: Device: AMO phacoemulsification equipment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Eyes With Stable IOP
Determine comparative IOP stability between Abbott and Alcon phacoemulsification equipment.
Measured: intraoperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Sep 2016 (estimated)
- Study startSep 2016
- Primary completionJan 2017
- Study completionJan 2017
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 Cataract SurgeryStudies 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 N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- Intuor Technologies, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Abbott Medical Optics
- Responsible party
- Sponsor
- Investigators
- Sean McCafferty, MD, Principal investigator, Arizona Eye Consultants
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02910362
- Sponsor's protocol ID
- CP-02
- Status last verified
- Oct 2018
- First submitted
- 13 Sep 2016
- Last updated
- 11 Oct 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intra-surgical Evaluation of CATS Tonometer Prism and AMO Versus Alcon Phacoemulsification Machines
- ClinicalTrials.gov ID
- NCT02910362
- Acronym / sponsor ID
- CP-02
- Conditions
- Cataract Surgery
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- Intuor Technologies, Inc.Industry (pharma, biotech, devices)
- Collaborators
- Abbott Medical Optics
- Study start
- Sep 2016 (actual)
- Primary completion
- Jan 2017 (actual)
- Study completion
- Jan 2017 (actual)
- First posted
- 22 Sep 2016 (estimated)
- Results
- Posted 28 Jul 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study will measure the dynamic real-time intraocular pressure (IOP) in the anterior chamber during standard phacoemulsification surgery.
What is known:
- Fluidics control is determined to be one of the primary drivers of physician decision making in choosing phacoemulsification equipment.
- Active pressure system fluidic control has a perceived and possibly real (based upon recent literature) improvement in intra-cameral IOP stability and reduced pressure fluctuations.
- Improved fluidics can allow for reduced dynamic IOP fluctuations, in-the-bag positioned phaco tip, and intra-cameral fluid flow all of which will likely improve corneal health post-operatively.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Alcon phacoemulsification equipment | Experimental | Device: Alcon phacoemulsification equipmentcataract surgery performed with the Alcon phacoemulsification equipment |
| AMO phacoemulsification equipment | Active comparator | Device: AMO phacoemulsification equipmentcataract surgery with the AMO phacoemulsification equipment |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- • Age 18 or greater
Key exclusion criteria (23 listed)
- • Uncontrolled systemic disease that in the opinion of the Investigator would put the subject's heath at risk
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 |
|---|---|---|
| Alcon phacoemulsification equipmentcataract surgery with Alcon phacoemulsification equipment. | Device | Alcon phacoemulsification equipment |
| AMO phacoemulsification equipmentcataract surgery with AMO phacoemulsification equipment. | Device | AMO phacoemulsification equipment |
Primary outcome
Number of Eyes With Stable IOP
Time frame: intraoperative
Determine comparative IOP stability between Abbott and Alcon phacoemulsification equipment.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Oct 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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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.
Sean McCafferty, MD principal investigator
Arizona Eye Consultants
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Alcon phacoemulsification equipment and AMO phacoemulsification equipment in people with Cataract Surgery, run by Intuor Technologies, Inc. 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 8 inclusion and 23 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 Oct 2018. 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.
Are results available for this study?
Yes. Results are posted in the registry (first posted 28 Jul 2017). 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?
Number of Eyes With Stable IOP (time frame: intraoperative). 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 Oct 2018.