Subjects Undergoing Cataract Surgery and Insertion of IOLPhase 1NCT01123343
Clinical Evaluation of TrueVision System: LRI and Capsulorhexis Templates
A Phase 1 study testing TrueVision 3D Visualization and Guidance System for MicroSurgery in people with Subjects Undergoing Cataract Surgery and Insertion of IOL, run by TrueVision Systems, Inc at 1 site in United States.
Trial summary
To evaluate the ability of the TRUEVISION 3D VISUALIZATION AND GUIDANCE SYSTEM FOR MICROSURGERY to provide the ophthalmic surgeon appropriate alignment, orientation and sizing information during cataract or refractive lens exchange surgery. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Subjects Undergoing Cataract Surgery and Insertion of IOL
- What is being tested?
- TrueVision 3D Visualization and Guidance System for MicroSurgery
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 35 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2010to Dec 2010
- Phase
- Phase 1
- 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Healthy eye with no previous ocular surgery
- Natural lens for which phacoemulsification extraction and posterior IOL implantation is planned
- Clear intraocular media other than cataract
- Potential visual acuity 20/30 or better
- Able to comply with preop and postop examination procedures
- Signed and dated informed consent
Who cannot join
- Keratometric astigmatism > 2.5 diopters
- Corneal pathology potentially affecting topography including corneal degeneration
- Irregular astigmatism
- Macular degeneration or any other macular disease which reduces potential acuity
- Previous corneal surgery (including LASIK, radial keratotomy, penetrating keratoplasty, etc)
- Use of systemic or ocular medications that affects vision
Show all 9Show fewer
- Acute or chronic systemic or ocular disease or illness that would increase risk or confound study results
- Use of Flomax or any other medication which negatively impacts surgical outcomes
- History of ocular trauma or ocular surgery
Trial locations and contacts
1 site in 1 country.
About this study
Official title: CLINICAL EVALUATION OF THE TRUEVISION 3D VISUALIZATION AND GUIDANCE SYSTEM FOR MICROSURGERY: LRI AND CAPSULORHEXIS TEMPLATES
To evaluate the ability of the TRUEVISION 3D VISUALIZATION AND GUIDANCE SYSTEM FOR MICROSURGERY to provide the ophthalmic surgeon appropriate alignment, orientation and sizing information during cataract or refractive lens exchange surgery. Device images, safety results and surgeon questionnaire will demonstrate that the TrueVision system provides clear images to assist surgeons during LRI or capsulorhexis procedures.
- Being tested
- TrueVision 3D Visualization and Guidance System for MicroSurgery
- Keywords
- limbal relaxing incision, LRI, capsulorhexis, surgical guidance, 3d visualization
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TrueVision 3D Visualization and Guidance System for MicroSurgeryDevice
Adjunct imaging tool (to the microscope oculars) that provides onscreen video guidance for alignment, orientation, and sizing during eye surgery, based on a surgeon's defined nomogram
| Study group | Role | What they receive |
|---|---|---|
| LRI Templates | Active comparator | To evaluate the ability of the TRUEVISION 3D VISUALIZATION AND GUIDANCE SYSTEM FOR MICROSURGERY to provide the ophthalmic surgeon appropriate alignment, orientation and sizing information during cataract or refractive lens exchange surgery compared to the current standard of care (manual markings or heuristic techniques) for LRI. Receives: Device: TrueVision 3D Visualization and Guidance System for MicroSurgery |
| Capsulorhexis Templates | Active comparator | To evaluate the ability of the TRUEVISION 3D VISUALIZATION AND GUIDANCE SYSTEM FOR MICROSURGERY to provide the ophthalmic surgeon appropriate alignment, orientation and sizing information during cataract or refractive lens exchange surgery compared to the current standard of care (manual markings or heuristic techniques) for Capsulorhexis. Receives: Device: TrueVision 3D Visualization and Guidance System for MicroSurgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
Demonstrate that the TrueVision system provides clear images to assist during LRI or capsulorhexis procedures
Measured: one month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 May 2010 (estimated)
- Study startJan 2010
- Primary completionJun 2010
- Study completionDec 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Subjects Undergoing Cataract Surgery and Insertion of IOLStudies 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
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 35 participants (actual)
Sponsor and investigators
- Lead sponsor
- TrueVision Systems, Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Mark Packer, MD, Study director, Oregon Eye AssociatesRobert Weinstock, MD, Principal investigator, Eye Institute of West FloridaJason Stahl, MD, Principal investigator, Durrie VisionDouglas Katsev, MD, Principal investigator, Sansum Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01123343
- Sponsor's protocol ID
- TVS-2009-001
- Status last verified
- Jun 2015
- First submitted
- 12 May 2010
- Last updated
- 29 Jun 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Jun 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- CLINICAL EVALUATION OF THE TRUEVISION 3D VISUALIZATION AND GUIDANCE SYSTEM FOR MICROSURGERY: LRI AND CAPSULORHEXIS TEMPLATES
- ClinicalTrials.gov ID
- NCT01123343
- Acronym / sponsor ID
- TVS-2009-001
- Keywords
- limbal relaxing incision, LRI, capsulorhexis, surgical guidance, 3d visualization
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 35 participants (actual)
- Lead sponsor
- TrueVision Systems, IncIndustry (pharma, biotech, devices)
- Study start
- Jan 2010
- Primary completion
- Jun 2010 (actual)
- Study completion
- Dec 2010 (actual)
- First posted
- 14 May 2010 (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 evaluate the ability of the TRUEVISION 3D VISUALIZATION AND GUIDANCE SYSTEM FOR MICROSURGERY to provide the ophthalmic surgeon appropriate alignment, orientation and sizing information during cataract or refractive lens exchange surgery. Device images, safety results and surgeon questionnaire will demonstrate that the TrueVision system provides clear images to assist surgeons during LRI or capsulorhexis procedures.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| LRI Templates | Active comparator | Device: TrueVision 3D Visualization and Guidance System for MicroSurgeryTo evaluate the ability of the TRUEVISION 3D VISUALIZATION AND GUIDANCE SYSTEM FOR MICROSURGERY to provide the ophthalmic surgeon appropriate alignment, orientation and sizing information during cataract or refractive lens exchange surgery compared to the current standard of care (manual markings or heuristic techniques) for LRI. |
| Capsulorhexis Templates | Active comparator | Device: TrueVision 3D Visualization and Guidance System for MicroSurgeryTo evaluate the ability of the TRUEVISION 3D VISUALIZATION AND GUIDANCE SYSTEM FOR MICROSURGERY to provide the ophthalmic surgeon appropriate alignment, orientation and sizing information during cataract or refractive lens exchange surgery compared to the current standard of care (manual markings or heuristic techniques) for Capsulorhexis. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Healthy eye with no previous ocular surgery
- Natural lens for which phacoemulsification extraction and posterior IOL implantation is planned
- Clear intraocular media other than cataract
- Potential visual acuity 20/30 or better
- Able to comply with preop and postop examination procedures
Key exclusion criteria (9 listed)
- Keratometric astigmatism > 2.5 diopters
- Corneal pathology potentially affecting topography including corneal degeneration
- Irregular astigmatism
- Macular degeneration or any other macular disease which reduces potential acuity
- Previous corneal surgery (including LASIK, radial keratotomy, penetrating keratoplasty, etc)
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 |
|---|---|---|
| TrueVision 3D Visualization and Guidance System for MicroSurgeryAdjunct imaging tool (to the microscope oculars) that provides onscreen video guidance for alignment, orientation, and sizing during eye surgery, based on a surgeon's defined nomogram | Device | Capsulorhexis Templates, LRI Templates |
Primary outcome
Demonstrate that the TrueVision system provides clear images to assist during LRI or capsulorhexis procedures
Time frame: one month
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 29 Jun 2015.
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.
Mark Packer, MD study director
Oregon Eye Associates
Robert Weinstock, MD principal investigator
Eye Institute of West Florida
Jason Stahl, MD principal investigator
Durrie Vision
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing TrueVision 3D Visualization and Guidance System for MicroSurgery in people with Subjects Undergoing Cataract Surgery and Insertion of IOL, run by TrueVision Systems, 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 6 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 29 Jun 2015. 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.
What does this 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.
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?
Demonstrate that the TrueVision system provides clear images to assist during LRI or capsulorhexis procedures (time frame: one month). 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 29 Jun 2015.