Refractive ErrorsTrIPLeNCT04545073
Outcomes of a Trifocal IOL in Post-refractive Patients
An observational study of Refractive Errors, run by Vance Thompson Vision ND at 1 site in United States.
Trial summary
To compare the prediction error of ORA vs formula for post-LASIK cataract patients when PanOptix IOL was implanted. Using post-operative outcomes to determine if preoperative IOL calculations, including Barrett TK, Barrett Universal II, Hill RBF, ASCRS post-refractive calculator, or intraoperative aberrometry is more… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Refractive Errors
- What is being tested?
- PanOptix
- Type of treatment
- Medical device
- How many people
- 200 participants
- Where
- 1 siteUnited States
- Study dates
- 9 Oct 2020to May 2021
- Phase
- Observational
- 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
Study population: Charts from up to 200 myopic post-refractive patients who have received PanOptix will be reviewed at at least two Vance Thompson Vision sites (Fargo, ND and Sioux Falls, SD). All patients will have had ORA used during the cataract surgery.
Who may be able to join
- Previous myopic refractive surgery
- At least 3 months post op cataract surgery with a trifocal IOL
Who cannot join
- Pre-existing or subsequent eye condition that interferes with accurate data collection (retinal detachment, etc.)
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
Vance Thompson Vision ND
West Fargo, North Dakota, 58078
Sarah Thiede, 701-566-5390, sarah.thiede@vancethompsonvision.com
Jake Hutchison, 701-566-5390, jake.hutchison@vancethompsonvision.com
About this study
To compare the prediction error of ORA vs formula for post-LASIK cataract patients when PanOptix IOL was implanted. Using post-operative outcomes to determine if preoperative IOL calculations, including Barrett TK, Barrett Universal II, Hill RBF, ASCRS post-refractive calculator, or intraoperative aberrometry is more accurate when the two methods disagree in patients who have had previous refractive surgery undergo cataract surgery.
Read the detailed description
The study will be non-interventional with data being collected prospectively and retrospectively between at least two surgical sites. All subjects will have previous LASIK and be at least 3 months post op PanOptix implantation. The study will enroll up to 200 patients and a statistical database will be created.
- Conditions
- Refractive Errors
- Being tested
- PanOptix
- Medical subject headings
- Refractive Errors
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PanOptixDevice
Trifocal IOL with ORA in post refractive patients
| Study group | Role | What they receive |
|---|---|---|
| Post-refractive trifocal IOL | Not described Receives: Device: PanOptix |
What is being measured
The primary outcome is the main question the study is designed to answer.
To determine if preoperative IOL calculations or intraoperative aberrometry is more accurate when the two methods disagree in patients who have had previous refractive surgery undergo cataract surgery.
- Percentage of eyes within +/- .5D of target for each formula and ORA.
- Overall % of eyes that have a disagreement between the two methods
Measured: Pre-op to 9 month visit
Secondary outcomes (7)
Post-operative monocular visual acuity
Monocular Uncorrected Distance, Intermediate, Near Visual Acuity
Measured: 3 to 9 month visit
Post-operative best corrected visual acuity
Manifest refraction, Best Corrected Distance Visual Acuity, Distance Corrected Intermediate, and Near Visual Acuity
Measured: 3 to 9 month visit
Post-operative uncorrected visual acuity
Binocular Uncorrected Distance, Intermediate, Near Visual Acuity, Best Corrected Distance Visual Acuity, Distance Corrected Intermediate, Near Visual Acuity
Measured: 3 to 9 month visit
Post-operative visual acuity
Percentage of eyes with Uncorrected Distance Visual Acuity of 20/20 or better, 20/25 or better, and 20/30 or better
Measured: 3 to 9 month visit
Post-operative visual acuity
Percentage of eyes with Uncorrected Corrected Intermediate Visual Acuity and Distance Corrected Intermediate Visual Acuity 20/20 or better, 20/25 or better, and 20/30 or better
Measured: 3 to 9 month visit
Post-operative visual acuity
Percentage of eyes with Uncorrected Distance Near Visual Acuity and Distance Corrected Near Visual Acuity of 20/20 or better, 20/25 or better, and 20/30 or better
Measured: 3 to 9 month visit
Patient's quality of vision and reported side-effects
Patient satisfaction questionnaire
Measured: 3 to 9 month visit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Sep 2020
- Study start9 Oct 2020
- Primary completionMar 2021 (estimated)
- Study completionMay 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Refractive ErrorsStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Other
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Vance Thompson Vision ND
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Michael Greenwood, MD, Principal investigator, Vance Thompson Vision ND
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04545073
- Sponsor's protocol ID
- IOL-VTV-01
- Acronym
- TrIPLe
- Status last verified
- Oct 2020
- First submitted
- 21 Aug 2020
- Last updated
- 19 Oct 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 19 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Outcomes of a Trifocal IOL in Post-refractive Patients
- ClinicalTrials.gov ID
- NCT04545073
- Acronym / sponsor ID
- TrIPLe / IOL-VTV-01
- Conditions
- Refractive Errors
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Vance Thompson Vision NDUniversity, hospital or other
- Study start
- 9 Oct 2020 (actual)
- Primary completion
- Mar 2021 (estimated)
- Study completion
- May 2021 (estimated)
- First posted
- 10 Sep 2020 (actual)
- 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 prediction error of ORA vs formula for post-LASIK cataract patients when PanOptix IOL was implanted. Using post-operative outcomes to determine if preoperative IOL calculations, including Barrett TK, Barrett Universal II, Hill RBF, ASCRS post-refractive calculator, or intraoperative aberrometry is more accurate when the two methods disagree in patients who have had previous refractive surgery undergo cataract surgery.
Detailed description
The study will be non-interventional with data being collected prospectively and retrospectively between at least two surgical sites. All subjects will have previous LASIK and be at least 3 months post op PanOptix implantation. The study will enroll up to 200 patients and a statistical database will be created.
Study design
- Observational model
- Cohort
- Time perspective
- Other
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Post-refractive trifocal IOL | – | Device: PanOptix |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Charts from up to 200 myopic post-refractive patients who have received PanOptix will be reviewed at at least two Vance Thompson Vision sites (Fargo, ND and Sioux Falls, SD). All patients will have had ORA used during the cataract surgery.
Key inclusion criteria (2 listed)
- Previous myopic refractive surgery
- At least 3 months post op cataract surgery with a trifocal IOL
Key exclusion criteria (1 listed)
- Pre-existing or subsequent eye condition that interferes with accurate data collection (retinal detachment, 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 |
|---|---|---|
| PanOptixTrifocal IOL with ORA in post refractive patients | Device | Post-refractive trifocal IOL |
Primary outcome
To determine if preoperative IOL calculations or intraoperative aberrometry is more accurate when the two methods disagree in patients who have had previous refractive surgery undergo cataract surgery.
Time frame: Pre-op to 9 month visit
1. Percentage of eyes within +/- .5D of target for each formula and ORA. 2. Overall % of eyes that have a disagreement between the two methods
7 secondary outcomes
Post-operative monocular visual acuity
Time frame: 3 to 9 month visit
Post-operative best corrected visual acuity
Time frame: 3 to 9 month visit
Post-operative uncorrected visual acuity
Time frame: 3 to 9 month visit
Post-operative visual acuity
Time frame: 3 to 9 month visit
Post-operative visual acuity
Time frame: 3 to 9 month visit
Post-operative visual acuity
Time frame: 3 to 9 month visit
Patient's quality of vision and reported side-effects
Time frame: 3 to 9 month visit
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Oct 2020.
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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.
Michael Greenwood, MD principal investigator
Vance Thompson Vision ND
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Refractive Errors, run by Vance Thompson Vision ND 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 2 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 19 Oct 2020. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Sarah Thiede (7015665390, sarah.thiede@vancethompsonvision.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To determine if preoperative IOL calculations or intraoperative aberrometry is more accurate when the two methods disagree in patients who have had previous refractive surgery undergo cataract surgery. (time frame: Pre-op to 9 month visit). 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 19 Oct 2020.