AstigmatismNCT02763124
Pseudophakic Astigmatic Reduction With Verion-LenSx Arcuate Incisions
A study testing Verion-LenSx in people with Astigmatism, run by Gainesville Eye Associates at 1 site in United States.
Trial summary
To assess the effectiveness of the Verion-LenSx guided arcuate incision technique to reduce astigmatism in a pseudophakic population. Read more about this study
- Who is it for?
- Ages 40 years and olderHealthy volunteers can take part
- Conditions the study is for
- Astigmatism
- What is being tested?
- Verion-LenSx
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- 1 siteUnited States
- Study dates
- May 2016to Oct 2016
- 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 40 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Age 40 or older
- Willing and able to provide informed consent for participation in the study.
Who cannot join
- -
Trial locations and contacts
1 site in 1 country.
United States1 site
Gainesville Eye Associates
Gainesville, Georgia, 30501
About this study
To assess the effectiveness of the Verion-LenSx guided arcuate incision technique to reduce astigmatism in a pseudophakic population.
Read the detailed description
The purpose of this study is to evaluate the effectiveness of corneal arcuate incisions when they are performed with a femtosecond laser system on subjects who have had previous cataract surgery. The procedure to be used would not be different from that employed during cataract surgery, except that the only corneal incisions made would be the partial-depth arcuate incisions at the laser.
- Conditions
- Astigmatism
- Being tested
- Verion-LenSx
- Keywords
- Pseudophakic
- Medical subject headings
- Astigmatism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Verion-LenSxProcedure or surgery
The Verion-LenSx femtosecond laser system will be used to create one or two partial-depth corneal arcuate incisions
| Study group | Role | What they receive |
|---|---|---|
| Verion-LenSx | Experimental | The Verion-LenSx femtosecond laser system will be used to perform one or two corneal arcuate incisions. Receives: Procedure: Verion-LenSx |
What is being measured
The primary outcome is the main question the study is designed to answer.
Uncorrected Monocular Distance Visual Acuity
Uncorrected monocular distance visual acuity, measured on a logMAR scale, (logarithm of the Minimum Angle of Resolution) which is a measure of visual acuity in which the smaller values indicate better visual acuity.
Measured: 60 days (+/- 10 days) after laser treatment
Secondary outcomes (3)
Change in Corneal Astigmatism
Vector change in the astigmatism measured on the cornea, in diopters
Measured: 60 days (+/- 10 days) after laser treatment
Change in Refractive Cylinder
The vector change in refractive cylinder in diopters
Measured: 60 days (+/- 10 days) after laser treatment
Spectacle Independence at Distance
Percentage of subjects that do not rely on spectacles for distance vision
Measured: 60 days (+/- 10 days) after laser treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 May 2016 (estimated)
- Study startMay 2016
- Primary completionOct 2016
- Study completionOct 2016
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 AstigmatismStudies 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
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- Gainesville Eye Associates
- Sponsor type
- University, hospital or other
- Collaborators
- Alcon, a Novartis Company
- Responsible party
- Principal investigator, Clayton Blehm, MD, Gainesville Eye Associates
- Investigators
- Clayton Blehm, MD, Principal investigator, Gainesville Eye Associates
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02763124
- Sponsor's protocol ID
- CB-16-001
- Status last verified
- Oct 2019
- First submitted
- 3 May 2016
- Last updated
- 1 Nov 2019
- 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 1 Nov 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pseudophakic Astigmatic Reduction With Verion-LenSx Arcuate Incisions
- ClinicalTrials.gov ID
- NCT02763124
- Acronym / sponsor ID
- CB-16-001
- Conditions
- Astigmatism
- Keywords
- Pseudophakic
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- Gainesville Eye AssociatesUniversity, hospital or other
- Collaborators
- Alcon, a Novartis Company
- Study start
- May 2016
- Primary completion
- Oct 2016 (actual)
- Study completion
- Oct 2016 (actual)
- First posted
- 5 May 2016 (estimated)
- Results
- Posted 1 Nov 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To assess the effectiveness of the Verion-LenSx guided arcuate incision technique to reduce astigmatism in a pseudophakic population.
Detailed description
The purpose of this study is to evaluate the effectiveness of corneal arcuate incisions when they are performed with a femtosecond laser system on subjects who have had previous cataract surgery. The procedure to be used would not be different from that employed during cataract surgery, except that the only corneal incisions made would be the partial-depth arcuate incisions at the laser.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Verion-LenSx | Experimental | Procedure: Verion-LenSxThe Verion-LenSx femtosecond laser system will be used to perform one or two corneal arcuate incisions. |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Age 40 or older
- Willing and able to provide informed consent for participation in the study.
Key exclusion criteria (1 listed)
- -
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 |
|---|---|---|
| Verion-LenSxThe Verion-LenSx femtosecond laser system will be used to create one or two partial-depth corneal arcuate incisions | Procedure or surgery | Verion-LenSx |
Primary outcome
Uncorrected Monocular Distance Visual Acuity
Time frame: 60 days (+/- 10 days) after laser treatment
Uncorrected monocular distance visual acuity, measured on a logMAR scale, (logarithm of the Minimum Angle of Resolution) which is a measure of visual acuity in which the smaller values indicate better visual acuity.
3 secondary outcomes
Change in Corneal Astigmatism
Time frame: 60 days (+/- 10 days) after laser treatment
Change in Refractive Cylinder
Time frame: 60 days (+/- 10 days) after laser treatment
Spectacle Independence at Distance
Time frame: 60 days (+/- 10 days) after laser treatment
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Nov 2019.
- 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.
Clayton Blehm, MD principal investigator
Gainesville Eye Associates
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Verion-LenSx in people with Astigmatism, run by Gainesville Eye Associates 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: finished, as of the sponsor's last update on 1 Nov 2019. 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 1 Nov 2019). 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?
Uncorrected Monocular Distance Visual Acuity (time frame: 60 days (+/- 10 days) after laser treatment). 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 1 Nov 2019; AzTrials last refreshed its copy on 6 Nov 2026.