MyopiaNCT04903301
Patient Satisfaction With Contoura Vision Topography-Guided LASIK
A study testing Contoura Vision LASIK in people with Myopia and Astigmatism, run by Rush Eye Associates at 1 site in United States.
Trial summary
To evaluate patient reported outcomes associated with quality of vision before and after treatment with Contoura Vision Topography-Guided LASIK. Read more about this study
- Who is it for?
- Ages 21 to 35 yearsHealthy volunteers can take part
- Conditions the study is for
- Myopia, Astigmatism
- What is being tested?
- Contoura Vision LASIK
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- 21 May 2021to 1 Nov 2023
- 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 21 to 35 years
- All sexes
- Healthy volunteers accepted
- Adult
Eligibility criteria: The study enrollment will include all willing patients with: pre-operative BCVA 20/20 for each eye individually, myopic refractive error up to -8.00 diopters, refractive astigmatism that ranges from 0 to 3 diopters, maximum spherical equivalent of -9.00 diopters, the designated age requirements, and only patients that have signed the informed consent document.
Exclusion criteria: Patients are excluded that are not willing to participate in a research trial, are unable to cooperate well enough to safely perform the procedure, fail to meet inclusion criteria, have ocular disease (including but not limited to keratoconus, macular degeneration, glaucoma, corneal dystrophy, dry eye syndrome and corneal scarring), and patients that have had previous ocular surgery. Any patients with known allergies to the post-operative medications or preservatives in the medications will also be excluded.
Trial locations and contacts
1 site in 1 country.
About this study
To evaluate patient reported outcomes associated with quality of vision before and after treatment with Contoura Vision Topography-Guided LASIK.
- Conditions
- Myopia, Astigmatism
- Being tested
- Contoura Vision LASIK
- Medical subject headings
- Myopia, Astigmatism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Contoura Vision LASIKProcedure or surgery
Topography-Guided LASIK using Phorcides Analytic Software
| Study group | Role | What they receive |
|---|---|---|
| Study Group | Experimental | Contoura Vision LASIK using Phorcides Analytic Software Receives: Procedure: Contoura Vision LASIK |
What is being measured
The primary outcome is the main question the study is designed to answer.
Global Vision Satisfaction Index
Analog Score from Adapted from PROWL Survey
Measured: 26 weeks
Secondary outcomes (3)
Vision
Uncorrected Visual Acuity using ETDRS
Measured: 26 weeks
Objective Scatter Index
HD Analyzer
Measured: 26 weeks
Higher Order Corneal Aberrations
Galilei Topography
Measured: 26 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 May 2021
- Study start21 May 2021
- Primary completion1 Nov 2023
- Study completion1 Nov 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MyopiaStudies 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
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Rush Eye Associates
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sloan W. Rush, MD, Rush Eye Associates
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04903301
- Sponsor's protocol ID
- CV-LASIK
- Status last verified
- Nov 2023
- First submitted
- 21 May 2021
- Last updated
- 18 Nov 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 18 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Patient Satisfaction With Contoura Vision Topography-Guided LASIK
- ClinicalTrials.gov ID
- NCT04903301
- Acronym / sponsor ID
- CV-LASIK
- Conditions
- Myopia, Astigmatism
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Rush Eye AssociatesUniversity, hospital or other
- Study start
- 21 May 2021 (actual)
- Primary completion
- 1 Nov 2023 (actual)
- Study completion
- 1 Nov 2023 (actual)
- First posted
- 26 May 2021 (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 evaluate patient reported outcomes associated with quality of vision before and after treatment with Contoura Vision Topography-Guided LASIK.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Study Group | Experimental | Procedure: Contoura Vision LASIKContoura Vision LASIK using Phorcides Analytic Software |
Who may qualify
- Ages
- 21 to 35 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
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 |
|---|---|---|
| Contoura Vision LASIKTopography-Guided LASIK using Phorcides Analytic Software | Procedure or surgery | Study Group |
Primary outcome
Global Vision Satisfaction Index
Time frame: 26 weeks
Analog Score from Adapted from PROWL Survey
3 secondary outcomes
Vision
Time frame: 26 weeks
Objective Scatter Index
Time frame: 26 weeks
Higher Order Corneal Aberrations
Time frame: 26 weeks
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 18 Nov 2023.
- Individual participant dataSharing planned: Undecided
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Contoura Vision LASIK in people with Myopia and Astigmatism, run by Rush 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?
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 18 Nov 2023. 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?
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?
Global Vision Satisfaction Index (time frame: 26 weeks). 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 18 Nov 2023.