MyopiaNCT05888337
Comparison of Contoura Vision Outcomes Programmed Using the Manifest Refraction Verses Using Phorcides Planning Software in Patients With Oblique Astigmatism
An observational study of Myopia and Astigmatism, run by Bismarck Lasik at 1 site in United States.
Trial summary
The objective is to compare the percentage of monocular UDVA -0.1 logMAR (20/16) outcomes for each planning strategy (Phorcides and manifest refraction) at the 3-month post operative visit. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Myopia, Astigmatism
- What is being tested?
- Contoura LASIK with Phorcides planning strategy and Contoura LASIK with manifest refraction planning strategy
- Type of treatment
- Medical device
- How many people
- 9 participants
- Where
- 1 siteUnited States
- Study dates
- 20 Jun 2023to 5 Dec 2023
- 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: Subjects 18 years of age or older who are interested in and appropriate candidates for LASIK.
Who may be able to join
- 18 years old and above
- Preoperative total corneal Pachymetry 490um or above
- BCVA 20/20 or better
- Stable refractive error <0.50D MRSE change in preceding year
- Good general and ocular health
- Preoperative exam completed within three months of surgery
Show all 11Show fewer
- Soft contact lens wear discontinued 3 days prior to preoperative exam and the procedure
- Residual stromal bed greater than 270um
- Candidates who qualify for Contoura treatment OU (≤ -8.0 D SPH and ≤ -3.0 D CYL)
- Candidates who elect to target both eyes targeted for emmetropia
- ≤ -3.0 D Oblique astigmatism as defined as an axis between 30-60 degrees or between 120-150 degrees
Who cannot join
- Subjects with usual relative and absolute contraindications for LASIK surgery (subjects with severe dry eye, subjects with recurrent corneal erosion, subjects with uncontrolled Glaucoma, subjects with collagen vascular disorders, keratoconus or signs of keratoconus, Uncontrolled Diabetes, Herpes, corneal dystrophies or degeneration; any irregular astigmatism)
- Pachymetry below 490
- Autoimmune or immunodeficiency diseases, Pregnant or nursing women
- Subjects with signs of inability to understand consent for study and procedure planned
- Subjects with history of previous ocular surgery
- The principal investigator reserves the right to declare a patient ineligible or non-evaluable based on medical evidence that indicates they are unsuitable for the trial.
- Pregnancy has a known effect on the stability of refractions and visual acuity. As such, subjects who become pregnant during the study will not be discontinued but their data may be excluded from analyses of effectiveness.
Trial locations and contacts
1 site in 1 country.
About this study
The objective is to compare the percentage of monocular UDVA -0.1 logMAR (20/16) outcomes for each planning strategy (Phorcides and manifest refraction) at the 3-month post operative visit.
Read the detailed description
This study is a randomized, prospective contralateral eye study of visual outcomes in eyes planned with Phorcides compared to eyes planned using the manifest refraction after successful bilateral LASIK surgery. Subjects will be assessed pre-operatively, operatively and at 3 months postoperatively. Clinical evaluations will include measurement of visual acuity, manifest refraction, and administration of a questionnaire.
- Conditions
- Myopia, Astigmatism
- Being tested
- Contoura LASIK with Phorcides planning strategy, Contoura LASIK with manifest refraction planning strategy
- 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 LASIK with Phorcides planning strategyDevice
Bilateral treatment with topography guided LASIK
Contoura LASIK with manifest refraction planning strategyDevice
Bilateral treatment with topography guided LASIK
| Study group | Role | What they receive |
|---|---|---|
| Contoura LASIK with Phorcides planning strategy | Not described Receives: Device: Contoura LASIK with Phorcides planning strategy | |
| Contoura LASIK with manifest refraction planning strategy | Not described Receives: Device: Contoura LASIK with manifest refraction planning strategy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of eyes with monocular UDVA of logMAR -0.10 (20/16) in each group
Measured: 3 months postoperatively
Secondary outcomes (1)
Percentage of eyes with monocular UDVA of logMAR -0.20 (20/12.5) in each group
Measured: 3 months postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jun 2023
- Study start20 Jun 2023
- Primary completion5 Dec 2023
- Study completion5 Dec 2023
Why it stopped: Difficult to find recruit patients with oblique astigmatism
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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 9 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bismarck Lasik
- Sponsor type
- University, hospital or other
- Collaborators
- Sengi
- Responsible party
- Sponsor
- Investigators
- Stephen A Wexler, MD, Principal investigator, Bismarck Lasik
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05888337
- Sponsor's protocol ID
- SW-23-01
- Status last verified
- Dec 2023
- First submitted
- 25 May 2023
- Last updated
- 13 Dec 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Contoura Vision Outcomes Programmed Using the Manifest Refraction Verses Using Phorcides Planning Software in Patients With Oblique Astigmatism
- ClinicalTrials.gov ID
- NCT05888337
- Acronym / sponsor ID
- SW-23-01
- Conditions
- Myopia, Astigmatism
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Difficult to find recruit patients with oblique astigmatism
- Enrolment
- 9 participants (actual)
- Lead sponsor
- Bismarck LasikUniversity, hospital or other
- Collaborators
- Sengi
- Study start
- 20 Jun 2023 (actual)
- Primary completion
- 5 Dec 2023 (actual)
- Study completion
- 5 Dec 2023 (actual)
- First posted
- 5 Jun 2023 (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.
The objective is to compare the percentage of monocular UDVA -0.1 logMAR (20/16) outcomes for each planning strategy (Phorcides and manifest refraction) at the 3-month post operative visit.
Detailed description
This study is a randomized, prospective contralateral eye study of visual outcomes in eyes planned with Phorcides compared to eyes planned using the manifest refraction after successful bilateral LASIK surgery. Subjects will be assessed pre-operatively, operatively and at 3 months postoperatively. Clinical evaluations will include measurement of visual acuity, manifest refraction, and administration of a questionnaire.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Contoura LASIK with Phorcides planning strategy | – | Device: Contoura LASIK with Phorcides planning strategy |
| Contoura LASIK with manifest refraction planning strategy | – | Device: Contoura LASIK with manifest refraction planning strategy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Subjects 18 years of age or older who are interested in and appropriate candidates for LASIK.
Key inclusion criteria (11 listed)
- 18 years old and above
- Preoperative total corneal Pachymetry 490um or above
- BCVA 20/20 or better
- Stable refractive error <0.50D MRSE change in preceding year
- Good general and ocular health
Key exclusion criteria (7 listed)
- Subjects with usual relative and absolute contraindications for LASIK surgery (subjects with severe dry eye, subjects with recurrent corneal erosion, subjects with uncontrolled Glaucoma, subjects with collagen vascular disorders, keratoconus or signs of keratoconus, Uncontrolled Diabetes, Herpes, corneal dystrophies or degeneration; any irregular astigmatism)
- Pachymetry below 490
- Autoimmune or immunodeficiency diseases, Pregnant or nursing women
- Subjects with signs of inability to understand consent for study and procedure planned
- Subjects with history of previous ocular surgery
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 LASIK with Phorcides planning strategyBilateral treatment with topography guided LASIK | Device | Contoura LASIK with Phorcides planning strategy |
| Contoura LASIK with manifest refraction planning strategyBilateral treatment with topography guided LASIK | Device | Contoura LASIK with manifest refraction planning strategy |
Primary outcome
Percentage of eyes with monocular UDVA of logMAR -0.10 (20/16) in each group
Time frame: 3 months postoperatively
1 secondary outcome
Percentage of eyes with monocular UDVA of logMAR -0.20 (20/12.5) in each group
Time frame: 3 months postoperatively
Results and safety
The study was stopped early (reason given: Difficult to find recruit patients with oblique astigmatism). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Dec 2023.
- 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.
Stephen A Wexler, MD principal investigator
Bismarck Lasik
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 Myopia and Astigmatism, run by Bismarck Lasik 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 11 inclusion and 7 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: stopped early, as of the sponsor's last update on 13 Dec 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 was stopped early (reason given: Difficult to find recruit patients with oblique astigmatism). Results are not available in the source record.
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?
Percentage of eyes with monocular UDVA of logMAR -0.10 (20/16) in each group (time frame: 3 months postoperatively). 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 13 Dec 2023.