MyopiaNCT05848817
Patient Reported Satisfaction With Contoura LASIK Utilizing the Phorcides Analytic Software
An observational study of Myopia, run by Mann Eye Institute at 1 site in United States.
Trial summary
The objective is to determine the percentage of subjects satisfied (Completely Satisfied or Very Satisfied) with vision after Phorcides Planned Contoura LASIK. Read more about this study
- Who is it for?
- Ages 21 to 39 years
- Conditions the study is for
- Myopia
- What is being tested?
- Contoura LASIK
- Type of treatment
- Medical device
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- 19 May 2023to 15 Aug 2024
- Phase
- Observational
- 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 21 to 39 years
- All sexes
- Adult
Study population: Subjects 21 to 39 years of who are appropriate candidates for laser refractive surgery.
Subjects are eligible for the study if they meet the following criteria:
Note: Ocular criteria must be met in both eyes.
- Appropriate candidate for uncomplicated bilateral LASIK surgery
- Gender: Males and Females.
- Age: 21 to 39 years of age.
- Refractive error range - SE refractive errors up to 0.00 to -9.00 D with maximum cylinder up to 3.00 D and sphere ≤ -8.00 D.
- If currently wearing contact lenses:
- Soft CTL wearers discontinue for minimum 3 days
- RGP CTL wearers discontinue for 1 month per decade of wear
- Stable refraction (2 consecutive manifest refractions within 0.25 SE)
- Stable K readings (2 consecutive K readings in 2 consecutive visits)
- Residual bed thickness 250um or greater
- Willing and able to comply with scheduled visits and other study procedures.
- Pre-surgery BCDVA of 20/20 (0.00 logMAR) or better in each eye.
If any of the following exclusion criteria are applicable to the subject or either eye, the subject should not be enrolled in the study.
- Subjects with history of previous ocular surgery.
- Subjects with topographic evidence of keratoconus, or ectasia.
- Subjects with autoimmune diseases.
- Subjects who are pregnant or nursing.
- Systemic disease likely to affect wound healing, such as diabetes and severe atopy.
- Any ocular disease (including un-controlled dry eye) which in the investigator's opinion would affect the outcome of refractive 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 determine the percentage of subjects satisfied (Completely Satisfied or Very Satisfied) with vision after Phorcides Planned Contoura LASIK.
Read the detailed description
This study is a single site, single-arm, prospective, observational study of subject satisfaction, after successful bilateral LASIK surgery. Subjects will be assessed pre-operatively, operatively and at 1 week, 1 month, and 3 months post-operatively. Clinical evaluations will include measurement of visual acuity, manifest refraction, and topography, aberrometry, and administration of the OSDI and PROWL questionnaires.
- Conditions
- Myopia
- Being tested
- Contoura LASIK
- Medical subject headings
- Myopia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Contoura LASIKDevice
Subjects receiving Phorcides Planned Contoura LASIK
| Study group | Role | What they receive |
|---|---|---|
| Contoura LASIK | Subjects receiving Phorcides Planned Contoura LASIK. Receives: Device: Contoura LASIK |
What is being measured
The primary outcome is the main question the study is designed to answer.
Subject Satisfaction
Percentage of subjects satisfied with vision after Phorcides Planned Contoura LASIK (answering Completely Satisfied or Very Satisfied on PROWL Questionnaire Question #1.
Measured: 3 Months Postoperative
Secondary outcomes (1)
Number of Eyes With Post-op Spherical Equivalent Within +/- 0.50 D
Measured: 3 Months Postoperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 May 2023
- Study start19 May 2023
- Primary completion15 Aug 2024
- Study completion15 Aug 2024
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 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
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mann Eye Institute
- Sponsor type
- University, hospital or other
- Collaborators
- Sengi
- Responsible party
- Sponsor
- Investigators
- Phillip Brunson, OD, Principal investigator, Mann Eye Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05848817
- Sponsor's protocol ID
- PB-23-01
- Status last verified
- Jul 2025
- First submitted
- 28 Apr 2023
- Last updated
- 17 Jul 2025
- Results posted
- Yes, on ClinicalTrials.gov
- 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 17 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Patient Reported Satisfaction With Contoura LASIK Utilizing the Phorcides Analytic Software
- ClinicalTrials.gov ID
- NCT05848817
- Acronym / sponsor ID
- PB-23-01
- Conditions
- Myopia
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Mann Eye InstituteUniversity, hospital or other
- Collaborators
- Sengi
- Study start
- 19 May 2023 (actual)
- Primary completion
- 15 Aug 2024 (actual)
- Study completion
- 15 Aug 2024 (actual)
- First posted
- 8 May 2023 (actual)
- Results
- Posted 17 Jul 2025
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 determine the percentage of subjects satisfied (Completely Satisfied or Very Satisfied) with vision after Phorcides Planned Contoura LASIK.
Detailed description
This study is a single site, single-arm, prospective, observational study of subject satisfaction, after successful bilateral LASIK surgery. Subjects will be assessed pre-operatively, operatively and at 1 week, 1 month, and 3 months post-operatively. Clinical evaluations will include measurement of visual acuity, manifest refraction, and topography, aberrometry, and administration of the OSDI and PROWL questionnaires.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Contoura LASIK | – | Device: Contoura LASIKSubjects receiving Phorcides Planned Contoura LASIK. |
Who may qualify
- Ages
- 21 to 39 years
- Sex
- All
- Age groups
- Adult
- Study population
- Subjects 21 to 39 years of who are appropriate candidates for laser refractive 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 LASIKSubjects receiving Phorcides Planned Contoura LASIK | Device | Contoura LASIK |
Primary outcome
Subject Satisfaction
Time frame: 3 Months Postoperative
Percentage of subjects satisfied with vision after Phorcides Planned Contoura LASIK (answering Completely Satisfied or Very Satisfied on PROWL Questionnaire Question #1.
1 secondary outcome
Number of Eyes With Post-op Spherical Equivalent Within +/- 0.50 D
Time frame: 3 Months Postoperative
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jul 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
Related trials for Myopia
Not yet recruitingObservational study
Corneal Biomechanics and Stromal Tissue Characteristics in Patients Undergoing SMILE
Myopia
Enrolling by invitation
Therapeutic Efficacy of Different Repeated Low-Intensity Red Light Devices and Different Usage Frequencies
Myopia
Not yet recruiting
Clinical Performance and Outcomes After Toric Lens Transition
Astigmatism
RecruitingPhase 3
A RCT of Spectacles With Aspherical Lenslets or 0.05% Atropine for Myopia Control
Myopia
Recruiting
Evaluation of Orthokeratology Lenses With a 5MM Optic Zone Diameter
Myopia, Astigmatism
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.
Phillip Brunson, OD principal investigator
Mann Eye Institute
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, run by Mann Eye Institute 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 17 Jul 2025. 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 17 Jul 2025). 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?
Subject Satisfaction (time frame: 3 Months Postoperative). 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 17 Jul 2025; AzTrials last refreshed its copy on 31 Oct 2026.