MyopiaNCT05486546
Contoura With Phorcides Compared to Wavefront Optimized LASIK
A study testing Contoura with Phorcides and WaveLight Wavefront Optimized in people with Myopia and Astigmatism, run by Daniel Terveen at 4 sites in United States.
Trial summary
Comparing post-operative visual acuity and patient reported satisfaction between Contoura with Phorcides and WaveLight Wavefront Optimized. Read more about this study
- Who is it for?
- Ages 21 to 38 years
- Conditions the study is for
- Myopia, Astigmatism
- What is being tested?
- Contoura with Phorcides and WaveLight Wavefront Optimized
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 4 sitesUnited States
- Study dates
- 15 Aug 2022to 1 Dec 2023
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 38 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Patients at least age 21 years of age undergoing LASIK eye surgery
- Willing and able to comprehend informed consent and complete 1 month post-op visit
- Potential postoperative BCDVA of 20/20 or better in each eye based on Investigator's medical opinion
- Candidates for Contoura with Phorcides (Myopic, astigmatism <3.0D)
- Both eyes targeted for plano
- Pre-operative total corneal Pachymetry 490um or above
Show all 12Show fewer
- Stable refractive error <0.50D change in preceding year
- Good general and ocular health
- Pre-operative exam completed within three months of surgery
- SCL discontinued 3 days prior to pre-op exam and the procedure
- Pachymetry above 490 with residual greater than 270um
- Candidates who, as determined by the investigator, can safely undergo LASIK
Who cannot join
- Patients under 21 years of age
- Concomitant ocular condition which would limit the BCVA at the discretion of the surgeon
- Patients with usual relative and absolute contraindications for LASIK surgery (Patients with severe dry eye, recurrent corneal erosion, uncontrolled Glaucoma, collagen vascular disorders, keratoconus or signs of keratoconus, uncontrolled Diabetes, Herpes)
- Pachymetry below 490
- Autoimmune or immunodeficiency diseases
- Pregnant or nursing women
Show all 10Show fewer
- Patients with signs of inability to understand consent for study and procedure planned
- Patients with history of previous ocular surgery
- Patients with strabismus or amblyopia
- Patients that have a BCDVA of 20/25 or worse in either eye
Trial locations and contacts
4 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States4 sites, 4 recruiting
- Recruiting
Vance Thompson Vison
Bozeman, Montana, 57105
Keeley Boever, 402-740-9420, keeley.boever@vancethompsonvision.com
- Recruiting
Vance Thompson Vision
Fargo, North Dakota, 57105
Keeley Boever, 402-740-9420, keeley.boever@vancethompsonvision.com
- Recruiting
Vance Thompson Vision
Omaha, Nebraska, 57105
Keeley Boever, 402-740-9420, keeley.boever@vancethompsonvision.com
- Recruiting
Vance Thompson Vision
Sioux Falls, South Dakota, 57108
Keeley Puls, 605-371-7075, keeley.puls@vancethompsonvision.com
About this study
Official title: Comparison of Visual Acuity and Quality of Life Following Contoura With Phorcides Compared to WaveLight Wavefront Optimized LASIK
Comparing post-operative visual acuity and patient reported satisfaction between Contoura with Phorcides and WaveLight Wavefront Optimized.
- Conditions
- Myopia, Astigmatism
- Being tested
- Contoura with Phorcides, WaveLight Wavefront Optimized
- Keywords
- Visual acuity, Refractive outcome, LASIK, Contrast sensitivity, Wavefront Optimized, Topography-guided
- 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 with PhorcidesProcedure or surgery
Participants that undergo LASIK surgery using Contoura with Phorcides Analytic Engine
WaveLight Wavefront OptimizedDevice
Participants that undergo LASIK surgery using WaveLight Wavefront Optimized
| Study group | Role | What they receive |
|---|---|---|
| Study: Phorcides | Experimental | Contoura with Phorcides used for surgical planning of LASIK procedure Receives: Procedure: Contoura with Phorcides |
| Control: Wavefront Optimized | Active comparator | WaveLight Wavefront Optimized used for surgical planning of LASIK procedure Receives: Device: WaveLight Wavefront Optimized |
What is being measured
The primary outcome is the main question the study is designed to answer.
Post-Op UDVA
Percent of participants with monocular UDVA of 20/16 or better
Measured: 3 months post-op
Secondary outcomes (5)
Post-OP BCVA
Percent of participants with monocular and binocular BCVA of 20/16 or better
Measured: 3 months post-op
Residual Refractive Error
Residual astigmatism and residual SE
Measured: 3 months post-op
Low Contrast Visual Acuity
25% low contrast visual acuity post-op
Measured: 3 months post-op
Pre-op and post-op visual acuity
Percent of participants with post-op UDVA equal to or better than their pre-op CDVA
Measured: 3 months post-op
Corrected Distance Visual Acuity
Compare percent of participants with post-operative and pre-operative CDVA
Measured: 3 months post-op
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Aug 2022
- Study start15 Aug 2022
- Primary completion1 Sep 2023 (estimated)
- Study completion1 Dec 2023 (estimated)
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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Daniel Terveen
- Sponsor type
- University, hospital or other
- Collaborators
- Alcon Research
- Responsible party
- Sponsor-investigator, Daniel Terveen, Vance Thompson Vision
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05486546
- Sponsor's protocol ID
- AMPLIO
- Status last verified
- Apr 2023
- First submitted
- 1 Aug 2022
- Last updated
- 26 Apr 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 26 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Visual Acuity and Quality of Life Following Contoura With Phorcides Compared to WaveLight Wavefront Optimized LASIK
- ClinicalTrials.gov ID
- NCT05486546
- Acronym / sponsor ID
- AMPLIO
- Conditions
- Myopia, Astigmatism
- Keywords
- Visual acuity, Refractive outcome, LASIK, Contrast sensitivity, Wavefront Optimized, Topography-guided
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Daniel TerveenUniversity, hospital or other
- Collaborators
- Alcon Research
- Study start
- 15 Aug 2022 (actual)
- Primary completion
- 1 Sep 2023 (estimated)
- Study completion
- 1 Dec 2023 (estimated)
- First posted
- 3 Aug 2022 (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.
Comparing post-operative visual acuity and patient reported satisfaction between Contoura with Phorcides and WaveLight Wavefront Optimized.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Study: Phorcides | Experimental | Procedure: Contoura with PhorcidesContoura with Phorcides used for surgical planning of LASIK procedure |
| Control: Wavefront Optimized | Active comparator | Device: WaveLight Wavefront OptimizedWaveLight Wavefront Optimized used for surgical planning of LASIK procedure |
Who may qualify
- Ages
- 21 to 38 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (12 listed)
- Patients at least age 21 years of age undergoing LASIK eye surgery
- Willing and able to comprehend informed consent and complete 1 month post-op visit
- Potential postoperative BCDVA of 20/20 or better in each eye based on Investigator's medical opinion
- Candidates for Contoura with Phorcides (Myopic, astigmatism <3.0D)
- Both eyes targeted for plano
Key exclusion criteria (10 listed)
- Patients under 21 years of age
- Concomitant ocular condition which would limit the BCVA at the discretion of the surgeon
- Patients with usual relative and absolute contraindications for LASIK surgery (Patients with severe dry eye, recurrent corneal erosion, uncontrolled Glaucoma, collagen vascular disorders, keratoconus or signs of keratoconus, uncontrolled Diabetes, Herpes)
- Pachymetry below 490
- Autoimmune or immunodeficiency diseases
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 with PhorcidesParticipants that undergo LASIK surgery using Contoura with Phorcides Analytic Engine | Procedure or surgery | Study: Phorcides |
| WaveLight Wavefront OptimizedParticipants that undergo LASIK surgery using WaveLight Wavefront Optimized | Device | Control: Wavefront Optimized |
Primary outcome
Post-Op UDVA
Time frame: 3 months post-op
Percent of participants with monocular UDVA of 20/16 or better
5 secondary outcomes
Post-OP BCVA
Time frame: 3 months post-op
Residual Refractive Error
Time frame: 3 months post-op
Low Contrast Visual Acuity
Time frame: 3 months post-op
Pre-op and post-op visual acuity
Time frame: 3 months post-op
Corrected Distance Visual Acuity
Time frame: 3 months post-op
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Apr 2023.
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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.
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Contoura with Phorcides and WaveLight Wavefront Optimized in people with Myopia and Astigmatism, run by Daniel Terveen at 4 sites 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 12 inclusion and 10 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: looking for participants now, as of the sponsor's last update on 26 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Daniel Terveen, MD (605-645-7999, daniel.terveen@vancethompsonvision.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Post-Op UDVA (time frame: 3 months post-op). 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 26 Apr 2023.