SurgeryNCT03075176
Topo-guided LASIK and Photorefractive Keratectomy vs Wavefront LASIK and Photorefractive Keratectomy
A study testing Wavefront optimized LASIK, Wavefront optimized Photorefractive Keratectomy and Topography-guided LASIK in people with Surgery and Myopia, run by University of Utah at 1 site in United States.
Trial summary
This study evaluates the difference in results between eyes that have been treated wavefront optimized laser vision correction (either LASIK or Photorefractive Keratectomy) compared to eyes treated with topography-guided laser vision correction (either LASIK or Photorefractive Keratectomy). Read more about this study
- Who is it for?
- Ages 21 years and older
- What is being tested?
- Wavefront optimized LASIK, Wavefront optimized Photorefractive Keratectomy and Topography-guided LASIK
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 39 participants
- Where
- 1 siteUnited States
- Study dates
- 13 Feb 2017to 12 Aug 2019
- 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 21 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- All subjects who are deemed suitable candidates for laser refractive surgery after routine refractive surgery screening will be considered eligible for participation in this study.
- Subjects must be at least 21 years of age and not pregnant or nursing (due to fluctuations in visual parameters during pregnancy)
Who cannot join
- Any patient who is not a suitable candidate for LASIK or PRK will not be included.
Trial locations and contacts
1 site in 1 country.
United States1 site
Moran Eye Center - Midvalley Location
Murray, Utah, 84107
About this study
Official title: Outcomes of Topography-guided LASIK and Photorefractive Keratectomy Compared to Wavefront Optimized LASIK and Photorefractive Keratectomy
This study evaluates the difference in results between eyes that have been treated wavefront optimized laser vision correction (either LASIK or Photorefractive Keratectomy) compared to eyes treated with topography-guided laser vision correction (either LASIK or Photorefractive Keratectomy). Each participant will receive wavefront optimized correction in one eye and topography-guided correction in the other.
Read the detailed description
Participants will have an in depth discussion with our refractive surgery coordinator regarding refractive surgery. Patients will choose LASIK or Photorefractive Keratectomy surgery based on our standard pre-operative discussion that is provided to all patients. As is standard for laser refractive candidates, the advantages and disadvantages of LASIK and Photorefractive Keratectomy compared to the other refractive surgical options will be discussed. Following patient selection of their preferred type of refractive procedure they will be randomized as discussed below, and only patients who elect for LASIK or Photorefractive Keratectomy will be included in our study.
Prior to surgery, one eye from each patient will be randomly assigned to receive either Wavefront optimized or Topography Guided treatment. Each patient in the study will have a fellow eye enrolled in the other treatment group. Patients will either receive LASIK treatment or Photorefractive Keratectomy treatment in both eyes but the eyes will be randomized to topography guided or wavefront optimized forms of treatment.
- Being tested
- Wavefront optimized LASIK, Wavefront optimized Photorefractive Keratectomy, Topography-guided LASIK, Topography-guided Photorefractive Keratectomy
- Keywords
- Photorefractive keratectomy, Laser-assisted in situ keratomileusis
- Medical subject headings
- Myopia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Wavefront optimized LASIKDevice
Wavefront optimized laser vision correction
Wavefront optimized Photorefractive KeratectomyDevice
Wavefront optimized laser vision correction
Topography-guided LASIKDevice
Topography-guided laser vision correction
Topography-guided Photorefractive KeratectomyDevice
Topography-guided laser vision correction
| Study group | Role | What they receive |
|---|---|---|
| Wavefront optimized LASIK | Active comparator | Participants who chose to have LASIK surgery were assigned to have Wavefront optimized LASIK in one eye and Topography-guided LASIK in the other eye (randomly chosen). Receives: Device: Wavefront optimized LASIK; Device: Topography-guided LASIK |
| Wavefront optimized Photorefractive Keratectomy | Active comparator | Participants who chose to have Photorefractive Keratectomy surgery were assigned to have Wavefront optimized Photorefractive Keratectomy in one eye and Topography-guided Photorefractive Keratectomy in the other eye (randomly chosen). Receives: Device: Wavefront optimized Photorefractive Keratectomy; Device: Topography-guided Photorefractive Keratectomy |
| Topography-guided LASIK | Active comparator | Participants who chose to have LASIK surgery were assigned to have Topography-guided LASIK in one eye and Wavefront optimized LASIK in the other eye (randomly chosen). Receives: Device: Wavefront optimized LASIK; Device: Topography-guided LASIK |
| Topography-guided Photorefractive Keratectomy | Active comparator | Participants who chose to have Photorefractive Keratectomy surgery were assigned to have Topography-guided Photorefractive Keratectomy in one eye and Wavefront optimized Photorefractive Keratectomy in the other eye (randomly chosen). Receives: Device: Wavefront optimized Photorefractive Keratectomy; Device: Topography-guided Photorefractive Keratectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Uncorrected Visual Acuity From Baseline to Month 12
Uncorrected visual acuity will be tested pre-operatively through month 12
Measured: 12 months
Secondary outcomes (1)
Change in Contrast Sensitivity From Baseline to Month 3
Contrast sensitivity will be tested pre-operatively and 3 months post-operatively
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Mar 2017
- Study start13 Feb 2017
- Primary completion12 Aug 2019
- Study completion12 Aug 2019
Why it stopped: Because of the bias in who qualified for the study it became apparent we would not get any statistically valid results.
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 SurgeryStudies of the same condition, open and under way.
- More trials run by University of UtahThe sponsor's other registered studies.
- 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
- Model description
- Each participant will receive wavefront optimized surgery in one eye and topography-guided surgery in the second eye.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 39 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Utah
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mark Mifflin, University of Utah
- Investigators
- Mark Mifflin, MD, Principal investigator, University of Utah Moran Eye Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03075176
- Sponsor's protocol ID
- IRB # 95434
- Status last verified
- Jun 2023
- First submitted
- 18 Feb 2017
- Last updated
- 17 Jul 2023
- 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 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Outcomes of Topography-guided LASIK and Photorefractive Keratectomy Compared to Wavefront Optimized LASIK and Photorefractive Keratectomy
- ClinicalTrials.gov ID
- NCT03075176
- Acronym / sponsor ID
- IRB # 95434
- Keywords
- Photorefractive keratectomy, Laser-assisted in situ keratomileusis
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Because of the bias in who qualified for the study it became apparent we would not get any statistically valid results.
- Enrolment
- 39 participants (actual)
- Lead sponsor
- University of UtahUniversity, hospital or other
- Study start
- 13 Feb 2017 (actual)
- Primary completion
- 12 Aug 2019 (actual)
- Study completion
- 12 Aug 2019 (actual)
- First posted
- 9 Mar 2017 (actual)
- Results
- Posted 17 Jul 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study evaluates the difference in results between eyes that have been treated wavefront optimized laser vision correction (either LASIK or Photorefractive Keratectomy) compared to eyes treated with topography-guided laser vision correction (either LASIK or Photorefractive Keratectomy). Each participant will receive wavefront optimized correction in one eye and topography-guided correction in the other.
Detailed description
Participants will have an in depth discussion with our refractive surgery coordinator regarding refractive surgery. Patients will choose LASIK or Photorefractive Keratectomy surgery based on our standard pre-operative discussion that is provided to all patients. As is standard for laser refractive candidates, the advantages and disadvantages of LASIK and Photorefractive Keratectomy compared to the other refractive surgical options will be discussed. Following patient selection of their preferred type of refractive procedure they will be randomized as discussed below, and only patients who elect for LASIK or Photorefractive Keratectomy will be included in our study.
Prior to surgery, one eye from each patient will be randomly assigned to receive either Wavefront optimized or Topography Guided treatment. Each patient in the study will have a fellow eye enrolled in the other treatment group. Patients will either receive LASIK treatment or Photorefractive Keratectomy treatment in both eyes but the eyes will be randomized to topography guided or wavefront optimized forms of treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 4
- Model description
- Each participant will receive wavefront optimized surgery in one eye and topography-guided surgery in the second eye.
| Arm | Type | Receives |
|---|---|---|
| Wavefront optimized LASIK | Active comparator | Device: Wavefront optimized LASIK, Device: Topography-guided LASIKParticipants who chose to have LASIK surgery were assigned to have Wavefront optimized LASIK in one eye and Topography-guided LASIK in the other eye (randomly chosen). |
| Wavefront optimized Photorefractive Keratectomy | Active comparator | Device: Wavefront optimized Photorefractive Keratectomy, Device: Topography-guided Photorefractive KeratectomyParticipants who chose to have Photorefractive Keratectomy surgery were assigned to have Wavefront optimized Photorefractive Keratectomy in one eye and Topography-guided Photorefractive Keratectomy in the other eye (randomly chosen). |
| Topography-guided LASIK | Active comparator | Device: Wavefront optimized LASIK, Device: Topography-guided LASIKParticipants who chose to have LASIK surgery were assigned to have Topography-guided LASIK in one eye and Wavefront optimized LASIK in the other eye (randomly chosen). |
| Topography-guided Photorefractive Keratectomy | Active comparator | Device: Wavefront optimized Photorefractive Keratectomy, Device: Topography-guided Photorefractive KeratectomyParticipants who chose to have Photorefractive Keratectomy surgery were assigned to have Topography-guided Photorefractive Keratectomy in one eye and Wavefront optimized Photorefractive Keratectomy in the other eye (randomly chosen). |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- All subjects who are deemed suitable candidates for laser refractive surgery after routine refractive surgery screening will be considered eligible for participation in this study.
- Subjects must be at least 21 years of age and not pregnant or nursing (due to fluctuations in visual parameters during pregnancy)
Key exclusion criteria (1 listed)
- Any patient who is not a suitable candidate for LASIK or PRK will not be included.
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 |
|---|---|---|
| Wavefront optimized LASIKWavefront optimized laser vision correction | Device | Topography-guided LASIK, Wavefront optimized LASIK |
| Wavefront optimized Photorefractive KeratectomyWavefront optimized laser vision correction | Device | Topography-guided Photorefractive Keratectomy, Wavefront optimized Photorefractive Keratectomy |
| Topography-guided LASIKTopography-guided laser vision correction | Device | Topography-guided LASIK, Wavefront optimized LASIK |
| Topography-guided Photorefractive KeratectomyTopography-guided laser vision correction | Device | Topography-guided Photorefractive Keratectomy, Wavefront optimized Photorefractive Keratectomy |
Primary outcome
Change in Uncorrected Visual Acuity From Baseline to Month 12
Time frame: 12 months
Uncorrected visual acuity will be tested pre-operatively through month 12
1 secondary outcome
Change in Contrast Sensitivity From Baseline to Month 3
Time frame: 3 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jul 2023.
- 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.
Mark Mifflin, MD principal investigator
University of Utah Moran Eye Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Wavefront optimized LASIK, Wavefront optimized Photorefractive Keratectomy and Topography-guided LASIK in people with Surgery and Myopia, run by University of Utah 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: stopped early, as of the sponsor's last update on 17 Jul 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?
Yes. Results are posted in the registry (first posted 17 Jul 2023). 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?
Change in Uncorrected Visual Acuity From Baseline to Month 12 (time frame: 12 months). 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 2023.