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Because of the bias in who qualified for the study it became apparent we would not get any statistically valid results.
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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). |
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| 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). |
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| 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). |
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| 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). |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Wavefront optimized LASIK | Device | Wavefront optimized laser vision correction |
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| Measure | Description | Time Frame |
|---|---|---|
| Change in Uncorrected Visual Acuity From Baseline to Month 12 | Uncorrected visual acuity will be tested pre-operatively through month 12 | 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Contrast Sensitivity From Baseline to Month 3 | Contrast sensitivity will be tested pre-operatively and 3 months post-operatively | 3 months |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Quality of Life Score From Baseline to 3 Months | The validated Quality of Life Impact of Refractive Correction survey will be administered pre-operatively and 3 months post surgery | 3 months |
Inclusion Criteria:
Subjects must be at least 21 years of age and not pregnant or nursing (due to fluctuations in visual parameters during pregnancy)
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Mark Mifflin, MD | University of Utah Moran Eye Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Moran Eye Center - Midvalley Location | Murray | Utah | 84107 | United States |
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39 participants were randomized, one participant withdrew, 38 completed wavefront surgery on one eye and topoguided surgery on the other eye. A total of 76 eyes were treated.
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| ID | Title | Description |
|---|---|---|
| FG000 | Wavefront Optimized LASIK | 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). Wavefront optimized LASIK: Wavefront optimized laser vision correction Topography-guided LASIK: Topography-guided laser vision correction |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Dec 9, 2021 |
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Each participant will receive wavefront optimized surgery in one eye and topography-guided surgery in the second eye.
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Participants will be masked as to which type of surgery they receive in either eye.
| Wavefront optimized Photorefractive Keratectomy | Device | Wavefront optimized laser vision correction |
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| Topography-guided LASIK | Device | Topography-guided laser vision correction |
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| Topography-guided Photorefractive Keratectomy | Device | Topography-guided laser vision correction |
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| FG001 |
| Wavefront Optimized Photorefractive Keratectomy |
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). Wavefront optimized Photorefractive Keratectomy: Wavefront optimized laser vision correction Topography-guided Photorefractive Keratectomy: Topography-guided laser vision correction |
| FG002 | Topography-guided LASIK | 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). Wavefront optimized LASIK: Wavefront optimized laser vision correction Topography-guided LASIK: Topography-guided laser vision correction |
| FG003 | Topography-guided Photorefractive Keratectomy | 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). Wavefront optimized Photorefractive Keratectomy: Wavefront optimized laser vision correction Topography-guided Photorefractive Keratectomy: Topography-guided laser vision correction |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Wavefront Optimized LASIK | 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). Wavefront optimized LASIK: Wavefront optimized laser vision correction Topography-guided LASIK: Topography-guided laser vision correction |
| BG001 | Wavefront Optimized Photorefractive Keratectomy | 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). Wavefront optimized Photorefractive Keratectomy: Wavefront optimized laser vision correction Topography-guided Photorefractive Keratectomy: Topography-guided laser vision correction |
| BG002 | Topography-guided LASIK | 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). Wavefront optimized LASIK: Wavefront optimized laser vision correction Topography-guided LASIK: Topography-guided laser vision correction |
| BG003 | Topography-guided Photorefractive Keratectomy | 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). Wavefront optimized Photorefractive Keratectomy: Wavefront optimized laser vision correction Topography-guided Photorefractive Keratectomy: Topography-guided laser vision correction |
| BG004 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Eyes |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Units | Eyes | Eyes |
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| Sex: Female, Male | Count of Units | Eyes | Eyes |
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| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants | Participants |
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| Region of Enrollment | Number | Eyes | Eyes |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Change in Uncorrected Visual Acuity From Baseline to Month 12 | Uncorrected visual acuity will be tested pre-operatively through month 12 | Twelve month data was not collected for any participants. Because of the bias in who qualified for the study it became apparent we would not get any statistically valid results. | Posted | 12 months |
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| Secondary | Change in Contrast Sensitivity From Baseline to Month 3 | Contrast sensitivity will be tested pre-operatively and 3 months post-operatively | Per 2018 protocol amendment contrast sensitivity assessment was removed from the study procedures and thus data was not collected. | Posted | 3 months |
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| Other Pre-specified | Change in Quality of Life Score From Baseline to 3 Months | The validated Quality of Life Impact of Refractive Correction survey will be administered pre-operatively and 3 months post surgery | The Quality of Life Impact of Refractive Correction survey was removed from the protocol with the 2018 amendment, thus this data was not collected. | Posted | 3 months |
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12 months
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Wavefront Optimized LASIK | 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). Wavefront optimized LASIK: Wavefront optimized laser vision correction Topography-guided LASIK: Topography-guided laser vision correction | 0 | 18 | 0 | 18 | 0 | 18 |
| EG001 | Wavefront Optimized Photorefractive Keratectomy | 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). Wavefront optimized Photorefractive Keratectomy: Wavefront optimized laser vision correction Topography-guided Photorefractive Keratectomy: Topography-guided laser vision correction | 0 | 20 | 0 | 20 | 0 | 20 |
| EG002 | Topography-guided LASIK | 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). Wavefront optimized LASIK: Wavefront optimized laser vision correction Topography-guided LASIK: Topography-guided laser vision correction | 0 | 18 | 0 | 18 | 0 | 18 |
| EG003 | Topography-guided Photorefractive Keratectomy | 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). Wavefront optimized Photorefractive Keratectomy: Wavefront optimized laser vision correction Topography-guided Photorefractive Keratectomy: Topography-guided laser vision correction | 0 | 20 | 0 | 20 | 0 | 20 |
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The study was terminated early. Because of strong selection bias in who qualified for the study, it became apparent we would not get any statistically valid results.
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Mark Mifflin, MD | University of Utah John A. Moran Eye Center | 801-213-4152 | Mark.Mifflin@hsc.utah.edu |
| May 15, 2023 |
| Prot_SAP_001.pdf |
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| ID | Term |
|---|---|
| D009216 | Myopia |
| ID | Term |
|---|---|
| D012030 | Refractive Errors |
| D005128 | Eye Diseases |
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| Eyes |
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| Between 18 and 65 years |
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| >=65 years |
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| Eyes |
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| Eyes |
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| Eyes |
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| OG003 | Topography-guided Photorefractive Keratectomy | 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). Wavefront optimized Photorefractive Keratectomy: Wavefront optimized laser vision correction Topography-guided Photorefractive Keratectomy: Topography-guided laser vision correction |
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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).
Wavefront optimized LASIK: Wavefront optimized laser vision correction
Topography-guided LASIK: Topography-guided laser vision correction
| OG003 | Topography-guided Photorefractive Keratectomy | 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). Wavefront optimized Photorefractive Keratectomy: Wavefront optimized laser vision correction Topography-guided Photorefractive Keratectomy: Topography-guided laser vision correction |
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