Myopia, Surgery
Conditions
Keywords
Photorefractive keratectomy, Laser-assisted in situ keratomileusis
Brief 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). 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.
Interventions
Wavefront optimized laser vision correction
DEVICEWavefront optimized Photorefractive Keratectomy
Wavefront optimized laser vision correction
DEVICETopography-guided LASIK
Topography-guided laser vision correction
DEVICETopography-guided Photorefractive Keratectomy
Topography-guided laser vision correction
Sponsors
University of Utah
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Masking description
Participants will be masked as to which type of surgery they receive in either eye.
Intervention model description
Each participant will receive wavefront optimized surgery in one eye and topography-guided surgery in the second eye.
Eligibility
Sex/Gender
ALL
Age
21 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 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)
Exclusion criteria
* Any patient who is not a suitable candidate for LASIK or PRK will not be included.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Uncorrected Visual Acuity From Baseline to Month 12 | 12 months | Uncorrected visual acuity will be tested pre-operatively through month 12 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Contrast Sensitivity From Baseline to Month 3 | 3 months | Contrast sensitivity will be tested pre-operatively and 3 months post-operatively |
Other
| Measure | Time frame | Description |
|---|---|---|
| Change in Quality of Life Score From Baseline to 3 Months | 3 months | The validated Quality of Life Impact of Refractive Correction survey will be administered pre-operatively and 3 months post surgery |
Countries
United States
Participant flow
Pre-assignment details
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.
Participants by arm
| Arm | Count |
|---|---|
| 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 | 18 |
| 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 | 18 |
| 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 | 20 |
| 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 | 20 |
| 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 | 18 |
| 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 | 18 |
| 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 | 20 |
| 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 | 20 |
| Total | 152 |
Baseline characteristics
| Characteristic | Total | Wavefront Optimized Photorefractive Keratectomy | Topography-guided LASIK | Topography-guided Photorefractive Keratectomy | Wavefront Optimized LASIK |
|---|---|---|---|---|---|
| Age, Categorical <=18 years | 0 Eyes | 0 Eyes | 0 Eyes | 0 Eyes | 0 Eyes |
| Age, Categorical >=65 years | 0 Eyes | 0 Eyes | 0 Eyes | 0 Eyes | 0 Eyes |
| Age, Categorical Between 18 and 65 years | 76 Eyes | 20 Eyes | 18 Eyes | 20 Eyes | 18 Eyes |
| Race and Ethnicity Not Collected | 0 Participants | — | — | — | — |
| Region of Enrollment United States | 76 Eyes | 20 Eyes | 18 Eyes | 20 Eyes | 18 Eyes |
| Sex: Female, Male Female | 42 Eyes | 10 Eyes | 11 Eyes | 10 Eyes | 11 Eyes |
| Sex: Female, Male Male | 34 Eyes | 10 Eyes | 7 Eyes | 10 Eyes | 7 Eyes |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 18 | 0 / 20 | 0 / 18 | 0 / 20 |
| other Total, other adverse events | 0 / 18 | 0 / 20 | 0 / 18 | 0 / 20 |
| serious Total, serious adverse events | 0 / 18 | 0 / 20 | 0 / 18 | 0 / 20 |
Outcome results
Primary
Change in Uncorrected Visual Acuity From Baseline to Month 12
Uncorrected visual acuity will be tested pre-operatively through month 12
Time frame: 12 months
Population: 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.
Secondary
Change in Contrast Sensitivity From Baseline to Month 3
Contrast sensitivity will be tested pre-operatively and 3 months post-operatively
Time frame: 3 months
Population: Per 2018 protocol amendment contrast sensitivity assessment was removed from the study procedures and thus data was not collected.
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
Time frame: 3 months
Population: The Quality of Life Impact of Refractive Correction survey was removed from the protocol with the 2018 amendment, thus this data was not collected.