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We are enrolling participants aged 22 and older to have LASIK surgery in both eyes. We will perform wavefront-guided LASIK in one eye and ray tracing-guided LASIK in the fellow eye of each participant. We are trying to see if there are any differences in the efficacy between the two types of LASIK procedures.
We are comparing the outcomes of wavefront-guided LASIK (laser in-situ keratomileusis) and ray tracing-guided LASIK for nearsightedness with and without astigmatism.
Wavefront aberrometry (a non-contact laser measuring device) is an automated device that measures the refractive status of the eye. This data is then transferred to the laser system and calculates a unique treatment to reduce or eliminate your nearsightedness with and without astigmatism (a non-spherical shape).
One eye will be treated with ray tracing-guided LASIK and the other eye treated with the wavefront-guided LASIK. Each participant will receive both wavefront-guided LASIK and ray-tracing guided LASIK. Both wavefront-guided LASIK and ray tracing-guided LASIK are FDA-approved procedures. Both procedures are being performed according to the FDA-approved labeling.
We plan to enroll up to 70 near-sighted study participants to undergo treatment in this clinical research trial.
The choice of which eye receives ray tracing-guided LASIK surgery and which eye receives wavefront-guided LASIK will be randomized (assigned at random) prior to enrollment.
Participants scheduled to undergo LASIK for the correction of myopia (nearsightedness) will be screened for eligibility. Eligible participants will be examined preoperatively to establish a baseline for ocular condition (the general health and glasses prescription of the eyes). Postoperatively, participants will undergo an ophthalmic evaluation (complete eye examination) at regular intervals as specified in this protocol. Re-treatments (a second operation on the same eye for residual nearsightedness, farsightedness and/or astigmatism) will not be allowed during the first twelve months of this study.. If a participant elects to undergo a re-treatment of the initial LASIK surgery prior to the 12-month post-operative visit, the data after the retreatment procedure will be excluded from the study analysis.
The primary aim of the research is to compare outcomes between the two procedures. All of the procedures performed during the study are considered standard of care for LASIK surgeries.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Wavefront-guided laser ablation | Active Comparator | Wavefront-guided LASIK |
|
| Ray tracing-guided LASIK | Active Comparator | Ray-tracing guided LASIK is being performed in one eye and Wavefront-guided LASIK is being performed in the fellow eye |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| LASIK | Procedure | Wavefront-guided LASIK is being performed in one eye and Ray-tracing guided LASIK is being performed in the fellow eye |
|
| Measure | Description | Time Frame |
|---|---|---|
| Uncorrected visual acuity | Uncorrected visual acuity using ETDRS charts | One year |
| Measure | Description | Time Frame |
|---|---|---|
| 5 and 25% best corrected low contrast visual acuity | Measurement of the change in 5 and 25% best corrected low contrast visual acuity using ETDRS charts | 12 months |
| Achieved versus attempted ablation depth measured by anterior segment OCT |
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Inclusion Criteria:
Age 22 and older
People with healthy eyes:
Nearsightedness between -1.00 diopters and -10.00 diopters.
Subjects with less than or equal to 3.00 diopters of astigmatism.
Subjects must have similar levels of nearsightedness in each eye.
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Edward E Manche, MD | Contact | 650 725 5765 | cornea@stanford.edu | |
| Theresa Enriquez, HS | Contact | 650 498 7020 | tenriquez@stanfordhealthcare.org |
| Name | Affiliation | Role |
|---|---|---|
| Edward E Manche, MD | Stanford University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Byers Eye Institute at Stanford University School of Medicine | Recruiting | Palo Alto | California | 94303 | United States |
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| ID | Term |
|---|---|
| D009216 | Myopia |
| D001251 | Astigmatism |
| ID | Term |
|---|---|
| D012030 | Refractive Errors |
| D005128 | Eye Diseases |
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| ID | Term |
|---|---|
| D020731 | Keratomileusis, Laser In Situ |
| ID | Term |
|---|---|
| D048988 | Corneal Surgery, Laser |
| D053685 | Laser Therapy |
| D013812 | Therapeutics |
| D055011 | Ablation Techniques |
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This is a prospective, randomized, contralateral fellow eye study comparing ray-tracing guided LASIK in one eye to wavefront-guided LASIK in the fellow eye of participants
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| LASIK | Procedure | Ray-tracing guided LASIK is being performed in one eye and Wavefront-guided LASIK is being performed in the fellow eye. |
|
Measurement of achieved ablation depth by comparing preoperative anterior segment OCT to postoperative anterior segment OCT
| One, three and twelve months |
| Self reported quality of vision and quality of life measures | A validated questionnaire will be administered preoperatively and at postoperative months 3, 6 and 12 | Three, six and twelve months |
| D013514 |
| Surgical Procedures, Operative |
| D000074431 | Keratectomy |
| D054140 | Refractive Surgical Procedures |
| D013508 | Ophthalmologic Surgical Procedures |