Ignite Creation Date:
2025-12-25 @ 2:00 AM
Ignite Modification Date:
2026-03-06 @ 1:34 PM
Study NCT ID:
NCT01140594
Status:
COMPLETED
Last Update Posted:
2022-04-11
First Post:
2010-06-02
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Wavefront-guided Photorefractive Keratectomy (PRK) Versus Wavefront-guided Lasik for Myopia
Sponsor:
Stanford University
Organization:
Study Overview
Official Title:
A Prospective Randomized Eye to Eye Comparison of Fellow Eyes Undergoing Lasik With the IntraLase(TM) FS Versus PRK
Status:
COMPLETED
Status Verified Date:
2022-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
A prospective comparison of eyes undergoing wavefront-guided LASIK in one eye and wavefront-guided PRK in their fellow eye for myopia.
Detailed Description:
This is a research study comparing the outcomes of LASIK surgery to PRK surgery for nearsightedness when using the two different procedures. You will have one eye treated with LASIK using the Intralase FS laser and your other eye treated with PRK. You will be one of 100 sighted patients at Stanford to undergo treatment in this clinical research trial. This will be a prospective, randomized, research study in which up to 200 consecutive eyes scheduled to undergo excimer laser in situ keratomileusis (LASIK) in one eye and photorefractive keratectomy (PRK) in the fellow eye for the correction of myopia (nearsightedness) with or without astigmatism will be enrolled. The choice of which eye receives LASIK and which eye receives PRK will be randomized prior to enrollment. Randomization will be done according to a randomization schedule. You will know which eye is being treated with which procedure. The randomization will determine only whether your right or left eye is treated with the LASIK procedure. The other eye will be treated with PRK. You have a fifty percent chance of having your left eye treated with LASIK as your right eye. Subjects will undergo either bilateral (both eyes at once) wavefront (a more precise custom laser system) guided LASIK and PRK treatments using the VISX Star S4 excimer laser. All subjects will be followed for one year after the vision correction procedure. Subjects scheduled to undergo LASIK and PRK for the correction of myopia (nearsightedness) with or without astigmatism will be screened for eligibility. Eligible subjects will be examined preoperatively to establish a baseline for ocular condition (the general health and glasses prescription of the eyes). Postoperatively, subjects will undergo an ophthalmic evaluation (complete eye examination) at regular intervals as specified in this protocol. Retreatments (a second operation on the same eye for residual nearsightedness) will not be allowed during the first six months of this study. If you elect to undergo a retreatment of your LASIK or PRK surgery prior to the 6-month post-operative visit, the retreated eye will be exited from the study as of the retreatment date.
Any significant new finding developed during the course of the research which may relate to the subject's willingness to continue participation will be provided to the subject or subject's representative in a timely manner.
Any significant new finding developed during the course of the research which may relate to the subject's willingness to continue participation will be provided to the subject or subject's representative in a timely manner.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| SQL 97234 | None | None | View |