Wavefront-guided Photorefractive Keratectomy (PRK) Versus Wavefront-guided Lasik for Myopia

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Edward E. Manche, Stanford University
ClinicalTrials.gov Identifier:
NCT01140594
First received: June 2, 2010
Last updated: March 9, 2014
Last verified: March 2014

June 2, 2010
March 9, 2014
August 2006
October 2014   (final data collection date for primary outcome measure)
  • Improvement in uncorrected visual acuity [ Time Frame: Baseline to one year ] [ Designated as safety issue: No ]
  • Changes in best spectacle corrected visual acuity [ Time Frame: Baseline to one year ] [ Designated as safety issue: Yes ]
  • Changes in 25 and 5% low contrast acuity [ Time Frame: baseline to one year ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT01140594 on ClinicalTrials.gov Archive Site
  • Changes in quality of vision [ Time Frame: baseline to one year ] [ Designated as safety issue: Yes ]
  • Comparison of dry eye signs and symptoms between LASIK and PRK [ Time Frame: baseline to one year ] [ Designated as safety issue: Yes ]
  • Changes in quality of vision [ Time Frame: baseline to one year ] [ Designated as safety issue: No ]
  • Changes in higher order aberrations [ Time Frame: Baseline to one year ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Wavefront-guided Photorefractive Keratectomy (PRK) Versus Wavefront-guided Lasik for Myopia
A Prospective Randomized Eye to Eye Comparison of Fellow Eyes Undergoing Lasik With the IntraLase(TM) FS Versus PRK

A prospective comparison of eyes undergoing wavefront-guided LASIK in one eye and wavefront-guided PRK in their fellow eye for myopia.

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.

Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
  • Myopia
  • Astigmatism
  • Procedure: Photorefractive keratectomy
    One eye undergoes wavefront-guided PRK with the Visx S4 CustomVue excimer laser.
    Other Name: PRK, CustomVue, Wavefront-guided
  • Procedure: Laser in-situ keratomileusis
    One eye undergoes wavefront-guided LASIK using the Visx S4 excimer laser.
    Other Name: LASIK, CustomVue, Visx, Intralase FS60
Not Provided
Manche EE, Haw WW. Wavefront-guided laser in situ keratomileusis (Lasik) versus wavefront-guided photorefractive keratectomy (Prk): a prospective randomized eye-to-eye comparison (an American Ophthalmological Society thesis). Trans Am Ophthalmol Soc. 2011 Dec;109:201-20.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
34
October 2014
October 2014   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Subjects age 21 and older with healthy eyes.
  • Nearsightedness between -0.75 diopters and -7.00 diopters with or without astigmatism of up to -3.50 diopters.

Exclusion Criteria:

  • Subjects under the age of 21.
  • Patients with thin corneas.
  • Patients with topographic irregularities.
  • Patients with keratoconus.
  • Patients with autoimmune diseases.
  • Patients who are pregnant or nursing.
  • Patients must have similar levels of nearsightedness in each eye. They can not be more than 1.0 diopter of difference between eyes.
  • Patients must have similar levels of astigmatism in each eye. They can not have more than 1.0 diopter of difference between eyes.
Both
21 Years and older
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01140594
SU-05192010-6082, SQL 97234
No
Edward E. Manche, Stanford University
Stanford University
Not Provided
Principal Investigator: Edward E. Manche Stanford University
Stanford University
March 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP