Status:
COMPLETED
Effect of Preoperative Pupil Size on Quality of Vision After Wavefront-Guided LASIK
Lead Sponsor:
Stanford University
Conditions:
Myopia
Eligibility:
All Genders
Phase:
PHASE4
Brief Summary
The purpose of this study is to evaluate whether the size of the pupil has an effect on quality of vision in patients undergoing LASIK surgery.
Detailed Description
Purpose: To prospectively evaluate the effect of preoperative pupil size on quality of vision after wavefront-guided LASIK. Methods: Fifty-one patients underwent LASIK for low myopia and completed qu...
Eligibility Criteria
Inclusion
- no more than 6.00 D of spherical myopia
- no more than 3.00 D of refractive astigmatism
- a stable refraction (less than 0.50D per year of sphere or cylinder)
- a corneal diameter of less than 11.0 mm to allow for suction ring fixation
- discontinuation of soft contact wear at least 7 days prior to preoperative evaluation
- visual acuity correctable to at least 20/20
- age older than 21 years
- ability to participate in follow-up examinations for 12 months after LASIK surgery
Exclusion
- use of rigid gas permeable contact lens
- severe dry eye symptoms
- severe blepharitis
- anterior segment abnormalities (i.e. cataracts, corneal scarring, or neovascularization within 1 mm of intended ablation zone)
- recurrent corneal erosion
- severe basement membrane disease
- progressive or unstable myopia or keratoconus
- unstable corneal mires on central keratometry
- corneal thickness in which LASIK procedure would result in less than 250 microns of remaining posterior corneal thickness below the flap postoperatively
- baseline standard manifest refraction of more than 0.75 D in sphere power
- or a difference of greater than 0.50 D in cylinder power compared with baseline standard cycloplegic refraction
- a baseline standard cycloplegic refraction differing more than 0.75 in sphere, 0.50 D in cylinder
- have a different type of astigmatism (i.e. with-the-rule) when the cylinder is greater than 0.50D compared to baseline standard cycloplegic refraction
- preoperative assessment of ocular topography and/or aberrations indicates that either eye is not suitable candidate for LASIK vision correction procedure (i.e. forme fruste keratoconus
- corneal warpage, or pellucid marginal degeneration)
- previous intraocular or corneal surgery
- history of herpes zoster or simplex keratitis
- patients on systemic corticosteroid or immunosuppressive therapy
- immunocompromised subjects or clinically significant atopic disease
- connective tissue disease
- diabetes
- steroid responder
- macular pathology
- pregnant or lactating patients
- patients with sensitivity to planned study concomitant medications
- patients participating in another ophthalmic drug or device clinical trial
Key Trial Info
Start Date :
May 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2005
Estimated Enrollment :
51 Patients enrolled
Trial Details
Trial ID
NCT00889941
Start Date
May 1 2004
End Date
November 1 2005
Last Update
April 29 2009
Active Locations (1)
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1
Stanford University School of Medicine
Stanford, California, United States, 94305