Effect of Preoperative Pupil Size on Quality of Vision After Wavefront-Guided LASIK

Trial ID or NCT#

NCT00889941

Status

not recruiting iconNOT RECRUITING

Purpose

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.

Official Title

Effect of Preoperative Pupil Size on Quality of Vision After Wavefront-Guided LASIK

Eligibility Criteria

Sexes Eligible for Study: ALL
Accepts Healthy Volunteers: No
Inclusion Criteria:
  1. 1. no more than 6.00 D of spherical myopia2. no more than 3.00 D of refractive astigmatism3. a stable refraction (less than 0.50D per year of sphere or cylinder)4. a corneal diameter of less than 11.0 mm to allow for suction ring fixation5. discontinuation of soft contact wear at least 7 days prior to preoperative evaluation6. visual acuity correctable to at least 20/207. age older than 21 years8. ability to participate in follow-up examinations for 12 months after LASIK surgery
Exclusion Criteria:
  1. 1. use of rigid gas permeable contact lens2. severe dry eye symptoms3. severe blepharitis4. anterior segment abnormalities (i.e. cataracts, corneal scarring, or neovascularization within 1 mm of intended ablation zone)5. recurrent corneal erosion6. severe basement membrane disease7. progressive or unstable myopia or keratoconus8. unstable corneal mires on central keratometry9. corneal thickness in which LASIK procedure would result in less than 250 microns of remaining posterior corneal thickness below the flap postoperatively10. baseline standard manifest refraction of more than 0.75 D in sphere power11. or a difference of greater than 0.50 D in cylinder power compared with baseline standard cycloplegic refraction12. a baseline standard cycloplegic refraction differing more than 0.75 in sphere, 0.50 D in cylinder13. have a different type of astigmatism (i.e. with-the-rule) when the cylinder is greater than 0.50D compared to baseline standard cycloplegic refraction14. 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 keratoconus15. corneal warpage, or pellucid marginal degeneration)16. previous intraocular or corneal surgery17. history of herpes zoster or simplex keratitis18. patients on systemic corticosteroid or immunosuppressive therapy19. immunocompromised subjects or clinically significant atopic disease20. connective tissue disease21. diabetes22. steroid responder23. macular pathology24. pregnant or lactating patients25. patients with sensitivity to planned study concomitant medications26. patients participating in another ophthalmic drug or device clinical trial

Investigator(s)

Edward Manche, MD
Edward Manche, MD
Ophthalmologist
Professor of Ophthalmology

Contact us to find out if this trial is right for you.

Contact

Edward Manche
650498702