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Completed

NCT Number: NCT00889941

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

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.

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Key information

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Stanford University School of Medicine

Stanford, California, 94305, United States

About this study

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 questionnaires regarding specific visual symptoms before and after surgery. Each eye was evaluated postoperatively at 1-week, 1-, 3-, 6- and 12-months. Pupils were stratified according to size: small (<5.5mm), medium (5.5 to 6.0mm) and large (>6.0mm). Mesopic pupil size and preoperative and postoperative variables were evaluated using analysis of variance (ANOVA). A regression model was also performed to determine the correlation between mean spherical equivalent and cylinder and visual symptoms.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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 criteria

  • 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

Treatment and study plan

LASIK

Procedure

laser-assisted in situ keratomileusis

Other names: laser-assisted in situ keratomileusis

Sponsors and collaborators

Lead sponsor

Stanford University

Other

Registry information

Important dates

Study start
2004
Primary completion
2005
Study completion
2005
First posted
Apr 29, 2009
Registry last updated
Apr 29, 2009

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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