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

NCT00889941 | Completed Phase 4 DMC

• 1 other identifier: SU-02082009-1758
• Study Type: interventional
• Target: 51
• Locations: 1 country
• Sites: 1

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.

Conditions

Myopia

Study Arms (3)

small

ACTIVE COMPARATOR

Procedure: LASIK

medium

ACTIVE COMPARATOR

Procedure: LASIK

large

ACTIVE COMPARATOR

Procedure: LASIK

Interventions

LASIK PROCEDURE

laser-assisted in situ keratomileusis

Also known as: laser-assisted in situ keratomileusis

large; medium; small

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Stanford University: lead

Study Sites (1)

Stanford University School of Medicine

Stanford, California, 94305, United States

Location

MeSH Terms

Conditions

Myopia

Interventions

Keratomileusis, Laser In Situ

Condition Hierarchy (Ancestors)

Refractive Errors; Eye Diseases

Intervention Hierarchy (Ancestors)

Corneal Surgery, Laser; Laser Therapy; Therapeutics; Ablation Techniques; Surgical Procedures, Operative; Keratectomy; Refractive Surgical Procedures; Ophthalmologic Surgical Procedures

Study Officials

• Annie Chan

  Stanford University

  SUB INVESTIGATOR

• Edward E. Manche

  Stanford University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: February 12, 2009
• First Posted: April 29, 2009
• Study Start: May 1, 2004
• Primary Completion: November 1, 2005
• Study Completion: November 1, 2005
• Last Updated: April 29, 2009

Record last verified: 2009-04

Locations

US (1)