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

Primary Purpose

Myopia

Status

Completed

Phase

Phase 4

Locations

United States

Study Type

Interventional

Intervention

LASIK

About this trial

This is an interventional treatment trial for Myopia

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Stanford University School of Medicine

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Arm Label

small

medium

large

Arm Description

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

NCT ID

NCT00889941

First Posted

February 12, 2009

Last Updated

April 28, 2009

Sponsor

Stanford University

1. Study Identification

Unique Protocol Identification Number

NCT00889941

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

April 2009

Overall Recruitment Status

Completed

Study Start Date

May 2004 (undefined)

Primary Completion Date

November 2005 (Actual)

Study Completion Date

November 2005 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor

Stanford University

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Myopia

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

51 (Actual)

8. Arms, Groups, and Interventions

Arm Title

small

Arm Type

Active Comparator

Arm Title

medium

Arm Type

Active Comparator

Arm Title

large

Arm Type

Active Comparator

Intervention Type

Procedure

Intervention Name(s)

LASIK

Other Intervention Name(s)

laser-assisted in situ keratomileusis

Intervention Description

laser-assisted in situ keratomileusis

10. Eligibility

Sex

All

Accepts Healthy Volunteers

Eligibility Criteria

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Annie Chan

Organizational Affiliation

Stanford University

Official's Role

Sub-Investigator

First Name & Middle Initial & Last Name & Degree

Edward E. Manche

Organizational Affiliation

Stanford University

Official's Role

Principal Investigator

Facility Information:

Facility Name

Stanford University School of Medicine

City

Stanford

State/Province

California

ZIP/Postal Code

94305

Country

United States

12. IPD Sharing Statement

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

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