NCT00350246

Brief Summary

This study will determine if there are short- and long-term postoperative differences in visual and corneal outcomes between different laser refractive surgical procedures.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
62

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started Jul 2004

Longer than P75 for phase_4

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2004

Completed
2 years until next milestone

First Submitted

Initial submission to the registry

July 7, 2006

Completed
3 days until next milestone

First Posted

Study publicly available on registry

July 10, 2006

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2009

Completed
Last Updated

January 28, 2010

Status Verified

January 1, 2010

Enrollment Period

4.5 years

First QC Date

July 7, 2006

Last Update Submit

January 27, 2010

Conditions

Myopia

Outcome Measures

Primary Outcomes (2)

  • keratocyte density at 5 years

  • nerve density at 5 years

Interventions

Laser Refractive SurgeryPROCEDURE

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Myopia 1-10 diopters No other ocular abnormalities except presbyopia

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (1)

Mayo Clinic

Rochester, Minnesota, 55905, United States

Location

Related Publications (2)

  • Patel SV, McLaren JW, Kittleson KM, Bourne WM. Subbasal nerve density and corneal sensitivity after laser in situ keratomileusis: femtosecond laser vs mechanical microkeratome. Arch Ophthalmol. 2010 Nov;128(11):1413-9. doi: 10.1001/archophthalmol.2010.253.

    PMID: 21060042DERIVED

  • Calvo R, McLaren JW, Hodge DO, Bourne WM, Patel SV. Corneal aberrations and visual acuity after laser in situ keratomileusis: femtosecond laser versus mechanical microkeratome. Am J Ophthalmol. 2010 May;149(5):785-93. doi: 10.1016/j.ajo.2009.12.023. Epub 2010 Mar 15.

    PMID: 20227675DERIVED

MeSH Terms

Conditions

Myopia

Condition Hierarchy (Ancestors)

Refractive ErrorsEye Diseases

Study Officials

  • William M. Bourne, M.D.

    Mayo Clinic

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

July 7, 2006

First Posted

July 10, 2006

Study Start

July 1, 2004

Primary Completion

January 1, 2009

Study Completion

January 1, 2009

Last Updated

January 28, 2010

Record last verified: 2010-01

Locations

US(1)