NCT01296867

Brief Summary

To study the postoperative results in myopic and hyperopic eyes treated with two different laser ablation algorithms (STD and F-CAT), both FDA approved.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
36

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Mar 2006

Typical duration for all trials

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

March 1, 2006

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2009

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2009

Completed
1.8 years until next milestone

First Submitted

Initial submission to the registry

February 15, 2011

Completed
1 day until next milestone

First Posted

Study publicly available on registry

February 16, 2011

Completed
Last Updated

February 16, 2011

Status Verified

February 1, 2011

Enrollment Period

3 years

First QC Date

February 15, 2011

Last Update Submit

February 15, 2011

Conditions

MyopiaHyperopia

Keywords

Laser ablation algorithmsExcimer laserRefractive correctionCorneal Asphericity Adjustment

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Forty eight myopic (24 patients) and 24 hyperopic eyes (12 patients)

You may qualify if:

  • Myopic and hyperopic eyes eligible for LASIK or PRK refractive correction
  • Central corneal thickness more than 500 micrometers

You may not qualify if:

  • Topographies of less than 55% of successful total sampled area and eyes exhibiting asphericity variations, in either the horizontal or the vertical axis, greater than 0.2
  • Corneal scarring
  • Cataract surgery
  • Corneal ulceration
  • Topographical abnormalities

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

MyopiaHyperopia

Condition Hierarchy (Ancestors)

Refractive ErrorsEye Diseases

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER

Study Record Dates

First Submitted

February 15, 2011

First Posted

February 16, 2011

Study Start

March 1, 2006

Primary Completion

March 1, 2009

Study Completion

May 1, 2009

Last Updated

February 16, 2011

Record last verified: 2011-02