NCT00172913

Brief Summary

In the interest of improving visual quality after LASIK we have designed a multifaceted study to test the theoretical, physical, biomechanical and functional effects of commercial and independently designed aspherical ablation profiles.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jun 2005

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
unknown

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

June 1, 2005

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

September 12, 2005

Completed
3 days until next milestone

First Posted

Study publicly available on registry

September 15, 2005

Completed
2.8 years until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2008

Completed
Last Updated

September 15, 2005

Status Verified

June 1, 2005

First QC Date

September 12, 2005

Last Update Submit

September 12, 2005

Conditions

Myopia

Keywords

Wavefront AberrationLASIKContrast SensitivityVisual PerformanceAblation Profile

Eligibility Criteria

Age0 Years+
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may not qualify if:

  • Eyes will also be divided into groups by refractive error: Low myopia 0-3D, moderate myopia 3-6D, and high myopia 6-9 D and very high myopia \> 9D MSRE. The size of the Optical Zone and Transitional Zone is measured, and results are compared for patients of similar refractive error (+/- 0.5 S +/- 0.5 C). Analysis is carried out using a matrix analysis of the total refractive error, comparison of Visual Acuity, Contrast Sensitivity and Responses on a Questionnaire to assess the patient's quality of vision.
  • Equal numbers of eyes from each of the four refractive error groups and from each of the three treatment groups (OATZ profile 5, OATZ profile 6, conventional) will be measured.
  • We will consider patients operated on by the same doctor (Dr. Lin). We will also compare treatments of patients and wavefront maps of patients who have similar spherical and cylindrical refractive errors.
  • Table 1. Examination Schedule (Definitions) Visit Time Preoperative Within 30 days of surgery Operative Day Day of surgery
  • Month postop 3-5 weeks following surgery 3 Months postop 10-14 weeks following surgery

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

National Taiwan University Hospital

Taipei, Taiwan

RECRUITING

MeSH Terms

Conditions

Myopia

Condition Hierarchy (Ancestors)

Refractive ErrorsEye Diseases

Study Officials

  • I-Jong Wang, MD,PHD

    National Taiwan University Hospiyal

    PRINCIPAL INVESTIGATOR

Central Study Contacts

I-Jong Wang, MD, PHD

CONTACT

886-2-23123456ijong@ha.mc.ntu.edu.tw

Study Design

Study Type
observational
Observational Model
DEFINED POPULATION
Time Perspective
OTHER
Sponsor Type
OTHER

Study Record Dates

First Submitted

September 12, 2005

First Posted

September 15, 2005

Study Start

June 1, 2005

Study Completion

July 1, 2008

Last Updated

September 15, 2005

Record last verified: 2005-06

Locations

TW(1)