Back to resultsTen-year Follow-up of Laser in Situ Keratomileusis in Patients 8 to 15 Years Old
Primary Purpose
Anisometropia
Status
Completed
Phase
Phase 4
Locations
Brazil
Study Type
Interventional
Intervention
LASIK
Sponsored by
About this trial
This is an interventional treatment trial for Anisometropia focused on measuring LASIK, safety, efficacy, stability, high anisometropia, patients 8 to 15 years old, conventional treatments have failed
Eligibility Criteria
Inclusion Criteria:
- High anisometropia (>3.50 D)
- Patients 8 to 15 years old
- Conventional treatments have failed
Exclusion Criteria:
- Diabetes
- Autoimmune diseases
- Topographic abnormalities
Sites / Locations
- IOG
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
1
Arm Description
Nine eyes of nine patients (3 male and 6 female) with high anisometropia (>3.50 D), were included in this study. Minimum follow-up was 10 years. All patients were treated with the Chiron Technolas 217 excimer laser.
Outcomes
Primary Outcome Measures
Secondary Outcome Measures
Full Information
NCT ID
NCT00800774
First Posted
December 1, 2008
Last Updated
November 21, 2009
Sponsor
Instituto de Olhos de Goiania
1. Study Identification
Unique Protocol Identification Number
NCT00800774
Brief Title
Ten-year Follow-up of Laser in Situ Keratomileusis in Patients 8 to 15 Years Old
Official Title
Ten-year Follow-up of Laser in Situ Keratomileusis in Patients 8 to 15 Years Old
Study Type
Interventional
2. Study Status
Record Verification Date
September 2008
Overall Recruitment Status
Completed
Study Start Date
January 1998 (undefined)
Primary Completion Date
September 2008 (Actual)
Study Completion Date
September 2008 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Instituto de Olhos de Goiania
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
The purpose of this study is to determine the safety, efficacy, predictability, and stability of laser in situ keratomileusis (LASIK) to correct high anisometropia in patients 8 to 15 years old in whom conventional treatments have failed.
Detailed Description
Nine eyes of nine patients (3 male and 6 female) with high anisometropia (>3.50 D), were included in this study. Minimum follow-up was 10 years. All patients were treated with the Chiron Technolas 217 excimer laser.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Anisometropia
Keywords
LASIK, safety, efficacy, stability, high anisometropia, patients 8 to 15 years old, conventional treatments have failed
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
9 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Experimental
Arm Description
Nine eyes of nine patients (3 male and 6 female) with high anisometropia (>3.50 D), were included in this study. Minimum follow-up was 10 years. All patients were treated with the Chiron Technolas 217 excimer laser.
Intervention Type
Procedure
Intervention Name(s)
LASIK
Intervention Description
Nine eyes of nine patients (3 male and 6 female) with high anisometropia (>3.50 D), were included in this study. Minimum follow-up was 10 years. All patients were treated with the Chiron Technolas 217 excimer laser.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
8 Years
Maximum Age & Unit of Time
15 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
High anisometropia (>3.50 D)
Patients 8 to 15 years old
Conventional treatments have failed
Exclusion Criteria:
Diabetes
Autoimmune diseases
Topographic abnormalities
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Belquiz A Nassaralla, MD, PhD
Organizational Affiliation
Instituto de Olhos de Goiania
Official's Role
Study Chair
Facility Information:
Facility Name
IOG
City
Goiania
State/Province
GO
Country
Brazil
12. IPD Sharing Statement
Learn more about this trial
Ten-year Follow-up of Laser in Situ Keratomileusis in Patients 8 to 15 Years Old
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