- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00800774
Ten-year Follow-up of Laser in Situ Keratomileusis in Patients 8 to 15 Years Old
November 21, 2009 updated by: Instituto de Olhos de Goiania
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.
Study Overview
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.
Study Type
Interventional
Enrollment (Actual)
9
Phase
- Phase 4
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
GO
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Goiania, GO, Brazil
- IOG
-
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
6 years to 13 years (Child)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- High anisometropia (>3.50 D)
- Patients 8 to 15 years old
- Conventional treatments have failed
Exclusion Criteria:
- Diabetes
- Autoimmune diseases
- Topographic abnormalities
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: 1
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.
|
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.
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Chair: Belquiz A Nassaralla, MD, PhD, Instituto de Olhos de Goiania
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
January 1, 1998
Primary Completion (Actual)
September 1, 2008
Study Completion (Actual)
September 1, 2008
Study Registration Dates
First Submitted
December 1, 2008
First Submitted That Met QC Criteria
December 1, 2008
First Posted (Estimate)
December 2, 2008
Study Record Updates
Last Update Posted (Estimate)
November 25, 2009
Last Update Submitted That Met QC Criteria
November 21, 2009
Last Verified
September 1, 2008
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- ARVO - BN - 2009
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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