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Ten-year Follow-up of Laser in Situ Keratomileusis in Patients 8 to 15 Years Old

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00800774
Recruitment Status : Completed
First Posted : December 2, 2008
Last Update Posted : November 25, 2009
Sponsor:
Information provided by:

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.

Condition or disease Intervention/treatment Phase
Anisometropia Procedure: LASIK Phase 4

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 Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 9 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Ten-year Follow-up of Laser in Situ Keratomileusis in Patients 8 to 15 Years Old
Study Start Date : January 1998
Primary Completion Date : September 2008
Study Completion Date : September 2008
Arms and Interventions

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.
Procedure: LASIK
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.


Outcome Measures

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   8 Years to 15 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00800774


Locations
Brazil
IOG
Goiania, GO, Brazil
Sponsors and Collaborators
Instituto de Olhos de Goiania
Investigators
Study Chair: Belquiz A Nassaralla, MD, PhD Instituto de Olhos de Goiania
More Information

ClinicalTrials.gov Identifier: NCT00800774     History of Changes
Other Study ID Numbers: ARVO - BN - 2009
First Posted: December 2, 2008    Key Record Dates
Last Update Posted: November 25, 2009
Last Verified: September 2008

Keywords provided by Instituto de Olhos de Goiania:
LASIK
safety
efficacy
stability
high anisometropia
patients 8 to 15 years old
conventional treatments have failed

Additional relevant MeSH terms:
Anisometropia
Refractive Errors
Eye Diseases