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

This study has been completed.
Sponsor:
Information provided by:
Instituto de Olhos de Goiania
ClinicalTrials.gov Identifier:
NCT00800774
First received: December 1, 2008
Last updated: November 21, 2009
Last verified: September 2008
  Purpose

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 Intervention Phase
Anisometropia
Procedure: LASIK
Phase 4

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Ten-year Follow-up of Laser in Situ Keratomileusis in Patients 8 to 15 Years Old

Further study details as provided by Instituto de Olhos de Goiania:

Enrollment: 9
Study Start Date: January 1998
Study Completion Date: September 2008
Primary Completion Date: September 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

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.

  Eligibility

Ages Eligible for Study:   8 Years to 15 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

ClinicalTrials.gov Identifier: NCT00800774     History of Changes
Other Study ID Numbers: ARVO - BN - 2009
Study First Received: December 1, 2008
Last Updated: November 21, 2009
Health Authority: Brazil: National Health Surveillance Agency

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

ClinicalTrials.gov processed this record on April 17, 2014