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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 August 19, 2014