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

Anisometropia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00800774
• Other study ID #: ARVO - BN - 2009
• Status: Completed
• Phase: Phase 4
• First received: December 1, 2008
• Last updated: November 21, 2009
• Start date: January 1998
• Est. completion date: September 2008

Study information

• Verified date: September 2008
• Source: Instituto de Olhos de Goiania
• Contact: n/a
• Is FDA regulated: No
• Health authority: Brazil: National Health Surveillance Agency
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 9
• Est. completion date: September 2008
• Est. primary completion date: September 2008
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 8 Years to 15 Years

Eligibility

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 Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Anisometropia

Intervention

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.

Locations

Country	Name	City	State
Brazil	IOG	Goiania	GO

Sponsors (1)

Lead Sponsor	Collaborator
Instituto de Olhos de Goiania

Country where clinical trial is conducted

Brazil,