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

Phase 4

Completed

• Conditions: Anisometropia
• Interventions: Procedure: LASIK

• Registration Number: NCT00800774
• Lead Sponsor: Instituto de Olhos de Goiania

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.

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 Timeline

• Study Start: 1998-01
• Status Verified: 2008-09
• Primary Completion: 2008-09
• Study Completion: 2008-09
• Study First Submitted: 2008-12-01
• Study First Submitted QC: 2008-12-01
• Study First Posted: 2008-12-02
• Last Update Submitted: 2009-11-21
• Last Update Posted: 2009-11-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 9

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

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
1	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.

Trial Locations

Locations (1)

IOG; 🇧🇷 Goiania, GO, Brazil