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

NCT ID: NCT00800774

Last Updated: 2009-11-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

9 participants

Study Classification

INTERVENTIONAL

Study Start Date

1998-01-31

Study Completion Date

2008-09-30

Brief Summary

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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

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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.

Conditions

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Anisometropia

Keywords

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LASIK safety efficacy stability high anisometropia patients 8 to 15 years old conventional treatments have failed

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

LASIK

Intervention Type PROCEDURE

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.

Interventions

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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.

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* High anisometropia (\>3.50 D)
* Patients 8 to 15 years old
* Conventional treatments have failed

Exclusion Criteria

* Diabetes
* Autoimmune diseases
* Topographic abnormalities
Minimum Eligible Age

8 Years

Maximum Eligible Age

15 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Instituto de Olhos de Goiania

OTHER

Sponsor Role lead

Principal Investigators

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Belquiz A Nassaralla, MD, PhD

Role: STUDY_CHAIR

Instituto de Olhos de Goiania

Locations

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IOG

Goiânia, Goiás, Brazil

Site Status

Countries

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Brazil

Other Identifiers

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ARVO - BN - 2009

Identifier Type: -

Identifier Source: org_study_id