NCT00800774

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
9

participants targeted

Target at below P25 for phase_4

Timeline
Completed

Started Jan 1998

Longer than P75 for phase_4

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 1998

Completed
10.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2008

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

December 1, 2008

Completed
1 day until next milestone

First Posted

Study publicly available on registry

December 2, 2008

Completed
Last Updated

November 25, 2009

Status Verified

September 1, 2008

Enrollment Period

10.7 years

First QC Date

December 1, 2008

Last Update Submit

November 21, 2009

Conditions

Anisometropia

Keywords

LASIKsafetyefficacystabilityhigh anisometropiapatients 8 to 15 years oldconventional treatments have failed

Study Arms (1)

1

EXPERIMENTAL

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

Interventions

LASIKPROCEDURE

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.

1

Eligibility Criteria

Age8 Years - 15 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

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

You may not qualify if:

  • Diabetes
  • Autoimmune diseases
  • Topographic abnormalities

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

IOG

Goiânia, Goiás, Brazil

Location

MeSH Terms

Conditions

Anisometropia

Interventions

Keratomileusis, Laser In Situ

Condition Hierarchy (Ancestors)

Refractive ErrorsEye Diseases

Intervention Hierarchy (Ancestors)

Corneal Surgery, LaserLaser TherapyTherapeuticsAblation TechniquesSurgical Procedures, OperativeKeratectomyRefractive Surgical ProceduresOphthalmologic Surgical Procedures

Study Officials

  • Belquiz A Nassaralla, MD, PhD

    Instituto de Olhos de Goiania

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

December 1, 2008

First Posted

December 2, 2008

Study Start

January 1, 1998

Primary Completion

September 1, 2008

Study Completion

September 1, 2008

Last Updated

November 25, 2009

Record last verified: 2008-09

Locations

BR(1)