NCT00131729

Brief Summary

The purpose of this study was to determine whether compliance with occlusion therapy for amblyopia could be improved and, secondly, if risk factors for non-compliance could be identified.

Trial Health

90
On Track

Trial Health Score

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

Enrollment
200

participants targeted

Target at P25-P50 for phase_3

Timeline
Completed

Started Jul 2001

Typical duration for phase_3

Geographic Reach
2 countries

2 active sites

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2001

Completed
4.1 years until next milestone

First Submitted

Initial submission to the registry

August 18, 2005

Completed
1 day until next milestone

First Posted

Study publicly available on registry

August 19, 2005

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2005

Completed
Last Updated

March 20, 2006

Status Verified

March 1, 2006

First QC Date

August 18, 2005

Last Update Submit

March 17, 2006

Conditions

Amblyopia

Keywords

AmblyopiaOcclusion therapyComplianceRisk factors

Outcome Measures

Primary Outcomes (1)

  • Percentage of compliance (realised/prescribed occlusion time) in the intervention and control group

Secondary Outcomes (1)

  • Secondary outcome measure was influence of social-economic, ethnic and clinical factors on compliance

Interventions

Educational programmeBEHAVIORAL

Eligibility Criteria

Age0 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • All newly diagnosed amblyopic children with an inter-ocular difference in visual acuity of at least 0.2 logMAR, strabismus and/or anisometropia or deprivation (e.g. cataract)

You may not qualify if:

  • Previous treatment for amblyopia
  • Neurological disorder
  • Medication
  • Other eye disorder
  • Decreased visual acuity caused by brain damage or trauma

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Universitäts-Augenklinik Frankfurt

Frankfurt am Main, 60590, Germany

Location

Leicester Royal Infirmary; Dept. of Ophthalmology

Leicester, LE2 7LX, United Kingdom

Location

MeSH Terms

Conditions

AmblyopiaPatient Compliance

Condition Hierarchy (Ancestors)

Brain DiseasesCentral Nervous System DiseasesNervous System DiseasesVision DisordersSensation DisordersNeurologic ManifestationsEye DiseasesSigns and SymptomsPathological Conditions, Signs and SymptomsPatient Acceptance of Health CareTreatment Adherence and ComplianceHealth BehaviorBehavior

Study Officials

  • Huibert J Simonsz, MD, PhD

    ErasmusMC, Department of Ophthalmology

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
SINGLE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

August 18, 2005

First Posted

August 19, 2005

Study Start

July 1, 2001

Study Completion

December 1, 2005

Last Updated

March 20, 2006

Record last verified: 2006-03

Locations

GB(1)DE(1)