NCT02003235

Brief Summary

The study will evaluate the effect of Reviview™, a dichoptic video display device for administrating a novel treatment protocol for Amblyopia (lazy eye) in kids. The effect of the treatment will be measured by the change from baseline in Visual acuity and in Stereoscopic Vision; and to assess the ease of use of and compliance by the patients.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
35

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Oct 2013

Longer than P75 for not_applicable

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2013

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

December 1, 2013

Completed
5 days until next milestone

First Posted

Study publicly available on registry

December 6, 2013

Completed
3.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 15, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 15, 2017

Completed
Last Updated

July 21, 2017

Status Verified

July 1, 2017

Enrollment Period

3.8 years

First QC Date

December 1, 2013

Last Update Submit

July 18, 2017

Conditions

Amblyopia

Keywords

Amblyopia

Outcome Measures

Primary Outcomes (1)

  • Improvement in VA in amblyopic eye

    3 months

Study Arms (1)

Single Arm

EXPERIMENTAL

Daily watching videos using Reviview™, a dichoptic video display device

Device: Daily watching videos using Reviview™, a dichoptic video display device, for 60 min

Interventions

Daily watching videos using Reviview™, a dichoptic video display device, for 60 minDEVICE
Single Arm

Eligibility Criteria

Age4 Years - 8 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Refractive or Strabismic Amblyopia, with best corrected visual acuity.
  • (1) Refractive Amblyopia, visual acuity score \<6:15 (worse then)
  • or (2) Strabismic Amblyopia, visual acuity score between 6:15 and 6:30

You may not qualify if:

  • Diagnosed with epilepsy, recently treated with occlusion or penalization therapy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Tel-Aviv Sourasky Medical Center

Tel Aviv, Israel

Location

MeSH Terms

Conditions

Amblyopia

Condition Hierarchy (Ancestors)

Brain DiseasesCentral Nervous System DiseasesNervous System DiseasesVision DisordersSensation DisordersNeurologic ManifestationsEye DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Haim Stolovitch, MD

    Tel-Aviv Sourasky Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 1, 2013

First Posted

December 6, 2013

Study Start

October 1, 2013

Primary Completion

July 15, 2017

Study Completion

July 15, 2017

Last Updated

July 21, 2017

Record last verified: 2017-07

Locations

IL(1)