NCT02495935

Brief Summary

This is a prospective, randomized, parallel group sham-controlled blinded clinical trial to assess the feasibility and efficacy of transcorneal electrical stimulation (TES) in the improvement of visual function outcomes in adults with amblyopia. The trial will assess the treatment effect of TES to Sham TES in the amblyopic eye of affected patients.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jul 2015

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

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, 2015

Completed
5 days until next milestone

First Submitted

Initial submission to the registry

July 6, 2015

Completed
7 days until next milestone

First Posted

Study publicly available on registry

July 13, 2015

Completed
5.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2020

Completed
Last Updated

March 5, 2020

Status Verified

March 1, 2020

Enrollment Period

5.1 years

First QC Date

July 6, 2015

Last Update Submit

March 4, 2020

Conditions

Amblyopia

Keywords

TESTranscorneal Electrical StimulationAmblyopia

Outcome Measures

Primary Outcomes (1)

  • Mean change in Best Corrected Visual Acuity (ETDRS letters)

    Change From Baseline in Best Corrected Visual Acuity (BCVA) as Measured by Early Treatment Diabetic Retinopathy Study (ETDRS) to Week 16 (4 weeks post last treatment).

    16 weeks

Study Arms (2)

OkuStim®

EXPERIMENTAL

The OkuStim® group will undergo 30-minute treatments once a week for 12 weeks at 200% threshold level according to their individual phosphene threshold (IPT) readings from the OkuStim® device at the pre-treatment visit (week 1). Rectangular biphasic current pulses (1-ms positive, directly followed by 1-ms negative) will be applied at a frequency of 20 Hz.

Device: OkuStim®

Sham-OkuStim®

SHAM COMPARATOR

Subjects in the Sham-OkuStim® group will wear treatment glasses and corneal electrodes for 30 minutes weekly for 12 weeks, but corneal electrodes will not be activated.

Device: Sham-OkuStim®

Interventions

OkuStim®DEVICE

Transcorneal Electrical Stimulation delivered by the Okuvision Stimulation Set manufactured by Okuvision GmbH, Reutlingen, Germany

Also known as: TES, Transcorneal Electrical Stimulation
OkuStim®
Sham-OkuStim®DEVICE

Transcorneal Electrical Stimulation delivered by the Okuvision Stimulation Set manufactured by Okuvision GmbH, Reutlingen, Germany

Sham-OkuStim®

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age ≥ 18 years
  • Diagnosis of amblyopia made by the principal investigators.
  • Best corrected visual acuity in the amblyopic eye equal to or worse than 20/70
  • Willing and able to give informed consent and to participate for the full duration of the study.
  • Strabismus less than 10 prism diopters.

You may not qualify if:

  • Any other significant ophthalmologic disorder or condition with relevant effect upon visual function as evaluated by principal investigator. (eg. Retinal degeneration, proliferative diabetic retinopathy, age related macular degeneration, optic nerve abnormality)
  • Women who are pregnant or women with childbearing potential who are unwilling to use medically acceptable means of birth control for study duration.
  • Presence of a pacemaker, any metal artifacts in head and trunk, any history of epileptic seizure or severe psychiatric disease (schizophrenia, etc.)
  • Inability to detect phosphenes above 0.5mA at time of threshold detection.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

WillsEye Hospital

Philadelphia, Pennsylvania, 19107, United States

RECRUITING

MeSH Terms

Conditions

Amblyopia

Condition Hierarchy (Ancestors)

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

Central Study Contacts

Avrey Thau

CONTACT

215-928-3418AThau@willseye.org

Nelson

CONTACT

LNelson@willseye.org

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD

Study Record Dates

First Submitted

July 6, 2015

First Posted

July 13, 2015

Study Start

July 1, 2015

Primary Completion

August 1, 2020

Study Completion

August 1, 2020

Last Updated

March 5, 2020

Record last verified: 2020-03

Locations

US(1)