Monitored Controlled Intermittent Alternate Occlusion (CIAO) Therapy for Intermittent Exotropia

NCT02902887 | Unknown

• 1 other identifier: HJW1601
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

This study presents an opportunity to understand a novel, previously unreported controlled intermittent alternate occlusion (CIAO) therapy glasses, which may improve the control of Intermittent exotropia (IXT).

Conditions

Intermittent Exotropia

Outcome Measures

Primary Outcomes (1)

• Control of the exodeviation assessment (scaled 1-5)

  Intermittent Exotropia Control Scale (1-5) 5 = Constant exotropia 4 = Exotropia \> 50% of the 30-second period before dissociation 3 = Exotropia \< 50% of the 30-second period before dissociation 2 = No exotropia unless dissociated, recovers in \> 5 seconds 1 = No exotropia unless dissociated, recovers in 1-5 seconds 0 = No exotropia unless dissociated, recovers in \< 1 second (phoria)

  3-month

Study Arms (2)

Monitored CIAO therapy

EXPERIMENTAL

Participants wear 3-hour CIAO therapy

Device: Controlled Intermittent Alternate Occlusion (CIAO ) glasses

Observation

NO INTERVENTION

No intervention, just observation

Interventions

Controlled Intermittent Alternate Occlusion (CIAO ) glasses DEVICE

Monitored CIAO therapy glasses

Monitored CIAO therapy

Eligibility Criteria

• Age: 3 Years - 11 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• The following criteria must be met for the patient to be enrolled in the study:
• Age 3 to 11 years old
• Intermittent exotropia (manifest deviation) meeting all of the following criteria:
• Intermittent exotropia at distance OR constant exotropia at distance and either intermittent exotropia or exophoria at near
• Exodeviation at least 10PD at distance OR 15PD at near measured by prism and alternate cover test (PACT)
• No previous surgical or non-surgical treatment for IXT (other than refractive correction)
• Visual acuity in the worse eye 20/40 (0.3 logMAR) or better on ATS HOTV for ages 3 - 5 and 20/25 (0.1 logMAR) or better on ATS HOTV for ages 6 - 11
• No hyperopia greater than +3.50 D spherical equivalent in either eye
• No myopia greater than -6.00 D spherical equivalent in either eye
• Patients must be wearing refractive correction (spectacles or contact lenses) for at least one week if refractive error (based on cycloplegic refraction performed within 6 months) meets any of the following:
• Myopia \> -0.50 D spherical equivalent in either eye
• Anisometropia \> 1.00 D spherical equivalent
• Astigmatism in either eye \> 2.00 D if ≤ 5 years old and \> 1.50 D if \> 5 years old
• Refractive correction for patients meeting the above refractive error criteria must meet the following guidelines:
• Anisometropia spherical equivalent must be within 0.25D of the full anisometropic difference correction

You may not qualify if:

• Only phoria at both distance and near
• Prior non-surgical treatment for IXT other than refractive correction (e.g., vergence therapy, occlusion, vision therapy/orthoptics, or deliberate over-minus with spectacles more than 0.50D)
• Previous amblyopia treatment other than refractive correction within 1 year
• Vision therapy/orthoptics for any reason within the last year
• Interocular visual acuity difference more than 0.2 logMAR (2 lines on ATS HOTV for patients 3 to \< 7 years old or 10 letters on E-ETDRS for patients ≥ 7 years old)
• Investigator planning to initiate amblyopia treatment

Sponsors & Collaborators

• Salus University: lead

Study Sites (1)

Salus University

Elkins Park, Pennsylvania, United States

RECRUITING

MeSH Terms

Interventions

Eyeglasses

Intervention Hierarchy (Ancestors)

Lenses; Optical Devices; Equipment and Supplies

Central Study Contacts

Jingyun Wang, PhD

CONTACT

215-780-1376; jwang@salus.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 8, 2016
• First Posted: September 16, 2016
• Study Start: August 1, 2016
• Primary Completion: May 1, 2021
• Study Completion: May 1, 2021
• Last Updated: April 5, 2019

Record last verified: 2019-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)