## Protocol Section
### Identification Module
**NCT ID:** NCT04955379

**Brief Title:** Study in Pediatric Volunteers of a Handheld Device Versus a Standard Diagnostic Device in Ophthalmic Refraction

**Official Title:** An Exploratory Study in Healthy Pediatric Volunteers to Evaluate the Performance of a Handheld Device Compared With Standard Eye Care Diagnostic Device in Measuring Ophthalmic Refraction

#### Organization Study ID Info
**ID:** EYEQUE-005
#### Organization
**Class:** INDUSTRY
**Full Name:** EyeQue Corp.
### Status Module
#### Completion Date
**Date:** 2023-07-31

**Type:** ESTIMATED

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2023-01-30

**Type:** ACTUAL

**Last Update Submit Date:** 2023-01-26

**Overall Status:** RECRUITING

#### Primary Completion Date
**Date:** 2023-07-31

**Type:** ESTIMATED

#### Start Date
**Date:** 2021-12-15

**Type:** ACTUAL

**Status Verified Date:** 2023-01

#### Study First Post Date
**Date:** 2021-07-08
**Type:** ACTUAL
**Study First Submit Date:** 2021-06-28
**Study First Submit QC Date:** 2021-07-06
### Sponsor Collaborators Module

#### Collaborators

**Class:** OTHER_GOV

**Name:** Sheba Medical Center

#### Lead Sponsor

**Class:** INDUSTRY

**Name:** EyeQue Corp.

#### Responsible Party

**Type:** SPONSOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** False

**Is US Export:** False

**Oversight Has DMC:** False

### Description Module

**Brief Summary:** This study is exploratory and examines whether the refraction results obtained from a novel optical device yields results similar to the ophthalmic refraction measurements obtained from an autorefractor in children.

**Detailed Description:** This study is exploratory and examines whether the refraction results obtained from a novel optical device yields results similar to the ophthalmic refraction measurements obtained from an autorefractor in the age stratum of 6 through 17 years.

### Conditions Module

**Conditions:**

- Refractive Errors

- Accomodation

- Diagnostic Self Evaluation

**Keywords:**

- Refraction

- Telehealth

- Vision

- Accommodation

### Design Module

#### Design Info

**Allocation:** NA

**Intervention Model:** SINGLE_GROUP

##### Masking Info

**Masking:** NONE

**Primary Purpose:** DIAGNOSTIC

#### Enrollment Info

**Count:** 50

**Type:** ESTIMATED

**Phases:**

- NA

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

**Description:** Subjects will be tested with the Autorefractor and the EQ103 device

**Intervention Names:**

- Device: EQ103

**Label:** Measurements

**Type:** OTHER

### Interventions

#### Intervention 1

**Arm Group Labels:**

- Measurements

**Description:** Ophthalmic Refractometer with a measurement and background channel

**Name:** EQ103

**Type:** DEVICE

### Outcomes Module

#### Primary Outcomes

**Description:** Tendency of, or achieving, statistical equivalence of refraction measurements EQ103 (non-cycloplegic) compared with autorefractor (non-cycloplegic)

**Measure:** Tendency of, or achieving, statistical equivalence of refraction measurements EQ103 (non-cycloplegic) compared with autorefractor (non-cycloplegic)

**Time Frame:** Day 1

#### Secondary Outcomes

**Description:** EyeQue EQ103 (non-cycloplegic) and the autorefractor (cycloplegic) assessed by refractive error measured by each device analyzed in the following age-strata.

Age Groups

* 6 to 12 y.o. \>12 to \<18 y.o.

**Measure:** EyeQue EQ103 (non-cycloplegic) and the autorefractor (cycloplegic) assessed by refractive error measured by each device analyzed by age-strata.

**Time Frame:** Day 1 and 14

**Description:** EyeQue EQ103 (non-cycloplegic) and the autorefractor (cycloplegic) assessed by refractive error measured by each device analyzed in the following age-strata.

Age Group

* 6 to 12 y.o.

**Measure:** EyeQue EQ103 (non-cycloplegic) and the autorefractor (cycloplegic) assessed by refractive error measured by each device analyzed by age-strata.

**Time Frame:** Day 1 and 14

**Description:** EQ103 without cycloplegia will be compared to EQ103 with cycloplegia in the following age-strata.

Age Group

* 6 to 12 y.o.

**Measure:** EQ103 without cycloplegia will be compared to EQ103 with cycloplegia by younger age-strata.

**Time Frame:** Day 1 and 14

### Eligibility Module

**Eligibility Criteria:** Inclusion Criteria:

* Male or Female
* Ages ≥6 y.o. and \<18 y.o.
* Binocular vision
* Parent(s) or Guardian(s) willing and able to give informed consent on behalf of the subject.
* Subject able to follow all study procedures and requirements

Exclusion Criteria:

* Spherical correction \> +8 or \< -10
* Using anticholinergic medications (including first-generation antihistamines) or other medications known to affect visual acuity within the greater of 3 days or 5 half-lives prior to enrolling in this study.
* Using an investigational drug or approved therapy for investigational use within the greater of 3 days or 5 half-lives prior to enrolling in this study.
* Has initiated any new medication in the past 2 weeks that, in the best medical judgment of the investigator, would impact their participation in the study or ability to use the EyeQue EQ103 device,
* Any self/caregiver-reported mental illness or condition of the subject, including but not limited to claustrophobia, fear of simulators, nyctophobia.
* Any self/caregiver-reported neurological diseases of the subject, including but not limited to: epilepsy, nystagmus.
* Any self/caregiver-reported glaucoma diagnosis of the subject.
* Eye disease, including but not limited to:

  * Cataracts
  * Macular degeneration
  * Eye infection (by self-report or observation)
  * Keratoconus
  * Diabetic neuropathy/retinopathy
  * Cytomegalovirus retinitis
  * Color blindness (any color deficiency)
  * Diabetic macular edema
  * Amblyopia
  * Chronic or acute uveitis
  * Strabismus
  * Astigmatism \> 3 diopters
  * Macular hole
* Lack physical dexterity to properly operate the EyeQue device.
* Lack the ability to follow instruction.
* Lack binocular vision.
* Are colorblind.
* Had eye surgery within the last 12 months.

**Healthy Volunteers:** True

**Maximum Age:** 17 Years

**Minimum Age:** 6 Years

**Sex:** ALL

**Standard Ages:**

- CHILD

### Contacts Locations Module

#### Central Contacts

**Contact 1:**

**Email:** noam.sapiens@eyeque.com

**Name:** Noam Sapiens, PhD

**Phone:** (510) 953-6433

**Phone Ext:** 600

**Role:** CONTACT

**Contact 2:**

**Name:** Ygal Rotenstreich

**Phone:** (408) 630-5086

**Role:** CONTACT

#### Locations

**Location 1:**

**City:** Tel HaShomer

**Contacts:**

***Contact 1:***

- **Email:** ygal.rotenstreich@sheba.health.gov.il

- **Name:** Ygal Rotenstreich

- **Phone:** +972-527485888

- **Role:** CONTACT

**Country:** Israel

**Facility:** Sheba Medical Center

**Status:** RECRUITING

**Zip:** 5262100

#### Overall Officials

**Official 1:**

**Affiliation:** Sponsor GmbH

**Name:** Noam Sapiens, PhD

**Role:** STUDY_DIRECTOR

### IPD Sharing Statement Module

**IPD Sharing:** NO

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000005128

- Term: Eye Diseases

### Condition Browse Module - Browse Branches

- Abbrev: BC11

- Name: Eye Diseases

- Abbrev: All

- Name: All Conditions

### Condition Browse Module - Browse Leaves

- ID: M14872

- Name: Refractive Errors

- Relevance: HIGH

- As Found: Refractive Errors

- ID: M8271

- Name: Eye Diseases

- Relevance: LOW

- As Found: Unknown

### Condition Browse Module - Meshes

- ID: D000012030

- Term: Refractive Errors

### Misc Info Module

- Version Holder: 2024-05-24
