## Protocol Section
### Identification Module
**NCT ID:** NCT06429280

**Brief Title:** Clinical Data Registry of Amblyopia Patients on Luminopia Treatment

**Official Title:** Clinical Data Registry of Amblyopia Patients on Luminopia Treatment

#### Organization Study ID Info
**ID:** R-AM-1
#### Organization
**Class:** INDUSTRY
**Full Name:** Luminopia
### Status Module
#### Completion Date
**Date:** 2026-12-01

**Type:** ESTIMATED

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-24

**Type:** ACTUAL

**Last Update Submit Date:** 2024-05-20

**Overall Status:** RECRUITING

#### Primary Completion Date
**Date:** 2026-04-01

**Type:** ESTIMATED

#### Start Date
**Date:** 2023-09-01

**Type:** ACTUAL

**Status Verified Date:** 2024-05

#### Study First Post Date
**Date:** 2024-05-24
**Type:** ACTUAL
**Study First Submit Date:** 2024-02-23
**Study First Submit QC Date:** 2024-05-20
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** INDUSTRY

**Name:** Luminopia

#### Responsible Party

**Type:** SPONSOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** False

**Oversight Has DMC:** False

### Description Module

**Brief Summary:** Amblyopia is the most prevalent cause of reduced monocular visual acuity in children and young adults, with estimates of prevalence ranging from 1% to 5%. The most common associated amblyogenic risk factors are uncorrected anisometropia, strabismus, or a combination of these. In addition to reduced visual acuity, amblyopic patients may also have measurable dysfunction of accommodation, fixation, binocularity, vergence, reading fluency, depth perception, and contrast sensitivity.

For the first time since the incorporation of atropine penalization into amblyopia management, physicians can now offer Luminopia, an FDA-approved dual action dichoptic treatment, to patients with amblyopia. Since the product became commercially available in November 2022, the number of patients on Luminopia therapy continues to grow. This presents a unique opportunity to gather real world evidence from a large number of patients, representative of how ophthalmologists and optometrists are applying this novel treatment in the real world. A registry of the clinical data associated with Luminopia treatment, with IRB oversight, will provide answers to key scientific questions using a large dataset.

### Conditions Module

**Conditions:**

- Amblyopia

### Design Module

#### Design Info

**Observational Model:** COHORT

**Time Perspective:** RETROSPECTIVE

#### Enrollment Info

**Count:** 500

**Type:** ESTIMATED

**Study Type:** OBSERVATIONAL

### Arms Interventions Module

### Interventions

#### Intervention 1

**Description:** Medical Device which treats unilateral amblyopia through therapeutic software which stimulate vision

**Name:** N/A this is an observational study of Standard of Care

**Type:** DEVICE

### Outcomes Module

#### Primary Outcomes

**Description:** Change in Visual Acuity from baseline to consecutive visits

**Measure:** Change in Visual Acuity from baseline to consecutive visits

**Time Frame:** 3, 6,12, 24 months

**Description:** Duration of Visual Acuity treatment and number of follow-up visits

**Measure:** Duration of Visual Acuity treatment and number of follow-up visits

**Time Frame:** 3, 6,12, 24 months

**Description:** Durability of Visual Acuity results post-treatment cessation

**Measure:** Durability of Visual Acuity results post-treatment cessation

**Time Frame:** 3, 6,12, 24 months

**Description:** Adherence with Luminopia treatment

**Measure:** Adherence with Luminopia treatment

**Time Frame:** 3, 6,12, 24 months

**Description:** Change in Stereoacuity from baseline to consecutive visits

**Measure:** Change in Stereoacuity from baseline to consecutive visits

**Time Frame:** 3, 6,12, 24 months

#### Secondary Outcomes

**Description:** Visual Acuity analyses will also be conducted by Prior Treatment

**Measure:** Visual Acuity analyses will also be conducted by Prior Treatment

**Time Frame:** 3, 6,12, 24 months

**Description:** Visual Acuity analyses will also be conducted by Amblyopia Type

**Measure:** Visual Acuity analyses will also be conducted by Amblyopia Type

**Time Frame:** 3, 6,12, 24 months

**Description:** Visual Acuity Analyses will also be conducted by Age

**Measure:** Visual Acuity Analyses will also be conducted by Age

**Time Frame:** 3, 6,12, 24 months

**Description:** Visual Acuity analyses will also be conducted by Baseline Angle of Deviation

**Measure:** Visual Acuity analyses will also be conducted by Baseline Angle of Deviation

**Time Frame:** 3, 6,12, 24 months

**Description:** Visual Acuity analyses will also be conducted by Severity (Baseline Visual Acuity)

**Measure:** Visual Acuity analyses will also be conducted by Severity (Baseline Visual Acuity)

**Time Frame:** 3, 6,12, 24 months

**Description:** Visual Acuity analyses will also be conducted by Adherence to Treatment

**Measure:** Visual Acuity analyses will also be conducted by Adherence to Treatment

**Time Frame:** 3, 6,12, 24 months

**Description:** Visual Acuity Analyses will also be conducted by Prescribed Dose

**Measure:** Visual Acuity Analyses will also be conducted by Prescribed Dose

**Time Frame:** 3, 6,12, 24 months

### Eligibility Module

**Eligibility Criteria:** Inclusion Criteria:

* Have a diagnosis of amblyopia
* Have undergone or currently undergoing Luminopia treatment for a minimum of 12 weeks

Exclusion Criteria:

-Have participated in prior Luminopia clinical trials

**Sampling Method:** PROBABILITY_SAMPLE

**Sex:** ALL

**Standard Ages:**

- CHILD

- ADULT

- OLDER_ADULT

**Study Population:** Patients with a diagnosis of Amblyopia

### Contacts Locations Module

#### Locations

**Location 1:**

**City:** San Ramon

**Contacts:**

***Contact 1:***

- **Email:** endria@luminopia.com

- **Name:** Endri Angjeli

- **Phone:** 978-806-7080

- **Role:** CONTACT

**Country:** United States

**Facility:** UCSF Benioff Children's Physicians

**State:** California

**Status:** RECRUITING

**Zip:** 94583

**Location 2:**

**City:** Santa Barbara

**Contacts:**

***Contact 1:***

- **Email:** endri@luminopia.com

- **Name:** Endri Angjeli

- **Phone:** 978-806-7080

- **Role:** CONTACT

**Country:** United States

**Facility:** Sansum Clinic

**State:** California

**Status:** RECRUITING

**Zip:** 93110

**Location 3:**

**City:** Crestview

**Contacts:**

***Contact 1:***

- **Email:** endri@luminopia.com

- **Name:** Endri Angjeli

- **Phone:** 978-806-7080

- **Role:** CONTACT

**Country:** United States

**Facility:** Okaloosa Ophthalmology

**State:** Florida

**Status:** RECRUITING

**Zip:** 32536

**Location 4:**

**City:** Gainesville

**Contacts:**

***Contact 1:***

- **Email:** endri@luminopia.com

- **Name:** Endri Angjeli

- **Phone:** 978-806-7080

- **Role:** CONTACT

**Country:** United States

**Facility:** Family Focus Eye Care

**State:** Florida

**Status:** RECRUITING

**Zip:** 32605

**Location 5:**

**City:** Maitland

**Contacts:**

***Contact 1:***

- **Email:** endri@luminopia.com

- **Name:** Endri Angjeli

- **Phone:** 978-806-7080

- **Role:** CONTACT

***Contact 2:***

- **Name:** Louis Blumenfeld

- **Role:** PRINCIPAL_INVESTIGATOR

**Country:** United States

**Facility:** Eye Physicians of Central Florida

**State:** Florida

**Status:** RECRUITING

**Zip:** 32751

**Location 6:**

**City:** Savannah

**Contacts:**

***Contact 1:***

- **Email:** endri@luminopia.com

- **Name:** Endri Angjeli

- **Phone:** 978-806-7080

- **Role:** CONTACT

**Country:** United States

**Facility:** Children's Eye Institute of Savannah

**State:** Georgia

**Status:** RECRUITING

**Zip:** 31406

**Location 7:**

**City:** Honolulu

**Contacts:**

***Contact 1:***

- **Email:** endri@luminopia.com

- **Name:** Endri Angjeli

- **Phone:** 978-806-7080

- **Role:** CONTACT

**Country:** United States

**Facility:** Honolulu Eye Clinic

**State:** Hawaii

**Status:** RECRUITING

**Zip:** 96813

**Location 8:**

**City:** Chicago

**Contacts:**

***Contact 1:***

- **Email:** endri@luminopia.com

- **Name:** Endri Angjeli

- **Phone:** 978-806-7080

- **Role:** CONTACT

**Country:** United States

**Facility:** Lurie Children's Hospital

**State:** Illinois

**Status:** RECRUITING

**Zip:** 60611

**Location 9:**

**City:** Indianapolis

**Contacts:**

***Contact 1:***

- **Email:** endri@luminopia.com

- **Name:** Endri Angjeli

- **Phone:** 978-806-7080

- **Role:** CONTACT

**Country:** United States

**Facility:** Riley Children's Hospital at IU Health

**State:** Indiana

**Status:** RECRUITING

**Zip:** 46202

**Location 10:**

**City:** Las Vegas

**Contacts:**

***Contact 1:***

- **Email:** endri@luminopia.com

- **Name:** Endri Angjeli

- **Phone:** 978-806-7080

- **Role:** CONTACT

**Country:** United States

**Facility:** Nevada Eye Physicians

**State:** Nevada

**Status:** RECRUITING

**Zip:** 89149

**Location 11:**

**City:** Concord

**Contacts:**

***Contact 1:***

- **Email:** endri@luminopia.com

- **Name:** Endri Angjeli

- **Phone:** 978-806-7080

- **Role:** CONTACT

**Country:** United States

**Facility:** Concord Eye Center

**State:** New Hampshire

**Status:** RECRUITING

**Zip:** 03301

**Location 12:**

**City:** Philadelphia

**Contacts:**

***Contact 1:***

- **Email:** endri@luminopia.com

- **Name:** Endri Angjeli

- **Phone:** 978-806-7080

- **Role:** CONTACT

**Country:** United States

**Facility:** Children's Hospital Of Philadelphia

**State:** Pennsylvania

**Status:** RECRUITING

**Zip:** 19104

**Location 13:**

**City:** Fort Worth

**Contacts:**

***Contact 1:***

- **Email:** endri@luminopia.com

- **Name:** Endri Angjeli

- **Phone:** 978-806-7080

- **Role:** CONTACT

**Country:** United States

**Facility:** Pediatric Eye Specialist

**State:** Texas

**Status:** RECRUITING

**Zip:** 76104

### IPD Sharing Statement Module

**IPD Sharing:** NO

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000001927

- Term: Brain Diseases

- ID: D000002493

- Term: Central Nervous System Diseases

- ID: D000009422

- Term: Nervous System Diseases

- ID: D000014786

- Term: Vision Disorders

- ID: D000012678

- Term: Sensation Disorders

- ID: D000009461

- Term: Neurologic Manifestations

- ID: D000005128

- Term: Eye Diseases

### Condition Browse Module - Browse Branches

- Abbrev: BC10

- Name: Nervous System Diseases

- Abbrev: BC11

- Name: Eye Diseases

- Abbrev: BC23

- Name: Symptoms and General Pathology

- Abbrev: All

- Name: All Conditions

### Condition Browse Module - Browse Leaves

- ID: M3891

- Name: Amblyopia

- Relevance: HIGH

- As Found: Amblyopia

- ID: M5204

- Name: Brain Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M5742

- Name: Central Nervous System Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M17530

- Name: Vision Disorders

- Relevance: LOW

- As Found: Unknown

- ID: M15490

- Name: Sensation Disorders

- Relevance: LOW

- As Found: Unknown

- ID: M12404

- Name: Neurologic Manifestations

- Relevance: LOW

- As Found: Unknown

- ID: M8271

- Name: Eye Diseases

- Relevance: LOW

- As Found: Unknown

### Condition Browse Module - Meshes

- ID: D000000550

- Term: Amblyopia

### Misc Info Module

- Version Holder: 2024-05-31
