## Protocol Section
### Identification Module
**NCT ID:** NCT05893979

**Acronym:** BIRCH

**Brief Title:** Myopia Control Spectacle Lens Cessation Study

**Official Title:** Myopia Control Spectacle Lens Use Cessation Study

#### Organization Study ID Info
**ID:** CPRO-2303-001
#### Organization
**Class:** INDUSTRY
**Full Name:** SightGlass Vision, Inc.
### Status Module
#### Completion Date
**Date:** 2025-01-31

**Type:** ESTIMATED

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2023-11-22

**Type:** ACTUAL

**Last Update Submit Date:** 2023-11-21

**Overall Status:** ACTIVE_NOT_RECRUITING

#### Primary Completion Date
**Date:** 2024-12-31

**Type:** ESTIMATED

#### Start Date
**Date:** 2023-06-23

**Type:** ACTUAL

**Status Verified Date:** 2023-11

#### Study First Post Date
**Date:** 2023-06-08
**Type:** ACTUAL
**Study First Submit Date:** 2023-05-30
**Study First Submit QC Date:** 2023-05-30
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** INDUSTRY

**Name:** SightGlass Vision, Inc.

#### Responsible Party

**Type:** SPONSOR

### Oversight Module

**Is FDA Regulated Device:** True

**Is FDA Regulated Drug:** False

**Is Unapproved Device:** True

**Is US Export:** True

**Oversight Has DMC:** False

### Description Module

**Brief Summary:** To quantify myopic progression (cycloplegic spherical equivalent refraction - cSER) following the cessation of use of specific spectacle lenses.

To quantify axial length progression following cessation of use of specific spectacle lenses.

### Conditions Module

**Conditions:**

- Myopia

- Myopia Progression

- Juvenile Myopia

### Design Module

#### Design Info

**Allocation:** NON_RANDOMIZED

**Intervention Model:** PARALLEL

##### Masking Info

**Masking:** NONE

**Primary Purpose:** TREATMENT

#### Enrollment Info

**Count:** 90

**Type:** ESTIMATED

**Phases:**

- NA

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

**Intervention Names:**

- Device: Spectacle Lenses

**Label:** Test Lens Group

**Type:** ACTIVE_COMPARATOR

#### Arm Group 2

**Intervention Names:**

- Device: Spectacle Lenses

**Label:** Control Lens Group

**Type:** ACTIVE_COMPARATOR

### Interventions

#### Intervention 1

**Arm Group Labels:**

- Control Lens Group

- Test Lens Group

**Description:** Standard Spectacle Lenses

**Name:** Spectacle Lenses

**Type:** DEVICE

### Outcomes Module

#### Primary Outcomes

**Description:** Change in cSER

**Measure:** Cycloplegic Spherical Equivalent Refraction (cSER)

**Time Frame:** 12 months

#### Secondary Outcomes

**Description:** Change in cSER

**Measure:** Cycloplegic Spherical Equivalent Refraction (cSER)

**Time Frame:** 6 months

**Description:** Change in AL

**Measure:** Axial Length (AL)

**Time Frame:** 12 months

### Eligibility Module

**Eligibility Criteria:** Inclusion Criteria:

* Previously a successfully completed participant in the CYPRESS Extension study;
* Agree to wear the assigned spectacles constantly except for sleeping, swimming, or other activities in which spectacle wear would be dangerous or otherwise not possible (minimum of 10 hours per day);
* Willingness to participate in the trial for up to 12 months without contact lens wear;
* The subject's parent(s) or legal guardian(s) must read, understand, and sign the Statement of Informed Consent and receive a fully executed copy of the form.

Exclusion Criteria:

* Known allergy to proparacaine, tetracaine, or tropicamide.

**Healthy Volunteers:** True

**Maximum Age:** 16 Years

**Minimum Age:** 9 Years

**Sex:** ALL

**Standard Ages:**

- CHILD

### Contacts Locations Module

#### Locations

**Location 1:**

**City:** Whittier

**Country:** United States

**Facility:** Golden Optometric Group

**State:** California

**Zip:** 90606

**Location 2:**

**City:** Longwood

**Country:** United States

**Facility:** Omega Vision Center PA

**State:** Florida

**Zip:** 32779

**Location 3:**

**City:** Pittsburg

**Country:** United States

**Facility:** Kannarr Eye Care

**State:** Kansas

**Zip:** 66762

**Location 4:**

**City:** Raytown

**Country:** United States

**Facility:** Advanced Eyecare PC

**State:** Missouri

**Zip:** 64133

**Location 5:**

**City:** Vestal

**Country:** United States

**Facility:** Sacco Eye Group

**State:** New York

**Zip:** 13850

**Location 6:**

**City:** Memphis

**Country:** United States

**Facility:** Total Eye Care

**State:** Tennessee

**Zip:** 38119

**Location 7:**

**City:** Houston

**Country:** United States

**Facility:** Vision Optique

**State:** Texas

**Zip:** 77205

**Location 8:**

**City:** Salt Lake City

**Country:** United States

**Facility:** William J Bogus, OD, FAAO

**State:** Utah

**Zip:** 84106

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000012030

- Term: Refractive Errors

- ID: D000005128

- Term: Eye Diseases

### Condition Browse Module - Browse Branches

- Abbrev: BC23

- Name: Symptoms and General Pathology

- Abbrev: All

- Name: All Conditions

- Abbrev: BC11

- Name: Eye Diseases

### Condition Browse Module - Browse Leaves

- ID: M20559

- Name: Disease Progression

- Relevance: LOW

- As Found: Unknown

- ID: M12168

- Name: Myopia

- Relevance: HIGH

- As Found: Myopia

- ID: M14872

- Name: Refractive Errors

- Relevance: LOW

- As Found: Unknown

- ID: M8271

- Name: Eye Diseases

- Relevance: LOW

- As Found: Unknown

### Condition Browse Module - Meshes

- ID: D000009216

- Term: Myopia

### Misc Info Module

- Version Holder: 2024-05-24
