## Protocol Section
### Identification Module
**NCT ID:** NCT00787579

**Brief Title:** Assessment of Bifocal and Prismatic Bifocal Spectacles for Myopia Control in Children

**Official Title:** Assessment of Bifocal and Prismatic Bifocal Spectacles for Myopia Control in Children

#### Organization Study ID Info
**ID:** Essilor
#### Organization
**Class:** INDUSTRY
**Full Name:** Essilor International
### Status Module
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2008-11-07

**Type:** ESTIMATED

**Last Update Submit Date:** 2008-11-06

**Overall Status:** COMPLETED

#### Primary Completion Date
**Date:** 2008-04

**Type:** ACTUAL

#### Start Date
**Date:** 2003-04

**Status Verified Date:** 2008-11

#### Study First Post Date
**Date:** 2008-11-07
**Type:** ESTIMATED
**Study First Submit Date:** 2008-11-04
**Study First Submit QC Date:** 2008-11-06
### Sponsor Collaborators Module

#### Collaborators

**Class:** OTHER

**Name:** Queensland University of Technology

#### Lead Sponsor

**Class:** INDUSTRY

**Name:** Essilor International

#### Responsible Party

**Old Name Title:** Desmond Cheng

**Old Organization:** Essilor International

### Oversight Module

**Oversight Has DMC:** False

### Description Module

**Brief Summary:** 1. To determine if the effect of near-addition lenses (bifocals) is more prominent for children with high myopia progression.
2. To study how different subject characteristics such as age, gender, baseline degree of myopia, baseline near phoria and baseline lag of accommodation affect the efficacy of bifocal lens wear in myopic children.
3. To investigate the effect of incorporating near base-in prisms along with the near-addition lenses (prismatic bifocals) on myopia progression in myopic children.

### Conditions Module

**Conditions:**

- Myopia

**Keywords:**

- Myopia, bifocal, children

### Design Module

#### Design Info

**Allocation:** RANDOMIZED

**Intervention Model:** PARALLEL

##### Masking Info

**Masking:** NONE

**Primary Purpose:** TREATMENT

#### Enrollment Info

**Count:** 135

**Type:** ACTUAL

**Phases:**

- NA

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

**Intervention Names:**

- Device: Bifocal spectacles

**Label:** Bifocal spectacles

**Type:** ACTIVE_COMPARATOR

#### Arm Group 2

**Intervention Names:**

- Device: Prismatic bifocal spectacles

**Label:** Prismatic bifocals

**Type:** ACTIVE_COMPARATOR

#### Arm Group 3

**Label:** Single vision spectacles

**Type:** NO_INTERVENTION

### Interventions

#### Intervention 1

**Arm Group Labels:**

- Bifocal spectacles

**Description:** +1.50D bifocal spectacles

**Name:** Bifocal spectacles

**Type:** DEVICE

#### Intervention 2

**Arm Group Labels:**

- Prismatic bifocals

**Description:** +1.50D bifocal spectacles combined with 3Δ base-in prisms

**Name:** Prismatic bifocal spectacles

**Type:** DEVICE

### Outcomes Module

#### Primary Outcomes

**Measure:** Myopia progression, measured by cycloplegic autorefraction

**Time Frame:** Every 6 months

#### Secondary Outcomes

**Measure:** Axial length, measured by A-scan ultrasonography

**Time Frame:** Every 6 months

### Eligibility Module

**Eligibility Criteria:** Inclusion Criteria:

* Age: 8 to 13 years
* Myopia: -1.00 to -5.00 D
* Myopia progression: at least 0.50 D/yr
* Astigmatism and anisometropia: not more than 1.50 D
* Distance monocular visual acuity: 6/6 or better
* Near monocular visual acuity: 0.4 M or better
* Stereoacuity: not more than 40 sec of arc at 40 cm

Exclusion Criteria:

* Strabismus
* Ocular diseases

**Healthy Volunteers:** True

**Maximum Age:** 13 Years

**Minimum Age:** 8 Years

**Sex:** ALL

**Standard Ages:**

- CHILD

### Contacts Locations Module

#### Locations

**Location 1:**

**City:** Mississauga

**Country:** Canada

**Facility:** Dr. Desmond Cheng & Associates

**State:** Ontario

**Zip:** L5N 7G5

#### Overall Officials

**Official 1:**

**Affiliation:** Queensland University of Technology

**Name:** Desmond Cheng, OD, MSc

**Role:** PRINCIPAL_INVESTIGATOR

### References Module

#### References

**Citation:** Cheng D, Woo GC, Drobe B, Schmid KL. Effect of bifocal and prismatic bifocal spectacles on myopia progression in children: three-year results of a randomized clinical trial. JAMA Ophthalmol. 2014 Mar;132(3):258-64. doi: 10.1001/jamaophthalmol.2013.7623.

**PMID:** 24435660

**Citation:** Cheng D, Schmid KL, Woo GC, Drobe B. Randomized trial of effect of bifocal and prismatic bifocal spectacles on myopic progression: two-year results. Arch Ophthalmol. 2010 Jan;128(1):12-9. doi: 10.1001/archophthalmol.2009.332.

**PMID:** 20065211

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000012030

- Term: Refractive Errors

- 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: 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
