## Protocol Section
### Identification Module
**NCT ID:** NCT04424979

**Brief Title:** Feasibility Tests for Various Prism Configurations for Visual Field Loss

**Official Title:** Visual Field Expansion Through Innovative Multi-Periscopic Prism Design

#### Organization Study ID Info
**ID:** MPP_Feasibility1
#### Organization
**Class:** OTHER
**Full Name:** Massachusetts Eye and Ear Infirmary
#### Secondary ID Infos
**ID:** R01EY023385
**Link:** https://reporter.nih.gov/quickSearch/R01EY023385
**Type:** NIH
### Status Module
#### Completion Date
**Date:** 2024-08

**Type:** ESTIMATED

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-03-13

**Type:** ACTUAL

**Last Update Submit Date:** 2024-03-11

**Overall Status:** RECRUITING

#### Primary Completion Date
**Date:** 2024-08

**Type:** ESTIMATED

#### Start Date
**Date:** 2020-11-06

**Type:** ACTUAL

**Status Verified Date:** 2024-03

#### Study First Post Date
**Date:** 2020-06-11
**Type:** ACTUAL
**Study First Submit Date:** 2020-06-05
**Study First Submit QC Date:** 2020-06-08
### Sponsor Collaborators Module

#### Collaborators

**Class:** NIH

**Name:** National Eye Institute (NEI)

#### Lead Sponsor

**Class:** OTHER

**Name:** Massachusetts Eye and Ear Infirmary

#### Responsible Party

**Investigator Affiliation:** Massachusetts Eye and Ear Infirmary

**Investigator Full Name:** Eli Peli

**Investigator Title:** Senior Scientist

**Type:** PRINCIPAL_INVESTIGATOR

### Oversight Module

**Is FDA Regulated Device:** True

**Is FDA Regulated Drug:** False

**Is US Export:** False

**Oversight Has DMC:** False

### Description Module

**Brief Summary:** The investigators will develop and test different configurations of high-power prisms to expand the field of vision of patients with visual field loss to assist them with obstacle detection when walking. The study will involve multiple visits (typically four) to Schepens Eye Research Institute for fitting and testing with the prism glasses. The overall objective is to determine best designs and fitting parameters for implementation in prism devices for future clinical trials.

### Conditions Module

**Conditions:**

- Hemianopia, Homonymous

- Tunnel Vision

- Visual Field Defect, Peripheral

- Visual Field Constriction Bilateral

- Visual Field Defect Homonymous Bilateral

**Keywords:**

- Visual field expansion

- Prisms

- Hemianopsia

- Tunnel vision

- Visual field loss

### Design Module

#### Design Info

**Allocation:** NA

**Intervention Model:** SINGLE_GROUP

##### Masking Info

**Masking:** NONE

**Primary Purpose:** DEVICE_FEASIBILITY

#### Enrollment Info

**Count:** 20

**Type:** ESTIMATED

**Phases:**

- NA

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

**Description:** Various configurations of high power prisms will be developed for each individual and custom fit into spectacles lenses.

**Intervention Names:**

- Device: High power prisms

**Label:** High power prisms

**Type:** EXPERIMENTAL

### Interventions

#### Intervention 1

**Arm Group Labels:**

- High power prisms

**Description:** High power prisms designed to shift images from blind areas into portions of the wearer's remaining, seeing, field of vision

**Name:** High power prisms

**Type:** DEVICE

### Outcomes Module

#### Primary Outcomes

**Description:** Horizontal and vertical extent of the expansion (in degrees) of the field of view

**Measure:** Field of view expansion

**Time Frame:** Through study completion, an average of four months

#### Secondary Outcomes

**Description:** Proportion of pedestrians detected (in simulated walking or simulated driving)

**Measure:** Pedestrian detection rate

**Time Frame:** Through study completion, an average of four months

### Eligibility Module

**Eligibility Criteria:** Inclusion Criteria:

* Visual field loss, either peripheral field loss or hemianopic field loss
* Visual acuity of at least 20/50 in the better eye
* In sufficiently good health to be able to complete sessions lasting 2-4 hours
* Able to independently walk short distances
* Able to give voluntary, informed consent
* Able to speak English

Exclusion Criteria:

* Any physical or mental impairments, including cognitive dysfunction, balance problems or other deficits that could impair the ability to walk or use the prism spectacles
* A history of seizures in the last 6 months
* Hemispatial neglect (subjects with hemianopic field loss only)

**Maximum Age:** 80 Years

**Minimum Age:** 7 Years

**Sex:** ALL

**Standard Ages:**

- CHILD

- ADULT

- OLDER_ADULT

### Contacts Locations Module

#### Central Contacts

**Contact 1:**

**Email:** sailaja_manda@meei.harvard.edu

**Name:** Sailaja Manda

**Phone:** 617 912 2522

**Role:** CONTACT

**Contact 2:**

**Email:** alex_bowers@meei.harvard.edu

**Name:** Alex Bowers, PhD

**Phone:** 617 912 2512

**Role:** CONTACT

#### Locations

**Location 1:**

**City:** Boston

**Country:** United States

**Facility:** Schepens Eye Research Institute

**State:** Massachusetts

**Status:** RECRUITING

**Zip:** 02114

#### Overall Officials

**Official 1:**

**Affiliation:** Schepens Eye Research Institute of Massachusetts Eye and Ear

**Name:** Eliezer Peli, MSc, OD

**Role:** PRINCIPAL_INVESTIGATOR

### IPD Sharing Statement Module

**IPD Sharing:** NO

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000014786

- Term: Vision Disorders

- ID: D000012678

- Term: Sensation Disorders

- ID: D000009461

- Term: Neurologic Manifestations

- ID: D000009422

- Term: Nervous System Diseases

- ID: D000001766

- Term: Blindness

- ID: D000005128

- Term: Eye Diseases

### Condition Browse Module - Browse Branches

- Abbrev: BC23

- Name: Symptoms and General Pathology

- Abbrev: All

- Name: All Conditions

- Abbrev: BC10

- Name: Nervous System Diseases

- Abbrev: BC11

- Name: Eye Diseases

### Condition Browse Module - Browse Leaves

- ID: M6475

- Name: Constriction, Pathologic

- Relevance: LOW

- As Found: Unknown

- ID: M9509

- Name: Hemianopsia

- Relevance: HIGH

- As Found: Hemianopia, Homonymous

- 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: M5047

- Name: Blindness

- Relevance: LOW

- As Found: Unknown

- ID: M8271

- Name: Eye Diseases

- Relevance: LOW

- As Found: Unknown

### Condition Browse Module - Meshes

- ID: D000006423

- Term: Hemianopsia

### Misc Info Module

- Version Holder: 2024-05-24
