Multiplexing Prism Fitting for Field Expansion of Monocular Vision

Not Applicable

Completed

• Conditions: Blind Left Eye; Blind Right Eye; One Eye Blindness
• Interventions: Device: Multiplexing Prism

• Registration Number: NCT06027216
• Lead Sponsor: Massachusetts Eye and Ear Infirmary

Brief Summary

The investigators are developing an assistive device, known as multiplexing prism that expands the field of view for individuals with acquired monocular vision (loss of an eye). The investigators are testing a simplified design and fitting protocol to provide field expansion for individuals with acquired monocular vision.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-08-29
• Study First Submitted QC: 2023-09-05
• Study First Posted: 2023-09-07
• Study Start: 2023-12-27
• Primary Completion: 2024-10-22
• Study Completion: 2024-12-31
• Results First Submitted: 2025-03-31
• Status Verified: 2025-04
• Results First Submitted QC: 2025-04-22
• Last Update Submitted: 2025-04-22
• Results First Posted: 2025-05-08
• Last Update Posted: 2025-05-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

• No medical health issues such as seizures, motor movements problem
• Loss of vision in one eye (less than 20/200) for >1 year)
• Visual acuity of the seeing eye: Better than 20/32 visual acuity with correction
• No visual field defect in the seeing eye (nasal field of at least >45degree)
• No medical health issues such as seizures, motor movements problem

Exclusion Criteria

• Patients with any physical or mental disabilities, including cognitive dysfunction, balance problems, or other deficits that could impair their ability to respond to the stimuli presented in this study will be excluded
• Any person with motor movements problem (e.g., unable to use extremities)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Field Expansion	Multiplexing Prism	Field of view on the nasal side (same side as the blind eye) with and without multiplexing prism

Primary Outcome Measures

Name	Time	Method
Gain in Visual Field With the Multiplexing Prism	Visit 2 of Study (approximately 2-3 weeks after 1st Visit)	Field expansion is calculated based on the difference of the maximum field of view on the nasal side of the seeing/functioning eye (same side as the blind eye) with and without multiplexing prism.

Secondary Outcome Measures

Name	Time	Method
Maximum Extent of Nasal Visual Field With the Multiplexing Prism	Visit 2 of Study (approximately 2-3 weeks after 1st Visit)	The farthest extent of the nasal visual field with the multiplexing prism placed in front of the seeing eye.

Trial Locations

Locations (1)

Schepens Eye Research Institute; 🇺🇸 Boston, Massachusetts, United States