Head Mounted Eye Tracking Aide for Loss of Central Vision (HETALCEV)

NCT02829606 | Completed

• 1 other identifier: 1603M84883
• Study Type: interventional
• Target: 8
• Locations: 1 country
• Sites: 1

Brief Summary

A device has been developed that has eye trackers integrated within the Head Mounted Display (HMD) and can remap text and images around the scotoma in real time to prevent information loss from a central scotoma. It can also carry out other types of image processing such as contrast enhancement and image magnification. The aim of this study is to assess the efficacy of this device on the visual performance of participants suffering from central vision loss, with and without remapping

Conditions

Age-related Macular Degeneration

Keywords

Age-related Macular Degeneration; Central Scotoma; Head Mounted Display

Outcome Measures

Primary Outcomes (1)

• Reading speed

  words/minute

  5 years

Study Arms (2)

small scotoma using Head Mounted Display No re-mapping

ACTIVE COMPARATOR

patients with scotoma smaller than 5 degrees NO re-mapping PLUS re-mapping

Other: small scotoma using Head Mounted Display No re-mapping; Other: Large scotoma using Head Mounted Display PLUS re-mapping

Large scotoma using Head Mounted Display PLUS re-mapping

ACTIVE COMPARATOR

patients with scotoma larger than 5 degrees NO re-mapping PLUS re-mapping

Other: small scotoma using Head Mounted Display No re-mapping; Other: Large scotoma using Head Mounted Display PLUS re-mapping

Interventions

small scotoma using Head Mounted Display No re-mapping OTHER

re-mapping software turned off

Large scotoma using Head Mounted Display PLUS re-mapping; small scotoma using Head Mounted Display No re-mapping

Large scotoma using Head Mounted Display PLUS re-mapping OTHER

re-mapping software turned on

Large scotoma using Head Mounted Display PLUS re-mapping; small scotoma using Head Mounted Display No re-mapping

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• years or older
• Central vision loss from bilateral central scotomas
• No cognitive impairment as indicated by a Mini-Mental State Examination (MMSE)

You may not qualify if:

• Failed MMSE

Sponsors & Collaborators

• University of Minnesota: lead

Study Sites (1)

University _of_Minnesota

Minneapolis, Minnesota, 55455, United States

Location

MeSH Terms

Conditions

Macular Degeneration; Scotoma

Condition Hierarchy (Ancestors)

Retinal Degeneration; Retinal Diseases; Eye Diseases; Vision Disorders; Sensation Disorders; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Erik van Kuijk, MD, PhD

  University of Minnesota

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 13, 2016
• First Posted: July 12, 2016
• Study Start: April 1, 2016
• Primary Completion: April 1, 2023
• Study Completion: May 1, 2024
• Last Updated: June 20, 2024

Record last verified: 2024-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)