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Visual Remapping for Age-Related Macular Degeneration

N/A
Recruiting
Led By Stephen Engel, Ph.D.
Research Sponsored by University of Minnesota
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Stable fixation (+/- 1 deg) using their PRL.
16 years or older
Must not have
Central vision loss of less than 5 deg diameter; scotomas that do not cover the fovea; unilateral scotomas
Timeline
Screening 3 weeks
Treatment Varies
Follow Up measured during fifth visit; each visit is one day only and this measure refers to data gathered during a < 1 hr long reading session during that day
Awards & highlights
No Placebo-Only Group

Summary

This trial will test how well people with central vision loss can read with and without different kinds of remapping of missing text to different parts of the visual field, compared to people with no vision loss.

Who is the study for?
This trial is for individuals aged 16 or older with central vision loss from age-related macular degeneration. Participants must have a stable gaze within one degree using their preferred retinal locus (PRL) and be able to calibrate an eye tracker. Those with cognitive impairment, poor fixation, or insufficient central vision loss are excluded.
What is being tested?
The study measures reading performance in patients with Central Vision Loss. It compares the effectiveness of traditional remapping versus personalized remapping of text to different visual fields in aiding reading.
What are the potential side effects?
Since this trial involves non-invasive techniques like eye tracking and visual tests rather than drugs or surgery, there are no direct side effects associated with the interventions being tested.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I can keep my gaze steady using my preferred retinal location.
Select...
I am 16 years old or older.
Select...
I have significant vision loss in the center of my field of view in both eyes.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
Select...
I have central vision loss but can still see directly in front of me.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~measured during third visit; each visit is one day only and this measure refers to data gathered during a < 1 hr long reading session during that day
This trial's timeline: 3 weeks for screening, Varies for treatment, and measured during third visit; each visit is one day only and this measure refers to data gathered during a < 1 hr long reading session during that day for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Reading Speed for Individual Words
Reading Speed for Natural Text Samples
Reading Speed for Sentences
+3 more
Secondary study objectives
Eye fixation quality for natural text samples
Eye fixation quality for sentences
Eye fixation quality for words
+2 more

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Patients with scotomaExperimental Treatment2 Interventions
No remapping (control condition), traditional remapping, personalized remapping
Group II: Normally sighted with artificial scotomaActive Control2 Interventions
No remapping (control condition), traditional remapping, personalized remapping

Find a Location

Who is running the clinical trial?

University of MinnesotaLead Sponsor
1,427 Previous Clinical Trials
1,620,465 Total Patients Enrolled
2 Trials studying Macular Degeneration
38 Patients Enrolled for Macular Degeneration
Stephen Engel, Ph.D.Principal InvestigatorUniversity of Minnesota

Media Library

Personalized Remapping Clinical Trial Eligibility Overview. Trial Name: NCT03848663 — N/A
Macular Degeneration Research Study Groups: Patients with scotoma, Normally sighted with artificial scotoma
Macular Degeneration Clinical Trial 2023: Personalized Remapping Highlights & Side Effects. Trial Name: NCT03848663 — N/A
Personalized Remapping 2023 Treatment Timeline for Medical Study. Trial Name: NCT03848663 — N/A
~0 spots leftby Nov 2024