Personalized Remapping for Macular Degeneration

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
University of Minnesota, Minneapolis, MN
Macular Degeneration+1 More
Personalized Remapping - Behavioral
Eligibility
Any Age
All Sexes
Eligible conditions
Select

Study Summary

Visual Remapping to Aid Reading With Field Loss

See full description

Eligible Conditions

  • Macular Degeneration
  • Age-related Macular Degeneration

Treatment Effectiveness

Effectiveness Estimate

1 of 3

Study Objectives

This trial is evaluating whether Personalized Remapping will improve 6 primary outcomes and 5 secondary outcomes in patients with Macular Degeneration. Measurement will happen over the course of Measured during fourth visit- each visit is one day only and this measure refers to data gathered during a < 1 hr long reading session during that day.

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
Eye fixation quality for natural text samples
Eye movement quality for natural text samples
Reading Speed for Natural Text Samples
Reading error rate for Natural Text Samples
Measured during fourth visit
Eye movement quality for sentences
Measured during fourth visit- each visit is one day only and this measure refers to data gathered during a < 1 hr long reading session during that day
Reading Speed for Sentences
Measured during fourth visit; each visit is one day only and this measure refers to data gathered during a < 1 hr long reading session during that day
Eye fixation quality for sentences
Reading error rate for Sentences
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
Reading Speed for Individual Words
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
Eye fixation quality for words
Reading error rate for Individual Words

Trial Safety

Safety Estimate

1 of 3

Trial Design

2 Treatment Groups

Normally sighted with artificial scotoma
1 of 2
Patients with scotoma
1 of 2
Active Control
Experimental Treatment

This trial requires 108 total participants across 2 different treatment groups

This trial involves 2 different treatments. Personalized Remapping is the primary treatment being studied. Participants will all receive the same treatment. There is no placebo group. The treatments being tested are not being studied for commercial purposes.

Patients with scotomaNo remapping (control condition), traditional remapping, personalized remapping
Normally sighted with artificial scotomaNo remapping (control condition), traditional remapping, personalized remapping

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: measured during fourth visit
This trial has the following approximate timeline: 3 weeks for initial screening, variable treatment timelines, and roughly measured during fourth visit for reporting.

Closest Location

University of Minnesota - Minneapolis, MN

Eligibility Criteria

This trial is for patients born any sex of any age. There are 5 eligibility criteria to participate in this trial as listed below.

Mark “yes” if the following statements are true for you:
16 years or older
Central vision loss of at least 5 deg diameter, including the fovea, from bilateral central scotomas
Stable fixation (+/- 1 deg) using their PRL.
No cognitive impairment as indicated by a Mini-Mental State Examination (MMSE).
Satisfactory calibration achievable using eye tracker

Patient Q&A Section

What is age-related macular degeneration?

"Age-related macular degeneration refers to the degeneration of the retina and the vision center in a person's eye, most commonly caused by old age. A person at age 85 will likely have 20/400 vision while a person in their 80s may only have 20/160 vision. A person 75 years old will have problems with peripheral vision even though they are not blind because of their age-related macular degeneration." - Anonymous Online Contributor

Unverified Answer

What are the signs of age-related macular degeneration?

"Recent findings, age-related macular degeneration was frequently diagnosed in the first decade of life and was associated with poor visual function. The early detection and treatment of this eye disease may be one of the most important preventive measures." - Anonymous Online Contributor

Unverified Answer

Can age-related macular degeneration be cured?

"Age-related macular degeneration is a progressive disease with a variable natural history and no known means of treatment. Patients usually suffer considerable vision deterioration and can be effectively managed with appropriate ophthalmic care." - Anonymous Online Contributor

Unverified Answer

What causes age-related macular degeneration?

"Diabetes may cause age-related macular degeneration, because the retinal blood vessels are enlarged in advanced diabetes. The retina is nourished by blood from the underlying retina, which may be insufficient in advanced diabetic macular degeneration." - Anonymous Online Contributor

Unverified Answer

What are common treatments for age-related macular degeneration?

"A small number of ophthalmologists specialize in treating patients with macular degeneration. This number of specialists has been increasing over time. Recently, treatment for early or late stage AMD has emerged as a common area of specialization for ophthalmologists. A significant number of ophthalmologists are treating dry AMD." - Anonymous Online Contributor

Unverified Answer

How many people get age-related macular degeneration a year in the United States?

"Every year in the US, around 32,000 new cases of AMD are diagnosed, making up 1.7% of American adults. About 50% of people with AMD will be diagnosed before their 60s and 80% after 80. While the burden of AMD is higher in women than in men, more men are diagnosed with cancer or stroke. It will take work to prevent the disease." - Anonymous Online Contributor

Unverified Answer

What are the common side effects of traditional remapping?

"The common side effects of conventional remapping were modestly increased photoreceptor, macular pigment pigment, and retinal pigment epithelium (RPE) alterations. The presence of macular lesions and choroidal lesions with no systemic signs may be additional risk factors for an increased frequency of adverse ocular and systemic side effects associated with conventional remapping procedures." - Anonymous Online Contributor

Unverified Answer

What is the average age someone gets age-related macular degeneration?

"An age-related macular degeneration prevention programme can help prevent blindness in those who are at high risk. However, those at low risk should be informed that the risk is not zero, and that they are likely to develop visual impairment despite the programme." - Anonymous Online Contributor

Unverified Answer

How does traditional remapping work?

"In comparison with classic retinal mapping, traditional remapping allows the placement of larger numbers of electrode sites. Although traditional remapping results in fewer visual field defects compared with classic remapping, neither procedure improves fixation patterns. However, in patients with poor fixation patterns, traditional remapping improves visual acuity." - Anonymous Online Contributor

Unverified Answer

Who should consider clinical trials for age-related macular degeneration?

"Based on previous results, it is likely that patients who received either intravitreal injections of bevacizumab or ranibizumab for 12 weeks in phase 3 clinical trials experienced significant visual improvements." - Anonymous Online Contributor

Unverified Answer

What is traditional remapping?

"Since this technique is easy and rapid, it can be considered as a good screening tool for retinal disease in this age group when not available in a general ophthalmology practice." - Anonymous Online Contributor

Unverified Answer

Does traditional remapping improve quality of life for those with age-related macular degeneration?

"The remapping procedure in our study did not significantly improve quality of life, and, in fact, we found it had a negative impact on wellbeing of the patients and their families. Although long-term follow-up is a requirement in such procedures, we would recommend that clinicians reconsider their use. We suggest that the development of a standardised method of mapping retinal regions with a special emphasis on the optic disc edge should be investigated as this may provide a more objective and reliable indicator of visual field defects." - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
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