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Age Related Macular DegenerationNCT02909985

Visual Activity Evoked by Infrared in Humans After Dark Adaptation

A study testing Tungsten halogen light with narrow bandpass filters in people with Age Related Macular Degeneration and Retinitis Pigmentosa, run by University of New Mexico at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

This pilot study will evaluate the visual response to infrared (IR) in humans after dark adaptation. The investigators plan to determine which wavelength and intensity the human eye is most sensitive to in healthy and color-blind participants by using a broad spectrum light source and wavelength-specific IR bandpass… Read more about this study

Who is it for?
Ages 18 years and olderHealthy volunteers can take part
What is being tested?
Tungsten halogen light with narrow bandpass filters
Could I receive a placebo?
No, everyone receives an active treatment
How many people
21 participants
Where
1 siteUnited States
Study dates
Sep 2015to Aug 2016
Phase
Interventional
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • Normal Vision
  • Colorblindness
  • Age related macular degeneration
  • Congenital Stationary Night Blindness

Who cannot join

  • Diabetes
  • Heart disease
  • History of eye injury
  • History of eye trauma
  • History of eye disease except for those specified in the inclusion criteria
  • Pregnant women will also be excluded from Aim 2 and 3
Show all 11Show fewer
  • Persons with allergies to adhesives will be excluded from Aim 2 and 3
  • Contact dermatitis
  • Documented adverse reaction to dilating drops
  • Documented adverse reaction to topical anesthetics
  • Vulnerable populations

Trial locations and contacts

1 site in 1 country.

United States1 site
  • University of New Mexico

    Albuquerque, New Mexico, 87131-0001

Other trials in United States

About this study

This pilot study will evaluate the visual response to infrared (IR) in humans after dark adaptation. The investigators plan to determine which wavelength and intensity the human eye is most sensitive to in healthy and color-blind participants by using a broad spectrum light source and wavelength-specific IR bandpass filters.

The long-term goal of this research is to better understand the role that IR plays in visual function, and whether this can be manipulated to allow for vision in certain retinal pathologies that result from loss of photoreceptor cells. The investigators central objective is to test the electrophysiologic response to IR in the dark-adapted retinal and visual pathways. The investigator's central hypothesis is that IR evokes a visual response in humans after dark adaptation, and the characteristics of this response suggest transient receptor potential (TRP) channel involvement. The investigators rationale is that a better understanding of how IR impacts vision may allow for an alternative mechanism for vision in a number of diseases that cause blindness from the degradation or loss of function of photoreceptor cells. The investigators will test the investigator's hypothesis with the following Aims:

Read more

Aim 1:

Arm 1: To determine the optimal IR wavelength for visual perception in dark-adapted human participants. The investigators hypothesize that the healthy human eye will detect IR irradiation, with a maximum sensitivity at a specific wavelength. Using a broad-spectrum light source with wavelength-specific bandpass filters, the spectral range of visual perception to IR will be evaluated.

Arm 2: To determine the optimal IR wavelength for visual perception in dark-adapted human participants who are colorblind. The investigators hypothesize that the colorblind human eye will detect IR irradiation, with a maximum sensitivity at a specific wavelength. Using a broad-spectrum light source with wavelength-specific bandpass filters, the spectral range of visual perception to IR will be evaluated.

Read the detailed description

BACKGROUND: Visual impairment affects 285 million people worldwide. The prevalence of visual impairment in the US is expected to rise from 3.3 million in 2000 to 5.5 million in 2020. This will exacerbate the current economic burden of vision loss, which is already $38.2 billion per year in direct and indirect costs. The leading cause of blindness in high-income countries is due to age-related macular degeneration (AMD), a disease that leads to gradual loss of the photoreceptor cell layer. An estimated 1.75 million people have AMD in the US and another 7.3 million are at risk. Importantly, despite the loss of photoreceptor cells in AMD, the other cellular layers in the retina remain largely intact.

The retina lines the back of the eye and is composed of structural layers. The outer nuclear layer contains photoreceptors called rods and cones. The inner nuclear layer includes bipolar, horizontal, and amacrine cells. Most anteriorly, the ganglion cell layer has axons that exit the eye as the optic nerve. Visual image formation begins when a photon of light enters the eye, passes through all retinal layers, and is absorbed by the photoreceptor cells. These cells transduce the photon of light into an electrochemical signal, which is communicated to bipolar cells, followed by the ganglion cells. Here, an action potential is generated and propagated via the optic nerve to the area of the brain where vision perception occurs. When the eye is dark-adapted, the cells in this pathway are potentially more sensitive to other types of stimuli, such as IR. The investigators believe cation channels called TRP channels in ganglion cells are activated by IR in this dark-adapted state, creating the visual response to IR. Heat is a known activator of certain subtypes of these channels elsewhere in the body. TRP channels are also responsible for IR vision in pit vipers and vampire bats.

Palczewska et al. reported that visual perception to IR occurred through a process of direct two-photon isomerization of visual pigments. However, other evidence suggests IR perception can occur through single IR photon absorption. Studies that use IR to test the functionality of implanted visual prosthesis have noted a greater response to IR in the non-implanted eye when compared to the implanted eye on both VEP tests and ERG. On ERG, a specialized response specific to IR was found called the scotopic threshold response (STR). This response occurs under dark-adapted conditions and correlates with a response at the ganglion cell layer. Direct IR activation of TRP channels on ganglion cells could initiate a visual response. Based on these findings, the investigators hypothesize the human response to IR under dark adaptation occurs at the level of the ganglion cells through heat-activated TRP channels.

RESEARCH DESIGN AIM1: To determine the optimal IR wavelength for human visual perception while dark-adapted in the healthy human eye.

Introduction for Aim 1: The objective of this aim is to determine the optimal wavelength of IR to which the human eye is sensitive. To obtain this objective, the investigators will test the working hypothesis that the healthy human eye, and those with colorblindness, will detect a range of IR wavelengths, with a preference for a specific wavelength. The investigators will test the working hypothesis using a broad-spectrum light source with wavelength-specific bandpass filters in the IR range. The investigators' rationale for this aim is that understanding the optimal IR wavelength of the human eye will aid in future investigations when testing the visual response to IR using diagnostic equipment. This is important because it could impact the way other ophthalmologic modalities use IR to diagnose and treat visual pathologies.

Research Design for Aim 1: A total of healthy 21 participants (15 with normal vision and 6 with colorblindness) aged 18 and older will be recruited using the University of New Mexico (UNM) Clinical and Translational Science Center (CTSC) Clinical Research Volunteer Registry HRRC-06412. Informed consent, participant demographics, past medial and visual history, and a general eye exam will be obtained using the CTSC research coordinator. Each participant will be placed in a dark room for an hour to allow for optimal dark adaptation of the eye. The investigators will use a broad-spectrum light source with wavelength-specific bandpass filters of different IR wavelengths. A total of 12 filters will be used ranging from 850 nm to 1400nm. Intensity curves will be built for each wavelength, by slowly turning up the power until the participant indicates a visual response to the stimulus.

Data Analysis for Aim 1: Data will be analyzed by the investigators. Descriptive statistics will be used to evaluate demographics, general and visual health information, and reported optimal wavelengths. The investigators' analysis will compare differences among responses for each wavelength. To the investigators' knowledge, there have been no studies evaluating which IR wavelength is optimal for human visual perception, thus the investigators assume a low effect size of 10%, which would produce an 82% chance of at least two out of 30 healthy participants giving a preferred response to a specific wavelength. The investigators will describe the estimated effect sizes in response to the findings.

Expected Outcomes for Aim 1: The investigators expect the human eye to perceive a range of IR wavelengths, but have a specific wavelength optimal in terms of brightness.

Potential Problems \& Alternative Strategies for Aim 1: To prevent sampling bias, the investigators plan to obtain a representative sample from New Mexico; however, participants may be younger and more educated than the general population. The confounding bias of light pollution may occur, which would prevent dark adaptation and decrease the IR sensitivity. A photometer will assess the room for background photons.

Being tested
Tungsten halogen light with narrow bandpass filters
Keywords
Infrared, Dark Adaptation, Vision, Scotopic Threshold Response, Transient Receptor Potential (TRP) Channels, Human
Medical subject headings
Macular Degeneration, Retinitis Pigmentosa, Night blindness, congenital stationary, Color Vision Defects

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Tungsten halogen light with narrow bandpass filtersOther

    As intensity in increased from 0 to 12 V, participants will say if/when they see a visual response to infrared light from a broad band tungsten halogen light source that passes through narrow bandpass filters ranging from 850 nm to 1400 nm. At the end of three trials per filter, the intensity will be turned up to 12 V, and participants will describe the color they see.

Study groups in NCT02909985
Study groupRoleWhat they receive
Visual response to IR in healthy eyesExperimental15 healthy participants will describe IR light passing through narrow bandpass filters over a broad-spectrum light source. As intensity increases from 0 to 12 V, participants will say if/when they see a visual response to infrared light from a broadband Tungsten halogen light with narrow bandpass filters ranging from 850 nm to 1400 nm. At the end of three trials per filter, the intensity will be turned up to 12 V, and participants will describe the color they see.
Receives: Other: Tungsten halogen light with narrow bandpass filters
Visual response to IR in colorblind eyesExperimental6 colorblind participants will describe IR light passing through narrow bandpass filters over a broad-spectrum light source. As intensity increases from 0 to 12 V, participants will say if/when they see a visual response to infrared light from a broadband Tungsten halogen light with narrow bandpass filters ranging from 850 nm to 1400 nm. At the end of three trials per filter, the intensity will be turned up to 12 V, and participants will describe the color they see.
Receives: Other: Tungsten halogen light with narrow bandpass filters

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Visual Perception to Infrared: Mean Minimal Intensity (uW) at Which Participants Could See IR Between 900 - 1400 nm.

    We measured the minimum threshold intensities (uW) via subjective perception of near IR light (900 - 1400 nm) in 50 nm intervals. After 30 minutes of dark adaptation and over three trials, participants verbalized by saying 'yes' to the minimal intensity they could see the IR stimulus as the power source for the light was slowly increased from 0V to 12 V. The voltage was averaged for the three trials at each wavelength. Analysis of variance was used to evaluate the effect of the wavelength on the threshold intensity. This was done for two groups/arms, one with normal color vision and one with colorblind vision.

    Measured: after 30 minutes of dark adaptation, up to 2 hours

Secondary outcomes (1)
  1. Description of Color

    A subjective description of color was given by each participant for each wavelength between 850 - 1400nm while at 12V.

    Measured: after 30 minutes of dark adaptation, up to 2 hours

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted21 Sep 2016 (estimated)
  2. Study startSep 2015
  3. Primary completionAug 2016
  4. Study completionAug 2016

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Diagnosis
Allocation
Non-randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Participant
Enrolment
21 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02909985
Sponsor's protocol ID
CTSC0004-6
Status last verified
Dec 2024
First submitted
6 May 2016
Last updated
13 Dec 2024
Data monitoring committee
No
Individual data sharing
No

Publications

  • Wittenborn JS, Zhang X, Feagan CW, Crouse WL, Shrestha S, Kemper AR, Hoerger TJ, Saaddine JB; Vision Cost-Effectiveness Study Group. The economic burden of vision loss and eye disorders among the United States population younger than 40 years. Ophthalmology. 2013 Sep;120(9):1728-35. doi: 10.1016/j.ophtha.2013.01.068. Epub 2013 Apr 28.

    PubMed 23631946
  • Pascolini D, Mariotti SP. Global estimates of visual impairment: 2010. Br J Ophthalmol. 2012 May;96(5):614-8. doi: 10.1136/bjophthalmol-2011-300539. Epub 2011 Dec 1.

    PubMed 22133988
  • Stockman A, Sharpe LT, Fach C. The spectral sensitivity of the human short-wavelength sensitive cones derived from thresholds and color matches. Vision Res. 1999 Aug;39(17):2901-27. doi: 10.1016/s0042-6989(98)00225-9.

    PubMed 10492818
  • Friedman DS, O'Colmain BJ, Munoz B, Tomany SC, McCarty C, de Jong PT, Nemesure B, Mitchell P, Kempen J; Eye Diseases Prevalence Research Group. Prevalence of age-related macular degeneration in the United States. Arch Ophthalmol. 2004 Apr;122(4):564-72. doi: 10.1001/archopht.122.4.564.

    PubMed 15078675
  • White JP, Urban L, Nagy I. TRPV1 function in health and disease. Curr Pharm Biotechnol. 2011 Jan 1;12(1):130-44. doi: 10.2174/138920111793937844.

    PubMed 20932253
  • Numazaki M, Tominaga M. Nociception and TRP Channels. Curr Drug Targets CNS Neurol Disord. 2004 Dec;3(6):479-85. doi: 10.2174/1568007043336789.

    PubMed 15578965
  • Gracheva EO, Ingolia NT, Kelly YM, Cordero-Morales JF, Hollopeter G, Chesler AT, Sanchez EE, Perez JC, Weissman JS, Julius D. Molecular basis of infrared detection by snakes. Nature. 2010 Apr 15;464(7291):1006-11. doi: 10.1038/nature08943. Epub 2010 Mar 14.

    PubMed 20228791
  • Gekeler F, Shinoda K, Blatsios G, Werner A, Zrenner E. Scotopic threshold responses to infrared irradiation in cats. Vision Res. 2006 Feb;46(3):357-64. doi: 10.1016/j.visres.2005.06.023. Epub 2005 Aug 2.

    PubMed 16081127
  • Pardue MT, Ball SL, Hetling JR, Chow VY, Chow AY, Peachey NS. Visual evoked potentials to infrared stimulation in normal cats and rats. Doc Ophthalmol. 2001 Sep;103(2):155-62. doi: 10.1023/a:1012202410144.

    PubMed 11720256
  • Chow AY, Pardue MT, Chow VY, Peyman GA, Liang C, Perlman JI, Peachey NS. Implantation of silicon chip microphotodiode arrays into the cat subretinal space. IEEE Trans Neural Syst Rehabil Eng. 2001 Mar;9(1):86-95. doi: 10.1109/7333.918281.

    PubMed 11482368
  • Sieving PA, Frishman LJ, Steinberg RH. Scotopic threshold response of proximal retina in cat. J Neurophysiol. 1986 Oct;56(4):1049-61. doi: 10.1152/jn.1986.56.4.1049.

    PubMed 3783228
  • Wakabayashi K, Gieser J, Sieving PA. Aspartate separation of the scotopic threshold response (STR) from the photoreceptor a-wave of the cat and monkey ERG. Invest Ophthalmol Vis Sci. 1988 Nov;29(11):1615-22.

    PubMed 3182196
  • Kolb H. Simple Anatomy of the Retina. 2005 May 1 [updated 2012 Jan 31]. In: Kolb H, Fernandez E, Jones B, Nelson R, editors. Webvision: The Organization of the Retina and Visual System [Internet]. Salt Lake City (UT): University of Utah Health Sciences Center; 1995-. Available from http://www.ncbi.nlm.nih.gov/books/NBK11533/

    PubMed 21413391
  • Palczewska G, Vinberg F, Stremplewski P, Bircher MP, Salom D, Komar K, Zhang J, Cascella M, Wojtkowski M, Kefalov VJ, Palczewski K. Human infrared vision is triggered by two-photon chromophore isomerization. Proc Natl Acad Sci U S A. 2014 Dec 16;111(50):E5445-54. doi: 10.1073/pnas.1410162111. Epub 2014 Dec 1.

    PubMed 25453064

Questions about this trial

What is this clinical trial studying?

A study testing Tungsten halogen light with narrow bandpass filters in people with Age Related Macular Degeneration and Retinitis Pigmentosa, run by University of New Mexico at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 13 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 13 Dec 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Visual Perception to Infrared: Mean Minimal Intensity (uW) at Which Participants Could See IR Between 900 - 1400 nm. (time frame: after 30 minutes of dark adaptation, up to 2 hours). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02909985, which also lists 14 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Dec 2024.

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