NCT02909985

Brief 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 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: 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
21

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Sep 2015

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2015

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

May 6, 2016

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2016

Completed
2 months until next milestone

First Posted

Study publicly available on registry

September 21, 2016

Completed
8.2 years until next milestone

Results Posted

Study results publicly available

December 13, 2024

Completed
Last Updated

December 13, 2024

Status Verified

December 1, 2024

Enrollment Period

11 months

First QC Date

May 6, 2016

Results QC Date

March 15, 2024

Last Update Submit

December 10, 2024

Conditions

Keywords

InfraredDark AdaptationVisionScotopic Threshold ResponseTransient Receptor Potential (TRP) ChannelsHuman

Outcome Measures

Primary Outcomes (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.

    after 30 minutes of dark adaptation, up to 2 hours

Secondary Outcomes (1)

  • Description of Color

    after 30 minutes of dark adaptation, up to 2 hours

Study Arms (2)

Visual response to IR in healthy eyes

EXPERIMENTAL

15 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.

Other: Tungsten halogen light with narrow bandpass filters

Visual response to IR in colorblind eyes

EXPERIMENTAL

6 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.

Other: Tungsten halogen light with narrow bandpass filters

Interventions

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.

Visual response to IR in colorblind eyesVisual response to IR in healthy eyes

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • Diabetes
  • Heart disease
  • History of eye injury
  • History of eye trauma
  • Pregnant women will also be excluded from Aim 2 and 3
  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of New Mexico

Albuquerque, New Mexico, 87131-0001, United States

Location

Related Publications (14)

  • 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.

    PMID: 23631946BACKGROUND
  • 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.

    PMID: 22133988BACKGROUND
  • 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.

    PMID: 10492818BACKGROUND
  • 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.

    PMID: 15078675BACKGROUND
  • 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.

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

    PMID: 15578965BACKGROUND
  • 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.

    PMID: 20228791BACKGROUND
  • 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.

    PMID: 16081127BACKGROUND
  • 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.

    PMID: 11720256BACKGROUND
  • 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.

    PMID: 11482368BACKGROUND
  • 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.

    PMID: 3783228BACKGROUND
  • 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.

    PMID: 3182196BACKGROUND
  • 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/

    PMID: 21413391BACKGROUND
  • 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.

    PMID: 25453064BACKGROUND

Related Links

MeSH Terms

Conditions

Macular DegenerationRetinitis PigmentosaNight blindness, congenital stationaryColor Vision Defects

Condition Hierarchy (Ancestors)

Retinal DegenerationRetinal DiseasesEye DiseasesEye Diseases, HereditaryRetinal DystrophiesGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesVision DisordersSensation DisordersNeurologic ManifestationsNervous System DiseasesCone DystrophySigns and SymptomsPathological Conditions, Signs and Symptoms

Limitations and Caveats

Color descriptions vary among individuals. Our sample size was too small to permit any assessment of gender bias. We were unable to standardize color descriptions with a reference color chart, as it was important to maintain dark adaptation in our participants. A color chart likely would have made this data more meaningful in understanding the colors reported and perceived by these participants.

Results Point of Contact

Title
L. Olivia Hopkins
Organization
University of New Mexico

Study Officials

  • Leslie Olivia Hopkins, MD

    University of New Mexico

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor-Clinical Educator

Study Record Dates

First Submitted

May 6, 2016

First Posted

September 21, 2016

Study Start

September 1, 2015

Primary Completion

August 1, 2016

Study Completion

August 1, 2016

Last Updated

December 13, 2024

Results First Posted

December 13, 2024

Record last verified: 2024-12

Data Sharing

IPD Sharing
Will not share

Locations