Head InjuryEarly Phase 1NCT06270680
Carotenoids for Collision Athletes
A Early Phase 1 study testing Vision Edge Pro in people with Head Injury and Carotenoids, run by Penn State University at 1 site in United States.
Trial summary
This is a supplement study being conducted to find out if collision sport athletes who are exposed to repetitive head impacts while supplementing with carotenoids will have decreased pro-inflammatory blood biomarkers, increases in macular pigment optical density, improved contrast sensitivity, greater retinal nerve… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Head Injury, Carotenoids
- What is being tested?
- Vision Edge Pro
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 31 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Aug 2024to 22 Nov 2024
- Phase
- Early Phase 1
- Are there results?
- None posted in the registry
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
- Collision sport athletes:
- Penn State student ages 18 and over
- Any gender
- Participating in club, or intramural collision-sports and is willing to participate in this study (examples: hockey, lacrosse, soccer, wrestling, rugby, boxing, basketball, cheer).
Who cannot join
- For all subjects:
- Subjects with concurrent injury that would impair their ability to perform the assigned procedures will be excluded.
- Under 18 years of age.
- Not a Penn State Student
- Not participating in a collision sport.
- Diagnosis of a learning disability impacting their capacity to consent.
Show all 9Show fewer
- History of ocular or neurological disease (glaucoma, macular degeneration, MS, Parkinson's)
- Concussion diagnosis within the last calendar year.
- However, if a subject sustains a concussion during the course of the study, they may remain as an active participant if they wish to do so.
Trial locations and contacts
1 site in 1 country.
United States1 site
The Pennsylvania State University
University Park, Pennsylvania, 16802
About this study
Official title: Efficacy of Carotenoids on Blood Biomarkers Following A Collision Sport Athletes
This is a supplement study being conducted to find out if collision sport athletes who are exposed to repetitive head impacts while supplementing with carotenoids will have decreased pro-inflammatory blood biomarkers, increases in macular pigment optical density, improved contrast sensitivity, greater retinal nerve fiber thickness, and better overall visual quality of life scores compared to collision athletes taking a placebo.
Read the detailed description
Originally adapted to augment macular pigment for anti-inflammatory, antioxidative, blue light, and visual performance purposes, supplementation with carotenoids has been tested in animal models for protective effects against traumatic brain injury (TBI). Results have been promising, as mice provided with the three main carotenoids (Lutein, Meso-Zeaxanthin, and Zeaxanthin) following TBI displayed reduced levels of pro-inflammatory markers (IL-1β, IL-6, and GFAP) and increased levels of GAP43, NCAM, and BDNF, signaling activation of anti-oxidant systems.
Due to inflammation of the visual system following trauma, immune responses in the eye are for both reparative and protective purposes. However, cytokines released by immune cells compromise visual acuity by means of inflammation and fibrosis (scarring). As such, inflammation to the visual system (including visual processing structures in the brain) carries the danger of visual impairment. Research examining chronic inflammatory responses in the optic tract and subsequent visual dysfunction found mTBI in rodent models to increase GFAP, tumor necrosis factor (TNF), and degeneration of axons up to 3.5 months post-injury. As such, inflammation of the visual system is a measurable phenomenon in rodent models, conveying the need for human subjects research. The nutrients found in the proposed test supplement, lutein, zeaxanthin, meso-zeaxanthin, along with the omega-3 fatty acids DHA and EPA, are deposited in the brain regions that are often found to be affected by a collision-related head injury. Thus, an exploratory study of this topic is proposed, utilizing the three main carotenoids in the form of a MacuHealth supplement.
Optical Coherence Tomography has become a critical clinical tool when discovering and diagnosing disease and neurological disorders of the eyes. It works to map the retina in order to give ophthalmologists precise measurements of the tissues which make up this important part of human anatomy and helps medical experts to diagnosis diseases of the eye such as Glaucoma and Macular Degeneration. In terms of retinal nerve fiber layer thickness (RNFL), a study found Olympic boxers to have thinner RNFL compared to controls. Another study found RNFL thickness as a significant predictor of athlete vs control status, with 4.8-um of thinning seen on average in athletes (boxing, football) when compared to controls.
Although vision disorders are so common, VQOL - to our knowledge - is not specifically addressed following exposure to repetitive head impacts (RHI), concussion, or during return-to-play protocol. In sports such as football, hockey, and boxing where participants are exposed to RHI, participation while experiencing decreased VQOL or visual functionality could prove costly to the health of those athletes. Poor visual acuity and photophobia following concussion have been cited as indicators of poor VQOL. As such, use of the VFQ-25 and the 10-Item Supplement may be important additions to current clinical practice when evaluating the baseline health status of athletes, and following the completion of a collision-sport season.
- Conditions
- Head Injury, Carotenoids
- Being tested
- Vision Edge Pro, Placebo
- Keywords
- Carotenoids, Brain injury, Head impacts, Vision
- Medical subject headings
- Craniocerebral Trauma, Brain Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vision Edge ProDrug
Also called Carotenoid supplement
Each dose will consist of one supplement capsule containing 10 mg lutein, 2 mg zeaxanthin, 10 mg mesozeaxanthin, 50mg EPA, 250mg DHA. Capsules are to be taken orally, once daily with a meal. Duration of supplementation will last approximately 2 - 5 months, depending on the length of the athletic seasons for the sports recruited.
PlaceboOther
A sunflower oil placebo containing 380 mg of sunflower oil
| Study group | Role | What they receive |
|---|---|---|
| Supplement Group | Experimental | The group receiving the carotenoid supplement. Receives: Drug: Vision Edge Pro |
| Placebo Group | Placebo comparator | The group receiving the placebo. Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Blood and saliva biomarkers via venous blood draw and spitting into sterile cup.
- To explore the effect of Lutein, Meso-Zeaxanthin, and Zeaxanthin supplementation on blood and saliva biomarkers following a single competitive season of collegiate collision sport. Specific markers will include GFAP, NF-L, UCH-L1, SBDP, Tau, S100B, BDNF, IL-1B, IL-6.
Measured: Up to 16 weeks
Visual Performance: Speed of visual processing
- To assess the visual performance parameter of speed of visual processing, measured in hertz (Hz). Measured using a densitometer.
Measured: Up to 16 weeks
Visual Performance: Contrast Sensitivity
- To assess visual performance parameter of contrast sensitivity, measured by the percentage threshold of contrast reached using M\&S Technologies Smart System Software.
Measured: Up to 16 weeks
Skin carotenoid concentration
- To measure skin carotenoid concentration to ensure compliance and bioavailability of the test supplement.
Measured: Up to 16 weeks
Retinal Nerve Fiber Layer Thickness
- Utilize Optical Coherence Tomography to examine changes in retinal nerve fiber layer thickness (RNFL) following exposure to repetitive head impacts during a single competitive season of collision sports.
Measured: Up to 16 weeks
Macular Pigment Optical Density
- To explore the effect of Lutein, Meso-Zeaxanthin, and Zeaxanthin supplementation on macular pigment optical density (MPOD) following supplementation over the course of a collegiate season. This is the measurement of blue light reduction by macular pigment, related to the amount of macular pigment carotenoids in an individual's body. Measured using densitometer.
Measured: Up to 16 weeks
Visual Quality of Life Scores
- To explore the effect of Lutein, Meso-Zeaxanthin, and Zeaxanthin supplementation on self-reported measures of visual quality of life (VQOL) using the National Eye Institute Visual Functioning Questionnaire-25 (VFQ-25). Scale title: The National Eye Institute 25-Item Viual Function Questionnaire; minimum value of 0, maximum value of 100; higher score means a better outcome.
Measured: Up to 16 weeks
Visual Quality of Life Scores
- To explore the effect of Lutein, Meso-Zeaxanthin, and Zeaxanthin supplementation on self-reported measures of visual quality of life (VQOL) using the 10-Item Neuro-Ophthalmic Supplement (10-Item Supplement). Scale title: Ten Item Neuro-Ophthalmic Supplement; minimum value of 0, maximum value of 100; higher score means a better outcome.
Measured: Up to 16 weeks
Secondary outcomes (2)
Demographic information
Secondary endpoints that will be measured are headache or migraine history, history of learning disability, dyslexia, ADD/ADHD, self- and family-history of psychiatric disorder. Recorded with yes or no answers.
Measured: Up to 16 weeks
Demographic information
Secondary endpoints that will be measured are duration of sport participation each week, measured in minutes.
Measured: Up to 16 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Feb 2024
- Study start1 Aug 2024
- Primary completion22 Nov 2024
- Study completion22 Nov 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (11)Papers the sponsor has linked to this study.
- Other trials for Head InjuryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Early Phase 1
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 31 participants (actual)
Sponsor and investigators
- Lead sponsor
- Penn State University
- Sponsor type
- University, hospital or other
- Collaborators
- MacuHealth, Orlando Regional Medical Center
- Responsible party
- Principal investigator, Semyon M. Slobounov, Ph.D., Penn State University
- Investigators
- Semyon Slobounov, PhD, Principal investigator, The Pennsylvania State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06270680
- Sponsor's protocol ID
- STUDY00023019
- Status last verified
- Mar 2025
- First submitted
- 3 Feb 2024
- Last updated
- 11 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Stringham JM, Hammond BR. Macular pigment and visual performance under glare conditions. Optom Vis Sci. 2008 Feb;85(2):82-8. doi: 10.1097/OPX.0b013e318162266e.
PubMed 18296924Stringham JM, Stringham NT, O'Brien KJ. Macular Carotenoid Supplementation Improves Visual Performance, Sleep Quality, and Adverse Physical Symptoms in Those with High Screen Time Exposure. Foods. 2017 Jun 29;6(7):47. doi: 10.3390/foods6070047.
PubMed 28661438Stringham JM, Johnson EJ, Hammond BR. Lutein across the Lifespan: From Childhood Cognitive Performance to the Aging Eye and Brain. Curr Dev Nutr. 2019 Jun 4;3(7):nzz066. doi: 10.1093/cdn/nzz066. eCollection 2019 Jul.
PubMed 31321376Gunal MY, Sakul AA, Caglayan AB, Erten F, Kursun OED, Kilic E, Sahin K. Protective Effect of Lutein/Zeaxanthin Isomers in Traumatic Brain Injury in Mice. Neurotox Res. 2021 Oct;39(5):1543-1550. doi: 10.1007/s12640-021-00385-3. Epub 2021 Jun 15.
PubMed 34129176Stepp MA, Menko AS. Immune responses to injury and their links to eye disease. Transl Res. 2021 Oct;236:52-71. doi: 10.1016/j.trsl.2021.05.005. Epub 2021 May 27.
PubMed 34051364Chen JJ, Bhatti MT. Papilledema. Int Ophthalmol Clin. 2019 Summer;59(3):3-22. doi: 10.1097/IIO.0000000000000274. No abstract available.
PubMed 31233413Vishwanathan R, Neuringer M, Snodderly DM, Schalch W, Johnson EJ. Macular lutein and zeaxanthin are related to brain lutein and zeaxanthin in primates. Nutr Neurosci. 2013 Jan;16(1):21-9. doi: 10.1179/1476830512Y.0000000024. Epub 2012 Jul 9.
PubMed 22780947Strong J. Retinal OCT Imaging - Ophthalmic Photographers' Society. Published 2011. Accessed January 5, 2023. https://www.opsweb.org/page/RetinalOCT
Childs C, Barker LA, Gage AM, Loosemore M. Investigating possible retinal biomarkers of head trauma in Olympic boxers using optical coherence tomography. Eye Brain. 2018 Dec 14;10:101-110. doi: 10.2147/EB.S183042. eCollection 2018.
PubMed 30588143Leong D, Morettin C, Messner LV, Steinmetz RJ, Pang Y, Galetta SL, Balcer LJ. Visual Structure and Function in Collision Sport Athletes. J Neuroophthalmol. 2018 Sep;38(3):285-291. doi: 10.1097/WNO.0000000000000572.
PubMed 28885451Armstrong RA. Visual problems associated with traumatic brain injury. Clin Exp Optom. 2018 Nov;101(6):716-726. doi: 10.1111/cxo.12670. Epub 2018 Feb 28.
PubMed 29488253
Study at a glance
From the registry record, last updated by the sponsor on 11 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Carotenoids on Blood Biomarkers Following A Collision Sport Athletes
- ClinicalTrials.gov ID
- NCT06270680
- Acronym / sponsor ID
- STUDY00023019
- Conditions
- Head Injury, Carotenoids
- Keywords
- Carotenoids, Brain injury, Head impacts, Vision
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 31 participants (actual)
- Lead sponsor
- Penn State UniversityUniversity, hospital or other
- Collaborators
- MacuHealth, Orlando Regional Medical Center
- Study start
- 1 Aug 2024 (actual)
- Primary completion
- 22 Nov 2024 (actual)
- Study completion
- 22 Nov 2024 (actual)
- First posted
- 21 Feb 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a supplement study being conducted to find out if collision sport athletes who are exposed to repetitive head impacts while supplementing with carotenoids will have decreased pro-inflammatory blood biomarkers, increases in macular pigment optical density, improved contrast sensitivity, greater retinal nerve fiber thickness, and better overall visual quality of life scores compared to collision athletes taking a placebo.
Detailed description
Originally adapted to augment macular pigment for anti-inflammatory, antioxidative, blue light, and visual performance purposes, supplementation with carotenoids has been tested in animal models for protective effects against traumatic brain injury (TBI). Results have been promising, as mice provided with the three main carotenoids (Lutein, Meso-Zeaxanthin, and Zeaxanthin) following TBI displayed reduced levels of pro-inflammatory markers (IL-1β, IL-6, and GFAP) and increased levels of GAP43, NCAM, and BDNF, signaling activation of anti-oxidant systems.
Due to inflammation of the visual system following trauma, immune responses in the eye are for both reparative and protective purposes. However, cytokines released by immune cells compromise visual acuity by means of inflammation and fibrosis (scarring). As such, inflammation to the visual system (including visual processing structures in the brain) carries the danger of visual impairment. Research examining chronic inflammatory responses in the optic tract and subsequent visual dysfunction found mTBI in rodent models to increase GFAP, tumor necrosis factor (TNF), and degeneration of axons up to 3.5 months post-injury. As such, inflammation of the visual system is a measurable phenomenon in rodent models, conveying the need for human subjects research. The nutrients found in the proposed test supplement, lutein, zeaxanthin, meso-zeaxanthin, along with the omega-3 fatty acids DHA and EPA, are deposited in the brain regions that are often found to be affected by a collision-related head injury. Thus, an exploratory study of this topic is proposed, utilizing the three main carotenoids in the form of a MacuHealth supplement.
Optical Coherence Tomography has become a critical clinical tool when discovering and diagnosing disease and neurological disorders of the eyes. It works to map the retina in order to give ophthalmologists precise measurements of the tissues which make up this important part of human anatomy and helps medical experts to diagnosis diseases of the eye such as Glaucoma and Macular Degeneration. In terms of retinal nerve fiber layer thickness (RNFL), a study found Olympic boxers to have thinner RNFL compared to controls. Another study found RNFL thickness as a significant predictor of athlete vs control status, with 4.8-um of thinning seen on average in athletes (boxing, football) when compared to controls.
Although vision disorders are so common, VQOL - to our knowledge - is not specifically addressed following exposure to repetitive head impacts (RHI), concussion, or during return-to-play protocol. In sports such as football, hockey, and boxing where participants are exposed to RHI, participation while experiencing decreased VQOL or visual functionality could prove costly to the health of those athletes. Poor visual acuity and photophobia following concussion have been cited as indicators of poor VQOL. As such, use of the VFQ-25 and the 10-Item Supplement may be important additions to current clinical practice when evaluating the baseline health status of athletes, and following the completion of a collision-sport season.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Supplement Group | Experimental | Drug: Vision Edge ProThe group receiving the carotenoid supplement. |
| Placebo Group | Placebo comparator | Other: PlaceboThe group receiving the placebo. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Collision sport athletes:
Key exclusion criteria (9 listed)
- For all subjects:
- However, if a subject sustains a concussion during the course of the study, they may remain as an active participant if they wish to do so.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Vision Edge ProAlso: Carotenoid supplementEach dose will consist of one supplement capsule containing 10 mg lutein, 2 mg zeaxanthin, 10 mg mesozeaxanthin, 50mg EPA, 250mg DHA. Capsules are to be taken orally, once daily with a meal. Duration of supplementation will last approximately 2 - 5 months, depending on the length of the athletic seasons for the sports recruited. | Drug | Supplement Group |
| PlaceboA sunflower oil placebo containing 380 mg of sunflower oil | Other | Placebo Group |
Primary outcome
Blood and saliva biomarkers via venous blood draw and spitting into sterile cup.
Time frame: Up to 16 weeks
1. To explore the effect of Lutein, Meso-Zeaxanthin, and Zeaxanthin supplementation on blood and saliva biomarkers following a single competitive season of collegiate collision sport. Specific markers will include GFAP, NF-L, UCH-L1, SBDP, Tau, S100B, BDNF, IL-1B, IL-6.
Visual Performance: Speed of visual processing
Time frame: Up to 16 weeks
2. To assess the visual performance parameter of speed of visual processing, measured in hertz (Hz). Measured using a densitometer.
Visual Performance: Contrast Sensitivity
Time frame: Up to 16 weeks
3. To assess visual performance parameter of contrast sensitivity, measured by the percentage threshold of contrast reached using M\&S Technologies Smart System Software.
Skin carotenoid concentration
Time frame: Up to 16 weeks
4. To measure skin carotenoid concentration to ensure compliance and bioavailability of the test supplement.
Retinal Nerve Fiber Layer Thickness
Time frame: Up to 16 weeks
5. Utilize Optical Coherence Tomography to examine changes in retinal nerve fiber layer thickness (RNFL) following exposure to repetitive head impacts during a single competitive season of collision sports.
Macular Pigment Optical Density
Time frame: Up to 16 weeks
6. To explore the effect of Lutein, Meso-Zeaxanthin, and Zeaxanthin supplementation on macular pigment optical density (MPOD) following supplementation over the course of a collegiate season. This is the measurement of blue light reduction by macular pigment, related to the amount of macular pigment carotenoids in an individual's body. Measured using densitometer.
Visual Quality of Life Scores
Time frame: Up to 16 weeks
7. To explore the effect of Lutein, Meso-Zeaxanthin, and Zeaxanthin supplementation on self-reported measures of visual quality of life (VQOL) using the National Eye Institute Visual Functioning Questionnaire-25 (VFQ-25). Scale title: The National Eye Institute 25-Item Viual Function Questionnaire; minimum value of 0, maximum value of 100; higher score means a better outcome.
Visual Quality of Life Scores
Time frame: Up to 16 weeks
8. To explore the effect of Lutein, Meso-Zeaxanthin, and Zeaxanthin supplementation on self-reported measures of visual quality of life (VQOL) using the 10-Item Neuro-Ophthalmic Supplement (10-Item Supplement). Scale title: Ten Item Neuro-Ophthalmic Supplement; minimum value of 0, maximum value of 100; higher score means a better outcome.
2 secondary outcomes
Demographic information
Time frame: Up to 16 weeks
Demographic information
Time frame: Up to 16 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Mar 2025.
- Background: PubMed 18296924Stringham JM, Hammond BR. Macular pigment and visual performance under glare conditions. Optom Vis Sci. 2008 Feb;85(2):82-8. doi: 10.1097/OPX.0b013e318162266e.
- Background: PubMed 28661438Stringham JM, Stringham NT, O'Brien KJ. Macular Carotenoid Supplementation Improves Visual Performance, Sleep Quality, and Adverse Physical Symptoms in Those with High Screen Time Exposure. Foods. 2017 Jun 29;6(7):47. doi: 10.3390/foods6070047.
- Background: PubMed 31321376Stringham JM, Johnson EJ, Hammond BR. Lutein across the Lifespan: From Childhood Cognitive Performance to the Aging Eye and Brain. Curr Dev Nutr. 2019 Jun 4;3(7):nzz066. doi: 10.1093/cdn/nzz066. eCollection 2019 Jul.
- Background: PubMed 34129176Gunal MY, Sakul AA, Caglayan AB, Erten F, Kursun OED, Kilic E, Sahin K. Protective Effect of Lutein/Zeaxanthin Isomers in Traumatic Brain Injury in Mice. Neurotox Res. 2021 Oct;39(5):1543-1550. doi: 10.1007/s12640-021-00385-3. Epub 2021 Jun 15.
- Background: PubMed 34051364Stepp MA, Menko AS. Immune responses to injury and their links to eye disease. Transl Res. 2021 Oct;236:52-71. doi: 10.1016/j.trsl.2021.05.005. Epub 2021 May 27.
- Background: PubMed 31233413Chen JJ, Bhatti MT. Papilledema. Int Ophthalmol Clin. 2019 Summer;59(3):3-22. doi: 10.1097/IIO.0000000000000274. No abstract available.
- Background: PubMed 22780947Vishwanathan R, Neuringer M, Snodderly DM, Schalch W, Johnson EJ. Macular lutein and zeaxanthin are related to brain lutein and zeaxanthin in primates. Nutr Neurosci. 2013 Jan;16(1):21-9. doi: 10.1179/1476830512Y.0000000024. Epub 2012 Jul 9.
- BackgroundStrong J. Retinal OCT Imaging - Ophthalmic Photographers' Society. Published 2011. Accessed January 5, 2023. https://www.opsweb.org/page/RetinalOCT
- Background: PubMed 30588143Childs C, Barker LA, Gage AM, Loosemore M. Investigating possible retinal biomarkers of head trauma in Olympic boxers using optical coherence tomography. Eye Brain. 2018 Dec 14;10:101-110. doi: 10.2147/EB.S183042. eCollection 2018.
- Background: PubMed 28885451Leong D, Morettin C, Messner LV, Steinmetz RJ, Pang Y, Galetta SL, Balcer LJ. Visual Structure and Function in Collision Sport Athletes. J Neuroophthalmol. 2018 Sep;38(3):285-291. doi: 10.1097/WNO.0000000000000572.
- Background: PubMed 29488253Armstrong RA. Visual problems associated with traumatic brain injury. Clin Exp Optom. 2018 Nov;101(6):716-726. doi: 10.1111/cxo.12670. Epub 2018 Feb 28.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Semyon Slobounov, PhD principal investigator
The Pennsylvania State University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Vision Edge Pro in people with Head Injury and Carotenoids, run by Penn State University 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 9 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 11 Mar 2025. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Blood and saliva biomarkers via venous blood draw and spitting into sterile cup. (time frame: Up to 16 weeks). The study lists 8 primary outcomes in all. 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 NCT06270680, which also lists 11 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 11 Mar 2025.