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Retinal Nerve Fiber Layer Thickness and Cerebrospinal Fluid Aβ/Tau

Association of Retinal Nerve Fiber Layer (RNFL) Thickness With Cerebrospinal Fluid Aβ and Tau Concentration

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03447613
Enrollment
86
Registered
2018-02-27
Start date
2013-08-01
Completion date
2014-12-31
Last updated
2018-11-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Alzheimer Disease

Keywords

retinal nerve fiber layer, cerebrospinal fluid Aβ and Tau

Brief summary

To test the hypothesis that retinal nerve fiber layer (RNFL) thickness is correlated with Aβ and Tau concentration of cerebrospinal fluid (CSF) in an older population.

Detailed description

retinal nerve fiber layer (RNFL) thickness changing has been reported in Alzheimer's Disease (AD) patients at an early stage, and has been demonstrated as a potential biomarker able to predict cognitive deterioration (Hinton DR et al., N Engl J Med 1986; London A et al. Nat Rev Neurol 2013; Chang LY et al., Alzheimers Dement 2014). However, whether RNFL thickness is correlated with cerebrospinal fluid (CSF) features of AD pathogenesis (e.g., Aβ and Tau) remains unclear. The investigators thus conducted this observational cohort study to test the correlation between RNFL thickness changing and CSF, to further validate RNFL as a potential AD biomarker.

Interventions

PROCEDUREsurgery

All participants were scheduled to have elective total hip or knee replacement surgery, ureteroscopic lithotripsy and transurethral resection of the prostate under spinal anesthesia at the Shanghai 10th People's Hospital. After 5 years, the investigaors will follow up the participants including cognitive functions, PET-CT, thickness of Retinal Nerve Fiber Layer.

Sponsors

Massachusetts General Hospital
CollaboratorOTHER
Shanghai 10th People's Hospital
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
CROSS_SECTIONAL

Eligibility

Sex/Gender
ALL
Age
50 Years to No maximum
Healthy volunteers
No

Inclusion criteria

1. 50 years old or older; 2. five years or more of education and scores of MMSE ≥ 24 points; 3. Chinese as their first language; 4. Having spinal anesthesia.

Exclusion criteria

1. prior diagnoses of neurologic diseases, e.g., dementia, Parkinson's diseases, multiple sclerosis or stroke according to DSM-IV; 2. history of mental disorders (e.g., major depressive disorder and schizophrenia) diagnosed according to DSM-IV; 3. known diseases contributing to the retina pathologies, e.g., diabetes, glaucoma or increased intraocular pressure (more than 22 mmHg), cataract, and macular degeneration and hypermyopia; 4. unwillingness to comply with the cognitive assessments; 5. ungradable images of OCT.

Design outcomes

Primary

MeasureTime frameDescription
Specific cognitive functionWithin one week before surgeryNeuropsychological test battery to assess specific cognitive function, including immediate memory, visuospatial memory and executive function.

Secondary

MeasureTime frameDescription
retinal nerve fiber layer (RNFL) thicknessWithin one week before surgeryOptical coherence tomography (Carl Zeiss Meditec, Inc., Dublin, CA, USA) to measure RNFL thickness
Cerebrospinal fluid (CSF) Aβ concentrationDuring the spinal anesthesia before the administration of the local anesthetic.ELISA kits (Aβ40: Cat. # 292-62301; Aβ42: Cat. # 296-64401, Wako, Richmond, VA) to measure Aβ concentration
Cerebrospinal fluid (CSF) Tau concentrationDuring the spinal anesthesia before the administration of the local anesthetic.ELISA kits (Tau: Cat. # KHB0041, Invitrogen, San Francisco, CA) to measure Aβ concentration
Global cognitive stateWithin one week before surgeryMini-Mental State Examination (MMSE) to assess global cognitive function

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026