Actively Recruiting

Age: 18Years - 80Years
All Genders
Healthy Volunteers
ID06803082

The Impact of Systemic Light Chain Amyloidosis on Eyes and Its Appendages

Led by Zhongshan Ophthalmic Center, Sun Yat-sen University · Updated on 2025-01-31

130

Participants Needed

1

Research Sites

N/A

Total Duration

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AI-Summary

What this Trial Is About

Systemic Light Chain (AL) Amyloidosis is a rare disease caused by abnormal plasma cells producing proteins that deposit in tissues and organs such as the kidneys, heart, and eyes, leading to damage. This study aims to understand how AL amyloidosis affects the eyes and their surrounding tissues, to identify early eye signs of the disease. It is an observational study including patients with AL amyloidosis and healthy controls, sponsored by Zhongshan Ophthalmic Center, Sun Yat-sen University. The study compares two groups: patients with systemic light chain amyloidosis and normal controls without systemic diseases. Patients with amyloidosis will have eye examinations every 2 months for a total of 4 visits over 6 months to observe ocular complications and disease progression. The control group consists of individuals without systemic disease for comparison. Participants will undergo various eye assessments including conjunctival mass, subconjunctival hemorrhage, retinal blood flow, visual field, intraocular pressure, and others at each visit. Researchers will track changes and complications in eye tissues over the 6-month follow-up period. The study aims to gather detailed information on eye involvement in AL amyloidosis and improve early diagnosis through these measures.

CONDITIONS

Brief Title

The Impact of Systemic Light Chain Amyloidosis on Eyes

Who Can Participate

Age: 18Years - 80Years
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Patients diagnosed with Systemic Light Chain Amyloidosis
  • No other severe systemic diseases affecting eye examination
  • Voluntary participation with signed informed consent
  • Age between 18 and 80 years, any gender
  • Stable general condition without systemic light chain amyloidosis (control group)
  • Control group participants also must have no other severe systemic diseases affecting eye examination
  • Control group participants must voluntarily participate with signed informed consent
  • Control group age between 18 and 80 years, any gender
Not Eligible

You will not qualify if you...

  • Eye diseases with clear causes such as ocular surface malignant tumors, corneal perforation, or severe trauma
  • Nystagmus
  • Severe ocular scar diseases or conjunctival scars with fornix shortening
  • Current signs of infection, including fever or antibiotic treatment
  • Mental abnormalities
  • Pregnant or breastfeeding women or those planning pregnancy within 2 years
  • NYHA Class IV heart disease with severe heart failure symptoms
  • NT-proBNP level greater than 8,500 ng/L (case group only)

AI-Screening

AI-Powered Screening

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Long-term Monitoring

Duration - 6 months

Participants with Systemic Light Chain Amyloidosis are observed to track ocular complications and progression over time.

Follow-up visits once every 2 months for a total of 4 visits

Trial Site Locations

Total: 1 location

1

Zhongshan Opthalmic Center

Guangzhou, Guangdong, China

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Research Team

M

Minglu Ma, Doctor

Y

Yanjie Yan

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

2

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