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Search / Trial NCT06803082

The Impact of Systemic Light Chain Amyloidosis on Eyes

Launched by ZHONGSHAN OPHTHALMIC CENTER, SUN YAT-SEN UNIVERSITY · Jan 26, 2025

Trial Information

Current as of November 14, 2025

Recruiting

Keywords

Systemic Light Chain Amyloidosis Ocular Complications

ClinConnect Summary

This clinical trial is investigating how systemic light chain amyloidosis, a rare disease where abnormal proteins build up in the body, affects the eyes. The study aims to understand if and how this condition impacts different parts of the eye and the surrounding tissues. Researchers want to find out about any eye problems that patients with this disease may experience and look for signs that can help with early diagnosis. The trial will involve 80 patients diagnosed with systemic light chain amyloidosis and 50 healthy individuals for comparison.

To participate, patients must be between 18 and 80 years old and have a confirmed diagnosis of systemic light chain amyloidosis without other serious health issues that could interfere with the study. Participants will undergo tests to evaluate their eye health over a six-month period. It's important to note that individuals with specific eye diseases, severe health conditions, or certain other factors cannot join the study. This trial is currently recruiting participants, and it offers a chance to contribute to understanding this rare condition and its effects on vision.

Gender

ALL

Eligibility criteria

  • Case Group
  • Inclusion Criteria:
  • 1. Patients diagnosed with "Systemic Light Chain Amyloidosis";
  • 2. No other severe systemic underlying diseases that affect the examination;
  • 3. Subjects voluntarily participate in this study, sign the informed consent form;
  • 4. Age between 18-80 years old, no gender restrictions.
  • Exclusion Criteria:
  • 1. Patients with eye diseases of clear causes such as ocular surface malignant tumors, corneal perforation, severe eye trauma, etc.;
  • 2. Patients with nystagmus;
  • 3. Severe ocular scar diseases; conjunctival scars with fornix shortening;
  • 4. Current signs of infection, including fever and undergoing antibiotic treatment;
  • 5. Mental abnormalities;
  • 6. Pregnant or breastfeeding women, or women planning to become pregnant within 2 years;
  • 7. NYHA Class IV: Heart disease patients cannot engage in any physical activity, with heart failure symptoms even at rest, and worsening with physical activity;
  • 8. NT-proBNP \> 8,500 ng/L.
  • Control Group
  • Inclusion Criteria:
  • 1. Stable general condition, not patients with "Systemic Light Chain Amyloidosis";
  • 2. No other severe systemic underlying diseases that affect the examination;
  • 3. Subjects voluntarily participate in this study, sign the informed consent form;
  • 4. Age between 18-80 years old, no gender restrictions.
  • Exclusion Criteria:
  • 1. Patients with eye diseases of clear causes such as ocular surface malignant tumors, corneal perforation, severe eye trauma, etc.;
  • 2. Patients with nystagmus;
  • 3. Severe ocular scar diseases; conjunctival scars with fornix shortening;
  • 4. Current signs of infection, including fever and undergoing antibiotic treatment;
  • 5. Mental abnormalities;
  • 6. Pregnant or breastfeeding women, or women planning to become pregnant within 2 years.

About Zhongshan Ophthalmic Center, Sun Yat Sen University

The Zhongshan Ophthalmic Center, affiliated with Sun Yat-sen University, is a leading institution in ophthalmic research and clinical care in China. Renowned for its commitment to advancing the field of ophthalmology, the center specializes in innovative treatments and technologies for various eye conditions. With a strong emphasis on clinical trials, the center aims to enhance patient outcomes through rigorous scientific investigation and collaboration with global research networks. Its multidisciplinary team of experts is dedicated to fostering cutting-edge research that translates into effective therapeutic strategies for vision preservation and restoration.

Locations

Guangzhou, Guangdong, China

Patients applied

0 patients applied

Trial Officials

chang he

Principal Investigator

Zhongshan Ophthalmic Center, Sun Yat-sen University

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported