Examining the effects of systemic light chain amyloidosis on eye health

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

This study looks at how systemic light chain amyloidosis affects eye health in people who have this rare condition.

Quick facts

• Study type: Observational
• Enrollment: 130 (estimated)
• Ages: 18 Years to 80 Years
• Sex: All
• Sponsor: Zhongshan Ophthalmic Center, Sun Yat-sen University (Academic / other)
• Locations: 1 site (Guangzhou, Guangdong)
• Trial ID: NCT06803082 on ClinicalTrials.gov

What this trial studies

This observational study aims to investigate the ocular complications associated with systemic light chain amyloidosis, a rare plasma cell disorder characterized by the deposition of amyloid proteins in various organs. The study will include patients diagnosed with this condition and assess their eye health, while excluding those with other significant ocular diseases. Participants will voluntarily provide informed consent and be aged between 18 and 80 years. The findings could enhance understanding of how this systemic disease impacts eye health.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18-80 diagnosed with systemic light chain amyloidosis without other severe systemic diseases.

Not a fit: Patients with clear causes of eye diseases or severe ocular conditions will not benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to improved diagnosis and management of ocular complications in patients with systemic light chain amyloidosis.

How similar studies have performed: While there is limited research specifically on ocular complications of systemic light chain amyloidosis, studies on amyloidosis have shown varying degrees of success in understanding its systemic effects.

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.

Where this trial is running

Guangzhou, Guangdong

• Zhongshan Opthalmic Center — Guangzhou, Guangdong, China (Recruiting)

Study contacts

• Principal investigator: chang he — Zhongshan Ophthalmic Center, Sun Yat-sen University
• Study coordinator: Minglu Ma, Doctor

Conditions Systemic Light Chain Amyloidosis; Ocular Complications