Study on Early Visual Dysfunction in Patients With Systemic Lupus Erythematosus

NCT07679776 | Enrolling By Invitation DMC

• 1 other identifier: PJ2025-06-26
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

• OCT, OCTA, fundus photography, and fundus autofluorescence ( FAF ) were used to observe the fundus physiological indexes of normal subjects and SLE patients, to explore the differences of subclinical retinal damage in SLE patients with different degrees of disease activity, to summarize the changes of subclinical retina in SLE patients without organic retinopathy, and to evaluate its correlation with disease activity, which is of great significance for improving the prognosis of visual function and improving the quality of life in SLE patients.
• By evaluating the visual psychophysical indicators, mainly the visual function test results of different colors and different frequencies, reflecting the functional status of the retina and the degree and characteristics of functional impairment in SLE patients with different degrees of disease activity, in order to screen out the clinical markers of SLE fundus lesions, and provide a reliable reference for the prevention and early intervention of visual impairment.

Conditions

Systemic Lupus Erythematosus (SLE); Visual Function

Outcome Measures

Primary Outcomes (1)

• contrast sensitivity

  Day 1

Study Arms (2)

SLE

SLE patients without retinopathy

Control

Normal group

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

A total of 50 patients ( 100 eyes ) who met the inclusion criteria were collected from the patients diagnosed with SLE in the Department of Rheumatology and Immunology of the First Affiliated Hospital of Anhui Medical University. Among them, the diagnosis of SLE is based on the 2019 European Rheumatism Association ( EULAR ) / American Rheumatism Association ( ACR ) SLE diagnostic criteria. At the same time, 50 age-matched healthy adults ( 100 eyes ) were recruited as the normal control group.

You may qualify if:

• the best corrected visual acuity ( BCVA ) of all cases must be ≥ 1.0 according to the international standard visual acuity char;
• intraocular pressure ( IOP ) in the normal range, namely 10 mmHg ≤ IOP ≤ 21 mmHg ;
• visual field meter examination center and peripheral visual field without defect ;
• no degeneration of fundus retina ;

You may not qualify if:

• obvious abnormality in cranial MRI ;
• history of glaucoma, cataract, retinal vascular disease, retinitis pigmentosa and other eye diseases ;
• history of refractive surgery such as corneal refractive surgery and cataract surgery ;
• other major disease history or systemic lesions affecting the eye ;
• history of disease affecting cognitive function, can understand and cooperate with the examination.

Sponsors & Collaborators

• The First Affiliated Hospital of Anhui Medical University: lead

Study Sites (1)

The First Affiliated Hospital of Anhui Medical University

Hefei, Anhui, China

Location

MeSH Terms

Conditions

Lupus Erythematosus, Systemic

Condition Hierarchy (Ancestors)

Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief physician, Doctoral supervisor

Study Record Dates

• First Submitted: April 24, 2026
• First Posted: July 1, 2026
• Study Start: January 1, 2025
• Primary Completion: December 31, 2025
• Study Completion: June 30, 2026
• Last Updated: July 1, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)