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Enrolling by Invitation

NCT Number: NCT07679776

Study on Early Visual Dysfunction in Patients With Systemic Lupus Erythematosus

* 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.

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Key information

Conditions

Systemic Lupus Erythematosus (SLE) Autoimmune Diseases Connective Tissue Diseases Immune System Diseases Lupus Erythematosus, Systemic Skin and Connective Tissue Diseases Visual Function

Sex eligibility

All sexes

Study type

Observational

Primary location

The First Affiliated Hospital of Anhui Medical University

Hefei, Anhui, China

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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 ;

Exclusion criteria

  • 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.

Treatment and study plan

Primary outcomes

  1. contrast sensitivity

    Time frame: Day 1

Sponsors and collaborators

Lead sponsor

The First Affiliated Hospital of Anhui Medical University

Other

Registry information

Important dates

Study start
2025
Primary completion
2025
Study completion
2026
First posted
Jul 1, 2026
Registry last updated
Jul 1, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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