RBR-5pz9pwv Description of ocular alterations in patientes with Sistemic Lupus Erythematosus

Date of registration: 06/20/2022 ^(mm/dd/yyyy)
Last approval date : 06/20/2022 ^(mm/dd/yyyy)

Study type:

Observational

Scientific title:

Trial identification

• UTN code: U1111-1277-5760

• Public title:

  en

  Description of ocular alterations in patientes with Sistemic Lupus Erythematosus

  pt-br

  Descriçao das alteraçoes oculares em pacientes com Lupus Eritematoso Sistemico

• Scientific acronym:

• Public acronym:
• Secondaries identifiers:
  • 48491521.7.0000.0049
    Issuing authority: Plataforma Brasil
  • 4.918.276
    Issuing authority: Comitê de Ética em Pesquisa do Hospital Universitário Prof. Edgard Santos da Universidade Federal da Bahia

Sponsors

• Primary sponsor: Universidade Federal da Bahia
• Secondary sponsor:
  • Institution: Servicos Medicos de Oftalmologia - SEMOF
• Supporting source:
  • Institution: Servicos Medicos de Oftalmologia - SEMOF

Health conditions

• Health conditions:

  en

  Systemic Lupus Erythematosous; Ophthalmopathies

  pt-br

  Lupus Eritematoso Sistemico; Oftalmopatias

• General descriptors for health conditions:

  en

  C20.111 Autoimmune diseases

  pt-br

  C20.111 Doenças autoimunes

• Specific descriptors:

  en

  C17.300.480 Systemic Erythematosous Lupus

  pt-br

  C17.300.480 Lupus Eritematoso Sistemico

  en

  C11 Ophthalmopathies

  pt-br

  C11 Oftalmopatias

Interventions

• Interventions:

  en

  This is a cross-sectional analytical study that will be carried out at the Rheumatology and Ophthalmology Services of the Professor Edgar Santos University Hospital (HUPES) and in the Serviços Médicos de Oftalmologia (SEMOF) General objective: To determine the prevalence of ophthalmologic alterations observed in a sample of patients with SLE. Specific objectives: 1) Describe ophthalmologic changes in SLE; 2) To evaluate the associations between ophthalmologic alterations found with clinical data and laboratory parameters of patients with lupus The sample calculation was performed using the WINPEP calculator, based on the study by Dias Santos A et al. (17), in which they observed a proportion of 31.1% of patients with at least one ocular manifestation. Thus, 329 individuals will be needed assuming a difference of 5% and a 95% confidence interval Patients who meet the selection criteria and agree to participate in the study, will sign the Free and Informed Consent Form and will be submitted to Rheumatological evaluation at the Rheumatology outpatient clinic of HUPES. The ophthalmological evaluation will be performed at the SEMOF, including anamnesis with identification of dry eye complaints (18), visual acuity with better correction, anterior segment biomicroscopy, TRFL (fluorescein tear film rupture test), ocular surface study, Schirmer test, tonometry, computerized keratoscopy, paquimetry, corneal specular microscopy, retinal fundus examination and Oct (Optical Coherence Tomography) of macula. Those who present alterations in the retinal examination may require complementation with angiofluoresceinography, which will be performed at the ophthalmology outpatient clinic of HUPES. Patients will be submitted to clinical consultation and rheumatological physical examination, in addition to collecting blood samples to determine autoantibody research (ANA, anti-SSA, anti-SSB, anti-DNA, anti-Sm and anticardiolipin). The disease activity will be evaluated using the SLEDAI instrument (19)

  pt-br

  Trata-se de um estudo analítico caráter transversal que será realizado nos Serviços de Reumatologia e Oftalmologia do Hospital Universitário Professor Edgar Santos (HUPES) e no Serviços Médicos de Oftalmologia (SEMOF) Objetivo geral: Determinar a prevalência das alterações oftalmológicas observadas numa amostra de pacientes com LES. Objetivos específicos: 1) Descrever as alterações oftalmológicas no LES; 2) Avaliar as associações entre as alterações oftalmológicas encontradas com os dados clínicos e parâmetros laboratoriais de pacientes com lúpus. O cálculo amostral foi realizado por meio da calculadora WINPEP, baseando-se no estudo de Dias Santos A et al.(17), no qual observaram uma proporção de 31,1% dos pacientes com ao menos uma manifestação ocular. Dessa forma, serão necessários 329 indivíduos assumindo uma diferença de 5% e um intervalo de confiança de 95%. Os pacientes que preencherem os critérios de seleção e aceitarem participar do estudo, assinarão o Termo de Consentimento Livre e Esclarecido e serão submetidos à avaliação Reumatológica no ambulatório de Reumatologia do HUPES. A avaliação oftalmológica será realizada no Serviços Médicos de Oftalmologia (SEMOF), incluindo anamnese com identificação de queixas de olho seco (18), acuidade visual com melhor correção, biomicroscopia de segmento anterior, TRFL (teste de ruptura do filme lacrimal com fluoresceína), estudo da superfície ocular, teste de Schirmer, tonometria, ceratoscopia computadorizada, paquimetria, microscopia especular de córnea, mapeamento de retina e OCT (Optical Coherence Tomography) de mácula. Aqueles que apresentarem alteração no exame de mapeamento de retina poderão necessitar de complementação com angiofluoresceínografia, que será realizada no ambulatório de oftalmologia do HUPES. Os pacientes serão submetidos à consulta clínica e exame físico reumatológicos, além de ser coletada amostra de sangue para determinar pesquisa de autoanticorpos (FAN, anti-SSA, anti-SSB, anti-DNA, anti-Sm e anticardiolipina). A atividade da doença será avaliada utilizando-se o instrumento SLEDAI (19)

• Descriptors:

  en

  H57 Eye Disorders and Appendix

  pt-br

  H57 Transtornos dos olhos e anexos

Recruitment

• Study status: Recruiting
• Countries
  • Brazil
• Date first enrollment: 09/01/2021 ^(mm/dd/yyyy)

• Target sample size:	Gender:	Minimum age:	Maximum age:
  329	-	18 Y	0

• Inclusion criteria:

  en

  Patients with SLE will be recruited at the Rheumatology outpatient clinic of HUPES and must meet the inclusion criteria for SLE according to the American College of Rheumatology updated in 2019 (16). Patients over 18 years of age followed at the Hupes Rheumatology outpatient clinic will be selected

  pt-br

  Todos os participantes deverão preencher os critérios de inclusão para LES de acordo com o Colégio Americano de Reumatologia atualizados em 2019 (16). Serão selecionados pacientes com idade acima de 18 anos acompanhados no ambulatório de Reumatologia do HUPES

• Exclusion criteria:

  en

  Exclusion criteria will be patients presenting clinical diagnosis of another rheumatologic disease; HIV; HTLV; severe Arterial Hypertention; diabetes mellitus and individuals who have other ophthalmologic pathologies not related to SLE

  pt-br

  Os critérios de exclusão serão pacientes que apresentem diagnóstico clínico de outra doença reumatológica; HIV; HTLV; HAS severa; diabetes melitus e indivíduos que tenham outras patologias oftalmológicas não relacionadas ao LES

Study type

• Study design:

• Expanded access program	Purpose	Intervention assignment	Number of arms	Masking type	Allocation	Study phase

Outcomes

• Primary outcomes:

  en

  To determine the prevalence of ophthalmologic alterations observed in a sample of patients with Systemic Lupus Erythematosus

  pt-br

  Determinar a prevalência das alterações oftalmológicas observadas numa amostra de pacientes com Lupus Eritematoso Sistemico

• Secondary outcomes:

  en

  Describe the associations between ophthalmologic alterations found with clinical data and laboratory parameters of patients with lupus

  pt-br

  Descrever as associações entre as alterações oftalmológicas encontradas com os dados clínicos e parâmetros laboratoriais de pacientes com lúpus

Contacts

• Public contact
  • Full name: Eneida Machado Alves
  • • Address: Rua Clarival do Prado Valladares
    • City: Salvador / Brazil
    • Zip code: 41820-000
  • Phone: +5571987750584
  • Email: eneidamachadoalves@gmail.com
  • Affiliation: Servicos Medicos de Oftalmologia - SEMOF
   
• Scientific contact
  • Full name: Eneida Machado Alves
  • • Address: Rua Clarival do Prado Valladares
    • City: Salvador / Brazil
    • Zip code: 41820-000
  • Phone: +5571987750584
  • Email: eneidamachadoalves@gmail.com
  • Affiliation: Servicos Medicos de Oftalmologia - SEMOF
   
• Site contact
  • Full name: Eneida Machado Alves
  • • Address: Rua Clarival do Prado Valladares
    • City: Salvador / Brazil
    • Zip code: 41820-000
  • Phone: +5571987750584
  • Email: eneidamachadoalves@gmail.com
  • Affiliation: Servicos Medicos de Oftalmologia - SEMOF
   

Additional links:

• Download in ICTRP format