A Study to Determine the Prevalence of Inflammatory Dry Eye Disease in Patients Prior to Cataract Removal (REVEAL)
2 de novembro de 2015 atualizado por: Allergan
This study will evaluate the prevalence of inflammatory dry eye disease in patients prior to cataract surgery.
No treatment is administered in this study.
Visão geral do estudo
Tipo de estudo
Observacional
Inscrição (Real)
204
Contactos e Locais
Esta seção fornece os detalhes de contato para aqueles que conduzem o estudo e informações sobre onde este estudo está sendo realizado.
Locais de estudo
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Manitoba
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Brandon, Manitoba, Canadá
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Nova Scotia
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Halifax, Nova Scotia, Canadá
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Ontario
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Barrie, Ontario, Canadá
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Ottawa, Ontario, Canadá
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Toronto, Ontario, Canadá
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Quebec
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Boisbriand, Quebec, Canadá
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Critérios de participação
Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.
Critérios de elegibilidade
Idades elegíveis para estudo
50 anos e mais velhos (Adulto, Adulto mais velho)
Aceita Voluntários Saudáveis
Não
Gêneros Elegíveis para o Estudo
Tudo
Método de amostragem
Amostra Não Probabilística
População do estudo
Patients with planned cataract removal surgery
Descrição
Inclusion Criteria:
- Scheduled to undergo cataract removal surgery
Exclusion Criteria:
- Current use of eye drops or oral medications for allergic conjunctivitis
- Serious ocular injury, intraocular surgery, or refractive surgery within 6 months in the study eye
- Use of a contact lens within 4 weeks
Plano de estudo
Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.
Como o estudo é projetado?
Detalhes do projeto
Coortes e Intervenções
Grupo / Coorte |
Intervenção / Tratamento |
|---|---|
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Patients with Planned Cataract Removal
Patients with planned cataract removal surgery are evaluated for the presence of inflammatory dry eye disease.
No treatment is administered.
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Sem intervenção
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O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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Percentage of Patients With a Presence of Matrix Metalloproteinase-9 (MMP-9) in the Study Eye
Prazo: Up to 60 Days Prior to Surgery
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Tear film was collected and a diagnostic test was used to determine the presence of MMP-9 in the study eye.
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Up to 60 Days Prior to Surgery
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Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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Percentage of Participants Suspected of Having Dry Eye With Elevated MMP-9
Prazo: Up to 60 days prior to cataract surgery
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Tear film was collected and a diagnostic test was used to determine the presence of MMP-9 in the study eye.
Suspected of having dry eye was defined as a response of "Yes" to the Investigator Dry Eye History question.
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Up to 60 days prior to cataract surgery
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Percentage of Participants With Elevated MMP-9 Without Prior Diagnosis or Physician Recommended Intervention
Prazo: Up to 60 days prior to cataract surgery
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Tear film was collected and a diagnostic test was used to determine the presence of MMP-9 in the study eye.
Participants without a prior diagnosis of keratoconjunctivitis sicca, dry eye or tear film insufficiency or physician recommended use of topical cyclosporine, artificial tears or punctal plugs are included in the analysis.
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Up to 60 days prior to cataract surgery
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Percentage of Participants With Elevated MMP-9 With Dry Eye Symptoms Without Conjunctival or Corneal Staining
Prazo: Up to 60 days prior to cataract surgery
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Tear film was collected and a diagnostic test was used to determine the presence of MMP-9 in the study eye.
Dry eye symptoms were measured by a score of at least ≥ 2 using the Subject Evaluation of Symptoms of Dryness (SESoD) questionnaire without conjunctival or corneal staining.
The SESoD assesses dry eye using a 5-point scale where 0= no dryness to 4= severe dryness.
Conjunctival and Corneal Staining were evaluated as part of the slit lamp biomicroscopy examination.
Eye structures and surfaces were assessed for dry eye signs using a 5-point scale where: 0=none, 0.5=trace, 1=mild, 2=moderate and 3=severe.
Higher values represent a worse outcome.
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Up to 60 days prior to cataract surgery
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Percentage of Participants With Elevated MMP-9 With Dry Eye Symptoms Without Any Signs
Prazo: Up to 60 days prior to cataract surgery
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Tear film was collected and a diagnostic test was used to determine the presence of MMP-9 in the study eye.
Dry eye symptoms were measured by a score of at least ≥ 2 using the SESoD questionnaire without any signs.
The SESoD assesses dry eye using a 5-point scale where 0= no dryness to 4= severe dryness.
Signs included conjunctival or corneal staining, Schirmer's score ≤ 7mm, or Tear Film Break-up Time [TFBUT] ≤ 10 seconds.
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Up to 60 days prior to cataract surgery
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Percentage of Participants With Elevated MMP-9 With at Least One Dry Eye Sign Without Dry Eye Symptoms
Prazo: Up to 60 days prior to cataract surgery
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Tear film was collected and a diagnostic test was used to determine the presence of MMP-9 in the study eye.
Dry Eye Signs included conjunctival or corneal staining, Schirmer's score ≤ 7 mm, or Tear Film Break-up Time [TFBUT] ≤ 10 seconds without Dry eye symptoms measured by a score of at least ≤ 1 using the SESoD questionnaire.
The SESoD assessed dry eye using a 5-point scale where 0= no dryness to 4= severe dryness.
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Up to 60 days prior to cataract surgery
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Percentage of Participants With Elevated MMP-9 With at Least One Dry Eye Sign and Dry Eye Symptoms
Prazo: Up to 60 days prior to cataract surgery
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Tear film was collected and a diagnostic test was used to determine the presence of MMP-9 in the study eye.
Dry Eye Signs included conjunctival or corneal staining, Schirmer's score ≤ 7mm, or Tear Film Break-up Time [TFBUT] ≤ 10 seconds with Dry eye symptoms measured by a score of at least ≥ 2 using the SESoD questionnaire.
The SESoD assessed dry eye using a 5-point scale where 0= no dryness to 4= severe dryness.
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Up to 60 days prior to cataract surgery
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Percentage of Participants With Elevated MMP-9 Who Routinely Use Artificial Tears
Prazo: Up to 60 Days Prior to Surgery
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Tear film was collected and a diagnostic test was used to determine the presence of MMP-9 in the study eye.
Artificial Tear usage was assessed by the investigator.
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Up to 60 Days Prior to Surgery
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Percentage of Participants With Elevated MMP-9 With Punctal Plugs
Prazo: Up to 60 Days Prior to Surgery
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Tear film was collected and a diagnostic test was used to determine the presence of MMP-9 in the study eye.
A history of punctual plug usage was assessed by the investigator.
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Up to 60 Days Prior to Surgery
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Percentage of Participants With Elevated MMP-9 With Corneal Staining Grade ≥ 1 and ≥ 2
Prazo: Up to 60 Days Prior to Surgery
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Tear film was collected and a diagnostic test was used to determine the presence of MMP-9 in the study eye.
Corneal Staining was evaluated as part of the slit lamp biomicroscopy examination.
Eye structures and surfaces were assessed for signs of dry eye using a 5-point scale where: 0=none, 0.5=trace, 1=mild, 2=moderate and 3=severe.
Higher values represent a worse outcome.
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Up to 60 Days Prior to Surgery
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Percentage of Participants With Elevated MMP-9 and an Ocular Surface Disease Index® (OSDI®) > 12, > 22 and ≥ 32
Prazo: Up to 60 Days Prior to Surgery
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Tear film was collected and a diagnostic test was used to determine the presence of MMP-9 in the study eye.
The OSDI consists of 12 questions to assess visual function, ocular symptoms and environmental triggers related to dry eye.
Each of the 12 questions is assessed using a 5-point scale (0=none of the time to 4=all of the time) which is converted to a total score between 0-100.
OSDI total scores of 0-12=normal (best), 13-22= mild ocular surface disease, 23-32 =moderate ocular surface disease, and 33-100=severe ocular surface disease (worst).
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Up to 60 Days Prior to Surgery
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Colaboradores e Investigadores
É aqui que você encontrará pessoas e organizações envolvidas com este estudo.
Patrocinador
Datas de registro do estudo
Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.
Datas Principais do Estudo
Início do estudo
1 de junho de 2013
Conclusão Primária (Real)
1 de março de 2014
Conclusão do estudo (Real)
1 de março de 2014
Datas de inscrição no estudo
Enviado pela primeira vez
18 de junho de 2013
Enviado pela primeira vez que atendeu aos critérios de CQ
18 de junho de 2013
Primeira postagem (Estimativa)
20 de junho de 2013
Atualizações de registro de estudo
Última Atualização Postada (Estimativa)
3 de dezembro de 2015
Última atualização enviada que atendeu aos critérios de controle de qualidade
2 de novembro de 2015
Última verificação
1 de novembro de 2015
Mais Informações
Termos relacionados a este estudo
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- GMA-RES-012-001
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