A Study to Determine the Prevalence of Inflammatory Dry Eye Disease in Patients Prior to Cataract Removal (REVEAL)
2 de noviembre de 2015 actualizado 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.
Descripción general del estudio
Estado
Terminado
Condiciones
Intervención / Tratamiento
Tipo de estudio
De observación
Inscripción (Actual)
204
Contactos y Ubicaciones
Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.
Ubicaciones de estudio
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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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Criterios de participación
Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.
Criterio de elegibilidad
Edades elegibles para estudiar
50 años y mayores (Adulto, Adulto Mayor)
Acepta Voluntarios Saludables
No
Géneros elegibles para el estudio
Todos
Método de muestreo
Muestra no probabilística
Población de estudio
Patients with planned cataract removal surgery
Descripción
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
Plan de estudios
Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.
¿Cómo está diseñado el estudio?
Detalles de diseño
Cohortes e Intervenciones
Grupo / Cohorte |
Intervención / Tratamiento |
|---|---|
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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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Sin intervención
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Percentage of Patients With a Presence of Matrix Metalloproteinase-9 (MMP-9) in the Study Eye
Periodo de tiempo: 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 resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Percentage of Participants Suspected of Having Dry Eye With Elevated MMP-9
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Fechas de registro del estudio
Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.
Fechas importantes del estudio
Inicio del estudio
1 de junio de 2013
Finalización primaria (Actual)
1 de marzo de 2014
Finalización del estudio (Actual)
1 de marzo de 2014
Fechas de registro del estudio
Enviado por primera vez
18 de junio de 2013
Primero enviado que cumplió con los criterios de control de calidad
18 de junio de 2013
Publicado por primera vez (Estimar)
20 de junio de 2013
Actualizaciones de registros de estudio
Última actualización publicada (Estimar)
3 de diciembre de 2015
Última actualización enviada que cumplió con los criterios de control de calidad
2 de noviembre de 2015
Última verificación
1 de noviembre de 2015
Más información
Términos relacionados con este estudio
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- GMA-RES-012-001
Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .