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A Study to Determine the Prevalence of Inflammatory Dry Eye Disease in Patients Prior to Cataract Removal (REVEAL)

2 november 2015 bijgewerkt door: 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.

Studie Overzicht

Toestand

Voltooid

Conditie

Interventie / Behandeling

Studietype

Observationeel

Inschrijving (Werkelijk)

204

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studie Locaties

  • Canada
    • Manitoba
      • Brandon, Manitoba, Canada
    • Nova Scotia
      • Halifax, Nova Scotia, Canada
    • Ontario
      • Barrie, Ontario, Canada
      • Ottawa, Ontario, Canada
      • Toronto, Ontario, Canada
    • Quebec
      • Boisbriand, Quebec, Canada

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

50 jaar en ouder (Volwassen, Oudere volwassene)

Accepteert gezonde vrijwilligers

Nee

Geslachten die in aanmerking komen voor studie

Allemaal

Bemonsteringsmethode

Niet-waarschijnlijkheidssteekproef

Studie Bevolking

Patients with planned cataract removal surgery

Beschrijving

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

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

Cohorten en interventies

Groep / Cohort
Interventie / Behandeling
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.
Ander: Geen tussenkomst
Geen tussenkomst

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Percentage of Patients With a Presence of Matrix Metalloproteinase-9 (MMP-9) in the Study Eye
Tijdsspanne: Up to 60 Days Prior to Surgery
Tear film was collected and a diagnostic test was used to determine the presence of MMP-9 in the study eye.
Up to 60 Days Prior to Surgery

Secundaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Percentage of Participants Suspected of Having Dry Eye With Elevated MMP-9
Tijdsspanne: Up to 60 days prior to cataract surgery
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.
Up to 60 days prior to cataract surgery
Percentage of Participants With Elevated MMP-9 Without Prior Diagnosis or Physician Recommended Intervention
Tijdsspanne: Up to 60 days prior to cataract surgery
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.
Up to 60 days prior to cataract surgery
Percentage of Participants With Elevated MMP-9 With Dry Eye Symptoms Without Conjunctival or Corneal Staining
Tijdsspanne: Up to 60 days prior to cataract surgery
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.
Up to 60 days prior to cataract surgery
Percentage of Participants With Elevated MMP-9 With Dry Eye Symptoms Without Any Signs
Tijdsspanne: Up to 60 days prior to cataract surgery
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.
Up to 60 days prior to cataract surgery
Percentage of Participants With Elevated MMP-9 With at Least One Dry Eye Sign Without Dry Eye Symptoms
Tijdsspanne: Up to 60 days prior to cataract surgery
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.
Up to 60 days prior to cataract surgery
Percentage of Participants With Elevated MMP-9 With at Least One Dry Eye Sign and Dry Eye Symptoms
Tijdsspanne: Up to 60 days prior to cataract surgery
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.
Up to 60 days prior to cataract surgery
Percentage of Participants With Elevated MMP-9 Who Routinely Use Artificial Tears
Tijdsspanne: Up to 60 Days Prior to Surgery
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.
Up to 60 Days Prior to Surgery
Percentage of Participants With Elevated MMP-9 With Punctal Plugs
Tijdsspanne: Up to 60 Days Prior to Surgery
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.
Up to 60 Days Prior to Surgery
Percentage of Participants With Elevated MMP-9 With Corneal Staining Grade ≥ 1 and ≥ 2
Tijdsspanne: Up to 60 Days Prior to Surgery
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.
Up to 60 Days Prior to Surgery
Percentage of Participants With Elevated MMP-9 and an Ocular Surface Disease Index® (OSDI®) > 12, > 22 and ≥ 32
Tijdsspanne: Up to 60 Days Prior to Surgery
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).
Up to 60 Days Prior to Surgery

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Sponsor

Allergan

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start

1 juni 2013

Primaire voltooiing (Werkelijk)

1 maart 2014

Studie voltooiing (Werkelijk)

1 maart 2014

Studieregistratiedata

Eerst ingediend

18 juni 2013

Eerst ingediend dat voldeed aan de QC-criteria

18 juni 2013

Eerst geplaatst (Schatting)

20 juni 2013

Updates van studierecords

Laatste update geplaatst (Schatting)

3 december 2015

Laatste update ingediend die voldeed aan QC-criteria

2 november 2015

Laatst geverifieerd

1 november 2015

Meer informatie

Termen gerelateerd aan deze studie

Aanvullende relevante MeSH-voorwaarden

Andere studie-ID-nummers

  • GMA-RES-012-001

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