- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT01882413
A Study to Determine the Prevalence of Inflammatory Dry Eye Disease in Patients Prior to Cataract Removal (REVEAL)
2. november 2015 opdateret af: 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.
Studieoversigt
Status
Afsluttet
Betingelser
Intervention / Behandling
Undersøgelsestype
Observationel
Tilmelding (Faktiske)
204
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
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Manitoba
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Brandon, Manitoba, Canada
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Nova Scotia
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Halifax, Nova Scotia, Canada
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Ontario
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Barrie, Ontario, Canada
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Ottawa, Ontario, Canada
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Toronto, Ontario, Canada
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Quebec
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Boisbriand, Quebec, Canada
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Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
50 år og ældre (Voksen, Ældre voksen)
Tager imod sunde frivillige
Ingen
Køn, der er berettiget til at studere
Alle
Prøveudtagningsmetode
Ikke-sandsynlighedsprøve
Studiebefolkning
Patients with planned cataract removal surgery
Beskrivelse
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
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
Kohorter og interventioner
Gruppe / kohorte |
Intervention / Behandling |
---|---|
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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Ingen indgriben
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
---|---|---|
Percentage of Patients With a Presence of Matrix Metalloproteinase-9 (MMP-9) in the Study Eye
Tidsramme: 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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Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
---|---|---|
Percentage of Participants Suspected of Having Dry Eye With Elevated MMP-9
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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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Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart
1. juni 2013
Primær færdiggørelse (Faktiske)
1. marts 2014
Studieafslutning (Faktiske)
1. marts 2014
Datoer for studieregistrering
Først indsendt
18. juni 2013
Først indsendt, der opfyldte QC-kriterier
18. juni 2013
Først opslået (Skøn)
20. juni 2013
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Skøn)
3. december 2015
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
2. november 2015
Sidst verificeret
1. november 2015
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- GMA-RES-012-001
Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .
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