Questa pagina è stata tradotta automaticamente e l'accuratezza della traduzione non è garantita. Si prega di fare riferimento al Versione inglese per un testo di partenza.

Meibography and Tear Scan Using the Oculus Keratograph 4 (KITCHENER)

31 ottobre 2013 aggiornato da: Centre for Contact Lens Research, University of Waterloo
The purpose of this study is to look at both the meibomian glands and the tear film using a new clinical instrument marketed in Canada which was recently acquired by the Centre for Contact Lens Research. These will be compared between two groups of individuals, one group with visible meibomian gland dysfunction (MGD) and one group of individuals with normal meibomian gland appearance. The hypothesis is that there will be a difference between normal individuals and individuals with MGD with respect to the appearance of the meibomian glands and certain tear film attributes.

Panoramica dello studio

Stato

Completato

Descrizione dettagliata

Meibomian gland dysfunction (MGD) is a common clinical condition and a major cause of evaporative dry eye with associated discomfort, visual disturbance and contact lens intolerance. In MGD, meibum is often abnormal, progressively changing in color from clear to yellow and in consistency from liquid to thick and toothpaste-like. Evaluation of the meibomian glands (MG) and lipid layer is vital. In a typical clinical setting, lid and lid margin evaluation is often performed via slitlamp biomicroscopy; however, the structure of the meibomian glands is often not clearly visualized when a slit lamp is used in isolation. Trans-illumination of the lids is necessary to clearly view these glands.

To date, infrared meibography has been the only method available for the assessment of meibomian gland structure. It is primarily regarded as a laboratory-specific procedure for meibomian gland drop out assessment in people suffering from MGD. Recently, the Keratograph 4 was released by OCULUS (Wetzlar, Germany). In addition to corneal and contact lens assessment features, the Keratograph 4 offers a tear film (TF) scan module able to objectively assess tear break-up time (TBUT) with a colour coded map highlighting the regions of tear break up. High-resolution images of tear meniscus can also be obtained and used for subjective assessment of tear meniscus height (TMH) with the help of built-in software. Preliminary research at the Centre for Contact Lens Research has demonstrated its ability to capture meibography images of the upper and lower lids.

The objectives of this study are to collect meibography, TBUT and TMH data using the Keratograph 4 in normal participants (no MGD) and participants with MGD and to compare these between the two groups and before and after the use of a meibomian gland evaluator. The primary outcome variables are meibography images, TBUT and TMH.

The study hypothesis is that here will be a difference between normal participants and participants with MGD, with respect to meibography images (MG drop out), TBUT measurements (area and time of break up) and TMH measurements.

Tipo di studio

Osservativo

Iscrizione (Effettivo)

39

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Luoghi di studio

    • Ontario
      • Waterloo, Ontario, Canada, N2L 3G1
        • Centre for Contact Lens Research, University of Waterloo

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

Da 17 anni a 70 anni (Bambino, Adulto, Adulto più anziano)

Accetta volontari sani

No

Sessi ammissibili allo studio

Tutto

Metodo di campionamento

Campione non probabilistico

Popolazione di studio

Non-contact lens wearers will be recruited using CCLR records and advertising approved by the UW Office of Research Ethics

Descrizione

Inclusion Criteria:

  • Is at least 17 years of age and has full legal capacity to volunteer
  • Has read and signed an information consent letter
  • Is willing and able to follow instructions and maintain the appointment schedule
  • Has had an ocular examination in the last two years
  • Clinical criteria defining non-dry eye (controls) for study inclusion (Group 1):

    1. Composite symptom score of ≤ 12 on the OSDI questionnaire
    2. Meibum secretion quality score of 0 (grade 0-3) at the central eight meibomian glands of the lower lid, in both eyes. Secretion quality score (grade 0-3):

Grade 0 = normal, clear oil expressed (i.e., cooking oil appearance) Grade 1= opaque, diffusely turbid, normal viscosity Grade 2 = opaque, increased viscosity Grade 3 = inspissated (i.e., toothpaste-like appearance) or no expressed material Clinical criteria defining MGD dry eye for study inclusion (Group 2):

  1. Composite symptom score of ≥ 13 on the OSDI questionnaire
  2. Meibum secretion quality score ≥ 1.0 (grade 0-3) at the central eight meibomian glands of the lower lid, in both eyes. Secretion quality score (grade 0-3):

Grade 0 = normal, clear oil expressed (i.e., cooking oil appearance) Grade 1 = opaque, diffusely turbid, normal viscosity Grade 2 = opaque, increased viscosity Grade 3 = inspissated (i.e., toothpaste-like appearance) or no expressed material

Exclusion Criteria:

  • Is a current contact lens wearer
  • Has any ocular disease
  • Is using any topical medications that may affect ocular health
  • Has known sensitivity to the diagnostic pharmaceuticals to be used in the study

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Modelli osservazionali: Caso di controllo
  • Prospettive temporali: Prospettiva

Coorti e interventi

Gruppo / Coorte
Partecipanti normali
Meibomian Gland Dysfunction

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Meibomium Gland Dropout Score - Evidence of Meibomian Gland Dysfunction (MGD) Confirmed by Meibograhpy Imaging Using the Keratograph 4 Measured on a Subjective Grading Scale (0-3) (Summing the Score for the Upper and Lower Lids for a Final Scale of 0-6)
Lasso di tempo: Before and after the use of a meibomian gland evaluator. Assessments will be separated by a period of at least 10 minutes.

Assessments will be made in normal participants (no MGD) and participants with MGD and compared between the two groups at baseline and after the use of a meibomian gland evaluator.

The meibomium gland dropout score subjective grading scale:

0 = no loss of mebomium glands

  1. = area of meibomium gland loss less than 33%
  2. = area of meibomium gland loss between 33% and 67%
  3. = area of meibomium gland loss more than 67%.
Before and after the use of a meibomian gland evaluator. Assessments will be separated by a period of at least 10 minutes.
Tear Breakup Time (TBUT). The Time Taken, in Seconds, for the Tear Film to Break up on the Surface of the Cornea.
Lasso di tempo: Before and after the use of a meibomian gland evaluator. Assessments will be separated by a period of at least 10 minutes.
Measurements will be made in normal participants (no MGD) and participants with MGD and compared between the two groups at baseline and after the use of a meibomian gland evaluator.
Before and after the use of a meibomian gland evaluator. Assessments will be separated by a period of at least 10 minutes.
Tear Meniscus Height (TMH). The Height of the Tear Film Meniscus at the Eyelid Margin.
Lasso di tempo: Before and after the use of a meibomian gland evaluator. Assessments will be separated by a period of at least 10 minutes.
Assessments will be made in normal participants (no MGD) and participants with MGD and compared between the two groups at baseline and after the use of a meibomian gland evaluator.
Before and after the use of a meibomian gland evaluator. Assessments will be separated by a period of at least 10 minutes.

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Investigatori

  • Investigatore principale: Lyndon Jones, PhD, University of Waterloo

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio

1 giugno 2011

Completamento primario (Effettivo)

1 ottobre 2012

Completamento dello studio (Effettivo)

1 ottobre 2012

Date di iscrizione allo studio

Primo inviato

21 giugno 2011

Primo inviato che soddisfa i criteri di controllo qualità

23 giugno 2011

Primo Inserito (Stima)

27 giugno 2011

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Stima)

26 novembre 2013

Ultimo aggiornamento inviato che soddisfa i criteri QC

31 ottobre 2013

Ultimo verificato

1 ottobre 2013

Maggiori informazioni

Termini relativi a questo studio

Altri numeri di identificazione dello studio

  • P/374/11/CCLR

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

3
Sottoscrivi