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Analysis of 86 Dacryoliths at the University Hospital Ostrava

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01826734
Recruitment Status : Completed
First Posted : April 8, 2013
Last Update Posted : September 5, 2016
Sponsor:
Information provided by (Responsible Party):
University Hospital Ostrava

Brief Summary:

Background Because dacryoliths occur at low frequency, few studies have focused on their composition.

The investigators aimed to present findings from morphological, chemical, and mineralogic analysis of 86 dacryoliths.

Methods The team studied 86 dacryoliths obtained during 832 dacryocystorhinostomies (DCR) performed for postsaccal obstruction. The samples were analyzed with atomic infrared spectrometry (80 samples), amino acid analysis (17 samples), scanning electron microscopy, and an electron microprobe with an energy dispersive detector (7 samples).


Condition or disease
Lacrimal Apparatus Diseases Lacrimal Duct Obstruction

Show Show detailed description

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Study Type : Observational
Actual Enrollment : 86 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Lacrimal Sac Dacryoliths (86 Samples): Chemical and Mineralogic Analyses
Study Start Date : January 1994
Actual Primary Completion Date : December 2012
Actual Study Completion Date : January 2013

Group/Cohort
Patients with dacryolits
The study population consisted of patients following a dacryolit extraction procedure. The extraction procedure was not a part of this study.



Primary Outcome Measures :
  1. The percentage of individual types of amino-acids in the dacryolits [ Time Frame: 18 months ]
    The obtained dacryolist were assessed physically and chemically. The authors will assess the obtained material for the presence of common amino acids.


Secondary Outcome Measures :
  1. The percentage individual elements in the dacryolits [ Time Frame: 18 months ]
    The obtained biological material will be assessed as regards to its elemental composition.


Biospecimen Retention:   Samples Without DNA
Dacryolits during the DCR procedure.


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
The study population consisted of patients complaining of lacrimation, with subsequent detection and extraction of a dacryolit.
Criteria

Inclusion Criteria:

  • patients over 18 years of age
  • patients complaining of lacrimation
  • patients following an extraction of a dacryolith

Exclusion Criteria:

  • not signing the Informed Consent
  • high risk of surgery (ASA IV)
  • presaccal obstruction treatment
  • revision EDCRs
  • incomplete follow-ups

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01826734


Locations
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Czech Republic
University Hospital Ostrava
Ostrava, Moravian-Silesian Region, Czech Republic, 70800
Sponsors and Collaborators
University Hospital Ostrava
Investigators
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Principal Investigator: Pavel Kominek, doc,MD,PhD,MBA University Hospital Ostrava

Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: University Hospital Ostrava
ClinicalTrials.gov Identifier: NCT01826734    
Other Study ID Numbers: FNO-ENT-Dacryoliths
First Posted: April 8, 2013    Key Record Dates
Last Update Posted: September 5, 2016
Last Verified: September 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by University Hospital Ostrava:
dacryolith
dacryocystorhinostomy
composition
chemical analysis
infrared spectrometry
scanning electron microscopy
elemental analysis
Additional relevant MeSH terms:
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Lacrimal Apparatus Diseases
Lacrimal Duct Obstruction
Eye Diseases