NCT01826734

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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
86

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jan 1994

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 1994

Completed
18.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2012

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2013

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

March 22, 2013

Completed
17 days until next milestone

First Posted

Study publicly available on registry

April 8, 2013

Completed
Last Updated

September 5, 2016

Status Verified

September 1, 2016

Enrollment Period

18.9 years

First QC Date

March 22, 2013

Last Update Submit

September 2, 2016

Conditions

Lacrimal Apparatus DiseasesLacrimal Duct Obstruction

Keywords

dacryolithdacryocystorhinostomycompositionchemical analysisinfrared spectrometryscanning electron microscopyelemental analysis

Outcome Measures

Primary Outcomes (1)

  • The percentage of individual types of amino-acids in the dacryolits

    The obtained dacryolist were assessed physically and chemically. The authors will assess the obtained material for the presence of common amino acids.

    18 months

Secondary Outcomes (1)

  • The percentage individual elements in the dacryolits

    18 months

Study Arms (1)

Patients with dacryolits

The study population consisted of patients following a dacryolit extraction procedure. The extraction procedure was not a part of this study.

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

The study population consisted of patients complaining of lacrimation, with subsequent detection and extraction of a dacryolit.

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Hospital Ostrava

Ostrava, Moravian-Silesian Region, 70800, Czechia

Location

Related Publications (4)

  • Iliadelis ED, Karabatakis VE, Sofoniou MK. Dacryoliths in a series of dacryocystorhinostomies: histologic and chemical analysis. Eur J Ophthalmol. 2006 Sep-Oct;16(5):657-62.

    PMID: 17061214BACKGROUND

  • Iliadelis E, Karabatakis V, Sofoniou M. Dacryoliths in chronic dacryocystitis and their composition (spectrophotometric analysis). Eur J Ophthalmol. 1999 Oct-Dec;9(4):266-8. doi: 10.1177/112067219900900402.

    PMID: 10651189BACKGROUND

  • Lew H, Lee SY, Yun YS. Measurement of pH, electrolytes and electrophoretic studies of tear proteins in tears of patients with dacryoliths: a novel concept for dacryoliths. Ophthalmologica. 2004 Mar-Apr;218(2):130-5. doi: 10.1159/000076149.

    PMID: 15004503BACKGROUND

  • Kominek P, Doskarova S, Svagera Z, Lach K, Cervenka S, Zelenik K, Matousek P. Lacrimal sac dacryoliths (86 samples): chemical and mineralogic analyses. Graefes Arch Clin Exp Ophthalmol. 2014 Mar;252(3):523-9. doi: 10.1007/s00417-013-2501-6. Epub 2013 Oct 30.

    PMID: 24170283DERIVED

Biospecimen

Retention: SAMPLES WITHOUT DNA

Dacryolits during the DCR procedure.

MeSH Terms

Conditions

Lacrimal Apparatus DiseasesLacrimal Duct Obstruction

Condition Hierarchy (Ancestors)

Eye Diseases

Study Officials

  • Pavel Kominek, doc,MD,PhD,MBA

    University Hospital Ostrava

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 22, 2013

First Posted

April 8, 2013

Study Start

January 1, 1994

Primary Completion

December 1, 2012

Study Completion

January 1, 2013

Last Updated

September 5, 2016

Record last verified: 2016-09

Data Sharing

IPD Sharing
Will not share

Locations

CZ(1)