Acquired Nasolacrimal Duct ObstructionANLDONCT02234700
Are Corneal Epithelial Defects Related to Changes in Ocular Bacterial Flora in Patients With ANLDO
An observational study of Acquired Nasolacrimal Duct Obstruction, run by Western Galilee Hospital-Nahariya at 1 site in Israel.
Trial summary
Comparison between patients with nasolacrimal duct obstruction and healthy patients and the influence of their bacterial flora on the corneal epithelium. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Acquired Nasolacrimal Duct Obstruction
- How many people
- 60 participants
- Where
- 1 siteIsrael
- Study dates
- Aug 2014to Feb 2015
- How long will I take part?
- 6 Months
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: 30 patients with nasolacrimal duct obstruction and 30 healthy patients
Who may be able to join
- 18 years of age or older, nasolacrimal duct obstruction
Who cannot join
- younger then 18 years of age
- ocular infections
- patients after repair of lacrimal duct surgery
- systemic active diseases
- patients taking medication that are know to influence bacterial flora of the eye
Trial locations and contacts
1 site in 1 country.
Israel1 site, 1 recruiting
- Recruiting
Western Galileeh Hospital
Naharya, 22402
Abdelhakim ayub, MD, 0502999110, abedayub@gmail.com
About this study
Official title: To Estimate Whether Corneal Epithelial Defects Occur in Patients With Acquired Nasolacrimal Duct Obstructions is Linked to Changes Occurring Within Ocular Bacterial Flora in These Patients, and What Are the Specific Changes in Their Flora.
Comparison between patients with nasolacrimal duct obstruction and healthy patients and the influence of their bacterial flora on the corneal epithelium.
Read the detailed description
Any patient with nasolacrimal duct obstruction above the age of 18 Comparing changes in their bacterial ocular flora to healthy patients without obstruction and above 18 years of age
- Conditions
- Acquired Nasolacrimal Duct Obstruction
What is being measured
The primary outcome is the main question the study is designed to answer.
the change of ocular normal flora in patients with nasolacrimal duct obstruction as a comparison to general population.
as the literature suggests most of the ocular flora is composed of Staphylococcus and Haemophilus, any change in these composition will be considered abnormal.
Measured: 6 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Sep 2014 (estimated)
- Study startAug 2014
- Primary completionFeb 2015 (estimated)
- Study completionFeb 2015 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acquired Nasolacrimal Duct ObstructionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 60 participants (estimated)
- Target duration
- 6 Months
Sponsor and investigators
- Lead sponsor
- Western Galilee Hospital-Nahariya
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Yanir Kassif, M.D, Study chair, Medical Center of the Galilee
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02234700
- Sponsor's protocol ID
- TASMC-14-AA-0071-CTIL
- Acronym
- ANLDO
- Status last verified
- Sep 2014
- First submitted
- 26 Aug 2014
- Last updated
- 9 Sep 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 9 Sep 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- To Estimate Whether Corneal Epithelial Defects Occur in Patients With Acquired Nasolacrimal Duct Obstructions is Linked to Changes Occurring Within Ocular Bacterial Flora in These Patients, and What Are the Specific Changes in Their Flora.
- ClinicalTrials.gov ID
- NCT02234700
- Acronym / sponsor ID
- ANLDO / TASMC-14-AA-0071-CTIL
- Conditions
- Acquired Nasolacrimal Duct Obstruction
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Western Galilee Hospital-NahariyaOther government
- Study start
- Aug 2014
- Primary completion
- Feb 2015 (estimated)
- Study completion
- Feb 2015 (estimated)
- First posted
- 9 Sep 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Comparison between patients with nasolacrimal duct obstruction and healthy patients and the influence of their bacterial flora on the corneal epithelium.
Detailed description
Any patient with nasolacrimal duct obstruction above the age of 18 Comparing changes in their bacterial ocular flora to healthy patients without obstruction and above 18 years of age
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Target follow-up
- 6 Months
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- 30 patients with nasolacrimal duct obstruction and 30 healthy patients
Key inclusion criteria (1 listed)
- 18 years of age or older, nasolacrimal duct obstruction
Key exclusion criteria (5 listed)
- younger then 18 years of age
- ocular infections
- patients after repair of lacrimal duct surgery
- systemic active diseases
- patients taking medication that are know to influence bacterial flora of the eye
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
the change of ocular normal flora in patients with nasolacrimal duct obstruction as a comparison to general population.
Time frame: 6 month
as the literature suggests most of the ocular flora is composed of Staphylococcus and Haemophilus, any change in these composition will be considered abnormal.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Sep 2014.
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Comparative Outcomes of Four Versus Two Balloon Inflation Points in Dacryoplasty for Primary Acquired Nasolacrimal Duct Obstruction
Primary Acquired Nasolacrimal Duct Obstruction
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Efficacy Evaluation of 5-Fluorouracil as an Adjuvant to Endoscopic Dacryocystorhinostomy in Managing Primary Acquired Nasolacrimal Duct Obstruction With Small Lacrimal Sac: A Randomized Controlled Study
Primary Acquired Nasolacrimal Duct Obstruction
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Yanir Kassif, M.D study chair
Medical Center of the Galilee
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Acquired Nasolacrimal Duct Obstruction, run by Western Galilee Hospital-Nahariya at 1 site in Israel.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 9 Sep 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact abdelhakim Ayub, MD (0502999110, abedayub@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
the change of ocular normal flora in patients with nasolacrimal duct obstruction as a comparison to general population. (time frame: 6 month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Sep 2014.