Lacrimal Apparatus DiseasesNCT04240431
Level of Lacrimal Passage Obstruction
An observational study of Lacrimal Apparatus Diseases, run by Minia University at 1 site in Egypt.
Trial summary
Detect anatomical level of acquired lacrimal passage obstructions among patients with epiphora. They were evaluated and divided into four groups Punctal, Canalicular, Nasolacrimal duct and Mixed groups according to level of obstruction Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Lacrimal Apparatus Diseases
- What is being tested?
- Probing /irrigation of lacrimal passages
- How many people
- 223 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jan 2017to 21 Dec 2019
- How long will I take part?
- 3 Days
- 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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients were divided into four main groups according to site of narrowing or obstruction Punctal group, Canalicular group, NLD group and Mixed group who had 2 or more levels of narrowing or obstruction
Who may be able to join
- Watering of the eye
- Acquired lacrimal obstructions
- Adult patients with
Who cannot join
- No previous lacrimal surgery
- Congenital lacrimal obstructions
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Symptomatic Acquired Lacrimal Passage Obstruction: Clinical Evaluation of the Level of Obstruction in Adult Patients of Upper Egypt
Detect anatomical level of acquired lacrimal passage obstructions among patients with epiphora. They were evaluated and divided into four groups Punctal, Canalicular, Nasolacrimal duct and Mixed groups according to level of obstruction
Read the detailed description
In a 3 years period adult patients with obstructive epiphora were evaluated clinically by Probing /irrigation of lacrimal passages to detect anatomical level of obstruction.
The main site of obstruction was the common canaliculus where 2/3 of patients had canalicular problems. The second common site of obstruction is nasolacrimal duct followed by the puncti.
- Conditions
- Lacrimal Apparatus Diseases
- Being tested
- Probing /irrigation of lacrimal passages
- Medical subject headings
- Lacrimal Apparatus Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Probing /irrigation of lacrimal passagesDiagnostic test
Probing of the lacrimal passage was done using #00 Bowman's lacrimal probe which can reveal any narrowing (resistance) or obstruction (soft stop) of the canaliculi during its advancement from punctum towards the lacrimal sac.
| Study group | Role | What they receive |
|---|---|---|
| Epiphora | Adult patients suffering from watering of the eye included in the study to detect level of obstruction Receives: Diagnostic Test: Probing /irrigation of lacrimal passages |
What is being measured
The primary outcome is the main question the study is designed to answer.
Level of obstruction of lacrimal system
The level was detected either Punctal, Canalicular, Nasolacrimal duct or Mixed
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jan 2020
- Study start1 Jan 2017
- Primary completion21 Dec 2019
- Study completion21 Dec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lacrimal Apparatus DiseasesStudies of the same condition, open and under way.
- More trials run by Minia UniversityThe sponsor's other registered studies.
- 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 only
- Time perspective
- Prospective
- Enrolment
- 223 participants (actual)
- Target duration
- 3 Days
Sponsor and investigators
- Lead sponsor
- Minia University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mohamed Farag Khalil Ibrahiem, Minia University
- Investigators
- Mohamed F Ibrahiem, MD, Principal investigator, Minia University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04240431
- Sponsor's protocol ID
- Minia2019
- Status last verified
- Jan 2020
- First submitted
- 21 Jan 2020
- Last updated
- 27 Jan 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Symptomatic Acquired Lacrimal Passage Obstruction: Clinical Evaluation of the Level of Obstruction in Adult Patients of Upper Egypt
- ClinicalTrials.gov ID
- NCT04240431
- Acronym / sponsor ID
- Minia2019
- Conditions
- Lacrimal Apparatus Diseases
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 223 participants (actual)
- Lead sponsor
- Minia UniversityUniversity, hospital or other
- Study start
- 1 Jan 2017 (actual)
- Primary completion
- 21 Dec 2019 (actual)
- Study completion
- 21 Dec 2019 (actual)
- First posted
- 27 Jan 2020 (actual)
- 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.
Detect anatomical level of acquired lacrimal passage obstructions among patients with epiphora. They were evaluated and divided into four groups Punctal, Canalicular, Nasolacrimal duct and Mixed groups according to level of obstruction
Detailed description
In a 3 years period adult patients with obstructive epiphora were evaluated clinically by Probing /irrigation of lacrimal passages to detect anatomical level of obstruction.
The main site of obstruction was the common canaliculus where 2/3 of patients had canalicular problems. The second common site of obstruction is nasolacrimal duct followed by the puncti.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Target follow-up
- 3 Days
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Epiphora | – | Diagnostic Test: Probing /irrigation of lacrimal passagesAdult patients suffering from watering of the eye included in the study to detect level of obstruction |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients were divided into four main groups according to site of narrowing or obstruction Punctal group, Canalicular group, NLD group and Mixed group who had 2 or more levels of narrowing or obstruction
Key inclusion criteria (3 listed)
- Watering of the eye
- Acquired lacrimal obstructions
- Adult patients with
Key exclusion criteria (2 listed)
- No previous lacrimal surgery
- Congenital lacrimal obstructions
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Probing /irrigation of lacrimal passagesProbing of the lacrimal passage was done using #00 Bowman's lacrimal probe which can reveal any narrowing (resistance) or obstruction (soft stop) of the canaliculi during its advancement from punctum towards the lacrimal sac. | Diagnostic test | Epiphora |
Primary outcome
Level of obstruction of lacrimal system
Time frame: 3 years
The level was detected either Punctal, Canalicular, Nasolacrimal duct or Mixed
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jan 2020.
- Individual participant dataSharing planned: No
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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.
Mohamed F Ibrahiem, MD principal investigator
Minia University
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 Lacrimal Apparatus Diseases, run by Minia University at 1 site in Egypt.
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 3 inclusion and 2 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: finished, as of the sponsor's last update on 27 Jan 2020. 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 Egypt. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Level of obstruction of lacrimal system (time frame: 3 years). 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 27 Jan 2020.