Punctal StenosisNCT04624022
AS OCT Evaluation for Perforated Punctual Plugs
An observational study of Punctal Stenosis, run by Minia University at 1 site in Egypt.
Trial summary
Evaluation of the perforated punctal plugs after implantation in cases of punctal stenosis regarding position and patency in the early postoperative period (during the first operative weak) Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Punctal Stenosis
- What is being tested?
- Anterior segment optical coherent tomography
- How many people
- 50 participants
- Where
- 1 siteEgypt
- Study dates
- 11 May 2020to 15 Nov 2020
- How long will I take part?
- 7 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients with epiphora will be evaluated to exclude other causes than punctal stenosis. Perforated punctal plugs were implanted under topical anaesthesia. patients follow up and AS-OCT
Who may be able to join
- Patients with punctal stenosis who will be treated by implantation of perorated punctal plugs
Who cannot join
- Patients who are not willing to participate in the study
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Ophthalmology department/ Minia University Hospital/Minia University
Minya, 61111
Heba R AttaAllah, MD, heba.ali@mu.edu.eg
Raafat Abdelrahman, MD, raafat.abdelrahman@mu.edu.eg
About this study
Official title: Evaluation of Implanted Perforated Lacrimal Punctal Plugs Using Anterior Segment Optical Coherence Tomography.
Evaluation of the perforated punctal plugs after implantation in cases of punctal stenosis regarding position and patency in the early postoperative period (during the first operative weak)
Read the detailed description
Prospective non randomized case series study included 50 eyes. The study is conducted on patients attending to the oculoplastic unit of ophthalmology department of Minia university hospital. Informed consents were obtained from the participants in this study. The study was adherent to the tenets of declaration of Heleniski.
Anterior segment optical coherence tomography(AS-OCT) was performed for the included patients after perforated plug implantation (during the first operative weak)
- Conditions
- Punctal Stenosis
- Being tested
- Anterior segment optical coherent tomography
- Keywords
- Punctual stenosis, Perforated Lacrimal Punctal Plugs, AS-OCT
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Anterior segment optical coherent tomographyDiagnostic test
Examination of the implanted perforated lacrimal plugs using anterior segment optical coherent tomography
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluation of the fitting of implanted perforated lacrimal plugs
Either plug is in place or rotated
Measured: first week post-operatively
Evaluation of the patency of the plugs
Either plug is patent or occluded
Measured: first week post-operatively
Evaluation any contents within the plugs
Blood/ Tears/ Debris
Measured: first week post-operatively
Evaluation of the lower tear film height
measuring the tear film meniscus height at the lower lid margin (at the centre of the inferior limbus), height is measured in micrometers
Measured: first week post-operatively
Evaluation of the tear level within the plug
Either within the lower half or upper half of the plug
Measured: first week post-operatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Nov 2020
- Study start11 May 2020
- Primary completion5 Nov 2020 (estimated)
- Study completion15 Nov 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Punctal StenosisStudies 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 only
- Time perspective
- Prospective
- Enrolment
- 50 participants (estimated)
- Target duration
- 7 Days
Sponsor and investigators
- Lead sponsor
- Minia University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Heba Radi AttaAllah, Minia University
- Investigators
- Heba AttaAllah, MD, Principal investigator, Minia University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04624022
- Sponsor's protocol ID
- 620-5/2020
- Status last verified
- Nov 2020
- First submitted
- 29 Oct 2020
- Last updated
- 10 Nov 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Abdallah RMA, Elshafei AMK, AttaAllah HR. Evaluation of implanted perforated lacrimal punctal plugs using anterior segment optical coherence tomography. Eye Vis (Lond). 2021 Oct 3;8(1):36. doi: 10.1186/s40662-021-00259-x.
PubMed 34600582
Study at a glance
From the registry record, last updated by the sponsor on 10 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Implanted Perforated Lacrimal Punctal Plugs Using Anterior Segment Optical Coherence Tomography.
- ClinicalTrials.gov ID
- NCT04624022
- Acronym / sponsor ID
- 620-5/2020
- Conditions
- Punctal Stenosis
- Keywords
- Punctual stenosis, Perforated Lacrimal Punctal Plugs, AS-OCT
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Minia UniversityUniversity, hospital or other
- Study start
- 11 May 2020 (actual)
- Primary completion
- 5 Nov 2020 (estimated)
- Study completion
- 15 Nov 2020 (estimated)
- First posted
- 10 Nov 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.
Evaluation of the perforated punctal plugs after implantation in cases of punctal stenosis regarding position and patency in the early postoperative period (during the first operative weak)
Detailed description
Prospective non randomized case series study included 50 eyes. The study is conducted on patients attending to the oculoplastic unit of ophthalmology department of Minia university hospital. Informed consents were obtained from the participants in this study. The study was adherent to the tenets of declaration of Heleniski.
Anterior segment optical coherence tomography(AS-OCT) was performed for the included patients after perforated plug implantation (during the first operative weak)
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Target follow-up
- 7 Days
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients with epiphora will be evaluated to exclude other causes than punctal stenosis. Perforated punctal plugs were implanted under topical anaesthesia. patients follow up and AS-OCT
Key inclusion criteria (1 listed)
- Patients with punctal stenosis who will be treated by implantation of perorated punctal plugs
Key exclusion criteria (1 listed)
- Patients who are not willing to participate in the study
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 |
|---|---|---|
| Anterior segment optical coherent tomographyExamination of the implanted perforated lacrimal plugs using anterior segment optical coherent tomography | Diagnostic test | – |
Primary outcome
Evaluation of the fitting of implanted perforated lacrimal plugs
Time frame: first week post-operatively
Either plug is in place or rotated
Evaluation of the patency of the plugs
Time frame: first week post-operatively
Either plug is patent or occluded
Evaluation any contents within the plugs
Time frame: first week post-operatively
Blood/ Tears/ Debris
Evaluation of the lower tear film height
Time frame: first week post-operatively
measuring the tear film meniscus height at the lower lid margin (at the centre of the inferior limbus), height is measured in micrometers
Evaluation of the tear level within the plug
Time frame: first week post-operatively
Either within the lower half or upper half of the plug
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Nov 2020.
- Derived from this study: PubMed 34600582Abdallah RMA, Elshafei AMK, AttaAllah HR. Evaluation of implanted perforated lacrimal punctal plugs using anterior segment optical coherence tomography. Eye Vis (Lond). 2021 Oct 3;8(1):36. doi: 10.1186/s40662-021-00259-x.
- Individual participant dataSharing planned: No
Related trials for Punctal Stenosis
Active, not recruitingPhase 4
A Comparative Analysis of the Effectiveness of Nepafenac Combined With a Lubricant Versus a Lubricant Alone in the Treatment of Epiphora Associated With Lacrimal Punctum Stenosis
Epiphora, Punctal Stenosis
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.
Heba AttaAllah, 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 Punctal Stenosis, 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 1 inclusion and 1 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 10 Nov 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Heba R AttaAllah, MD (00201002554107, heba.ali@mu.edu.ed), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evaluation of the fitting of implanted perforated lacrimal plugs (time frame: first week post-operatively). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04624022, which also lists 1 linked publication.
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 10 Nov 2020.