ModalitiesNCT06798025
Three Different Modalities for Treatment of Inflammatory Punctal Stenosis
A study testing Punctal dilation, Punctal dilation and topical medication and Triamcinolone acetonide in people with Modalities and Treatment, run by Tanta University at 1 site in Egypt.
Trial summary
This study aimed to compare the efficacy of three various modalities of treatment of inflammatory punctal stenosis (Punctal dilatation alone, combined punctal dilatation with topical medications, or peri-punctal injection of Triamcinolone acetonide) Read more about this study
- Who is it for?
- Ages 33 to 75 years
- Conditions the study is for
- Modalities, Treatment, Inflammatory Punctal Stenosis
- What is being tested?
- Punctal dilation, Punctal dilation and topical medication and Triamcinolone acetonide
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteEgypt
- Study dates
- 20 Jul 2023to 30 Jun 2024
- Phase
- Interventional
- 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 33 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age from 33 to 75.
- Both sexes.
- Patients with inflammatory punctal stenosis or occlusion complaining of symptomatic epiphora.
Who cannot join
- Subjects with previous lacrimal surgeries.
- Subjects with lid margin malposition such as ectropion, entropion, or lid retraction.
- Subjects with medial lid masses obscuring the punctum.
- Subjects with a history of ocular trauma involving the medial aspect of the lid margin.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparative Study Between Three Different Modalities for Treatment of Inflammatory Punctal Stenosis
This study aimed to compare the efficacy of three various modalities of treatment of inflammatory punctal stenosis (Punctal dilatation alone, combined punctal dilatation with topical medications, or peri-punctal injection of Triamcinolone acetonide)
Read the detailed description
Acquired punctal stenosis is a condition in which the external opening of the lacrimal canaliculus, located in the nasal part of the palpebral margin, is narrowed or occluded. This condition results from chronic inflammation of the external punctum, leading to gradual fibrotic changes in the ostium, followed by progressive occlusion of the duct.
Different modalities were described for the treatment of acquired punctual stenosis. Repeated dilatation of the stenotic punctum is a simple procedure that may provide temporary improvement of the symptoms, but restenosis is common unless additional procedures are performed. Many other methods were used to augment punctual size, including 1-snip, 2-snip, and 3-snip punctoplasty, supplemented with adding sutures or Mini-Monoka insertion and punch punctoplasty.
- Conditions
- Modalities, Treatment, Inflammatory Punctal Stenosis
- Being tested
- Punctal dilation, Punctal dilation and topical medication, Triamcinolone acetonide
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Punctal dilationProcedure or surgery
Patients were treated with punctal dilatation only.
Punctal dilation and topical medicationDrug
Patients were treated with a combination of punctal dilation and topical medication in the form of preservative-free steroid eye drops based on dexamethasone sodium phosphate (0.1%) and preservative-free artificial tears based on sodium hyaluronate, polyethylene, and propylene Glycol.
Triamcinolone acetonideDrug
Patients were treated with a peri-punctual injection of Triamcinolone acetonide.
| Study group | Role | What they receive |
|---|---|---|
| Group A | Experimental | Patients were treated with punctal dilatation only Receives: Procedure: Punctal dilation |
| Group B | Experimental | Patients were treated with a combination of punctual dilation and topical medication in the form of preservative-free steroid eye drops based on dexamethasone sodium phosphate (0.1%) and preservative-free artificial tears based on sodium hyaluronate, polyethylene, and propylene Glycol. Receives: Drug: Punctal dilation and topical medication |
| Group C | Experimental | Patients were treated with a peri-punctual injection of Triamcinolone acetonide. Receives: Drug: Triamcinolone acetonide |
What is being measured
The primary outcome is the main question the study is designed to answer.
Degree of patient satisfaction
The degree of patient satisfaction was assessed using 3-point Likert Scale (1=Not satisfied, 2: No Difference, 3:Satisfied)
Measured: 3 months postoperatively
Secondary outcomes (1)
Punctal diameter
The punctal diameter of cases was measured before and after 1 month and 3 months of treatment.
Measured: 3 months postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jan 2025
- Study start20 Jul 2023
- Primary completion30 Jun 2024
- Study completion30 Jun 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ModalitiesStudies of the same condition, open and under way.
- More trials run by Tanta 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tanta University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yomna EL-Saied Mohamed Ibrahim, Tanta University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06798025
- Sponsor's protocol ID
- 36264MS245/2/23
- Status last verified
- Jan 2025
- First submitted
- 23 Jan 2025
- Last updated
- 29 Jan 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The data will be available upon a reasonable request from the corresponding author after the end of study for one year.
Study at a glance
From the registry record, last updated by the sponsor on 29 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Study Between Three Different Modalities for Treatment of Inflammatory Punctal Stenosis
- ClinicalTrials.gov ID
- NCT06798025
- Acronym / sponsor ID
- 36264MS245/2/23
- Conditions
- Modalities, Treatment, Inflammatory Punctal Stenosis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Tanta UniversityUniversity, hospital or other
- Study start
- 20 Jul 2023 (actual)
- Primary completion
- 30 Jun 2024 (actual)
- Study completion
- 30 Jun 2024 (actual)
- First posted
- 29 Jan 2025 (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.
This study aimed to compare the efficacy of three various modalities of treatment of inflammatory punctal stenosis (Punctal dilatation alone, combined punctal dilatation with topical medications, or peri-punctal injection of Triamcinolone acetonide)
Detailed description
Acquired punctal stenosis is a condition in which the external opening of the lacrimal canaliculus, located in the nasal part of the palpebral margin, is narrowed or occluded. This condition results from chronic inflammation of the external punctum, leading to gradual fibrotic changes in the ostium, followed by progressive occlusion of the duct.
Different modalities were described for the treatment of acquired punctual stenosis. Repeated dilatation of the stenotic punctum is a simple procedure that may provide temporary improvement of the symptoms, but restenosis is common unless additional procedures are performed. Many other methods were used to augment punctual size, including 1-snip, 2-snip, and 3-snip punctoplasty, supplemented with adding sutures or Mini-Monoka insertion and punch punctoplasty.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Group A | Experimental | Procedure: Punctal dilationPatients were treated with punctal dilatation only |
| Group B | Experimental | Drug: Punctal dilation and topical medicationPatients were treated with a combination of punctual dilation and topical medication in the form of preservative-free steroid eye drops based on dexamethasone sodium phosphate (0.1%) and preservative-free artificial tears based on sodium hyaluronate, polyethylene, and propylene Glycol. |
| Group C | Experimental | Drug: Triamcinolone acetonidePatients were treated with a peri-punctual injection of Triamcinolone acetonide. |
Who may qualify
- Ages
- 33 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age from 33 to 75.
- Both sexes.
- Patients with inflammatory punctal stenosis or occlusion complaining of symptomatic epiphora.
Key exclusion criteria (4 listed)
- Subjects with previous lacrimal surgeries.
- Subjects with lid margin malposition such as ectropion, entropion, or lid retraction.
- Subjects with medial lid masses obscuring the punctum.
- Subjects with a history of ocular trauma involving the medial aspect of the lid margin.
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 |
|---|---|---|
| Punctal dilationPatients were treated with punctal dilatation only. | Procedure or surgery | Group A |
| Punctal dilation and topical medicationPatients were treated with a combination of punctal dilation and topical medication in the form of preservative-free steroid eye drops based on dexamethasone sodium phosphate (0.1%) and preservative-free artificial tears based on sodium hyaluronate, polyethylene, and propylene Glycol. | Drug | Group B |
| Triamcinolone acetonidePatients were treated with a peri-punctual injection of Triamcinolone acetonide. | Drug | Group C |
Primary outcome
Degree of patient satisfaction
Time frame: 3 months postoperatively
The degree of patient satisfaction was assessed using 3-point Likert Scale (1=Not satisfied, 2: No Difference, 3:Satisfied)
1 secondary outcome
Punctal diameter
Time frame: 3 months postoperatively
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 29 Jan 2025.
- Individual participant dataSharing planned: Yes. The data will be available upon a reasonable request from the corresponding author after the end of study for one year.
Related trials for Modalities
Recruiting
68Ga-XMFH01 PET/Fluorescence Imaging in Prostate Cancer
Prostate Cancer (Diagnosis), ACP3
Not yet recruiting
Transcranial Magnetic Stimulation for Methamphetamine Use Disorder During Pregnancy
Methamphetamine Use Disorder, Pregnancy
Not yet recruiting
"Effectiveness of a Telerehabilitation Program Versus a Conventional Rehabilitation Program in Patients With Subacromial Pain"
Subacromial Impingement Syndrome
Active, not recruitingPhase 3
Nivolumab After Combined Modality Therapy in Treating Patients With High Risk Stage II-IIIB Anal Cancer
Anal Basaloid Carcinoma, Anal Canal Cloacogenic Carcinoma
Not yet recruitingObservational study
Changes in Land-Based Motor Function After Routine Hydrotherapy in Children With Cerebral Palsy
Cerebral Palsy
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Punctal dilation, Punctal dilation and topical medication and Triamcinolone acetonide in people with Modalities and Treatment, run by Tanta 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 4 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 29 Jan 2025. 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?
Degree of patient satisfaction (time frame: 3 months postoperatively). 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 29 Jan 2025.