Punctal StenosisNCT05586620
3 Snip Punctoplasty With and Without Mitomycine C.
A study testing 3-snip punctoplasty and 3-snip punctoplasty and Mitomycin C in people with Punctal Stenosis, run by Al-Azhar University at 1 site in Egypt.
Trial summary
Punctal stenosis is a progressive constriction of the puncta with resultant epiphora. One of the most effective treatment options is 1- to 4-snip punctoplasty combined with or without Mitomycin-C. Read more about this study
- Who is it for?
- Ages 16 to 63 years
- Conditions the study is for
- Punctal Stenosis
- What is being tested?
- 3-snip punctoplasty and 3-snip punctoplasty and Mitomycin C
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jun 2021to 10 Jun 2022
- 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 16 to 63 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Patients with recurrence of punctal stenosis at the end of 1 month following punctal dilatation.
Who cannot join
- patients with associated lacrimal passage obstruction
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparative Study on 3 Snip Punctoplasty With and Without Mitomycine C in the Management of Punctual Stenosis or Occlusion
Punctal stenosis is a progressive constriction of the puncta with resultant epiphora. One of the most effective treatment options is 1- to 4-snip punctoplasty combined with or without Mitomycin-C.
- Conditions
- Punctal Stenosis
- Being tested
- 3-snip punctoplasty, 3-snip punctoplasty and Mitomycin C
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
3-snip punctoplastyProcedure or surgery
punctoplasty, more commonly known as watery eye surgery, is an ophthalmic surgical procedure performed to correct punctal stenosis (a condition that causes tears to overflow from the eyes) by widening the punctal opening to allow the tears to drain with ease.
3-snip punctoplasty and Mitomycin CProcedure or surgery
punctoplasty, more commonly known as watery eye surgery, is an ophthalmic surgical procedure performed to correct punctal stenosis (a condition that causes tears to overflow from the eyes) by widening the punctal opening to allow the tears to drain with ease.
Mitomycin C is a chemotherapeutic agent that acts by inhibiting DNA synthesis
| Study group | Role | What they receive |
|---|---|---|
| 3-snip punctoplasty | Active comparator | Not described Receives: Procedure: 3-snip punctoplasty |
| 3-snip punctoplasty with mitomycin C | Active comparator | Not described Receives: Procedure: 3-snip punctoplasty and Mitomycin C |
What is being measured
The primary outcome is the main question the study is designed to answer.
Punctal patency
Punctum will be assessed by inspection of the lid by slitlamb examination, whither obstructed or not
Measured: Baseline
Punctal patency
Punctum will be assessed by inspection of the lid by slitlamb examination, whither obstructed or not
Measured: 1 week postoperative
Punctal patency
Punctum will be assessed by inspection of the lid by slitlamb examination, whither obstructed or not
Measured: 1 month postoperative
Punctal patency
Punctum will be assessed by inspection of the lid by slitlamb examination, whither obstructed or not
Measured: 3 months postoperative
Presence of Epiphora
It will be assessed by inspection of the lid by slitlamb examination.
Measured: Baseline
Presence of Epiphora
It will be assessed by inspection of the lid by slitlamb examination.
Measured: 1 week postoperative
Presence of Epiphora
It will be assessed by inspection of the lid by slitlamb examination.
Measured: 1 month postoperative
Presence of Epiphora
It will be assessed by inspection of the lid by slitlamb examination.
Measured: 3 month postoperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Oct 2022
- Study start1 Jun 2021
- Primary completion1 Jun 2022
- Study completion10 Jun 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- Al-Azhar University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ehab tharwat, Al-Azhar University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05586620
- Sponsor's protocol ID
- 3 Snip Punctoplasty
- Status last verified
- Oct 2022
- First submitted
- 15 Oct 2022
- Last updated
- 19 Oct 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Study on 3 Snip Punctoplasty With and Without Mitomycine C in the Management of Punctual Stenosis or Occlusion
- ClinicalTrials.gov ID
- NCT05586620
- Acronym / sponsor ID
- 3 Snip Punctoplasty
- Conditions
- Punctal Stenosis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- Al-Azhar UniversityUniversity, hospital or other
- Study start
- 1 Jun 2021 (actual)
- Primary completion
- 1 Jun 2022 (actual)
- Study completion
- 10 Jun 2022 (actual)
- First posted
- 19 Oct 2022 (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.
Punctal stenosis is a progressive constriction of the puncta with resultant epiphora. One of the most effective treatment options is 1- to 4-snip punctoplasty combined with or without Mitomycin-C.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 3-snip punctoplasty | Active comparator | Procedure: 3-snip punctoplasty |
| 3-snip punctoplasty with mitomycin C | Active comparator | Procedure: 3-snip punctoplasty and Mitomycin C |
Who may qualify
- Ages
- 16 to 63 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (1 listed)
- Patients with recurrence of punctal stenosis at the end of 1 month following punctal dilatation.
Key exclusion criteria (1 listed)
- patients with associated lacrimal passage obstruction
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 |
|---|---|---|
| 3-snip punctoplastypunctoplasty, more commonly known as watery eye surgery, is an ophthalmic surgical procedure performed to correct punctal stenosis (a condition that causes tears to overflow from the eyes) by widening the punctal opening to allow the tears to drain with ease. | Procedure or surgery | 3-snip punctoplasty |
| 3-snip punctoplasty and Mitomycin Cpunctoplasty, more commonly known as watery eye surgery, is an ophthalmic surgical procedure performed to correct punctal stenosis (a condition that causes tears to overflow from the eyes) by widening the punctal opening to allow the tears to drain with ease. Mitomycin C is a chemotherapeutic agent that acts by inhibiting DNA synthesis | Procedure or surgery | 3-snip punctoplasty with mitomycin C |
Primary outcome
Punctal patency
Time frame: Baseline
Punctum will be assessed by inspection of the lid by slitlamb examination, whither obstructed or not
Punctal patency
Time frame: 1 week postoperative
Punctum will be assessed by inspection of the lid by slitlamb examination, whither obstructed or not
Punctal patency
Time frame: 1 month postoperative
Punctum will be assessed by inspection of the lid by slitlamb examination, whither obstructed or not
Punctal patency
Time frame: 3 months postoperative
Punctum will be assessed by inspection of the lid by slitlamb examination, whither obstructed or not
Presence of Epiphora
Time frame: Baseline
It will be assessed by inspection of the lid by slitlamb examination.
Presence of Epiphora
Time frame: 1 week postoperative
It will be assessed by inspection of the lid by slitlamb examination.
Presence of Epiphora
Time frame: 1 month postoperative
It will be assessed by inspection of the lid by slitlamb examination.
Presence of Epiphora
Time frame: 3 month postoperative
It will be assessed by inspection of the lid by slitlamb examination.
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 19 Oct 2022.
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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.
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 3-snip punctoplasty and 3-snip punctoplasty and Mitomycin C in people with Punctal Stenosis, run by Al-Azhar 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: finished, as of the sponsor's last update on 19 Oct 2022. 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?
Punctal patency (time frame: Baseline). The study lists 8 primary outcomes in all. 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 19 Oct 2022.