EpiphoraNCT04680078
Placement of Three Interrupted Sutures After Triangular Three-snip Punctoplasty
A study testing Placement of three interrupted sutures after Triangular Three-snip Punctoplasty of the lower punctum and Conventional Triangular Three-snip Punctoplasty of the lower punctum in people with Epiphora, run by Menoufia University at 1 site in Egypt.
Trial summary
a prospective randomized study conducted upon 40 eyes of 24 patients with lower punctual stenosis (grade 1 or 2 according to Kashkouli scale) attending at Menoufia University hospitals and Kafr Elsheikh ophthalmic eye center. The upper punctum and canaliculus were patent. Read more about this study
- Who is it for?
- Ages 17 years and olderHealthy volunteers can take part
- Conditions the study is for
- Epiphora
- What is being tested?
- Placement of three interrupted sutures after Triangular Three-snip Punctoplasty of the lower punctum and Conventional Triangular Three-snip Punctoplasty of the lower punctum
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jan 2019to 23 Dec 2020
- 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 17 years and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- primary acquired lower punctal stenosis grade 1 or 2 according to Kashkouli et al. , patent upper punctum and both canaliculi as well as patent nasolacrimal duct , normal lower eyelid margin position
Who cannot join
- Patients with Congenital punctal stenosis, Acute conjunctival allergic punctal stenosis, Punctal stenosis associated with radiotherapy, Lid malposition, Canalicular, lacrimal sac and nasolacrimal duct obstruction revealed after syringing , Previous eyelid or lacrimal drainage system surgery, Blepharitis and ocular surface disorders, Patients with dry eye were excluded.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Comparison Between Placement of Three Interrupted Sutures After Triangular Three-snip Punctoplasty vs Conventional Triangular Three-snip Punctoplasty for Treatment of Lower Punctal Stenosis
a prospective randomized study conducted upon 40 eyes of 24 patients with lower punctual stenosis (grade 1 or 2 according to Kashkouli scale) attending at Menoufia University hospitals and Kafr Elsheikh ophthalmic eye center. The upper punctum and canaliculus were patent. All patients were complaining of epiphora and had a thorough ophthalmological examination including dye disappearance test, and slit-lamp examination. A Nettelship dilator is used to enlarge the stenotic lacrimal punctum. A single blade of a small Westcott spring scissor or Vannus scissor is placed within the ampulla of the lacrimal canaliculus, with the remaining blade placed on the conjunctival surface of the posterior aspect of the eyelid. The first vertical snip is made at the vertical canaliculus. The second vertical snip is made from the edge of the first snip to create a flap. The final horizontal snip was made at the base. The triangular flap is removed and three sutures are placed, in an interrupted manner, at the posterior wall of the ampulla using 10-0 nylon. The sutures are removed 1 week after the surgery. Topical moxifloxacin 0.5% eye drops and fluorometholone 0.1% eye drops were used four times daily for one week.Patients were then followed up for 6 months after the surgery.
Read the detailed description
This is a prospective non-randomized study which includes 40 eyelids of 24 patients with acquired lower punctal stenosis grade 1 or grade 2 according to Kashkouli scale attending at Menoufia University hospitals and Kafr Elsheikh ophthalmic eye center in the period from January 2019 to June 2020. Ethics approval from the institutional review board was obtained, and a written informed consent was taken from every patient according to the Declaration of Helsinki.
A full history and examination were done for patients for evaluation of proximal lacrimal drainage system and exclusion of other causes of epiphora rather than punctal stenosis, Inspection of face and periorbital region for position of the eyelids and puncta, Gross nasal deformity, Facial symmetry, presence of any swelling or fistula in the lacrimal sac area , palpation of lacrimal sac for regurge test , slitlamp examination of lid margin for coaptation with the globe , blepharitis or rubbing lashes , skin for laceration or eczema , conjunctiva for papillae , follicles, hyperemia or discharge , cornea for punctate keratitis, filaments or abrasions , lower Tear meniscus height (TMH) using a 1 mm slit beam , punctal orifices position, shape , grading of stenosis according to Kashkouli et al.
Fluorescein dye disappearance test (FDDT) where the fluorescence of the tear meniscus was observed with the help of cobalt-blue filter. FDDT was graded according to Ozgur et al., scale according the time of dye clearance.
Diagnostic probing and syringing were done to ensure anatomically patent nasolacrimal system and to detect any obstruction distal to the punctum.
Patients were examined for results in visits at one week, 1month, 3 months and 6 months.
Satisfactory surgical outcome was defined as postoperative patent lower eyelid punctum and improved Epiphora and FDDT grade at 6 months after surgery.
Surgical procedure
Surgery was performed using an operating microscope under local anaesthesia. We transconjunctivally infiltrate 2% (w/v) lidocaine (with epinephrine in a 1:100,000 weight ratio) from the posterior aspect of the eyelid into the region of the lacrimal canaliculus and punctum.A Nettelship dilator is used to enlarge the stenotic lacrimal punctum. A single blade of a small Westcott spring scissor or Vannus scissor is placed within the ampulla of the lacrimal canaliculus, with the remaining blade placed on the conjunctival surface of the posterior aspect of the eyelid. The first vertical snip is made at the vertical canaliculus. The second vertical snip is made from the edge of the first snip to create a flap. The final horizontal snip was made at the base. The triangular flap is removed and three sutures are placed, in an interrupted manner, at the posterior wall of the ampulla using 10-0 nylon. The sutures are removed 1 week after the surgery. Topical moxifloxacin 0.5% eye drops and fluorometholone 0.1% eye drops were used four times daily for one week.Patients were then followed up in 1 week , 1 month , 3 months , 6 months period.
- Conditions
- Epiphora
- Being tested
- Placement of three interrupted sutures after Triangular Three-snip Punctoplasty of the lower punctum, Conventional Triangular Three-snip Punctoplasty of the lower punctum
- 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.
Placement of three interrupted sutures after Triangular Three-snip Punctoplasty of the lower punctumProcedure or surgery
A Nettelship dilator is used to enlarge the stenotic lacrimal punctum. A single blade of a small Westcott spring scissor or Vannus scissor is placed within the ampulla of the lacrimal canaliculus, with the remaining blade placed on the conjunctival surface of the posterior aspect of the eyelid. The first vertical snip is made at the vertical canaliculus. The second vertical snip is made from the edge of the first snip to create a flap. The final horizontal snip was made at the base. The triangular flap is removed and three sutures are placed, in an interrupted manner, at the posterior wall of the ampulla using 10-0 nylon. The sutures are removed 1 week after the surgery.
Conventional Triangular Three-snip Punctoplasty of the lower punctumProcedure or surgery
A Nettelship dilator is used to enlarge the stenotic lacrimal punctum. A single blade of a small Westcott spring scissor or Vannus scissor is placed within the ampulla of the lacrimal canaliculus, with the remaining blade placed on the conjunctival surface of the posterior aspect of the eyelid. The first vertical snip is made at the vertical canaliculus. The second vertical snip is made from the edge of the first snip to create a flap. The final horizontal snip was made at the base. The triangular flap is then removed .
| Study group | Role | What they receive |
|---|---|---|
| Placement of three interrupted sutures after Triangular Three-snip Punctoplasty of the lower punctum | Active comparator | After instillation of topical benoxinate hydrochloride 0.4%, subconjunctival injection of 2% lidocaine was done beneath the lower punctum, then Nettleship dilator was used to dilate the punctum. A single blade of a small Westcott spring scissor or Vannus scissor is placed within the ampulla of the lacrimal canaliculus, with the remaining blade placed on the conjunctival surface of the posterior aspect of the eyelid. The first vertical snip is made at the vertical canaliculus. The second vertical snip is made from the edge of the first snip to create a flap. The final horizontal snip was made at the base. The triangular flap is removed and three sutures are placed, in an interrupted manner, at the posterior wall of the ampulla using 10-0 nylon. Hemostasis was done by compression with a cotton tip for one minute until bleeding stop. The sutures are removed 1 week after the surgery. Receives: Procedure: Placement of three interrupted sutures after Triangular Three-snip Punctoplasty of the lower punctum |
| Conventional Triangular Three-snip Punctoplasty of the lower punctum | Active comparator | After instillation of topical benoxinate hydrochloride 0.4%, subconjunctival injection of 2% lidocaine was done beneath the lower punctum, then Nettleship dilator was used to dilate the punctum. A single blade of a small Westcott spring scissor or Vannus scissor is placed within the ampulla of the lacrimal canaliculus, with the remaining blade placed on the conjunctival surface of the posterior aspect of the eyelid. The first vertical snip is made at the vertical canaliculus. The second vertical snip is made from the edge of the first snip to create a flap. The final horizontal snip was made at the base. Hemostasis was done by compression with a cotton tip for one minute until bleeding stop. Receives: Procedure: Conventional Triangular Three-snip Punctoplasty of the lower punctum |
What is being measured
The primary outcome is the main question the study is designed to answer.
Degree of improvement of epiphora by Munk score
Measurement of improvement of epiphora by use of Munk score as follow :
Grade 0 : No Epiphora. Grade 1 : Occasional epiphora requiring drying or dabbing less than twice a day.
Grade 2 : Epiphora requiring dabbing two to four times per day. Grade 3 : Epiphora requiring dabbing five to ten times per day. Grade 4 : Epiphora requiring dabbing more than ten times daily or constant tearing.
Measured: 6 months
Degree of improvement of lacrimal drainage by Dye disappearance test
Performed by putting a drop of 2% fluorescein sodium in the conjunctival sac followed by assessment after 5 minutes of the remaining dye in the tear meniscus. Results were graded according to the following scale
Grade 1 : <3 minutes Grade 2 : 3-5 minutes Grade 3 : >5 minutes
Measured: 6 months
Slit lamp assesment of the state of the lower punctum
Slit lamp examination of the lower punctum and its grading according to Kashkouli scale as follows:
Grade 0 : No punctum (agenesis) Grade 1 : Papilla is covered with a membrane (difficult to recognize) Grade 2 : Less than normal size, but recognizable Grade 3 : Normal Grade 4 : Small slit (<2 mm) Grade 5 : Large slit (≥2 mm)
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Dec 2020
- Study start1 Jan 2019
- Primary completion20 Dec 2020 (estimated)
- Study completion23 Dec 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for EpiphoraStudies of the same condition, open and under way.
- More trials run by Menoufia 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
- 24 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Menoufia University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hesham Mohamed Abdulhady, Menoufia University
- Investigators
- sameh s mandour, MD, Principal investigator, Menoufia University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04680078
- Sponsor's protocol ID
- MenoufiaU112019
- Status last verified
- Dec 2020
- First submitted
- 17 Dec 2020
- Last updated
- 22 Dec 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 22 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Comparison Between Placement of Three Interrupted Sutures After Triangular Three-snip Punctoplasty vs Conventional Triangular Three-snip Punctoplasty for Treatment of Lower Punctal Stenosis
- ClinicalTrials.gov ID
- NCT04680078
- Acronym / sponsor ID
- MenoufiaU112019
- Conditions
- Epiphora
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 24 participants (estimated)
- Lead sponsor
- Menoufia UniversityUniversity, hospital or other
- Study start
- 1 Jan 2019 (actual)
- Primary completion
- 20 Dec 2020 (estimated)
- Study completion
- 23 Dec 2020 (estimated)
- First posted
- 22 Dec 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.
a prospective randomized study conducted upon 40 eyes of 24 patients with lower punctual stenosis (grade 1 or 2 according to Kashkouli scale) attending at Menoufia University hospitals and Kafr Elsheikh ophthalmic eye center. The upper punctum and canaliculus were patent. All patients were complaining of epiphora and had a thorough ophthalmological examination including dye disappearance test, and slit-lamp examination. A Nettelship dilator is used to enlarge the stenotic lacrimal punctum. A single blade of a small Westcott spring scissor or Vannus scissor is placed within the ampulla of the lacrimal canaliculus, with the remaining blade placed on the conjunctival surface of the posterior aspect of the eyelid. The first vertical snip is made at the vertical canaliculus. The second vertical snip is made from the edge of the first snip to create a flap. The final horizontal snip was made at the base. The triangular flap is removed and three sutures are placed, in an interrupted manner, at the posterior wall of the ampulla using 10-0 nylon. The sutures are removed 1 week after the surgery. Topical moxifloxacin 0.5% eye drops and fluorometholone 0.1% eye drops were used four times daily for one week.Patients were then followed up for 6 months after the surgery.
Detailed description
This is a prospective non-randomized study which includes 40 eyelids of 24 patients with acquired lower punctal stenosis grade 1 or grade 2 according to Kashkouli scale attending at Menoufia University hospitals and Kafr Elsheikh ophthalmic eye center in the period from January 2019 to June 2020. Ethics approval from the institutional review board was obtained, and a written informed consent was taken from every patient according to the Declaration of Helsinki.
A full history and examination were done for patients for evaluation of proximal lacrimal drainage system and exclusion of other causes of epiphora rather than punctal stenosis, Inspection of face and periorbital region for position of the eyelids and puncta, Gross nasal deformity, Facial symmetry, presence of any swelling or fistula in the lacrimal sac area , palpation of lacrimal sac for regurge test , slitlamp examination of lid margin for coaptation with the globe , blepharitis or rubbing lashes , skin for laceration or eczema , conjunctiva for papillae , follicles, hyperemia or discharge , cornea for punctate keratitis, filaments or abrasions , lower Tear meniscus height (TMH) using a 1 mm slit beam , punctal orifices position, shape , grading of stenosis according to Kashkouli et al.
Fluorescein dye disappearance test (FDDT) where the fluorescence of the tear meniscus was observed with the help of cobalt-blue filter. FDDT was graded according to Ozgur et al., scale according the time of dye clearance.
Diagnostic probing and syringing were done to ensure anatomically patent nasolacrimal system and to detect any obstruction distal to the punctum.
Patients were examined for results in visits at one week, 1month, 3 months and 6 months.
Satisfactory surgical outcome was defined as postoperative patent lower eyelid punctum and improved Epiphora and FDDT grade at 6 months after surgery.
Surgical procedure
Surgery was performed using an operating microscope under local anaesthesia. We transconjunctivally infiltrate 2% (w/v) lidocaine (with epinephrine in a 1:100,000 weight ratio) from the posterior aspect of the eyelid into the region of the lacrimal canaliculus and punctum.A Nettelship dilator is used to enlarge the stenotic lacrimal punctum. A single blade of a small Westcott spring scissor or Vannus scissor is placed within the ampulla of the lacrimal canaliculus, with the remaining blade placed on the conjunctival surface of the posterior aspect of the eyelid. The first vertical snip is made at the vertical canaliculus. The second vertical snip is made from the edge of the first snip to create a flap. The final horizontal snip was made at the base. The triangular flap is removed and three sutures are placed, in an interrupted manner, at the posterior wall of the ampulla using 10-0 nylon. The sutures are removed 1 week after the surgery. Topical moxifloxacin 0.5% eye drops and fluorometholone 0.1% eye drops were used four times daily for one week.Patients were then followed up in 1 week , 1 month , 3 months , 6 months period.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Placement of three interrupted sutures after Triangular Three-snip Punctoplasty of the lower punctum | Active comparator | Procedure: Placement of three interrupted sutures after Triangular Three-snip Punctoplasty of the lower punctumAfter instillation of topical benoxinate hydrochloride 0.4%, subconjunctival injection of 2% lidocaine was done beneath the lower punctum, then Nettleship dilator was used to dilate the punctum. A single blade of a small Westcott spring scissor or Vannus scissor is placed within the ampulla of the lacrimal canaliculus, with the remaining blade placed on the conjunctival surface of the posterior aspect of the eyelid. The first vertical snip is made at the vertical canaliculus. The second vertical snip is made from the edge of the first snip to create a flap. The final horizontal snip was made at the base. The triangular flap is removed and three sutures are placed, in an interrupted manner, at the posterior wall of the ampulla using 10-0 nylon. Hemostasis was done by compression with a cotton tip for one minute until bleeding stop. The sutures are removed 1 week after the surgery. |
| Conventional Triangular Three-snip Punctoplasty of the lower punctum | Active comparator | Procedure: Conventional Triangular Three-snip Punctoplasty of the lower punctumAfter instillation of topical benoxinate hydrochloride 0.4%, subconjunctival injection of 2% lidocaine was done beneath the lower punctum, then Nettleship dilator was used to dilate the punctum. A single blade of a small Westcott spring scissor or Vannus scissor is placed within the ampulla of the lacrimal canaliculus, with the remaining blade placed on the conjunctival surface of the posterior aspect of the eyelid. The first vertical snip is made at the vertical canaliculus. The second vertical snip is made from the edge of the first snip to create a flap. The final horizontal snip was made at the base. Hemostasis was done by compression with a cotton tip for one minute until bleeding stop. |
Who may qualify
- Ages
- 17 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- primary acquired lower punctal stenosis grade 1 or 2 according to Kashkouli et al. , patent upper punctum and both canaliculi as well as patent nasolacrimal duct , normal lower eyelid margin position
Key exclusion criteria (1 listed)
- Patients with Congenital punctal stenosis, Acute conjunctival allergic punctal stenosis, Punctal stenosis associated with radiotherapy, Lid malposition, Canalicular, lacrimal sac and nasolacrimal duct obstruction revealed after syringing , Previous eyelid or lacrimal drainage system surgery, Blepharitis and ocular surface disorders, Patients with dry eye were excluded.
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 |
|---|---|---|
| Placement of three interrupted sutures after Triangular Three-snip Punctoplasty of the lower punctumA Nettelship dilator is used to enlarge the stenotic lacrimal punctum. A single blade of a small Westcott spring scissor or Vannus scissor is placed within the ampulla of the lacrimal canaliculus, with the remaining blade placed on the conjunctival surface of the posterior aspect of the eyelid. The first vertical snip is made at the vertical canaliculus. The second vertical snip is made from the edge of the first snip to create a flap. The final horizontal snip was made at the base. The triangular flap is removed and three sutures are placed, in an interrupted manner, at the posterior wall of the ampulla using 10-0 nylon. The sutures are removed 1 week after the surgery. | Procedure or surgery | Placement of three interrupted sutures after Triangular Three-snip Punctoplasty of the lower punctum |
| Conventional Triangular Three-snip Punctoplasty of the lower punctumA Nettelship dilator is used to enlarge the stenotic lacrimal punctum. A single blade of a small Westcott spring scissor or Vannus scissor is placed within the ampulla of the lacrimal canaliculus, with the remaining blade placed on the conjunctival surface of the posterior aspect of the eyelid. The first vertical snip is made at the vertical canaliculus. The second vertical snip is made from the edge of the first snip to create a flap. The final horizontal snip was made at the base. The triangular flap is then removed . | Procedure or surgery | Conventional Triangular Three-snip Punctoplasty of the lower punctum |
Primary outcome
Degree of improvement of epiphora by Munk score
Time frame: 6 months
Measurement of improvement of epiphora by use of Munk score as follow : Grade 0 : No Epiphora. Grade 1 : Occasional epiphora requiring drying or dabbing less than twice a day. Grade 2 : Epiphora requiring dabbing two to four times per day. Grade 3 : Epiphora requiring dabbing five to ten times per day. Grade 4 : Epiphora requiring dabbing more than ten times daily or constant tearing.
Degree of improvement of lacrimal drainage by Dye disappearance test
Time frame: 6 months
Performed by putting a drop of 2% fluorescein sodium in the conjunctival sac followed by assessment after 5 minutes of the remaining dye in the tear meniscus. Results were graded according to the following scale Grade 1 : <3 minutes Grade 2 : 3-5 minutes Grade 3 : >5 minutes
Slit lamp assesment of the state of the lower punctum
Time frame: 6 months
Slit lamp examination of the lower punctum and its grading according to Kashkouli scale as follows: Grade 0 : No punctum (agenesis) Grade 1 : Papilla is covered with a membrane (difficult to recognize) Grade 2 : Less than normal size, but recognizable Grade 3 : Normal Grade 4 : Small slit (<2 mm) Grade 5 : Large slit (≥2 mm)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Dec 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.
sameh s mandour, MD principal investigator
Menoufia University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Placement of three interrupted sutures after Triangular Three-snip Punctoplasty of the lower punctum and Conventional Triangular Three-snip Punctoplasty of the lower punctum in people with Epiphora, run by Menoufia 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 22 Dec 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?
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 improvement of epiphora by Munk score (time frame: 6 months). The study lists 3 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 22 Dec 2020.