to Compare Lacrimal Dilator-facilitated Incisionless and Standard STB With Wescott ScissorsNCT04345172
Lacrimal Dilator-Facilitated vs Standard Sub-Tenon's Block
A study testing sub-Tenon's block with a lacrimal dilator group or a Wescott scissors in people with to Compare Lacrimal Dilator-facilitated Incisionless and Standard STB With Wescott Scissors, run by Baskent University at 1 site in Turkey (Türkiye).
Trial summary
Standard sub-Tenon's block involves incision (dissection) of conjunctiva and Tenon's capsule with the help of blunt scissors and forceps, insertion of a blunt sub-Tenon's cannula under the Tenon's capsule and injection of local anaesthetic agent. Read more about this study
- Who is it for?
- Ages 20 to 90 yearsHealthy volunteers can take part
- Conditions the study is for
- to Compare Lacrimal Dilator-facilitated Incisionless and Standard STB With Wescott Scissors
- What is being tested?
- sub-Tenon's block with a lacrimal dilator group or a Wescott scissors
- Type of treatment
- Pill or oral medicine, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 64 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jan 2019to 15 Oct 2019
- 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 20 to 90 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- patients undergoing cataract surgery by phacoemulsification and intraocular lens implantation
Who cannot join
- allergy to lidocaine, history of previous retinal and strabismus surgery, bleeding disorders and oral anticoagulant use, presence of glaucoma or high IOP, thick pterygia, any pathological condition that conjunctiva and Tenon's capsule cannot be lifted away from the sclera
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Baskent University, Adana Research and Training Center
Adana, 01250
About this study
Official title: Lacrimal Dilator-Facilitated Incisionless Vs. Standard Sub-Tenon's Block: A Randomized, Prospective and Non-inferiority Comparative Study
Standard sub-Tenon's block involves incision (dissection) of conjunctiva and Tenon's capsule with the help of blunt scissors and forceps, insertion of a blunt sub-Tenon's cannula under the Tenon's capsule and injection of local anaesthetic agent. This block is frequently associated with minor complications such as chemosis and subconjunctival haemorrhage. Different variations of incisionless sub-Tenon's block including the use of lacrimal dilator have been described to reduce minor complications and facilitate insertion of blunt cannula. Lacrimal dilator creates a small aperture in the conjunctiva and Tenon's capsule thus avoids incision. After ethics approval, patients undergoing elective cataract surgery were enrolled to receive sub-Tenon's block performed without incision with a lacrimal dilator (Group LD) or with incision using Wescott scissors and blunt forceps (Group WS). All patients received 3 mL 2% lidocaine without any adjuvant. No sedation was administered. Demographic of the patients, duration of the procedure, analgesia (pain), akinesia, duration of the procedure intraoperative chemosis, subconjunctival haemorrhage on the first postoperative day. We aimed to compare lacrimal dilator-facilitated and standard sub-Tenon's block effectiveness and incidence of chemosis and subconjunctival haemorrhage.
Read the detailed description
The patients were randomly allocated to receive STB performed with a lacrimal dilator (Group LD) and with a Wescott scissors (Group WS). Randomization was ensured by sealed envelopes prepared according to a computer-generated table and the envelopes were opened by the operator just before the sub-Tenon's block.
Study protocol Local anaesthetic eye drops were installed into the conjunctiva, followed by iodine 5% aqueous drops to the conjunctival sac for 3 minutes.19 An eye lid speculum was inserted.
In group LD, the conjunctiva and Tenon's capsule were lifted together tightly with a blunt forceps like a tent in the inferonasal quadrant and a punctal dilatator was placed tangential to the globe creating a round and small hole at 5 mm posterior to limbus. The block was performed using smooth rounded tip, 19 G, 1 inch sub-Tenon's cannula .
In Group WS, after lifting the conjunctiva and Tenon's capsule together with a blunt forceps, incision was performed with a blunt tip Westcott scissors in the inferonasal conjunctival at 5 mm posterior to limbus to expose sub-Tenon's space. The block was performed with the above sub-Tenon's cannula.
All patients received lidocaine 2%, 3 mL without any adjuvant. No sedative was administered. All the blocks and surgeries were performed by the same investigator, but block evaluations were made by another investigator who was blinded to the technique used. All patients were discharged on the day of surgery.
The parameters recorded included demographic of the patients, duration of the procedure, analgesia (pain), akinesia, duration of the procedure intraoperative chemosis, subconjunctival haemorrhage on the first postoperative day. Analgesia was evaluated using a numeric rating scale for pain (0-10; 0 - no pain, 10 - the worst imaginable pain) immediately after the operation. Akinesia (ocular movements) were checked according to 4-primary gazes 10 minutes after STB. Chemosis and conjunctival haemorrhage (1st postoperative day) were assessed according to the number of quadrant or quadrants affected (superior nasal, superior temporal, inferior nasal, inferior temporal) using a 5-point scale (0-4; 0 - no for chemosis and haemorrhage, 4 for chemosis or haemorrhage in all 4 quadrants).
- Conditions
- to Compare Lacrimal Dilator-facilitated Incisionless and Standard STB With Wescott Scissors
- Being tested
- sub-Tenon's block with a lacrimal dilator group or a Wescott scissors
- Keywords
- sub-Tenon's block, lacrimal dilator, Wescott scissors, chemosis, subconjunctival haemorrhage
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
sub-Tenon's block with a lacrimal dilator group or a Wescott scissorsDevice
Local anaesthetic eye drops were installed into the conjunctiva, followed by iodine 5% aqueous drops to the conjunctival sac for 3 minutes.19 An eye lid speculum was inserted.
In group LD, the conjunctiva and Tenon's capsule were lifted together tightly with a blunt forceps like a tent in the inferonasal quadrant and a punctal dilatator (Castroviejo Lacrimal Dilatator, Katena Products, Inc, Denville, NJ, USA) was placed tangential to the globe creating a round and small hole at 5 mm posterior to limbus (Fig.1). The block was performed using smooth rounded tip, 19 G, 1 inch sub-Tenon's cannula (Visitec, Beaver-Visitec International Ltd, Warwickshire, UK).
In Group WS, after lifting the conjunctiva and Tenon's capsule together with a blunt forceps, incision was performed with a blunt tip Westcott scissors in the inferonasal conjunctival at 5 mm posterior to limbus to expose sub-Tenon's space.
| Study group | Role | What they receive |
|---|---|---|
| a lacrimal dilator group (Group LD) | Active comparator | The patients allocated to receive STB performed with a lacrimal dilator Receives: Device: sub-Tenon's block with a lacrimal dilator group or a Wescott scissors |
| a Wescott scissors (Group WS) | Active comparator | The patients allocated to receive STB performed with a Wescott scissors Receives: Device: sub-Tenon's block with a lacrimal dilator group or a Wescott scissors |
What is being measured
The primary outcome is the main question the study is designed to answer.
chemosis
swelling of the conjunctiva
Measured: 10 minutes after intervention
Secondary outcomes (1)
subconjunctival haemorrhage
haemorrhage due to tearing or severing of blood vessels during dissection and injection
Measured: on the postoperative first day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Apr 2020
- Study start1 Jan 2019
- Primary completion30 Sep 2019
- Study completion15 Oct 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for to Compare Lacrimal Dilator-facilitated Incisionless and Standard STB With Wescott ScissorsStudies 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
- Randomised
- Intervention model
- Parallel groups
- Model description
- a randomized, prospective, non-inferiority comparative study
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 64 participants (actual)
Sponsor and investigators
- Lead sponsor
- Baskent University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Oya Yalcin Cok, Baskent University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04345172
- Sponsor's protocol ID
- KA19/165
- Status last verified
- Apr 2020
- First submitted
- 10 Apr 2020
- Last updated
- 14 Apr 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: This will be decided according to the content of the request
Study at a glance
From the registry record, last updated by the sponsor on 14 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Lacrimal Dilator-Facilitated Incisionless Vs. Standard Sub-Tenon's Block: A Randomized, Prospective and Non-inferiority Comparative Study
- ClinicalTrials.gov ID
- NCT04345172
- Acronym / sponsor ID
- KA19/165
- Conditions
- to Compare Lacrimal Dilator-facilitated Incisionless and Standard STB With Wescott Scissors
- Keywords
- sub-Tenon's block, lacrimal dilator, Wescott scissors, chemosis, subconjunctival haemorrhage
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 64 participants (actual)
- Lead sponsor
- Baskent UniversityUniversity, hospital or other
- Study start
- 1 Jan 2019 (actual)
- Primary completion
- 30 Sep 2019 (actual)
- Study completion
- 15 Oct 2019 (actual)
- First posted
- 14 Apr 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.
Standard sub-Tenon's block involves incision (dissection) of conjunctiva and Tenon's capsule with the help of blunt scissors and forceps, insertion of a blunt sub-Tenon's cannula under the Tenon's capsule and injection of local anaesthetic agent. This block is frequently associated with minor complications such as chemosis and subconjunctival haemorrhage. Different variations of incisionless sub-Tenon's block including the use of lacrimal dilator have been described to reduce minor complications and facilitate insertion of blunt cannula. Lacrimal dilator creates a small aperture in the conjunctiva and Tenon's capsule thus avoids incision. After ethics approval, patients undergoing elective cataract surgery were enrolled to receive sub-Tenon's block performed without incision with a lacrimal dilator (Group LD) or with incision using Wescott scissors and blunt forceps (Group WS). All patients received 3 mL 2% lidocaine without any adjuvant. No sedation was administered. Demographic of the patients, duration of the procedure, analgesia (pain), akinesia, duration of the procedure intraoperative chemosis, subconjunctival haemorrhage on the first postoperative day. We aimed to compare lacrimal dilator-facilitated and standard sub-Tenon's block effectiveness and incidence of chemosis and subconjunctival haemorrhage.
Detailed description
The patients were randomly allocated to receive STB performed with a lacrimal dilator (Group LD) and with a Wescott scissors (Group WS). Randomization was ensured by sealed envelopes prepared according to a computer-generated table and the envelopes were opened by the operator just before the sub-Tenon's block.
Study protocol Local anaesthetic eye drops were installed into the conjunctiva, followed by iodine 5% aqueous drops to the conjunctival sac for 3 minutes.19 An eye lid speculum was inserted.
In group LD, the conjunctiva and Tenon's capsule were lifted together tightly with a blunt forceps like a tent in the inferonasal quadrant and a punctal dilatator was placed tangential to the globe creating a round and small hole at 5 mm posterior to limbus. The block was performed using smooth rounded tip, 19 G, 1 inch sub-Tenon's cannula .
In Group WS, after lifting the conjunctiva and Tenon's capsule together with a blunt forceps, incision was performed with a blunt tip Westcott scissors in the inferonasal conjunctival at 5 mm posterior to limbus to expose sub-Tenon's space. The block was performed with the above sub-Tenon's cannula.
All patients received lidocaine 2%, 3 mL without any adjuvant. No sedative was administered. All the blocks and surgeries were performed by the same investigator, but block evaluations were made by another investigator who was blinded to the technique used. All patients were discharged on the day of surgery.
The parameters recorded included demographic of the patients, duration of the procedure, analgesia (pain), akinesia, duration of the procedure intraoperative chemosis, subconjunctival haemorrhage on the first postoperative day. Analgesia was evaluated using a numeric rating scale for pain (0-10; 0 - no pain, 10 - the worst imaginable pain) immediately after the operation. Akinesia (ocular movements) were checked according to 4-primary gazes 10 minutes after STB. Chemosis and conjunctival haemorrhage (1st postoperative day) were assessed according to the number of quadrant or quadrants affected (superior nasal, superior temporal, inferior nasal, inferior temporal) using a 5-point scale (0-4; 0 - no for chemosis and haemorrhage, 4 for chemosis or haemorrhage in all 4 quadrants).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- a randomized, prospective, non-inferiority comparative study
| Arm | Type | Receives |
|---|---|---|
| a lacrimal dilator group (Group LD) | Active comparator | Device: sub-Tenon's block with a lacrimal dilator group or a Wescott scissorsThe patients allocated to receive STB performed with a lacrimal dilator |
| a Wescott scissors (Group WS) | Active comparator | Device: sub-Tenon's block with a lacrimal dilator group or a Wescott scissorsThe patients allocated to receive STB performed with a Wescott scissors |
Who may qualify
- Ages
- 20 to 90 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- patients undergoing cataract surgery by phacoemulsification and intraocular lens implantation
Key exclusion criteria (1 listed)
- allergy to lidocaine, history of previous retinal and strabismus surgery, bleeding disorders and oral anticoagulant use, presence of glaucoma or high IOP, thick pterygia, any pathological condition that conjunctiva and Tenon's capsule cannot be lifted away from the sclera
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 |
|---|---|---|
| sub-Tenon's block with a lacrimal dilator group or a Wescott scissorsLocal anaesthetic eye drops were installed into the conjunctiva, followed by iodine 5% aqueous drops to the conjunctival sac for 3 minutes.19 An eye lid speculum was inserted. In group LD, the conjunctiva and Tenon's capsule were lifted together tightly with a blunt forceps like a tent in the inferonasal quadrant and a punctal dilatator (Castroviejo Lacrimal Dilatator, Katena Products, Inc, Denville, NJ, USA) was placed tangential to the globe creating a round and small hole at 5 mm posterior to limbus (Fig.1). The block was performed using smooth rounded tip, 19 G, 1 inch sub-Tenon's cannula (Visitec, Beaver-Visitec International Ltd, Warwickshire, UK). In Group WS, after lifting the conjunctiva and Tenon's capsule together with a blunt forceps, incision was performed with a blunt tip Westcott scissors in the inferonasal conjunctival at 5 mm posterior to limbus to expose sub-Tenon's space. | Device | a Wescott scissors (Group WS), a lacrimal dilator group (Group LD) |
Primary outcome
chemosis
Time frame: 10 minutes after intervention
swelling of the conjunctiva
1 secondary outcome
subconjunctival haemorrhage
Time frame: on the postoperative first day
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 14 Apr 2020.
- Individual participant dataSharing planned: Undecided. This will be decided according to the content of the request
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 sub-Tenon's block with a lacrimal dilator group or a Wescott scissors in people with to Compare Lacrimal Dilator-facilitated Incisionless and Standard STB With Wescott Scissors, run by Baskent University at 1 site in Turkey (Türkiye).
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 14 Apr 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 Turkey (Türkiye). 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?
chemosis (time frame: 10 minutes after intervention). 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 14 Apr 2020.