BlepharoptosisNCT02959697
Subconjunctival Injection of Local Anesthetic in Anterior Blepharoptosis Repair
A study testing Subcut. + Subconj. Xylocaine and Blepharoptosis Repair in people with Blepharoptosis and Ptosis, run by University of Manitoba at 2 sites in Canada.
Trial summary
Blepharoptosis (ptosis) repair is a common and generally well tolerated surgical procedure usually performed using local anesthetic. However, a subset of patients appears to experience intraoperative pain/discomfort during ptosis repair using an anterior approach with subcutaneous local anesthetic. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Blepharoptosis, Ptosis
- What is being tested?
- Subcut. + Subconj. Xylocaine and Blepharoptosis Repair
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 100 participants
- Where
- 2 sitesCanada
- Study dates
- 1 Sep 2017to 1 Jun 2023
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Must be 18 years of age or older and able to give informed consent in English
- Must have bilateral blepharoptosis undergoing repair using an anterior approach
- The degree of ptosis must be approximately symmetrical, with a difference in margin-reflex distance of 1 mm or less between the two sides
Who cannot join
- Previous eyelid surgery or trauma
- Congenital, mechanical, myogenic or neurogenic forms of ptosis
- Unable to give informed consent
Trial locations and contacts
2 sites in 1 country.
Canada2 sites, 2 recruiting
- Recruiting
Buhler Eye Centre, Misericordia Hospital
Winnipeg, Manitoba, R3C 1A2
Matthew Lee-Wing, MD, (204) 774-6581, matthew.lee-wing@myumanitoba.ca
- Recruiting
Private Office (Dr. Lee-Wing). 1010-233 Kennedy st.
Winnipeg, Manitoba, R3C 3J5
Matthew Lee-Wing, MD, (204) 946-0649
About this study
Blepharoptosis (ptosis) repair is a common and generally well tolerated surgical procedure usually performed using local anesthetic. However, a subset of patients appears to experience intraoperative pain/discomfort during ptosis repair using an anterior approach with subcutaneous local anesthetic. Posterior subconjuctival local anesthetic is currently used for eyelid procedures such as chalazion incision and drainage and full-thickness eyelid resections. The purpose of this study is to determine whether an additional subconjunctival injection of local anesthetic, through the posterior aspect of the eyelid, reduces intraoperative pain during anterior ptosis repair.
Read the detailed description
Patients will be recruited from Dr. Matthew Lee-Wing's practice. Eligible participants include those requiring bilateral blepharoptosis repair requiring an anterior surgical approach. The patient will need to have a similar degree of ptosis in each eye (as measured by each eye's "Marginal Reflex Distance #1"). Patients will be given information regarding the outcomes of interest, and informed re: risks and benefits of participating.
Upon agreeing to participate, the patient will be asked to sign a consent form indicating their wish to participate in the study (see below).
Each patient will have blepharoptosis repair surgery on both of their eyes. One eye will act as a control in that the operation will proceed in a manner in-line with current practice (IE with subcutaneous local anesthetic alone). The other eye will receive both subcutaneous local anesthetic, as well as an additional injection of local anesthetic underneath the conjunctiva of the upper eyelid (IE on the inner surface of the eyelid). The eye/side receiving only the standard, subcutaneous local anesthetic will also receive a sham injection of normal saline in order to prevent the patient from knowing which side is receiving the additional anesthetic dose. Dr. Lee-Wing will perform all of the surgeries within the study, and will be blinded as to which patient is receiving the additional anesthetic. The blinding will be accomplished by the assisting treatment room nurse, who will use an algorithm to randomly select which eyelid will receive the subconjunctival Xylocaine and which will receive the subconjunctival Normal Saline.
Following their procedure, each patient will complete a questionnaire designed to assess their intraoperative pain.
Statistical analysis will be performed, and will compare the patient's intraoperative pain rating for the eyelid that received the sham Normal Saline injection and the eyelid that received the Xylocaine injection. The presence of post-operative lagophthalmos/fluorescein staining will be compared between the two groups, as will the post-operative Marginal Reflex Distance 1. The above comparisons will be made using McNemar's test.
- Conditions
- Blepharoptosis, Ptosis
- Being tested
- Subcut. + Subconj. Xylocaine, Subcut. + Sham Subconj. Injection, Blepharoptosis Repair
- Keywords
- Blepharoptosis, Ptosis, Surgery, Pain Reduction, Anesthetic, Local Anesthetic, Subconjunctival
- Medical subject headings
- Blepharoptosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Subcut. + Subconj. XylocaineDrug
Also called Xylocaine
Patient will receive the standard subcutaneous local anesthetic as well as an additional subconjunctival injection of local anesthetic (Xylocaine).
Subcut. + Sham Subconj. InjectionDrug
Also called Normal Saline
Patient will receive the standard subcutaneous local anesthetic as well as a subconjunctival sham injection of Normal Saline.
Blepharoptosis RepairProcedure or surgery
Also called Ptosis Repair
Patients will undergo blepharoptosis repair using an anterior approach.
| Study group | Role | What they receive |
|---|---|---|
| Subcut. + Subconj. Injection | Experimental | Patients will undergo standard blepharoptosis repair using an anterior approach, with an added injection of local anesthetic (Xylocaine) beneath the conjunctiva of the lid being operated on. They will still receive the standard subcutaneous local anesthetic given during blepharoptosis repair. Receives: Drug: Subcut. + Subconj. Xylocaine; Procedure: Blepharoptosis Repair |
| Subcut. + Sham Subconj. Injection | Sham comparator | Patients will undergo standard blepharoptosis repair using an anterior approach, however they will not receive the additional subconjunctival Xylocaine injection. Instead, they will receive a sham injection of Normal Saline to prevent them from knowing which eye received the additional anesthetic. Receives: Drug: Subcut. + Sham Subconj. Injection; Procedure: Blepharoptosis Repair |
What is being measured
The primary outcome is the main question the study is designed to answer.
0-10 Numerical Pain Scale
Patients will be asked to describe the intraoperative pain they experienced in each eye during surgery. Results will be compared with McNemar's test.
Measured: 6 Years
Secondary outcomes (2)
Presence of post-operative lagophthalmos/fluorescein staining
The presence or absence of lagophthalmos and fluorescein staining will be assessed in each eye at the post-operative follow up appointment, and will be compared with McNemar's test.
Measured: 6 Years
Post-Operative margin-reflex distance 1
Post-operative margin-reflex distance 1 (MDR1 - distance between the pupillary light reflex and the lower edge of the upper lid) will be measured in each eye. The difference between the MDR1 of each eye will be analyzed using paired Student's T-testing.
Measured: 6 Years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Nov 2016 (estimated)
- Study start1 Sep 2017
- Primary completion1 May 2023 (estimated)
- Study completion1 Jun 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for BlepharoptosisStudies of the same condition, open and under way.
- More trials run by University of ManitobaThe 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
- Single group
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Manitoba
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Matthew Lee-Wing, MD, Principal investigator, University of Manitoba
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02959697
- Sponsor's protocol ID
- HS20066 (B2016:085)
- Status last verified
- May 2022
- First submitted
- 31 Oct 2016
- Last updated
- 10 Jun 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Subconjunctival Injection of Local Anesthetic in Anterior Blepharoptosis Repair
- ClinicalTrials.gov ID
- NCT02959697
- Acronym / sponsor ID
- HS20066 (B2016:085)
- Conditions
- Blepharoptosis, Ptosis
- Keywords
- Blepharoptosis, Ptosis, Surgery, Pain Reduction, Anesthetic, Local Anesthetic, Subconjunctival
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- University of ManitobaUniversity, hospital or other
- Study start
- 1 Sep 2017 (actual)
- Primary completion
- 1 May 2023 (estimated)
- Study completion
- 1 Jun 2023 (estimated)
- First posted
- 9 Nov 2016 (estimated)
- 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.
Blepharoptosis (ptosis) repair is a common and generally well tolerated surgical procedure usually performed using local anesthetic. However, a subset of patients appears to experience intraoperative pain/discomfort during ptosis repair using an anterior approach with subcutaneous local anesthetic. Posterior subconjuctival local anesthetic is currently used for eyelid procedures such as chalazion incision and drainage and full-thickness eyelid resections. The purpose of this study is to determine whether an additional subconjunctival injection of local anesthetic, through the posterior aspect of the eyelid, reduces intraoperative pain during anterior ptosis repair.
Detailed description
Patients will be recruited from Dr. Matthew Lee-Wing's practice. Eligible participants include those requiring bilateral blepharoptosis repair requiring an anterior surgical approach. The patient will need to have a similar degree of ptosis in each eye (as measured by each eye's "Marginal Reflex Distance #1"). Patients will be given information regarding the outcomes of interest, and informed re: risks and benefits of participating.
Upon agreeing to participate, the patient will be asked to sign a consent form indicating their wish to participate in the study (see below).
Each patient will have blepharoptosis repair surgery on both of their eyes. One eye will act as a control in that the operation will proceed in a manner in-line with current practice (IE with subcutaneous local anesthetic alone). The other eye will receive both subcutaneous local anesthetic, as well as an additional injection of local anesthetic underneath the conjunctiva of the upper eyelid (IE on the inner surface of the eyelid). The eye/side receiving only the standard, subcutaneous local anesthetic will also receive a sham injection of normal saline in order to prevent the patient from knowing which side is receiving the additional anesthetic dose. Dr. Lee-Wing will perform all of the surgeries within the study, and will be blinded as to which patient is receiving the additional anesthetic. The blinding will be accomplished by the assisting treatment room nurse, who will use an algorithm to randomly select which eyelid will receive the subconjunctival Xylocaine and which will receive the subconjunctival Normal Saline.
Following their procedure, each patient will complete a questionnaire designed to assess their intraoperative pain.
Statistical analysis will be performed, and will compare the patient's intraoperative pain rating for the eyelid that received the sham Normal Saline injection and the eyelid that received the Xylocaine injection. The presence of post-operative lagophthalmos/fluorescein staining will be compared between the two groups, as will the post-operative Marginal Reflex Distance 1. The above comparisons will be made using McNemar's test.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Subcut. + Subconj. Injection | Experimental | Drug: Subcut. + Subconj. Xylocaine, Procedure: Blepharoptosis RepairPatients will undergo standard blepharoptosis repair using an anterior approach, with an added injection of local anesthetic (Xylocaine) beneath the conjunctiva of the lid being operated on. They will still receive the standard subcutaneous local anesthetic given during blepharoptosis repair. |
| Subcut. + Sham Subconj. Injection | Sham comparator | Drug: Subcut. + Sham Subconj. Injection, Procedure: Blepharoptosis RepairPatients will undergo standard blepharoptosis repair using an anterior approach, however they will not receive the additional subconjunctival Xylocaine injection. Instead, they will receive a sham injection of Normal Saline to prevent them from knowing which eye received the additional anesthetic. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Must be 18 years of age or older and able to give informed consent in English
- Must have bilateral blepharoptosis undergoing repair using an anterior approach
- The degree of ptosis must be approximately symmetrical, with a difference in margin-reflex distance of 1 mm or less between the two sides
Key exclusion criteria (3 listed)
- Previous eyelid surgery or trauma
- Congenital, mechanical, myogenic or neurogenic forms of ptosis
- Unable to give informed consent
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 |
|---|---|---|
| Subcut. + Subconj. XylocaineAlso: XylocainePatient will receive the standard subcutaneous local anesthetic as well as an additional subconjunctival injection of local anesthetic (Xylocaine). | Drug | Subcut. + Subconj. Injection |
| Subcut. + Sham Subconj. InjectionAlso: Normal SalinePatient will receive the standard subcutaneous local anesthetic as well as a subconjunctival sham injection of Normal Saline. | Drug | Subcut. + Sham Subconj. Injection |
| Blepharoptosis RepairAlso: Ptosis RepairPatients will undergo blepharoptosis repair using an anterior approach. | Procedure or surgery | Subcut. + Sham Subconj. Injection, Subcut. + Subconj. Injection |
Primary outcome
0-10 Numerical Pain Scale
Time frame: 6 Years
Patients will be asked to describe the intraoperative pain they experienced in each eye during surgery. Results will be compared with McNemar's test.
2 secondary outcomes
Presence of post-operative lagophthalmos/fluorescein staining
Time frame: 6 Years
Post-Operative margin-reflex distance 1
Time frame: 6 Years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jun 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.
Matthew Lee-Wing, MD principal investigator
University of Manitoba
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Subcut. + Subconj. Xylocaine and Blepharoptosis Repair in people with Blepharoptosis and Ptosis, run by University of Manitoba at 2 sites in Canada.
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 3 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 Jun 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Canada. 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. Some participants in this study may receive a placebo. 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 Matthew Lee-Wing, MD ((204) 946-0649, matthew.lee-wing@myumanitoba.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
0-10 Numerical Pain Scale (time frame: 6 Years). 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 10 Jun 2022.