Subconjunctival Injection of Local Anesthetic in Anterior Blepharoptosis Repair
Phase: NA
Conditions: Blepharoptosis, Ptosis
Sponsor: University of Manitoba

Subconjunctival Injection of Local Anesthetic in Anterior Blepharoptosis 
Repair: Study Protocol and Statistical Analysis
Investigators: Dr. Matthew Lee-Wing, Dr. Jeremy Levi
Status: Recruiting
Document Date: June 6th, 2022
Study Start Date: September 1st, 2017
Anticipated Completion Date: June 2023
Sponsor: The University of Manitoba
Ethics Approval: The University of Manitoba Bannatyne Campus Biomedical Research Ethics 
Board. Affiliated with the University of Manitoba. Approval Number: HS20066 (B2016:085). 
Address: P126, Pathology Building, 770 Bannatyne Ave., University of Manitoba, Winnipeg, 
Manitoba, Canada. R3E 0W3.
Study Design: Single group interventonal study. Randomized allocation. 100 participants 
anticipated (200 eyes). Patients to receive two subconjunctival injections each (one to each 
eye), giving two study arms (intervention vs. sham).
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Participants will be recruited from Dr. Lee-Wing’s patient population. They will include those 
who have elected to undergo bilateral ptosis repair and participate in the study. They must 
meet the following inclusion criteria in order to be deemed eligible to participate:
1. Age over 18 and able to provide informed consent in English.
2. Must have bilateral blepharoptosis undergoing repair using an anterior approach.
3. The degree of ptosis must be approximately symmetrical, with a difference in “Margin
Reflex Distance one (the distance between the pupillary light reflex and the margin of the upper 
lid)” of 1 mm or less between the two sides.
Participants will be excluded if they meet the following criteria:
1. Previous eyelid surgery or trauma.
2. Have congenital, mechanical, myogenic, or neurogenic form of ptosis.
3. Bleeding disorder or inability to discontinue anti-coagulants pre-operatively.
4. Cognitive impairment
After learning about the risks and benefits of participation, each patient will sign an informed 
consent form on the day of their surgery. Each patient will then receive an intra-operative 
posterior subconjunctival injection in both eyes. One injection will contain xylocaine (a local 
anesthetic) while the other will contain normal saline (a sham injection). All surgeries will be 
performed by Dr. Lee-Wing. Both the participants as well as Dr. Lee-Wing will be blinded as to 
which eye receives the intervention and the sham injection.
Post-operatively, patients will be asked to complete a pain scale questionnaire immediately 
following their surgery. Specifically, they will be asked to compare their pain in each eye. The 
results of this assessment will be compared using McNemar’s Test, and will constitute the 
primary outcome of the study. The secondary outcomes will include:
1. The presence or absence of post-operative lagophthalmos/fluorescein staining, as assessed 
at the post-operative follow-up. Comparison between the xylocaine injection group and the 
normal saline injection group will be performed using McNemar’s Test.
2. Post-operative “Margin Reflex Distance One” (as described above) will be compared 
between the xylocaine injection group and the normal saline injection group. The difference 
between the two groups will be evaluated using a Paired Student’s T-Test.
Surgical procedures will be performed at the Buhler Eye Care Centre, Misericordia Hospital, 99 
Cornish Ave., Winnipeg, Manitoba, Canada, R3C 1A2.
Data will be intermittently reviewed by Dr. Lee-Wing throughout the study period.
This study has received Ethics Approval from the University of Manitoba: HS20066 
(B2016:085).
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