NCT02959697

Brief 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. 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Sep 2017

Longer than P75 for not_applicable

Geographic Reach
1 country

2 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 31, 2016

Completed
9 days until next milestone

First Posted

Study publicly available on registry

November 9, 2016

Completed
10 months until next milestone

Study Start

First participant enrolled

September 1, 2017

Completed
5.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2023

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2023

Completed
Last Updated

June 10, 2022

Status Verified

May 1, 2022

Enrollment Period

5.7 years

First QC Date

October 31, 2016

Last Update Submit

June 7, 2022

Conditions

BlepharoptosisPtosis

Keywords

BlepharoptosisPtosisSurgeryPain ReductionAnestheticLocal AnestheticSubconjunctival

Outcome Measures

Primary Outcomes (1)

  • 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.

    6 Years

Secondary Outcomes (2)

  • Presence of post-operative lagophthalmos/fluorescein staining

    6 Years

  • Post-Operative margin-reflex distance 1

    6 Years

Study Arms (2)

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.

Drug: Subcut. + Subconj. XylocaineProcedure: 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.

Drug: Subcut. + Sham Subconj. InjectionProcedure: Blepharoptosis Repair

Interventions

Subcut. + Subconj. XylocaineDRUG

Patient will receive the standard subcutaneous local anesthetic as well as an additional subconjunctival injection of local anesthetic (Xylocaine).

Also known as: Xylocaine
Subcut. + Subconj. Injection
Subcut. + Sham Subconj. InjectionDRUG

Patient will receive the standard subcutaneous local anesthetic as well as a subconjunctival sham injection of Normal Saline.

Also known as: Normal Saline
Subcut. + Sham Subconj. Injection
Blepharoptosis RepairPROCEDURE

Patients will undergo blepharoptosis repair using an anterior approach.

Also known as: Ptosis Repair
Subcut. + Sham Subconj. InjectionSubcut. + Subconj. Injection

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • Previous eyelid surgery or trauma
  • Congenital, mechanical, myogenic or neurogenic forms of ptosis
  • Unable to give informed consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Buhler Eye Centre, Misericordia Hospital

Winnipeg, Manitoba, R3C 1A2, Canada

RECRUITING

Private Office (Dr. Lee-Wing). 1010-233 Kennedy st.

Winnipeg, Manitoba, R3C 3J5, Canada

RECRUITING

MeSH Terms

Conditions

Blepharoptosis

Interventions

LidocaineSaline Solution

Condition Hierarchy (Ancestors)

Eyelid DiseasesEye Diseases

Intervention Hierarchy (Ancestors)

AcetanilidesAnilidesAmidesOrganic ChemicalsAniline CompoundsAminesCrystalloid SolutionsIsotonic SolutionsSolutionsPharmaceutical Preparations

Study Officials

  • Matthew Lee-Wing, MD

    University of Manitoba

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Matthew Lee-Wing, MD

CONTACT

(204) 946-0649matthew.lee-wing@myumanitoba.ca

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 31, 2016

First Posted

November 9, 2016

Study Start

September 1, 2017

Primary Completion

May 1, 2023

Study Completion

June 1, 2023

Last Updated

June 10, 2022

Record last verified: 2022-05

Locations

CA(2)