Clinical Trials Logo

Clinical 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. 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.


Clinical Trial 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


Related Conditions & MeSH terms


NCT number NCT02959697
Study type Interventional
Source University of Manitoba
Contact Matthew Lee-Wing, MD
Phone (204) 946-0649
Email matthew.lee-wing@myumanitoba.ca
Status Recruiting
Phase N/A
Start date September 1, 2017
Completion date June 1, 2023

See also
  Status Clinical Trial Phase
Completed NCT00864656 - Eyelid Position Interdependence in Involutional Ptosis Patients Submitted to 10% Phenylephrine N/A
Recruiting NCT02501187 - Risk of Dry Eye Post Different Surgeries for Blepharoptosis Repair N/A
Completed NCT00793988 - Vibration-Assisted Anaesthesia Phase 4
Completed NCT02367677 - Digital Photographs to Evaluate Blepharoptosis N/A
Recruiting NCT01239498 - Saline Injection - Assisted Anesthesia in Eyelid Surgery Phase 4
Not yet recruiting NCT05358977 - Fibrin Sealant in Eyelid Surgery Phase 2/Phase 3
Completed NCT01848041 - Safety and Efficacy Study of RVL-1201 in Acquired Blepharoptosis Phase 1/Phase 2
Completed NCT01350024 - Comparison of Postoperative Pain With Two Different Types of Local Anesthesia in Surgery for a Drooping Eyelid N/A
Completed NCT06047418 - Blepharoptosis in Indonesia: A 5-Year Multicenter Study on Characteristics and Surgical Evaluation
Active, not recruiting NCT03149367 - Surgical Management of Blepharoptosis N/A
Completed NCT03565887 - Study of Safety and Efficacy of RVL-1201 in the Treatment of Blepharoptosis Phase 3
Recruiting NCT01968174 - Astigmatic Changes Secondary to Eyelid Surgeries N/A
Completed NCT03536949 - Study of Safety of RVL-1201 in Treatment of Blepharoptosis Phase 3
Active, not recruiting NCT04678115 - Clinical Trial Comparing Two Non-Surgical Treatments for Severe Blepharoptosis N/A
Not yet recruiting NCT04235803 - Telemedicine Follow-up for Routine, Low-Risk Oculoplastic Surgery N/A
Completed NCT02988856 - Magnetic Correction of Eye Lid Paralysis N/A
Terminated NCT03239418 - NMES to Improve Eyelid Functions in Cranial Nerve (CN) III and VII Palsy N/A
Not yet recruiting NCT02638610 - Assessment of Changes of Periocular Skin Sensation Following Eyelid and Ocular Surface Surgeries N/A
Enrolling by invitation NCT05945615 - Oxymetazoline Drops for Acquired Blepharoptosis From Synkinesis Phase 3
Recruiting NCT06292182 - Red Light Ptosis Proof-of-Concept N/A