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Brimonidine for Intraoperative Hemostasis

Primary Purpose

Dermatochalasis of Eyelid, Ptosis, Eyelid, Ectropion

Status
Recruiting
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Brimonidine Topical
Sponsored by
University of Louisville
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Dermatochalasis of Eyelid

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Above the age of 18
  • Ophthalmic conditions requiring oculoplastic surgery

Exclusion Criteria:

  • Known allergy or adverse effects to brimonidine
  • Hypotony
  • Acute ophthalmic infection
  • History of hypotension
  • Orthostatic hypotension
  • Pregnancy
  • History of Central Nervous System (CNS) depression from medication use
  • Thrombotic disorders
  • Asymmetrical oculoplastic conditions that may interfere with tear drainage (e.g. unilateral NLDO)
  • Current use of brimonidine

Sites / Locations

  • University of LouisvilleRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Brimonidine intervention

Control Arm

Arm Description

We will compare hemostasis between 2 surgical sides of the same patient. One side will be randomized to receive Brimonidine (0.15% or 0.2%) in addition to standard hemostasis measures, while the other side will receive only standard hemostasis measures (preoperative discontinuation of blood thinners, preoperative injection of lidocaine with epinephrine).

We will compare hemostasis between 2 surgical sides of the same patient. One side will be randomized to receive Brimonidine (0.15% or 0.2%) in addition to standard hemostasis measures, while the other side will receive only standard hemostasis measures (preoperative discontinuation of blood thinners, preoperative injection of lidocaine with epinephrine).

Outcomes

Primary Outcome Measures

Hemostasis
Change in Hemostasis Score

Secondary Outcome Measures

Full Information

First Posted
June 6, 2022
Last Updated
June 6, 2023
Sponsor
University of Louisville
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1. Study Identification

Unique Protocol Identification Number
NCT05480098
Brief Title
Brimonidine for Intraoperative Hemostasis
Official Title
Efficacy of Intraoperative Brimonidine for Hemostasis During Eyelid Surgery
Study Type
Interventional

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Recruiting
Study Start Date
May 26, 2022 (Actual)
Primary Completion Date
December 30, 2024 (Anticipated)
Study Completion Date
December 30, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Louisville

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No

5. Study Description

Brief Summary
The purpose of this study is to observe and report the effects of topical ophthalmic brimonidine in oculofacial plastic surgery.
Detailed Description
Brimonidine ophthalmic solution (Alphagan) is mainstay in glaucoma therapy to reduce intraocular pressure. The medication is an alpha2 adrenergic agonist, which increases uveoscleral outflow of aqueous humor. Alpha2 agonists also have vasoconstrictive properties, which has been utilized in over-the-counter medications like Lumify for redness relief. An unexploited utility of its vasoconstrictive property is reduction in intraoperative bleeding during ophthalmic surgery. The purpose of this study is to observe and report the effects of brimonidine in oculofacial plastic surgery. There are reports in ophthalmic literature that observe the hemostatic effect of topical brimonidine across different subspecialties. It has been shown to reduce intraoperative bleeding and post-operative subconjunctival hemorrhages in pterygium removal, strabismus surgery, LASIK, and cataract surgery. One study claimed that it had a comparable hemostatic effect to phenylephrine. Many of the procedures in oculoplastic surgery involve manipulation and incision of eyelid skin and conjunctival tissue. Some examples include blepharoplasty, ptosis repair, medial spindles, lateral tarsal strips, canthotomy and cantholysis with subsequent repair, retraction repair, and orbital fracture repair. Rapid and adequate control of intraoperative bleeding is crucial to the success of oculoplastic surgery. Although surgeons take proper precautions to prevent inadequate hemostasis (discontinuing blood thinners, use of electrocautery, and administration of intradermal epinephrine), excessive bleeding can still occur. This can impair surgeon performance by obscuring visualization, and negatively affect the patient due to prolonged operative times, and delayed healing due to hematoma formation. The most feared complication of oculoplastic surgery is intraorbital hemorrhage, which can cause orbital compartment syndrome causing vision loss. Therefore, any intervention to minimize bleeding is very advantageous to the patient. Use of Brimonidine drops intraoperatively will improve hemostasis, resulting in improved visualization, reduced operative time under anesthesia, and reduced risk of significant intraorbital hemorrhage. Due to both brimonidine's vasoconstrictive properties and relatively favorable safety profile, it raises the question: can brimonidine be used to achieve better hemostasis in oculoplastic procedures?

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dermatochalasis of Eyelid, Ptosis, Eyelid, Ectropion, Entropion

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Model Description
A randomized, prospective clinical trial will be performed with IRB approval to compare intraoperative application of ophthalmic brimonidine solution to standard methods of hemostasis control. This study will be blinded to the surgeon grading the severity of bleeding and the patient unaware which side would receive the intervention. Topical brimonidine ophthalmic solution will be placed intraoperatively to the open surgical wound of one eyelid and we will assess the severity of bleeding via a surgeon's grading scale. The fellow eye's surgical wound will be used as the control. The laterality of intervention is randomized. Reduction of bleeding severity is the primary outcome as graded by a subjective surgeon's grading scale. A secondary outcome may be severity of postoperative bruising in the study eye versus the fellow control eye, as graded by post-operative bruising severity.
Masking
ParticipantCare Provider
Masking Description
This study will be blinded to the surgeon grading the severity of bleeding and the patient will be unaware which side would receive the intervention.
Allocation
Randomized
Enrollment
100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Brimonidine intervention
Arm Type
Experimental
Arm Description
We will compare hemostasis between 2 surgical sides of the same patient. One side will be randomized to receive Brimonidine (0.15% or 0.2%) in addition to standard hemostasis measures, while the other side will receive only standard hemostasis measures (preoperative discontinuation of blood thinners, preoperative injection of lidocaine with epinephrine).
Arm Title
Control Arm
Arm Type
No Intervention
Arm Description
We will compare hemostasis between 2 surgical sides of the same patient. One side will be randomized to receive Brimonidine (0.15% or 0.2%) in addition to standard hemostasis measures, while the other side will receive only standard hemostasis measures (preoperative discontinuation of blood thinners, preoperative injection of lidocaine with epinephrine).
Intervention Type
Drug
Intervention Name(s)
Brimonidine Topical
Other Intervention Name(s)
Alphagan
Intervention Description
Topical brimonidine intraoperatively for hemostasis
Primary Outcome Measure Information:
Title
Hemostasis
Description
Change in Hemostasis Score
Time Frame
At the time of surgery.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Above the age of 18 Ophthalmic conditions requiring oculoplastic surgery Exclusion Criteria: Known allergy or adverse effects to brimonidine Hypotony Acute ophthalmic infection History of hypotension Orthostatic hypotension Pregnancy History of Central Nervous System (CNS) depression from medication use Thrombotic disorders Asymmetrical oculoplastic conditions that may interfere with tear drainage (e.g. unilateral NLDO) Current use of brimonidine
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Christopher Compton, MD
Phone
5025880550
Email
christopher.compton@louisville.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Jeremy Clark, MD
Phone
5025880550
Email
jeremy.clark.3@louisville.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Christopher Compton, MD
Organizational Affiliation
University of Louisville
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Louisville
City
Louisville
State/Province
Kentucky
ZIP/Postal Code
40202
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Christopher Compton, MD
Phone
502-588-0550
Email
christopher.compton@louisville.edu
First Name & Middle Initial & Last Name & Degree
Julia Elpers, MD
Phone
5025880550
Email
julia.elpersmd@gmail.com
First Name & Middle Initial & Last Name & Degree
Julia Elpers, MD

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
17765438
Citation
Hong S, Kim CY, Seong GJ, Han SH. Effect of prophylactic brimonidine instillation on bleeding during strabismus surgery in adults. Am J Ophthalmol. 2007 Sep;144(3):469-70. doi: 10.1016/j.ajo.2007.04.038.
Results Reference
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PubMed Identifier
32105500
Citation
Ucar F, Cetinkaya S. The Results of Preoperative Topical Brimonidine Usage in Pterygium Surgery. J Ocul Pharmacol Ther. 2020 May;36(4):234-237. doi: 10.1089/jop.2019.0085. Epub 2020 Feb 27.
Results Reference
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PubMed Identifier
34055396
Citation
Kim DH, Yang HK, Han SB, Hwang JM. Effect of Topical Brimonidine 0.15% on Conjunctival Injection after Strabismus Surgery in Children. J Ophthalmol. 2021 May 4;2021:5574194. doi: 10.1155/2021/5574194. eCollection 2021.
Results Reference
background
PubMed Identifier
20890238
Citation
Kim CS, Nam KY, Kim JY. Effect of prophylactic topical brimonidine (0.15%) administration on the development of subconjunctival hemorrhage after intravitreal injection. Retina. 2011 Feb;31(2):389-92. doi: 10.1097/IAE.0b013e3181eef28e.
Results Reference
background
PubMed Identifier
33684337
Citation
Ucar F, Cetinkaya S. The Results of Preoperative Use of Topical Brimonidine in Strabismus Surgery. J Ocul Pharmacol Ther. 2021 May;37(4):230-235. doi: 10.1089/jop.2020.0144. Epub 2021 Mar 8.
Results Reference
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Brimonidine for Intraoperative Hemostasis

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