Brimonidine for Intraoperative Hemostasis

Ptosis, Eyelid Clinical Trial

Official title:

Efficacy of Intraoperative Brimonidine for Hemostasis During Eyelid Surgery

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05480098
• Other study ID #: 21.0989
• Status: Recruiting
• Phase: Phase 4
• Start date: May 26, 2022
• Est. completion date: December 30, 2024

Study information

• Verified date: June 2023
• Source: University of Louisville
• Contact: Christopher Compton, MD
• Phone: 5025880550
• Email: christopher.compton[@]louisville.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to observe and report the effects of topical ophthalmic brimonidine in oculofacial plastic surgery.

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?

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: December 30, 2024
• Est. primary completion date: December 30, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Blepharoptosis
• Cutis Laxa
• Ectropion
• Entropion
• Ptosis, Eyelid

Intervention

Drug:
• Brimonidine Topical
Topical brimonidine intraoperatively for hemostasis

Locations

Country	Name	City	State
United States	University of Louisville	Louisville	Kentucky

Sponsors (1)

Lead Sponsor	Collaborator
University of Louisville

Country where clinical trial is conducted

United States, 

References & Publications (5)

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. — View 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. — View 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. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Hemostasis	Change in Hemostasis Score	At the time of surgery.