Brimonidine Tartrate for Pterygium Surgery

NCT04683159 | Unknown

• 1 other identifier: Red Eye 2.0
• Study Type: interventional
• Target: 66
• Locations: 0 countries
• Sites: N/A

Brief Summary

Pterygium excision and conjunctival autograft surgery is commonly done to treat pterygiums. Excessive bleeding during the procedure creates a challenging operating field, prolongs surgery time, and prolongs healing. Brimonidine tartrate has a vasoconstrictive effect, which helps to reduce the amount of blood flow and hyperemia to the eye. Preoperative use of brimonidine has been shown to decrease subconjunctival hemorrhage during procedures such as cataract surgery, laser assisted in situ keratomileusis, strabismus surgery, and intravitreal injections. The focus of this study is to assess the effect of preoperative application of brimonidine tartrate 0.15% (Alphagan) and 0.025% (Lumify) on reducing hemorrhage during pterygium excision and conjunctival autograft surgery.

Conditions

Pterygium; Subconjunctival Hemorrhage

Keywords

Brimonidine tartrate; Pterygium surgery; Subconjunctival hemorrhage

Outcome Measures

Primary Outcomes (3)

• Subconjunctival hemorrhage grading

  Subconjunctival hemorrhage grading of images at POD0, POW1, and POM1 will be done as follows: a score of 1-4 for the number of quadrants involved, and a score of 1-4 for the amount of involvement in the quadrant (1 = 0-25% coverage, 2 = 26-50% coverage, 3 = 51-75% coverage, 4 = 76-100% coverage). A total maximum score of 16 may be given, with 0 indicating no subconjunctival hemorrhage present. This grading algorithm is adapted from previously published methods (Munoz 2009, Hong 2007, Norden 2002). Grading will be done by an independent reviewer blinded to the randomization of participants.

  Post-operative Day 0 (30 minutes following operation)

• Subconjunctival hemorrhage grading

  Subconjunctival hemorrhage grading of images will be done as follows: a score of 1-4 for the number of quadrants involved, and a score of 1-4 for the amount of involvement in the quadrant (1 = 0-25% coverage, 2 = 26-50% coverage, 3 = 51-75% coverage, 4 = 76-100% coverage). A total maximum score of 16 may be given, with 0 indicating no subconjunctival hemorrhage present. This grading algorithm is adapted from previously published methods (Munoz 2009, Hong 2007, Norden 2002). Grading will be done by an independent reviewer blinded to the randomization of participants.

  Post-operative Week 1

• Subconjunctival hemorrhage grading

  Subconjunctival hemorrhage grading of images will be done as follows: a score of 1-4 for the number of quadrants involved, and a score of 1-4 for the amount of involvement in the quadrant (1 = 0-25% coverage, 2 = 26-50% coverage, 3 = 51-75% coverage, 4 = 76-100% coverage). A total maximum score of 16 may be given, with 0 indicating no subconjunctival hemorrhage present. This grading algorithm is adapted from previously published methods (Munoz 2009, Hong 2007, Norden 2002). Grading will be done by an independent reviewer blinded to the randomization of participants.

  Post-operative Month 1 (4 weeks)

Secondary Outcomes (11)

• Hyperemia

  Baseline

• Hyperemia

  Post-drop (5 minutes after administration)

• Hyperemia

  Post-operative day 0 (30 minutes after surgery)

• Hyperemia

  Post-operative week 1

• Hyperemia

  Post-operative month 1

Study Arms (3)

Control

NO INTERVENTION

No intervention, only routine pre-operative drops

Brimonidine 0.15%

EXPERIMENTAL

Routine pre-operative drops + 1 drop of brimonidine tartrate 0.15% in the operating eye

Drug: Brimonidine Tartrate 0.15% Oph Soln

Brimonidine 0.025%

EXPERIMENTAL

Routine pre-operative drops + 1 drop of brimonidine tartrate 0.025% in the operating eye

Drug: Brimonidine Tartrate 0.025% Oph Soln

Interventions

Brimonidine Tartrate 0.15% Oph Soln DRUG

1 drop of brimonidine 0.15% (\~0.05mL) 15 minutes prior to surgery

Also known as: Alphagan-P

Brimonidine 0.15%

Brimonidine Tartrate 0.025% Oph Soln DRUG

1 drop of brimonidine 0.025% (\~0.05mL) 15 minutes prior to surgery

Also known as: Lumify

Brimonidine 0.025%

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• All patients over age 18 who are scheduled for pterygium surgery who have provided informed consent, in accordance with application regulations and guidelines

You may not qualify if:

• Patients who are on anticoagulation or antiplatelet therapy
• Patients on monoamine oxidase (MOA) inhibitor therapy
• Patients who have undergone any conjunctival surgery in the past
• Any complication during pterygium excision

Sponsors & Collaborators

• Uptown Eye Specialists: lead

Related Publications (6)

• Desco MC, Navea A, Ferrer E, Menezo JL. Effect of prophylactic brimonidine on bleeding complications after cataract surgery. Eur J Ophthalmol. 2005 Mar-Apr;15(2):228-32. doi: 10.1177/112067210501500209.

  PMID: 15812765 BACKGROUND

• 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.

  PMID: 17765438 BACKGROUND

• 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.

  PMID: 20890238 BACKGROUND

• Munoz G, Albarran-Diego C, Sakla HF, Javaloy J. Increased risk for flap dislocation with perioperative brimonidine use in femtosecond laser in situ keratomileusis. J Cataract Refract Surg. 2009 Aug;35(8):1338-42. doi: 10.1016/j.jcrs.2009.03.029.

  PMID: 19631117 BACKGROUND

• Norden RA. Effect of prophylactic brimonidine on bleeding complications and flap adherence after laser in situ keratomileusis. J Refract Surg. 2002 Jul-Aug;18(4):468-71. doi: 10.3928/1081-597X-20020701-10.

  PMID: 12160159 BACKGROUND

• 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.

  PMID: 32105500 BACKGROUND

MeSH Terms

Conditions

Pterygium

Interventions

Brimonidine Tartrate

Condition Hierarchy (Ancestors)

Conjunctival Diseases; Eye Diseases

Intervention Hierarchy (Ancestors)

Quinoxalines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• Eric Tam, MD

  Uptown Eye Specialists

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Eric Tam, MD

CONTACT

416-292-0330; etam@uptowneye.ca

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: The surgeon (care provider/investigator) will be masked to the intervention at the time of operation and during follow-ups (day 0, week 1, month 1). Outcomes assessor will be blinded to the investigation when quantifying degree of hemorrhage
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Participants will be randomly assigned to one of three groups (control, brimonidine 0.15%, or brimonindine 0.025%), running in parallel.

Study Record Dates

• First Submitted: December 20, 2020
• First Posted: December 24, 2020
• Study Start: February 1, 2021
• Primary Completion: July 1, 2021
• Study Completion: September 1, 2021
• Last Updated: December 24, 2020

Record last verified: 2020-12

Data Sharing

• IPD Sharing: Will not share