Brimonidine for Subconjunctival Hemorrhage From Femtosecond Laser Assisted Cataract Surgery

NCT04633954 | Completed

• 1 other identifier: Red Eye 1.0
• Study Type: interventional
• Target: 56
• Locations: 1 country
• Sites: 1

Brief Summary

Laser-assisted cataract surgery is a common and precise procedure done to remove cataracts from the eye. This procedure involves putting on a suction cup that applies a mild vacuum seal around the eye to stabilize the eye during the laser procedure. This suction cup often causes some bleeding under the conjunctiva around the eye which takes a few days to disappear. The purpose of this study is to test the use of a well-known eye medication (normally for treating glaucoma) called Brimonidine tartrate 0.15% (or Alphagan-P) in patients having laser-assisted cataract surgery. The use of Brimonidine to reduce bleeding under the conjunctiva is investigational, which means it has not been approved by Health Canada for use outside of research studies like this one. This study will see if Brimonidine will help to reduce bleeding under the conjunctiva in patients having laser-assisted cataract surgery.

Conditions

Subconjunctival Hemorrhage; Cataract Surgery

Keywords

Brimonidine Tartrate; Femtosecond laser assisted cataract surgery; Bulbar redness; Subconjunctival hemorrhage; Cataract Surgery

Outcome Measures

Primary Outcomes (2)

• Bulbar Redness Score

  Bulbar redness score measured with Oculus 5M Keratograph will detect the amount of redness before and after FLACS. The Oculus Keratograph 5M BR score uses a clinical grading scale of 0.0-4.0 in 0.1 step. A higher score correlates to increased bulbar redness.

  Pre-operatively

• Bulbar Redness Score

  Bulbar redness score measured with Oculus 5M Keratograph will detect the amount of redness before and after FLACS. The Oculus Keratograph 5M BR score uses a clinical grading scale of 0.0-4.0 in 0.1 step. A higher score correlates to increased bulbar redness.

  15 minutes post-operatively

Secondary Outcomes (4)

• Analyzed Area

  Pre-operatively

• Analyzed Area

  15 minutes post-operatively

• Attempts of Vacuum

  During the operation

• Duration of surgery

  During the operation

Study Arms (2)

Brimonidine Group

EXPERIMENTAL

Patients in this arm receive an extra drop of brimonidine in addition to routine eye drops prior to femtosecond laser assisted cataract surgery (FLACS)

Drug: Brimonidine Tartrate 0.15% Oph Soln

Control Group

NO INTERVENTION

Patients in this arm only receive routine eye drops prior to femtosecond laser assisted cataract surgery (FLACS)

Interventions

Brimonidine Tartrate 0.15% Oph Soln DRUG

One drop of Brimonidine Tartrate 0.15% Oph Soln prior to FLACS

Brimonidine Group

Eligibility Criteria

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

You may qualify if:

• All patients who are schedules for femtosecond laser assisted cataract surgery who have provided informed consent, in accordance with application regulations and guidelines

You may not qualify if:

• Patients who have been on anticoagulation or antiplatelet therapy
• Patients who have undergone any conjunctival surgery in the past
• Any complication during cataract extraction

Sponsors & Collaborators

• Uptown Eye Specialists: lead

Study Sites (1)

Uptown Eye Speicialists

Brampton, Ontario, L6Y0P6, Canada

Location

Related Publications (5)

• Pasquali TA, Aufderheide A, Brinton JP, Avila MR, Stahl ED, Durrie DS. Dilute brimonidine to improve patient comfort and subconjunctival hemorrhage after LASIK. J Refract Surg. 2013 Jul;29(7):469-75. doi: 10.3928/1081597X-20130617-05.

  PMID: 23820229 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

• 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

• 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

MeSH Terms

Interventions

Brimonidine Tartrate

Intervention Hierarchy (Ancestors)

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Ophthalmologist & Medical Director

Study Record Dates

• First Submitted: November 8, 2020
• First Posted: November 18, 2020
• Study Start: June 6, 2019
• Primary Completion: August 31, 2019
• Study Completion: August 31, 2019
• Last Updated: November 18, 2020

Record last verified: 2020-11

Locations

CA (1)