Brimonidine Tartrate for Pterygium Surgery
Primary Purpose
Pterygium, Subconjunctival Hemorrhage
Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Brimonidine Tartrate 0.15% Oph Soln
Brimonidine Tartrate 0.025% Oph Soln
Sponsored by
About this trial
This is an interventional prevention trial for Pterygium focused on measuring Brimonidine tartrate, Pterygium surgery, Subconjunctival hemorrhage
Eligibility Criteria
Inclusion Criteria:
- All patients over age 18 who are scheduled for pterygium surgery who have provided informed consent, in accordance with application regulations and guidelines
Exclusion Criteria:
- 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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
No Intervention
Experimental
Experimental
Arm Label
Control
Brimonidine 0.15%
Brimonidine 0.025%
Arm Description
No intervention, only routine pre-operative drops
Routine pre-operative drops + 1 drop of brimonidine tartrate 0.15% in the operating eye
Routine pre-operative drops + 1 drop of brimonidine tartrate 0.025% in the operating eye
Outcomes
Primary Outcome Measures
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.
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.
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.
Secondary Outcome Measures
Hyperemia
Hyperemia will be quantified in the same manner as Ucar et al. (Ucar, 2020). Vessels on the images converted to black and white with Adobe Photoshop - vessels will be converted to black, while the rest of the sclera will be white. ImageJ (public domain software) will then be used to quantify the number of black pixels (vessels). Hyperemia will be reported as the number of black pixels per image.
Hyperemia
Hyperemia will be quantified in the same manner as Ucar et al. (Ucar, 2020). Vessels on the images converted to black and white with Adobe Photoshop - vessels will be converted to black, while the rest of the sclera will be white. ImageJ (public domain software) will then be used to quantify the number of black pixels (vessels). Hyperemia will be reported as the number of black pixels per image.
Hyperemia
Hyperemia will be quantified in the same manner as Ucar et al. (Ucar, 2020). Vessels on the images converted to black and white with Adobe Photoshop - vessels will be converted to black, while the rest of the sclera will be white. ImageJ (public domain software) will then be used to quantify the number of black pixels (vessels). Hyperemia will be reported as the number of black pixels per image.
Hyperemia
Hyperemia will be quantified in the same manner as Ucar et al. (Ucar, 2020). Vessels on the images converted to black and white with Adobe Photoshop - vessels will be converted to black, while the rest of the sclera will be white. ImageJ (public domain software) will then be used to quantify the number of black pixels (vessels). Hyperemia will be reported as the number of black pixels per image.
Hyperemia
Hyperemia will be quantified in the same manner as Ucar et al. (Ucar, 2020). Vessels on the images converted to black and white with Adobe Photoshop - vessels will be converted to black, while the rest of the sclera will be white. ImageJ (public domain software) will then be used to quantify the number of black pixels (vessels). Hyperemia will be reported as the number of black pixels per image.
Duration of operation
The length of time it takes the pterygium operation
Visual Acuity
logMAR visual acuity
Visual Acuity
logMAR visual acuity
Visual Acuity
logMAR visual acuity
Steroid usage
Duration & frequency of steroid usage
Steroid usage
Duration & frequency of steroid usage
Full Information
NCT ID
NCT04683159
First Posted
December 20, 2020
Last Updated
December 20, 2020
Sponsor
Uptown Eye Specialists
1. Study Identification
Unique Protocol Identification Number
NCT04683159
Brief Title
Brimonidine Tartrate for Pterygium Surgery
Official Title
The Effect of Brimonidine Tartrate on Subconjunctival Hemorrhage During Pterygium Surgery
Study Type
Interventional
2. Study Status
Record Verification Date
December 2020
Overall Recruitment Status
Unknown status
Study Start Date
February 2021 (Anticipated)
Primary Completion Date
July 2021 (Anticipated)
Study Completion Date
September 2021 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Uptown Eye Specialists
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
5. Study Description
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.
Detailed Description
During pterygium excision and conjunctival autograft surgery, incision into the conjunctiva of the operated eye causes a significant amount of subconjunctival hemorrhage. Brimonidine-tartrate is a selective alpha-2-adrenergic agonist. The 0.15% concentration (Alphagan) is commonly used to treat glaucoma, while the 0.025% (Lumify) is an over-the-counter drop used for its vasoconstrictive anti-hyperemia effect. Brimonidine 0.15% has been evaluated in other studies to reduce bleeding in LASIK, cataract surgery, strabismus surgery, as well as intravitreal injections. In these mentioned clinical trials, brimonidine was found to safely reduce subconjunctival hemorrhage intraoperatively and hyperemia postoperatively. Interestingly, prophylactic topical brimonidine was found to increase risk of early flap slippage in LASIK due to molecular interference with flap stabilization. Because creation of a flap is not a component of pterygium surgery, preoperative brimonidine does not interfere with healing.
A recent study by Ucar et al. has validated the use of preoperative brimonidine 0.15% for conjunctival whitening prior to pterygium surgery, allowing for minimized hyperemia and reduced surgical duration (Ucar, 2020). However, the long-term clinical outcomes, and efficacy of brimonidine 0.025% has yet to be examined. This study aims to further examine the comparative efficacy of preoperative brimonidine at different concentrations to reduce subconjunctival hemorrhage during pterygium surgery.
Potential side effects of topical application of brimonidine eye drop may include blurred or loss of vision, burning, dry, or itching eyes, discharge or excessive tearing, disturbed color perception, double vision, halos around lights, headache, itching of the eye, night blindness, photophobia, redness of the eye or inner lining of the eyelid, swelling of the eyelid, tearing of the eye, tunnel vision. Side effects of this medication are self-limited, and reversible after the medication is stopped.
The risk of this study to the subject is negligible as the standard surgical procedure will be followed. This trial will be conducted in compliance with the protocol, GCP, and the applicable regulatory requirement as set by William Osler Health System Ethics Review Board.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pterygium, Subconjunctival Hemorrhage
Keywords
Brimonidine tartrate, Pterygium surgery, Subconjunctival hemorrhage
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Participants will be randomly assigned to one of three groups (control, brimonidine 0.15%, or brimonindine 0.025%), running in parallel.
Masking
Care ProviderInvestigatorOutcomes Assessor
Masking Description
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
Allocation
Randomized
Enrollment
66 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Control
Arm Type
No Intervention
Arm Description
No intervention, only routine pre-operative drops
Arm Title
Brimonidine 0.15%
Arm Type
Experimental
Arm Description
Routine pre-operative drops + 1 drop of brimonidine tartrate 0.15% in the operating eye
Arm Title
Brimonidine 0.025%
Arm Type
Experimental
Arm Description
Routine pre-operative drops + 1 drop of brimonidine tartrate 0.025% in the operating eye
Intervention Type
Drug
Intervention Name(s)
Brimonidine Tartrate 0.15% Oph Soln
Other Intervention Name(s)
Alphagan-P
Intervention Description
1 drop of brimonidine 0.15% (~0.05mL) 15 minutes prior to surgery
Intervention Type
Drug
Intervention Name(s)
Brimonidine Tartrate 0.025% Oph Soln
Other Intervention Name(s)
Lumify
Intervention Description
1 drop of brimonidine 0.025% (~0.05mL) 15 minutes prior to surgery
Primary Outcome Measure Information:
Title
Subconjunctival hemorrhage grading
Description
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.
Time Frame
Post-operative Day 0 (30 minutes following operation)
Title
Subconjunctival hemorrhage grading
Description
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.
Time Frame
Post-operative Week 1
Title
Subconjunctival hemorrhage grading
Description
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.
Time Frame
Post-operative Month 1 (4 weeks)
Secondary Outcome Measure Information:
Title
Hyperemia
Description
Hyperemia will be quantified in the same manner as Ucar et al. (Ucar, 2020). Vessels on the images converted to black and white with Adobe Photoshop - vessels will be converted to black, while the rest of the sclera will be white. ImageJ (public domain software) will then be used to quantify the number of black pixels (vessels). Hyperemia will be reported as the number of black pixels per image.
Time Frame
Baseline
Title
Hyperemia
Description
Hyperemia will be quantified in the same manner as Ucar et al. (Ucar, 2020). Vessels on the images converted to black and white with Adobe Photoshop - vessels will be converted to black, while the rest of the sclera will be white. ImageJ (public domain software) will then be used to quantify the number of black pixels (vessels). Hyperemia will be reported as the number of black pixels per image.
Time Frame
Post-drop (5 minutes after administration)
Title
Hyperemia
Description
Hyperemia will be quantified in the same manner as Ucar et al. (Ucar, 2020). Vessels on the images converted to black and white with Adobe Photoshop - vessels will be converted to black, while the rest of the sclera will be white. ImageJ (public domain software) will then be used to quantify the number of black pixels (vessels). Hyperemia will be reported as the number of black pixels per image.
Time Frame
Post-operative day 0 (30 minutes after surgery)
Title
Hyperemia
Description
Hyperemia will be quantified in the same manner as Ucar et al. (Ucar, 2020). Vessels on the images converted to black and white with Adobe Photoshop - vessels will be converted to black, while the rest of the sclera will be white. ImageJ (public domain software) will then be used to quantify the number of black pixels (vessels). Hyperemia will be reported as the number of black pixels per image.
Time Frame
Post-operative week 1
Title
Hyperemia
Description
Hyperemia will be quantified in the same manner as Ucar et al. (Ucar, 2020). Vessels on the images converted to black and white with Adobe Photoshop - vessels will be converted to black, while the rest of the sclera will be white. ImageJ (public domain software) will then be used to quantify the number of black pixels (vessels). Hyperemia will be reported as the number of black pixels per image.
Time Frame
Post-operative month 1
Title
Duration of operation
Description
The length of time it takes the pterygium operation
Time Frame
During surgery
Title
Visual Acuity
Description
logMAR visual acuity
Time Frame
Baseline
Title
Visual Acuity
Description
logMAR visual acuity
Time Frame
Post-operative week 1
Title
Visual Acuity
Description
logMAR visual acuity
Time Frame
Post-operative month 1
Title
Steroid usage
Description
Duration & frequency of steroid usage
Time Frame
Post-operative week 1
Title
Steroid usage
Description
Duration & frequency of steroid usage
Time Frame
Post-operative month 1
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
All patients over age 18 who are scheduled for pterygium surgery who have provided informed consent, in accordance with application regulations and guidelines
Exclusion Criteria:
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Eric Tam, MD
Phone
416-292-0330
Email
etam@uptowneye.ca
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Eric Tam, MD
Organizational Affiliation
Uptown Eye Specialists
Official's Role
Principal Investigator
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
15812765
Citation
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.
Results Reference
background
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
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
19631117
Citation
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.
Results Reference
background
PubMed Identifier
12160159
Citation
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.
Results Reference
background
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
background
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Brimonidine Tartrate for Pterygium Surgery
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