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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
Uptown Eye Specialists
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Pterygium focused on measuring Brimonidine tartrate, Pterygium surgery, Subconjunctival hemorrhage

Eligibility Criteria

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

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

    First Posted
    December 20, 2020
    Last Updated
    December 20, 2020
    Sponsor
    Uptown Eye Specialists
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    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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