Brimonidine Tartrate for Pterygium Surgery

Sponsor
Uptown Eye Specialists (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT04683159
Collaborator
(none)
66
3
7

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Drug: Brimonidine Tartrate 0.15% Oph Soln
  • Drug: Brimonidine Tartrate 0.025% Oph Soln
N/A

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.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
66 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
Participants will be randomly assigned to one of three groups (control, brimonidine 0.15%, or brimonindine 0.025%), running in parallel.Participants will be randomly assigned to one of three groups (control, brimonidine 0.15%, or brimonindine 0.025%), running in parallel.
Masking:
Triple (Care Provider, Investigator, Outcomes 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
Primary Purpose:
Prevention
Official Title:
The Effect of Brimonidine Tartrate on Subconjunctival Hemorrhage During Pterygium Surgery
Anticipated Study Start Date :
Feb 1, 2021
Anticipated Primary Completion Date :
Jul 1, 2021
Anticipated Study Completion Date :
Sep 1, 2021

Arms and Interventions

Arm Intervention/Treatment
No Intervention: Control

No intervention, only routine pre-operative drops

Experimental: Brimonidine 0.15%

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

Drug: Brimonidine Tartrate 0.15% Oph Soln
1 drop of brimonidine 0.15% (~0.05mL) 15 minutes prior to surgery
Other Names:
  • Alphagan-P
  • Experimental: Brimonidine 0.025%

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

    Drug: Brimonidine Tartrate 0.025% Oph Soln
    1 drop of brimonidine 0.025% (~0.05mL) 15 minutes prior to surgery
    Other Names:
  • Lumify
  • Outcome Measures

    Primary Outcome Measures

    1. Subconjunctival hemorrhage grading [Post-operative Day 0 (30 minutes following operation)]

      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.

    2. Subconjunctival hemorrhage grading [Post-operative Week 1]

      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.

    3. Subconjunctival hemorrhage grading [Post-operative Month 1 (4 weeks)]

      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

    1. Hyperemia [Baseline]

      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.

    2. Hyperemia [Post-drop (5 minutes after administration)]

      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.

    3. Hyperemia [Post-operative day 0 (30 minutes after surgery)]

      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.

    4. Hyperemia [Post-operative week 1]

      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.

    5. Hyperemia [Post-operative month 1]

      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.

    6. Duration of operation [During surgery]

      The length of time it takes the pterygium operation

    7. Visual Acuity [Baseline]

      logMAR visual acuity

    8. Visual Acuity [Post-operative week 1]

      logMAR visual acuity

    9. Visual Acuity [Post-operative month 1]

      logMAR visual acuity

    10. Steroid usage [Post-operative week 1]

      Duration & frequency of steroid usage

    11. Steroid usage [Post-operative month 1]

      Duration & frequency of steroid usage

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    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

    Contacts and Locations

    Locations

    No locations specified.

    Sponsors and Collaborators

    • Uptown Eye Specialists

    Investigators

    • Principal Investigator: Eric Tam, MD, Uptown Eye Specialists

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    Responsible Party:
    Uptown Eye Specialists
    ClinicalTrials.gov Identifier:
    NCT04683159
    Other Study ID Numbers:
    • Red Eye 2.0
    First Posted:
    Dec 24, 2020
    Last Update Posted:
    Dec 24, 2020
    Last Verified:
    Dec 1, 2020
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    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
    Keywords provided by Uptown Eye Specialists
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Dec 24, 2020