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Brimonidine Tartrate for Pterygium Surgery

NCT ID: NCT04683159

Last Updated: 2020-12-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

66 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-02-28

Study Completion Date

2021-09-30

Brief Summary

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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

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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.

Conditions

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Pterygium Subconjunctival Hemorrhage

Keywords

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Brimonidine tartrate Pterygium surgery Subconjunctival hemorrhage

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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

PREVENTION

Blinding Strategy

TRIPLE

Caregivers Investigators Outcome Assessors
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

Study Groups

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Control

No intervention, only routine pre-operative drops

Group Type NO_INTERVENTION

No interventions assigned to this group

Brimonidine 0.15%

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

Group Type EXPERIMENTAL

Brimonidine Tartrate 0.15% Oph Soln

Intervention Type DRUG

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

Brimonidine 0.025%

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

Group Type EXPERIMENTAL

Brimonidine Tartrate 0.025% Oph Soln

Intervention Type DRUG

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

Interventions

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Brimonidine Tartrate 0.15% Oph Soln

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

Intervention Type DRUG

Brimonidine Tartrate 0.025% Oph Soln

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

Intervention Type DRUG

Other Intervention Names

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Alphagan-P Lumify

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Uptown Eye Specialists

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Eric Tam, MD

Role: PRINCIPAL_INVESTIGATOR

Uptown Eye Specialists

Central Contacts

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Eric Tam, MD

Role: CONTACT

Phone: 416-292-0330

Email: [email protected]

References

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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.

Reference Type BACKGROUND
PMID: 15812765 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 17765438 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 20890238 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 19631117 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 12160159 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 32105500 (View on PubMed)

Other Identifiers

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Red Eye 2.0

Identifier Type: -

Identifier Source: org_study_id