Efficacy of Intraoperative Brimonidine for Hemostasis During Eyelid Surgery

21.0989

The purpose of this study is to observe and report the effects of topical ophthalmic brimonidine in oculofacial plastic surgery.

2022-05-26

2024-12-30

2024-12-30

Recruiting

Early phase I

100

Inclusion Criteria: * Above the age of 18 * Ophthalmic conditions requiring oculoplastic surgery Exclusion Criteria: * Known allergy or adverse effects to brimonidine * Hypotony * Acute ophthalmic infection * History of hypotension * Orthostatic hypotension * Pregnancy * History of Central Nervous System (CNS) depression from medication use * Thrombotic disorders * Asymmetrical oculoplastic conditions that may interfere with tear drainage (e.g. unilateral NLDO) * Current use of brimonidine

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE4'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'interventionModelDescription': "A randomized, prospective clinical trial will be performed with IRB approval to compare intraoperative application of ophthalmic brimonidine solution to standard methods of hemostasis control. This study will be blinded to the surgeon grading the severity of bleeding and the patient unaware which side would receive the intervention. Topical brimonidine ophthalmic solution will be placed intraoperatively to the open surgical wound of one eyelid and we will assess the severity of bleeding via a surgeon's grading scale. The fellow eye's surgical wound will be used as the control. The laterality of intervention is randomized. Reduction of bleeding severity is the primary outcome as graded by a subjective surgeon's grading scale. A secondary outcome may be severity of postoperative bruising in the study eye versus the fellow control eye, as graded by post-operative bruising severity.", 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'DOUBLE', 'maskingDescription': 'This study will be blinded to the surgeon grading the severity of bleeding and the patient will be unaware which side would receive the intervention.', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER']}}, 'enrollmentInfo': {'count': 100, 'type': 'ESTIMATED'}}

2023-06-08