Sturge Weber Syndrome | Treatment of Port-wine Mark in Sturge-Weber Syndrome Using Topical Timolol
Sturge Weber Syndrome research study
What is the primary objective of this study?
Primary Objective: • To assess the possible utility of topical timolol in the management of port-wine mark (PWM) in Sturge-Weber syndrome in children.
Who is eligible to participate?
Inclusion criteria: - Age from 2 years to 10 years - Port-Wine Mark - English fluent and literate substitute decision maker - Substitute decision maker vision sufficient to read informed consent document Exclusion criteria: - Active ocular infection (conjunctivitis, keratitis,) - History of systemic conditions including hypo/hypertension, hypoglycemia, bradycardia, asthma or any contraindication to beta blocker use - Unable to comply with required follow-up - Substitute decision maker not English fluent or not literate - Substitute decision maker unable to read consent document - Patient already using systemic beta-blocker or beta-agonist (Patients already using topical beta-blocker for glaucoma will not be excluded from study).
Which medical condition, disease, disorder, syndrome, illness, or injury is researched?
Sturge Weber Syndrome
Interventions can include giving participants drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available or noninvasive approaches such as surveys, education, and interviews.
Drug:Timolol0.5% timolol maleate ophthalmic gel-forming solution applied once
Drug:Preservative free artificial tear gel.Preservative free artificial tear gel applied topically twice a day.
Research studies and clinical trials typically have two or more research arms. An arm is a group of people who receive the same treatment in the study.
TimololParticipants in this group will receive topical timolol
PlaceboParticipants in this group will receive Preservative free artificial tear gel.
Start Date: February 2012
Completed Date: December 2019
Phase: Phase 1
Primary Outcome: Appearance of Port-wine Mark at treatment site
Study sponsors, principal investigator, and references
Principal Investigator: Alex V Levin, MD, MHSc
Lead Sponsor: Wills Eye
Collaborator: University of Medicine and Dentistry of New Jersey
Hennedige AA, Quaba AA, Al-Nakib K. Sturge-Weber syndrome and dermatomal facial port-wine stains: incidence, association with glaucoma, and pulsed tunable dye laser treatment effectiveness. Plast Reconstr Surg. 2008 Apr;121(4):1173-80. doi: 10.1097/01.prs.0000304606.33897.71.