Actively Recruiting // Brandt Lab // Clinical Trials // Cornea // Dry Eye // GVHD // Michele Martin // Jan 28 2019
Scleral Contact Lens Reduction of Dry Eye Inflammation in Patients with Graft-Versus-Host Disease (GVHD)
- Investigator Initiated
- Principal Investigator: Curtis Brandt, PhD
- Clinical Collaborator: Michele Martin, OD
- Study Coordinator: Kris Dietzman
Study objective:
The use of scleral contact lenses for increased comfort and vision in ocular graft vs host patients with dry eye disease.
Study design:
The study will include three clinic visits over a 3-month period. Visits will consist of an Ocular Surface Disease Index (OSDI) questionnaire, tear film collection, and slit lamp photography in addition to regular clinical activities.
Inclusion criteria:
- Male or female patients ≥ 18 years of age with confirmed diagnosis of dry eye and GVHD
- Ability to discontinue topical anti-inflammatory medications for 10 days prior to Visit 1
- Systemically stable with GVHD under control as determined by referring physician or transplant medicine team
- Scleral contact lenses prescribed by treating eye doctor as standard-of-care for GVHD associated dry eye
Exclusion criteria:
- Any active ocular disease other than dry eye
- Contact lens wear
- Any ocular surgery in the last 6 months
- Any topical medicine other than lubricants or tears
- Systemic anti-inflammatory therapies for at least 3 months before initial sample collection
- Relapse of malignancy
- Active infection in any part of the body