None listed
Conditions
Brief summary
The purpose of this study is to evaluate dry eye symptoms and signs in patients having laser in situ keratomileusis (LASIK) randomized to receive either stimulation therapy or unpreserved artificial tears pre- and post-LASIK.
Interventions
Arm 1 – Neurostimulation device (EMS 2000) - Lacrimal gland neurostimulation is self-administered nasally during waking hours. The current provided is approximately 1 milliamp with the patient controlling the amplitude with a knob. The recommended duration of treatment is approximately 30 seconds and the recommended treatment frequency is every two to four hours. The duration of the intervention period is three months. The allocated treatment will commence two days prior to LASIK and continu
Arm 1 – Neurostimulation device (EMS 2000) - Lacrimal gland neurostimulation is self-administered nasally during waking hours. The current provided is approximately 1 milliamp with the patient controlling the amplitude with a knob. The recommended duration of treatment is approximately 30 seconds and the recommended treatment frequency is every two to four hours. The duration of the intervention period is three months. The allocated treatment will commence two days prior to LASIK and continue post-LASIK. Adherence to the intervention will be monitored by questioning of participants by study staff with responses recorded on case report forms. Arm 2 – One drop of unpreserved artificial tears per eye to be self-administered during waking hours every two to four hours or as needed for a period of three months. The allocated treatment will commence two days prior to LASIK and continue post-LASIK. Patient reports of their use of artificial tears are recorded on case report forms to monitor adherence to the intervention.
Sponsors
Oculeve, Inc.
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
21 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Patients meeting all criteria for appropriateness of LASIK surgery instituted by the treating centre with an established date for bilateral primary LASIK surgery Willing to sign the informed consent and deemed capable of complying with the requirements of the study protocol Normal lid anatomy, blinking function and closure Corrected visual acuity of 20/25 (Snellen equivalent) or better in each eye
Exclusion criteria
Cardiac demand pacemaker, implanted defibrillator, or other active implanted metallic or electronic device Diagnosed epilepsy with seizures within the past five years Coagulation disorders such as haemophilia and thrombocytopenia Active or uncontrolled severe systemic allergy, chronic seasonal allergies, rhinitis or sinusitis requiring treatment or active/untreated nasal infection at the time of the baseline examination Punctal plugs Contact lens wear during the study Lacrimal, nasal or sinus neoplasia, significant trauma, or invasive surgery Chronic or recurrent epistaxis, history of cocaine abuse, or Wegener’s granulomatosis Participation in any clinical trial with a new active substance or a new device during the past three months Women who are pregnant, planning a pregnancy or nursing at study entry
Outcome results
None listed