Normal-Tension Glaucoma Clinical Trial
Official title:
Pilot Study on Ambulatory Intraocular Pressure and Blood Pressure Monitoring in Glaucoma
Purpose: To study the feasibility of a larger study by determining the tolerability of
measuring blood pressure (BP) and intraocular pressure (IOP) over 24 hours in an ambulatory
fashion with automatic devices.
Participants: 20 patients with moderate to severe normal tension glaucoma and 20
non-glaucomatous patients.
Procedures (methods): Both BP and IOP will be measured automatically in each participant in
an ambulatory fashion during a 24-hour period. BP will be monitored using an appropriately
sized cuff Oscar 2 (Suntech Medical, Morrisville, NC), which will be placed by a person
trained in ambulatory BP monitoring devices. The device will be set up to automatically
inflate every 30 minutes during the day and every hour during the night to measure and
record the BP. IOP will be measured using Sensimed Triggerfish contact lens (Sensimed AG,
Lausanne, Switzerland); the measurements will be taken and recorded every 10 minutes. The
contact lens will be inserted by eye doctors (investigators). Both monitoring devices will
be removed the following day.
| Status | Completed |
| Enrollment | 36 |
| Est. completion date | July 2014 |
| Est. primary completion date | July 2014 |
| Accepts healthy volunteers | Accepts Healthy Volunteers |
| Gender | Both |
| Age group | 18 Years to 80 Years |
| Eligibility |
Inclusion Criteria: - 1) Patients with normal tension glaucoma - Age minimum: 18 years - Willingness to participate in the study and to sign the informed consent form. - Willingness to complete a screening visit and a study visit, both at the UNC eye clinic. - Established diagnosis of untreated or medically treated normal tension glaucoma irrespective of blood pressure level. Those currently treated with topical drops will only be included in the study if they accept to stop their medication according to the following plan: 1) Those treated with Alphagan, Combigan or Cosopt (or Trusopt, Azopt, Diamox, Neptazane) will be asked to stop their medication for a week, do the study for 24 hours, and then resume with their medication. 2) Those treated with Timolol or Xalatan (or Travatan, Lumigan) will be asked to stop their drops for one month, do the study for 24 hours, and then resume the medication regimen. The reason for this is that the study aims at investigating the relationship between blood pressure and intraocular pressure in untreated patients either for glaucoma or high blood pressure. The difference in duration of time during which patients will be off their glaucoma medication depends on the time it takes to clear the drug in the system. In both cases, glaucoma medication will be stopped from the day following the screening visit. 2) Non-glaucomatous healthy controls - Age minimum: 18 years - Willingness to participate in the study and to sign a consent form - Willingness to complete a screening visit at UNC eye clinic - Normal eye examination Exclusion Criteria: - 1) Patients with normal tension glaucoma - Age less than 18 years or greater than 80 years. - Patients with high intraocular pressure (> 21 mmHg). - Patients who have had any type of glaucoma surgery in the past. - Non-glaucomatous optic neuropathy. - Intraocular surgery within the last 3 months. - Patients with uveitis - Ocular abnormalities preventing measurement of intraocular pressure by applanation - Patients on medication to treat high blood pressure will not be included in the study. - Patients with hyperthyroidism - Patients on medication that may raise blood pressure: i.e. systemic or topical steroids taken for 3 or more years for other chronic conditions; cholesterol lowering medications, specifically cholestyramine (Prevalite or Questran) or colestipol (Colestid); oral contraceptives that contain higher concentrations of estrogen, specifically: Ovral, Ogestrel, Demulen, Ovon, and Ortho-Novum; and the antidepressants trimipramine (Surmontil) and venlafaxine (Effexor). - Patients on estrogen taken for menopause because it may lower blood pressure - Patients not willing to stop their glaucoma medication temporarily - Patients with dry eye disease 2) Control Patients - Age less than 18 years or greater than 80 years. - Patients with high intraocular pressure (> 21 mmHg). - Patients who have had any type of glaucoma surgery in the past. - Non-glaucomatous optic neuropathy. - Intraocular surgery within the last 3 months. - Patients with uveitis - Ocular abnormalities preventing measurement of intraocular pressure by applanation - Patients on medication to treat high blood pressure will not be included in the study. - Patients with hyperthyroidism - Patients on medication that may raise blood pressure: i.e. systemic or topical steroids taken for 3 or more years for other chronic conditions; cholesterol lowering medications, specifically cholestyramine (Prevalite or Questran) or colestipol (Colestid); oral contraceptives that contain higher concentrations of estrogen, specifically: Ovral, Ogestrel, Demulen, Ovon, and Ortho-Novum; and the antidepressants trimipramine (Surmontil) and venlafaxine (Effexor). - Patients on estrogen taken for menopause because it may lower blood pressure - Patients with dry eye disease |
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Diagnostic
| Country | Name | City | State |
|---|---|---|---|
| United States | UNC Kittner Eye Center | Chapel Hill | North Carolina |
| Lead Sponsor | Collaborator |
|---|---|
| University of North Carolina, Chapel Hill | Sensimed AG |
United States,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Blood Pressure Trends | Subjects will be fitted with a blood pressure cuff, and blood pressure trends will be measured over a 24 hour period. | 24 Hours | No |
| Primary | Intraocular Pressure | Subjects will be a fitted with a Sensimed Triggerfish contact lens, and their intraocular pressure will be measured 144 times over a 24 hour period. | 24 Hours | No |