Status:
COMPLETED
Pilot Study on Ambulatory Intraocular Pressure and Blood Pressure Monitoring in Glaucoma
Lead Sponsor:
University of North Carolina, Chapel Hill
Collaborating Sponsors:
Sensimed AG
Conditions:
Normal-Tension Glaucoma
Eligibility:
All Genders
18-80 years
Phase:
NA
Brief Summary
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 automati...
Detailed Description
Chart review will be performed to select potential glaucoma participants. These potential participants will be invited to participate in the study, either by phone or face-to-face during scheduled vis...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
July 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2014
Estimated Enrollment :
36 Patients enrolled
Trial Details
Trial ID
NCT01912599
Start Date
July 1 2013
End Date
July 1 2014
Last Update
June 17 2016
Active Locations (1)
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1
UNC Kittner Eye Center
Chapel Hill, North Carolina, United States, 27599-7040