Pilot Study on Ambulatory Intraocular Pressure and Blood Pressure Monitoring in Glaucoma

NCT01912599 | Completed Results

• 1 other identifier: 12-2514
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

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 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.

Conditions

Normal-Tension Glaucoma

Keywords

Glaucoma; Intraocular Pressure; Blood Pressure

Outcome Measures

Primary Outcomes (5)

• Arterial Pressure

  The blood pressure value shown in the table is the mean of all measurements taken over the 24 hour period, so it is the average value.

  24 Hours

• Intraocular Pressure

  The IOP provided is the average of all 144 measurements taken during the 24 hour period.

  24 Hours

• Mean Perfusion Pressure

  The value shown in the table is the mean of all measurements taken over the 24 hour period, so it is the average value.

  24 Hours

• Diastolic Pressure

  The value shown in the table is the mean of all measurements taken over the 24 hour period, so it is the average value.

  24 Hours

• Systolic Pressure

  The value shown in the table is the mean of all measurements taken over the 24 hour period, so it is the average value.

  24 Hours

Study Arms (2)

Non-Glaucomatous

ACTIVE COMPARATOR

Patients with no history of glaucoma. Subjects will be fitted with Sensimed Triggerfish for 24 observation of IOP and with a blood pressure monitor for 24 hour observation of blood pressure trends.

Device: Sensimed Triggerfish; Device: Blood Pressure

Glaucoma

ACTIVE COMPARATOR

Patients that are currently being treated for moderate to severe normal-tension glaucoma. Subjects will be fitted with Sensimed Triggerfish for 24 observation of IOP and with a blood pressure monitor for 24 hour observation of blood pressure trends.

Device: Sensimed Triggerfish; Device: Blood Pressure

Interventions

Sensimed Triggerfish DEVICE

IOP will be measured with the Sensimed Triggerfish, which is a disposable silicone contact lens embedded with a wireless sensor. The sensing resistive gauge in the device is circular around the center of the lens and is placed over a circumference of 11.5 mm in diameter. This corresponds to the corneoscleral junction position, where maximum corneal deformation occurs as a result of changes in IOP. A soft patch containing the receiving antenna will be applied around the eye and transmits the information via wire to the recorder that the patient will wear around the waist. The patient can continue to wear spectacles during monitoring. The device records a total of 144 measurements over a 24-hour period.

Glaucoma; Non-Glaucomatous

Blood Pressure DEVICE

Patients in both groups will be fitted with a blood pressure cuff that will measure pressures for 24 hours.

Glaucoma; Non-Glaucomatous

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \) 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.
• \) 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

You may not qualify if:

• \) 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
• \) Control Patients

Sponsors & Collaborators

• University of North Carolina, Chapel Hill: lead
• Sensimed AG: collaborator

Study Sites (1)

UNC Kittner Eye Center

Chapel Hill, North Carolina, 27599-7040, United States

Location

MeSH Terms

Conditions

Low Tension Glaucoma; Glaucoma

Interventions

Blood Pressure

Condition Hierarchy (Ancestors)

Ocular Hypertension; Eye Diseases; Optic Nerve Diseases

Intervention Hierarchy (Ancestors)

Vital Signs; Physical Examination; Diagnostic Techniques and Procedures; Diagnosis; Hemodynamics; Cardiovascular Physiological Phenomena; Circulatory and Respiratory Physiological Phenomena

Limitations and Caveats

The limitation is that the contact lens expresses the IOP values in a unit that is not convertible to mmHg. Therefore, we do not know exactly what the cutoff of normal IOP with the lens is.

Results Point of Contact

• Title: Jean-Claude Mwanza, MD, MPH, PhD
• Organization: University of North Carolina

jean-claude_mwanza@med.unc.edu

919-843-4917

Study Officials

• Jean-Claude Mwanza, MD, PhD

  University of North Carolina, Chapel Hill

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 26, 2013
• First Posted: July 31, 2013
• Study Start: July 1, 2013
• Primary Completion: July 1, 2014
• Study Completion: July 1, 2014
• Last Updated: June 17, 2016
• Results First Posted: June 17, 2016

Record last verified: 2014-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)