Comparing Diurnal Fluctuations in Intra Ocular Pressure Measured in Same Day Versus Different Days in Glaucoma Patients

NCT ID: NCT01709916

Last Updated: 2015-02-24

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 50 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2012-11-30
• Study Completion Date: 2014-09-30

Brief Summary

Glaucoma is one of the leading causes of blindness in the west. The disease caused by high intra ocular pressure (IOP) and characterized by damage to the optic nerve and gradual loss of visual field. Intra ocular pressure change during the day. To evaluate the efficiency of the therapy it is common to measure the intra ocular pressure at different times of the day. Most ophthalmologists admit the patient for one day at which intra ocular pressure is measured at different times. This method does not mimic the patient daily routine and may not reflect the true diurnal fluctuations.

For this reason some ophthalmologists measure the intra ocular pressure at different times and at different days. It is not known if both methods give similar diurnal curves.

Detailed Description

A study physician will install anesthetic eye drops and will color the eye drops film with fluorescein. Study physician will use tonometer to measure the intra ocular pressure in each eye. This is a standard procedure done in any ophthalmological examination. Each patient will undergo intraocular pressure examination at 8:00, 12:00 and 16:00.

In the first day intra ocular pressure will be measured at 8:00, 12:00 and 16:00, same day measurements. The day after intra ocular pressure will be measured at 8:00, two days after at 12:00 and three days after at 16:00. One month later the patient will undergo another serious of intra ocular pressure measurements.

In the first day intra ocular pressure will be measured at 8:00, 12:00 and 16:00, same day measurements. The day after intra ocular pressure will be measured at 8:00, two days after at 12:00 and three days after at 16:00.

The relationship between the two diurnal curves will be analyzed.

Conditions

Glaucoma

Study Design

• Observational Model Type: CASE_ONLY
• Study Time Perspective: PROSPECTIVE

Study Groups

Glaucoma patients

Glaucoma patients treated with eye drops to lower the IOP.

No interventions assigned to this group

Eligibility Criteria

Inclusion Criteria

• Glaucoma patient.
• Age 18-80 years
• Able to read and understand Hebrew, able to sign informed consent in Hebrew.

Exclusion Criteria

• Ophthalmic laser treatment or surgery 3 months prior to enrollment.
• Eye infection or inflammation.
• Corneal pathology altering IOP measurement.
• Patients not cooperating during IOP measurement.
• non compliant patients

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Carmel Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Orna Geyer

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Orna Geyer, MD

Role: PRINCIPAL_INVESTIGATOR

Carmel Medical Center

Locations

Carmel Medical Center

Haifa, , Israel

Countries

Israel

Other Identifiers

CMC-11-0037-CTIL

Identifier Type: -

Identifier Source: org_study_id