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

Glaucoma Clinical Trial

— IOP  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01709916
• Other study ID #: CMC-11-0037-CTIL
• Status: Completed
• Phase: N/A
• First received: October 17, 2012
• Last updated: February 23, 2015
• Start date: November 2012
• Est. completion date: September 2014

Study information

• Verified date: February 2015
• Source: Carmel Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: Israel: Clalit Health Services
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: September 2014
• Est. primary completion date: September 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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

Study Design

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

• Glaucoma

Locations

Country	Name	City	State
Israel	Carmel Medical Center	Haifa

Sponsors (1)

Lead Sponsor	Collaborator
Carmel Medical Center

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	IOP at different times of the day at same day versus different times and different days	measurements of intra ocular pressure at different times of the day at same day versus different times and different days.	5 weeks	No