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

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ClinicalTrials.gov Identifier: NCT01709916
Recruitment Status : Completed
First Posted : October 18, 2012
Last Update Posted : February 24, 2015
Sponsor:
Information provided by (Responsible Party):
Orna Geyer, Carmel Medical Center

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.


Condition or disease
Glaucoma

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.


Study Type : Observational
Estimated Enrollment : 50 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Comparing Diurnal Fluctuations in Intra Ocular Pressure Measured in Same Day Versus Different Days in Glaucoma Patients
Study Start Date : November 2012
Actual Primary Completion Date : September 2014
Actual Study Completion Date : September 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Glaucoma

Group/Cohort
Glaucoma patients
Glaucoma patients treated with eye drops to lower the IOP.



Primary Outcome Measures :
  1. IOP at different times of the day at same day versus different times and different days [ Time Frame: 5 weeks ]
    measurements of intra ocular pressure at different times of the day at same day versus different times and different days.



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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Glaucoma patients using eye drops to lower intra ocular pressure.
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01709916


Locations
Israel
Carmel Medical Center
Haifa, Israel, 34362
Sponsors and Collaborators
Carmel Medical Center
Investigators
Principal Investigator: Orna Geyer, MD Carmel Medical Center

Responsible Party: Orna Geyer, Professor, Carmel Medical Center
ClinicalTrials.gov Identifier: NCT01709916     History of Changes
Other Study ID Numbers: CMC-11-0037-CTIL
First Posted: October 18, 2012    Key Record Dates
Last Update Posted: February 24, 2015
Last Verified: February 2015

Keywords provided by Orna Geyer, Carmel Medical Center:
Glaucoma
intra ocular pressure
diurnal fluctuations

Additional relevant MeSH terms:
Glaucoma
Ocular Hypertension
Eye Diseases