Comparing Diurnal Fluctuations in Intra Ocular Pressure M... | NCT01709916

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

NCT01709916

Sponsor

Carmel Medical Center

Status

Completed

Last Update Posted

Feb 24, 2015Estimated

Enrollment

50Estimated

Phase

Not provided

Conditions

Glaucoma

Interventions

Not provided

Countries

Israel

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Feb 2015

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Nov 2012

Primary Completion Date

Sep 2014Actual

Completion Date

Sep 2014Actual

First Submitted Date

Oct 17, 2012

First Submission Date that Met QC Criteria

Oct 17, 2012

First Posted Date

Oct 18, 2012Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Feb 23, 2015

Last Update Posted Date

Feb 24, 2015Estimated

Description Module

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.

The relationship between the two diurnal curves will be analyzed.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

50Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Glaucoma patients		Glaucoma patients treated with eye drops to lower the IOP.

Interventions

Not provided

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

80 Years

Standard Ages

AdultOlder Adult

Study Population

Glaucoma patients using eye drops to lower intra ocular pressure.

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Orna Geyer, MD	Carmel Medical Center	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Carmel Medical Center		Haifa		34362	Israel

Condition Browse Module

MeSH Terms

ID	Term
D005901	Glaucoma

Ancestor Terms

ID	Term
D009798	Ocular Hypertension
D005128	Eye Diseases

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Browse Branches

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