Central Corneal Thickness and 24-hour Fluctuation of Intraocular Pressure (CCT-IOP)

July 2, 2015 updated by: Fotis Topouzis, Aristotle University Of Thessaloniki

The purpose of this study is to determine whether 24-hour fluctuation of intraocular pressure (IOP) is associated with central corneal thickness (CCT) in subjects with ocular hypertension or open angle glaucoma and in age-matched controls. Also to evaluate whether mean IOP reduction as a response to latanoprost (0.005% Xalatan) is associated with CCT, after a 4-weeks period of treatment.

Also, to evaluate whether 24-hour fluctuation of IOP is associated with corneal hysteresis (CH) measured by Ocular Response Analyzer (ORA).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

174

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Greece
      • Thessaloniki, Greece, 54636
        • A' Department of Ophthalmology, Aristotle University of Thessaloniki, AHEPA Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

50 years to 85 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

Males and females >50 years old with:

  • Primary Open-Angle Glaucoma newly diagnosed or with anti-glaucoma medical treatment < =12 weeks
  • Pseudoexfoliative Glaucoma newly diagnosed or with anti-glaucoma medical treatment <= 12 weeks
  • Ocular Hypertensives newly diagnosed or with anti-glaucoma medical treatment <= 12 weeks
  • Age-matched controls
  • IOP>=22mmHg at the eligibility visit for glaucoma patients and ocular hypertensives

Exclusion Criteria:

For Eye

  • Use of any ophthalmic medication (drops) during the study (except for natural tears)
  • Inflammation of any aetiology
  • Previous eye surgery or laser
  • Corneal abnormalities (oedema, dystrophies etc) For Subjects
  • Systemic diseases which affect the cornea (such as autoimmune diseases)
  • Inability to participate due to advanced age or serious illness
  • Mean IOP>36mmHg in either eye at the eligibility visit.
  • Subjects who cannot safety discontinue use of all IOP-lowering medication(s) for washout
  • Subjects with severe central visual field loss in either eye. Severe central visual field loss is defined as sensitivity <=10dB in at least 2 of the 4 visual field test points closest to the point of fixation
  • Other types of glaucoma (such as angle-closure glaucoma and secondary glaucomas)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Ocular hypertensives

This study includes two groups.

  1. Subjects with ocular hypertension and
  2. Controls. Group 2 undergoes only 1 visit (visit 1) without any intervention. Group 1 undergoes visit 1 without intervention. Then they receive treatment (1 eyedrop of latanoprost (0.005%) dosed once a day in both eyes at 8:00pm for a 4-weeks period for 1 month) and undergo the visit 2 under the effect of treatment.
Drug: Latanoprost
1 eyedrop of latanoprost (0.005%) dosed once a day at 8:00pm for a 4-weeks period
Other Names:
  • 0.005% Xalatan

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Correlation analyses between mean central corneal thickness (CCT) and 24-hour intraocular pressure (IOP) fluctuation and between mean CCT and mean IOP reduction from baseline after a 4-weeks period of treatment with latanoprost.
Time Frame: Before and after a 4-weeks period of treatment with latanoprost.
Before and after a 4-weeks period of treatment with latanoprost.

Secondary Outcome Measures

Outcome Measure
Time Frame
Correlation analyses between corneal hysteresis (CH) and 24-hour intraocular pressure (IOP) fluctuation and between CH and mean IOP reduction from baseline after a 4-weeks period of treatment with latanoprost.
Time Frame: Before and after a 4-weeks period of treatment with latanoprost.
Before and after a 4-weeks period of treatment with latanoprost.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Aristotle University Of Thessaloniki

Investigators

  • Principal Investigator: Fotis Topouzis, MD, Aristotle University Of Thessaloniki

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2009

Primary Completion (Actual)

July 1, 2014

Study Completion (Actual)

July 1, 2014

Study Registration Dates

First Submitted

July 15, 2009

First Submitted That Met QC Criteria

July 15, 2009

First Posted (Estimate)

July 17, 2009

Study Record Updates

Last Update Posted (Estimate)

July 7, 2015

Last Update Submitted That Met QC Criteria

July 2, 2015

Last Verified

July 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 83155
  • EudraCT: 2008-004629-41

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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