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

This study is currently recruiting participants.
Verified June 2011 by Aristotle University Of Thessaloniki
Sponsor:
Information provided by:
Aristotle University Of Thessaloniki
ClinicalTrials.gov Identifier:
NCT00941525
First received: July 15, 2009
Last updated: June 24, 2011
Last verified: June 2011
History of Changes
  Purpose

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).


Condition Intervention Phase
Open Angle Glaucoma
Ocular Hypertension
 Drug: Latanoprost
 Phase 4

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Basic Science
Official Title: Central Corneal Thickness and 24-hour Fluctuation of Intraocular Pressure

Resource links provided by NLM:

Drug Information available for: Latanoprost
U.S. FDA Resources

Further study details as provided by Aristotle University Of Thessaloniki:

Primary Outcome Measures:
  • 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. ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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. ] [ Designated as safety issue: No ]

Estimated Enrollment: 200
Study Start Date: September 2009
Estimated Study Completion Date: April 2012
Estimated Primary Completion Date: April 2012 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: Latanoprost
    1 eyedrop of latanoprost (0.005%) dosed once a day at 8:00pm for a 4-weeks period
    Other Name: 0.005% Xalatan
  Eligibility

Ages Eligible for Study:   50 Years to 85 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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)
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00941525

Contacts
Contact: Fotis Topouzis, MD +302310994920 ftopouzis@otenet.gr

Locations
Greece
A' Department of Ophthalmology, Aristotle University of Thessaloniki, AHEPA Hospital Recruiting
Thessaloniki, Greece, 54636
Contact: Fotis Topouzis, MD     +302310994920     ftopouzis@otenet.gr    
Principal Investigator: Fotis Topouzis, MD            
Sponsors and Collaborators
Aristotle University Of Thessaloniki
Investigators
Principal Investigator: Fotis Topouzis, MD Aristotle University Of Thessaloniki
  More Information

Publications:

Responsible Party: Fotis Topouzis, Assistant Professor of Ophthalmology, Aristotle University of Thessaloniki
ClinicalTrials.gov Identifier: NCT00941525     History of Changes
Other Study ID Numbers: 83155, EudraCT: 2008-004629-41
Study First Received: July 15, 2009
Last Updated: June 24, 2011
Health Authority: Greece: National Organization of Medicines

Keywords provided by Aristotle University Of Thessaloniki:
Central corneal thickness
24hour fluctuation of intraocular pressure
Open angle glaucoma
Ocular hypertension

Additional relevant MeSH terms:
Glaucoma
Glaucoma, Open-Angle
Hypertension
Ocular Hypertension
Eye Diseases
Vascular Diseases
 Cardiovascular Diseases
Latanoprost
Antihypertensive Agents
Cardiovascular Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 16, 2013