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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified June 2011 by Aristotle University Of Thessaloniki.
Recruitment status was  Recruiting
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
  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:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

ClinicalTrials.gov processed this record on September 22, 2014