Status:
COMPLETED
Central Corneal Thickness and 24-hour Fluctuation of Intraocular Pressure
Lead Sponsor:
Aristotle University Of Thessaloniki
Conditions:
Open Angle Glaucoma
Ocular Hypertension
Eligibility:
All Genders
50-85 years
Phase:
PHASE4
Brief Summary
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 angl...
Eligibility Criteria
Inclusion
- 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
- 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)
Key Trial Info
Start Date :
September 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2014
Estimated Enrollment :
174 Patients enrolled
Trial Details
Trial ID
NCT00941525
Start Date
September 1 2009
End Date
July 1 2014
Last Update
July 7 2015
Active Locations (1)
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1
A' Department of Ophthalmology, Aristotle University of Thessaloniki, AHEPA Hospital
Thessaloniki, Greece, 54636