Central Corneal Thickness and 24-hour Fluctuation of Intraocular Pressure
NCT ID: NCT00941525
Last Updated: 2015-07-07
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE4
174 participants
INTERVENTIONAL
2009-09-30
2014-07-31
Brief Summary
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Also, to evaluate whether 24-hour fluctuation of IOP is associated with corneal hysteresis (CH) measured by Ocular Response Analyzer (ORA).
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
BASIC_SCIENCE
NONE
Study Groups
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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.
Latanoprost
1 eyedrop of latanoprost (0.005%) dosed once a day at 8:00pm for a 4-weeks period
Interventions
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Latanoprost
1 eyedrop of latanoprost (0.005%) dosed once a day at 8:00pm for a 4-weeks period
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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)
50 Years
85 Years
ALL
Yes
Sponsors
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Aristotle University Of Thessaloniki
OTHER
Responsible Party
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Fotis Topouzis
Professior
Principal Investigators
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Fotis Topouzis, MD
Role: PRINCIPAL_INVESTIGATOR
Aristotle University Of Thessaloniki
Locations
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A' Department of Ophthalmology, Aristotle University of Thessaloniki, AHEPA Hospital
Thessaloniki, , Greece
Countries
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References
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Nouri-Mahdavi K, Hoffman D, Coleman AL, Liu G, Li G, Gaasterland D, Caprioli J; Advanced Glaucoma Intervention Study. Predictive factors for glaucomatous visual field progression in the Advanced Glaucoma Intervention Study. Ophthalmology. 2004 Sep;111(9):1627-35. doi: 10.1016/j.ophtha.2004.02.017.
Asrani S, Zeimer R, Wilensky J, Gieser D, Vitale S, Lindenmuth K. Large diurnal fluctuations in intraocular pressure are an independent risk factor in patients with glaucoma. J Glaucoma. 2000 Apr;9(2):134-42. doi: 10.1097/00061198-200004000-00002.
European Glaucoma Prevention Study (EGPS) Group; Miglior S, Pfeiffer N, Torri V, Zeyen T, Cunha-Vaz J, Adamsons I. Predictive factors for open-angle glaucoma among patients with ocular hypertension in the European Glaucoma Prevention Study. Ophthalmology. 2007 Jan;114(1):3-9. doi: 10.1016/j.ophtha.2006.05.075. Epub 2006 Oct 27.
Gordon MO, Beiser JA, Brandt JD, Heuer DK, Higginbotham EJ, Johnson CA, Keltner JL, Miller JP, Parrish RK 2nd, Wilson MR, Kass MA. The Ocular Hypertension Treatment Study: baseline factors that predict the onset of primary open-angle glaucoma. Arch Ophthalmol. 2002 Jun;120(6):714-20; discussion 829-30. doi: 10.1001/archopht.120.6.714.
Orzalesi N, Rossetti L, Invernizzi T, Bottoli A, Autelitano A. Effect of timolol, latanoprost, and dorzolamide on circadian IOP in glaucoma or ocular hypertension. Invest Ophthalmol Vis Sci. 2000 Aug;41(9):2566-73.
Larsson LI, Mishima HK, Takamatsu M, Orzalesi N, Rossetti L. The effect of latanoprost on circadian intraocular pressure. Surv Ophthalmol. 2002 Aug;47 Suppl 1:S90-6. doi: 10.1016/s0039-6257(02)00296-5.
Orzalesi N, Rossetti L, Bottoli A, Fumagalli E, Fogagnolo P. The effect of latanoprost, brimonidine, and a fixed combination of timolol and dorzolamide on circadian intraocular pressure in patients with glaucoma or ocular hypertension. Arch Ophthalmol. 2003 Apr;121(4):453-7. doi: 10.1001/archopht.121.4.453.
Liu JH, Kripke DF, Weinreb RN. Comparison of the nocturnal effects of once-daily timolol and latanoprost on intraocular pressure. Am J Ophthalmol. 2004 Sep;138(3):389-95. doi: 10.1016/j.ajo.2004.04.022.
Orzalesi N, Rossetti L, Bottoli A, Fogagnolo P. Comparison of the effects of latanoprost, travoprost, and bimatoprost on circadian intraocular pressure in patients with glaucoma or ocular hypertension. Ophthalmology. 2006 Feb;113(2):239-46. doi: 10.1016/j.ophtha.2005.10.045.
Luce DA. Determining in vivo biomechanical properties of the cornea with an ocular response analyzer. J Cataract Refract Surg. 2005 Jan;31(1):156-62. doi: 10.1016/j.jcrs.2004.10.044.
Congdon NG, Broman AT, Bandeen-Roche K, Grover D, Quigley HA. Central corneal thickness and corneal hysteresis associated with glaucoma damage. Am J Ophthalmol. 2006 May;141(5):868-75. doi: 10.1016/j.ajo.2005.12.007. Epub 2006 Mar 9.
Kotecha A, Elsheikh A, Roberts CR, Zhu H, Garway-Heath DF. Corneal thickness- and age-related biomechanical properties of the cornea measured with the ocular response analyzer. Invest Ophthalmol Vis Sci. 2006 Dec;47(12):5337-47. doi: 10.1167/iovs.06-0557.
Larsson LI. Intraocular pressure over 24 hours after repeated administration of latanoprost 0.005% or timolol gel-forming solution 0.5% in patients with ocular hypertension. Ophthalmology. 2001 Aug;108(8):1439-44. doi: 10.1016/s0161-6420(01)00605-4.
Kida T, Liu JH, Weinreb RN. Effect of 24-hour corneal biomechanical changes on intraocular pressure measurement. Invest Ophthalmol Vis Sci. 2006 Oct;47(10):4422-6. doi: 10.1167/iovs.06-0507.
Other Identifiers
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EudraCT: 2008-004629-41
Identifier Type: -
Identifier Source: secondary_id
83155
Identifier Type: -
Identifier Source: org_study_id
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