Central Corneal Thickness and 24-hour Fluctuation of Intraocular Pressure

Ocular Hypertension Clinical Trial

— CCT-IOP  

Official title:

Central Corneal Thickness and 24-hour Fluctuation of Intraocular Pressure

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00941525
• Other study ID #: 83155
• Secondary ID: EudraCT: 2008-00
• Status: Completed
• Phase: Phase 4
• First received: July 15, 2009
• Last updated: July 2, 2015
• Start date: September 2009
• Est. completion date: July 2014

Study information

• Verified date: July 2015
• Source: Aristotle University Of Thessaloniki
• Contact: n/a
• Is FDA regulated: No
• Health authority: Greece: National Organization of Medicines
• Study type: Interventional

Clinical Trial 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 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 174
• Est. completion date: July 2014
• Est. primary completion date: July 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 50 Years to 85 Years

Eligibility

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 Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Glaucoma, Open-Angle
• Ocular Hypertension
• Open Angle Glaucoma

Intervention

Drug:
• Latanoprost
1 eyedrop of latanoprost (0.005%) dosed once a day at 8:00pm for a 4-weeks period

Locations

Country	Name	City	State
Greece	A' Department of Ophthalmology, Aristotle University of Thessaloniki, AHEPA Hospital	Thessaloniki

Sponsors (1)

Lead Sponsor	Collaborator
Aristotle University Of Thessaloniki

Country where clinical trial is conducted

Greece, 

References & Publications (14)

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. — View Citation

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. Epub 2006 Mar 9. — View Citation

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. Epub 2006 Oct 27. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. Review. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

* Note: There are 14 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.		Before and after a 4-weeks period of treatment with latanoprost.	No
Secondary	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.		Before and after a 4-weeks period of treatment with latanoprost.	No