Central Corneal Thickness and 24-hour Fluctuation of Intraocular Pressure

Aristotle University Of Thessaloniki174 enrolled

Overview

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).

Study Type

INTERVENTIONAL

Allocation

Purpose

BASIC_SCIENCE

Masking

NONE

Enrollment

174

Conditions

Open Angle Glaucoma Ocular Hypertension

Interventions

Eligibility

Sex: ALLMin age: 50 YearsMax age: 85 YearsHealthy volunteers:

Medical Language ↔ Plain English

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)

Outcomes

Primary Outcomes

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.

Secondary Outcomes

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.