Central Corneal Thickness and 24-hour Fluctuation of Intraocular Pressure

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).

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Key information

Conditions

Open Angle Glaucoma Eye Diseases Glaucoma Glaucoma, Open-Angle Ocular Hypertension

Age range

50 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

A' Department of Ophthalmology, Aristotle University of Thessaloniki, AHEPA Hospital

Thessaloniki, 54636, Greece

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

latanoprost

Drug

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

Other names: 0.005% Xalatan

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.

Time frame: Before and after a 4-weeks period of treatment with latanoprost.

Sponsors and collaborators

Lead sponsor

Aristotle University Of Thessaloniki

Other

Registry information

Acronym: CCT-IOP

Important dates

Study start: 2009
Primary completion: 2014
Study completion: 2014
First posted: Jul 17, 2009
Registry last updated: Jul 7, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed