Central Corneal Thickness and 24-hour Fluctuation of Intraocular Pressure

Phase 4

Completed

• Conditions: Open Angle Glaucoma; Ocular Hypertension
• Interventions: Drug: Latanoprost

• Registration Number: NCT00941525
• Lead Sponsor: Aristotle University Of Thessaloniki

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 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).

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2009-07-15
• Study First Submitted QC: 2009-07-15
• Study First Posted: 2009-07-17
• Study Start: 2009-09
• Primary Completion: 2014-07
• Study Completion: 2014-07
• Status Verified: 2015-07
• Last Update Submitted: 2015-07-02
• Last Update Posted: 2015-07-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 174

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

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Ocular hypertensives	Latanoprost	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.

Primary Outcome Measures

Name	Time	Method
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.

Secondary Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (1)

A' Department of Ophthalmology, Aristotle University of Thessaloniki, AHEPA Hospital; 🇬🇷 Thessaloniki, Greece