Central Corneal Thickness and 24-hour Fluctuation of Intraocular Pressure

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00941525

Acronym

CCT-IOP

Enrollment

174

Registered

2009-07-17

Start date

2009-09-30

Completion date

2014-07-31

Last updated

2015-07-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Ocular Hypertension, Open Angle Glaucoma

Keywords

Central corneal thickness, 24hour fluctuation of intraocular pressure, Open angle glaucoma, Ocular hypertension

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).

Interventions

DRUGLatanoprost

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

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

BASIC_SCIENCE

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

50 Years to 85 Years

Healthy volunteers

Yes

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)

Design outcomes

Primary

Measure	Time frame
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

Measure	Time frame
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.

Countries

Greece

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026