Continuous Intraocular Pressure (IOP) Measurement and Ability to Detect Treatment Effect

Not Applicable

Completed

• Conditions: Glaucoma; Ocular Hypertension
• Interventions: Drug: travoprost 0.003%

• Registration Number: NCT01491867
• Lead Sponsor: Semmelweis University

Brief Summary

Continuous intraocular pressure (IOP) measurement with a contact lens sensor may provide more information on the drug-related IOP change than 24-hour IOP measurement with Goldmann applanation tonometry (GAT.

Detailed Description

* Participants are washed ot from all glaucoma medication for 6 weeks

* one eye per participant is investigated (study eye)

* 24-h intraocular pressure (IOP) curve is obtained with Goldmann tonometry and Sensimed contact lens sensor tonometry twice, in 14 days

* for Sensimed contact lens curves median values (in arbitrary units), for Goldmann applanation tonometry, mean and SD values are used to characterize the curves, for comparisions % changes are used for the corresponding time periods

* treatment (travoprost 0.005% 1/day) is given to all eyes for 3 months 24-h Goldmann and Sensimed IOP curves are repeated

* IOP curves are determined in arbitrary units and mmHg, respectively, and compared for reproducibility (untreated phase) and relative (%)change (untreated curve vs. under treatment curve) with both methods, respectively

Study Timeline

• Study Start: 2011-12
• Study First Submitted: 2011-12-12
• Study First Submitted QC: 2011-12-13
• Study First Posted: 2011-12-14
• Primary Completion: 2012-10
• Study Completion: 2012-10
• Status Verified: 2013-03
• Last Update Submitted: 2013-03-20
• Last Update Posted: 2013-03-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 9

Inclusion Criteria

• primary open-angle glaucoma (POAG), ocular hypertension(OHT)
• 18 years or older
• C/D <= 0.7
• no risk for visual field damage
• IOP > 22 mmHg

Exclusion Criteria

• Pregnancy and lactation
• Known intolerance to travoprost, topical anesthetic
• Previous ocular surgery at any time
• Previous ocular laser treatment within 1 year

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Travoprost arm	travoprost 0.003%	All individuals receive travoprost 0.003% 1/day in both eyes after 6 weeks wash-out for 3 months

Primary Outcome Measures

Name	Time	Method
Continuous intraocular pressure (IOP) measurement	3 months	24-h intraocular pressure (IOP) decrease induced by travoprost 0.003% 1/day as measured with Goldmann tonometry and Sensimed contact lens sensor

Secondary Outcome Measures

Name	Time	Method
Continuous intraocula pressure (IOP) Measurement	3 months	Reproducibility of intraocular pressure measurements with the Sensimed contact lens sensor methods

Trial Locations

Locations (2)

Departement of Ophthalmology; 🇭🇺 Budapest, Pest, Hungary

Semmelweis University; 🇭🇺 Budapest, Hungary