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Completed

NCT Number: NCT01491867

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

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.

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Key information

Conditions

Glaucoma Eye Diseases Ocular Hypertension

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Departement of Ophthalmology, Budapest, Pest County, Hungary

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About this study

  • 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

Who can participate

Healthy volunteers accepted: No

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

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

Treatment and study plan

travoprost 0.003%

Drug

Instillation of travoprost 0.003% 1/die in both eyes for 3 months

Primary outcomes

  1. Continuous intraocular pressure (IOP) measurement

    Time frame: 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 outcomes

  1. Continuous intraocula pressure (IOP) Measurement

    Time frame: 3 months

    Reproducibility of intraocular pressure measurements with the Sensimed contact lens sensor methods

Sponsors and collaborators

Lead sponsor

Semmelweis University

Other

Registry information

Official study title

Evaluation of Continuous IOP Measurement and the Influence of Drug Induced IOP Decrease on the Measurement

Important dates

Study start
2011
Primary completion
2012
Study completion
2012
First posted
Dec 14, 2011
Registry last updated
Mar 22, 2013

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

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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.

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