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

Semmelweis University

Status: Completed

Conditions: Glaucoma; Ocular Hypertension

Treatments: Drug: travoprost 0.003%

Study type: Interventional

Funder types: Other

Identifiers

NCT01491867

4481/2011

Details and patient eligibility

About

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.

Full 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

Enrollment: 9 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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9 participants in 1 patient group

Travoprost arm

Experimental group

Description:

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

Treatment:

Drug: travoprost 0.003%