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Main
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Note: This record shows only the 20 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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Netherlands Trial Register |
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Last refreshed on:
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28 April 2013 |
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Main ID: |
NTR866 |
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Date of registration:
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09/01/2007 |
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Primary sponsor: |
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Public title:
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Physiological diurnal variability and characteristics of the ocular pulse amplitude (OPA) with the dynamic contour tonometer (DCT- PASCAL®).
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Scientific title:
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Physiological diurnal variability and characteristics of the ocular pulse amplitude (OPA) with the dynamic contour tonometer (DCT- PASCAL®).
- Intraocular pressure, dynamic contour tonometry, ocular pulse amplitude. |
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Date of first enrolment:
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5/1/2006 |
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Target sample size:
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28 |
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Recruitment status: |
complete |
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URL:
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http://www.trialregister.nl/trialreg/admin/rctview.asp?TC=866 |
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Study type:
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intervention |
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Study design:
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Randomised: No; Masking: None; Control: Not applicable; Group: [default]; Type: [default]
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Countries of recruitment
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The Netherlands
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Contacts
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Name:
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S.
Pourjavan |
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Address:
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Department of Ophthalmology
Clinique université St. Luc, UCL
Ave. Hippocrate 10
1100
Brussels
Belgium |
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Telephone:
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0032.2.7211952 |
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Email:
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sayehpourjavan@yahoo.com |
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Affiliation:
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Name:
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S.
Pourjavan |
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Address:
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Department of Ophthalmology
Clinique université St. Luc, UCL
Ave. Hippocrate 10
1100
Brussels
Belgium |
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Telephone:
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0032.2.7211952 |
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Email:
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sayehpourjavan@yahoo.com |
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Affiliation:
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Key inclusion & exclusion criteria
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Inclusion criteria: Healthy participant with intraocular pressure lower than 22 mmHg measured by Goldmann applanation tonometry.
Exclusion criteria: 1. History of previous ocular trauma, refractive or intraocular surgery and corneal surface diseases as well as contact lens wearers;
2. Corneal astigmatism higher than 3.00 diopters and/or ametropia higher than 6.00 diopters;
3. Use of systemic medications which could interfere with blood pressure or pulse rate.
Age minimum:
Age maximum:
Gender:
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Health Condition(s) or Problem(s) studied
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No condition, healthy person, Intraocular measurements
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Intervention(s)
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A prospective study including fifty two eyes of twenty eight healthy subjects (15 female, 13 male) with GAT IOP measurements lower than 22 mmHg. The oral consent was obtained from each patient. The IOP measurements by dynamic contour tonometer (SMT Swiss Microtechnology, Switzerland) were performed under topical anaesthesia (oxybuprocaine hydrochloride 0.4mg/ml, Thea Pharma).
The same experienced ophthalmologist performed all the examinations in a non masked fashion. The measurements were taken on the same day at 9:00 am, 1:00 pm and 4:00 pm. To reduce biases due to prior knowledge of the IOP, the examinations were performed as per this following pattern: two consecutive GAT followed by three consecutive DCT IOP measurements(Results are digitaly shown).
A 10 minute break was taken between GAT and DCT to minimize a tonographic effect. Only the DCT measurements with quality 1 and 2 were taken into account.
The CCT, the blood pressure (BP) and pulse rate were recorded at 4:00 pm after the last IOP measurements with Tensoval® blood pressure meter (Hartmann AG, Heidenheim, Germany).
The CCT was measured by ultrasound pachymetry Pachette?(DGH 500 Technology, Inc, Philadelphia, PA).
The mean of five readings was considered for the measurement of CCT.
Mean IOP and OPA values were calculated for each time session.
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Primary Outcome(s)
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We found that the OPA remained constant during the usual outpatient office hours with a negligible inter-measurement variability.
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Secondary Outcome(s)
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OPA was significantly correlated with IOP values.
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Secondary ID(s)
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ISRCTN25577616
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N/O
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Source(s) of Monetary Support
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