Condition category
Eye Diseases
Date applied
01/02/2007
Date assigned
01/02/2007
Last edited
06/02/2007
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr S Pourjavan

ORCID ID

Contact details

Department of Ophthalmology
Clinique Université St. Luc (UCL)
Ave. Hippocrate 10
Brussels
1100
Belgium
+32 (0)2 721 1952
sayehpourjavan@yahoo.com

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

Acronym

Study hypothesis

To study the physiological diurnal variability of the Ocular Pulse Amplitude (OPA) and its correlations with other biophysical parameters.

Ethics approval

Not provided at time of registration

Study design

Prospective randomised study

Primary study design

Interventional

Secondary study design

Single-centre

Trial setting

Not specified

Trial type

Screening

Patient information sheet

Condition

Intraocular measurements, no condition, healthy person

Intervention

A prospective study including fifty-two eyes of twenty-eight healthy subjects (15 female, 13 male) with GAT IntraOcular Pressure (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 0.4 mg/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 Dynamic Contour Tonometer (DCT) IOP measurements (results are digitally shown).

A ten-minute break was taken between GAT and DCT to minimise a tonographic effect. Only the DCT measurements with quality one and two were taken into account.

The Central Corneal Thickness (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.

Intervention type

Other

Phase

Not Specified

Drug names

Primary outcome measures

We found that the OPA remained constant during the usual outpatient office hours with a negligible inter-measurement variability.

Secondary outcome measures

OPA was significantly correlated with IOP values.

Overall trial start date

05/01/2006

Overall trial end date

09/01/2006

Reason abandoned

Eligibility

Participant inclusion criteria

Healthy participants with intraocular pressure lower than 22 mmHg measured by Goldmann Applanation Tonometry (GAT).

Participant type

Patient

Age group

Not Specified

Gender

Both

Target number of participants

28

Participant 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

Recruitment start date

05/01/2006

Recruitment end date

09/01/2006

Locations

Countries of recruitment

Netherlands

Trial participating centre

Department of Ophthalmology
Brussels
1100
Belgium

Sponsor information

Organisation

Clinique Université St. Luc (UCL) (Belgium)

Sponsor details

Department of Ophthalmology
Ave. Hippocrate 10
Brussels
1100
Belgium

Sponsor type

Hospital/treatment centre

Website

http://www.saintluc.be/

Funders

Funder type

Other

Funder name

Not provided at time of registration

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes