Physiological diurnal variability and characteristics of the ocular pulse amplitude with the dynamic contour tonometer
| ISRCTN | ISRCTN25577616 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN25577616 |
| Secondary identifying numbers | NL852, NTR866 |
- Submission date
- 01/02/2007
- Registration date
- 01/02/2007
- Last edited
- 15/01/2021
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Eye Diseases
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Dr S Pourjavan
Scientific
Scientific
Department of Ophthalmology
Clinique Université St. Luc (UCL)
Ave. Hippocrate 10
Brussels
1100
Belgium
| Phone | +32 (0)2 721 1952 |
|---|---|
| sayehpourjavan@yahoo.com |
Study information
| Study design | Prospective randomised study |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Single-centre |
| Study setting(s) | Not specified |
| Study type | Screening |
| Scientific title | Physiological diurnal variability and characteristics of the ocular pulse amplitude with the dynamic contour tonometer |
| Study objectives | To study the physiological diurnal variability of the Ocular Pulse Amplitude (OPA) and its correlations with other biophysical parameters. |
| Ethics approval(s) | Not provided at time of registration |
| Health condition(s) or problem(s) studied | 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 |
| Primary outcome measure | 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 study start date | 05/01/2006 |
| Completion date | 09/01/2006 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Not Specified |
| Sex | Both |
| Target number of participants | 28 |
| Total final enrolment | 28 |
| Key inclusion criteria | Healthy participants with intraocular pressure lower than 22 mmHg measured by Goldmann Applanation Tonometry (GAT). |
| Key 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 |
| Date of first enrolment | 05/01/2006 |
| Date of final enrolment | 09/01/2006 |
Locations
Countries of recruitment
- Belgium
- Netherlands
Study participating centre
Department of Ophthalmology
Brussels
1100
Belgium
1100
Belgium
Sponsor information
Clinique Université St. Luc (UCL) (Belgium)
Hospital/treatment centre
Hospital/treatment centre
Department of Ophthalmology
Ave. Hippocrate 10
Brussels
1100
Belgium
| Website | http://www.saintluc.be/ |
|---|---|
"ROR" |
https://ror.org/03s4khd80 |
Funders
Funder type
Other
Not provided at time of registration
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 01/12/2007 | 15/01/2021 | Yes | No |
Editorial Notes
15/01/2021: The following changes have been made:
1. Publication reference added.
2. The final enrolment number has been added from the reference.
3. The NTR numbers have been added.
