Comparison of dynamic contour tonometry with Goldmann applanation tonometry for measurement of IOP in patients following penetrating keratoplasty
| ISRCTN | ISRCTN47431897 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN47431897 |
| Secondary identifying numbers | N0231178202 |
- Submission date
- 29/09/2006
- Registration date
- 29/09/2006
- Last edited
- 03/06/2010
- 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
Mr Andre Ismail
Scientific
Scientific
Eye Unit
Southampton General Hospital
Tremona Road
Southampton
SO16 6YD
United Kingdom
| Phone | +44 (0)7880551176 |
|---|---|
| ari485-work@yahoo.co.uk |
Study information
| Study design | Randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Not specified |
| Study type | Not Specified |
| Scientific title | |
| Study objectives | To determine whether there is a 'significant difference' in the measurement of eye pressures in patients having had a penetrating keratoplasty (corneal transplant), by using two established methods of measurement - firstly 'dynamic contour tonometry' and secondly 'Goldmann applanation tonometry'? A 'significant difference' will be measured as greater than 2mm Hg pressure between the two methods. |
| Ethics approval(s) | Not provided at time of registration |
| Health condition(s) or problem(s) studied | Eye Diseases |
| Intervention | Patients who have undergone corneal transplant surgery will be contacted from a database of all patients who have undergone this surgery at Southampton Eye Unit. Patients will be asked to attend the eye clinic for one visit only. Assessments will be conducted by two of the investigators - A.Ismail (Specialist registrar Ophthalmology), and M.Lamont (Senior House Officer Ophthalmology). Each patient will have their intraocular pressure and corneal thickness measured. These measurements are routinely performed in the eye clinic and are not unduly intrusive or burdensome. In order to compare pressure measurements by DCT and GAT, the following is performed: 1) It is randomised whether DCT or GAT measurement occurs first. 2) It is also randomised which investigator will perform the measurement first. 3) Each investigator measures the patients intraocular pressure in the eye being studied alternately by GAT and DCT 3 times in succession. 4) The second investigator is blind to the readings, and performs the same measurements successively. 5) In total, the patient will have their eye pressure measured 12 times in succession. 6) The corneal thickness of the eye will be measured by ultrasound pachymetry. On average, measurement of the eye pressure by either of the methods takes roughly 5 seconds, and is completely painless. Disposable tonometer heads will be used for both instruments and between patients. There are no known complications for either technique for the patient, aside from possible inaccuracy of reading. The measurement of corneal thickness by ultrasound pachymetry is almost an identical procedure from the patients point of view. The ultrasound probe is sterilised between patients, as is normal clinical practice. Once again there are no known complications of this investigation to the patient. Once these readings have been taken, the patient is discharged from the eye clinic, back to their usual follow up. Informal discussions with patients that have been seen in the clinic with corneal transplants have shown a positive response to research in this area, and a willingness to participate in the small added length of time to their clinic visit. |
| Intervention type | Other |
| Primary outcome measure | The difference in intraocular pressure measurements between DCT and GAT for each patient. 2mm Hg will be seen as significant. |
| Secondary outcome measures | Not provided at time of registration |
| Overall study start date | 30/01/2006 |
| Completion date | 28/02/2006 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Not Specified |
| Sex | Not Specified |
| Target number of participants | 10 patients. No controls - comparative study. |
| Key inclusion criteria | Not provided at time of registration |
| Key exclusion criteria | Not provided at time of registration |
| Date of first enrolment | 30/01/2006 |
| Date of final enrolment | 28/02/2006 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
Eye Unit
Southampton
SO16 6YD
United Kingdom
SO16 6YD
United Kingdom
Sponsor information
Record Provided by the NHSTCT Register - 2006 Update - Department of Health
Government
Government
The Department of Health, Richmond House, 79 Whitehall
London
SW1A 2NL
United Kingdom
| Phone | +44 (0)20 7307 2622 |
|---|---|
| dhmail@doh.gsi.org.uk | |
| Website | http://www.dh.gov.uk/Home/fs/en |
Funders
Funder type
Government
Southampton University Hospitals NHS Trust (UK) NHS R&D Support Funding
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 | 01/07/2007 | Yes | No |
