Selective Laser Trabeculoplasty and its effect on fluid flow out of the eyes
| ISRCTN | ISRCTN65144700 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN65144700 |
| Secondary identifying numbers | PROTOCOL 1 |
- Submission date
- 23/03/2008
- Registration date
- 25/04/2008
- Last edited
- 05/04/2012
- 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 Kin Sheng Lim
Scientific
Scientific
Department of Ophthalmology
St Thomas' Hospital
Westminster Bridge Road
London
SE1 7EH
United Kingdom
Study information
| Study design | Randomised prospective non-controlled two armed trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient information sheet |
| Scientific title | A randomised study of different levels of total energy delivered in Selective Laser Trabeculoplasty |
| Study acronym | SLTLIM |
| Study objectives | Different levels of total energy delivered in selective laser trabeculoplasty (SLT) will have different effects on outflow facility and intra-ocular pressure. |
| Ethics approval(s) | Ethics approval received from the St Thomas' Hospital Local Ethics Committee in September 2005 (ref: 05/Q0702/42). |
| Health condition(s) or problem(s) studied | Ocular hypertension (OHT) and primary open-angle glaucoma (POAG) |
| Intervention | Participants will be randomised to one of two different levels of total energy: 1. Treated with a lower total energy to the drainage angle 2. Treated with a higher energy level (of approximately double of the total energy as the first group) There will only be one treatment given to each patient. Follow-up will be for three months. |
| Intervention type | Other |
| Primary outcome measure | 1. Intra-ocular pressure: measured with a Goldmann's applanation tonometer, using a topical anaesthetic, and fluorescein as the disclosing agent. The right eye will be measured first, followed by measurement of the left. This sequence will be repeated three times. The three measurements for each eye will be averaged and reported as intra-ocular pressure. 2. Outflow facility: measured from the rate of decay of intra-ocular pressure in the supine position during application of a recording Schiötz or pneumotonometer over a period of 4 minutes. The "R" values of the curve at every 30-second time point will be manually entered into the McLaren tonography computer program. The program fits a second-degree polynomial by least squares to the nine data points and determines the best-fit values for time 0 and time 4 minutes by extrapolation. These initial and final values of the tonometer scale reading will be used to look up the value for the facility of outflow using the 1955 scale approved by the Committee on Standardisation of Tonometers. Outcomes will be measured at baseline, one month and three months. |
| Secondary outcome measures | Complications, measured at baseline, one month and three months. |
| Overall study start date | 01/11/2006 |
| Completion date | 01/06/2008 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Both |
| Target number of participants | 46 |
| Key inclusion criteria | 1. Participants aged 21 - 85 years, male and female 2. Newly diagnosed ocular hypertension and primary open-angle glaucoma that require treatment |
| Key exclusion criteria | 1. Previous intraocular surgery 2. Advanced glaucoma 3. Very high presenting intra-ocular pressure (greater than 35 mmHg) |
| Date of first enrolment | 01/11/2006 |
| Date of final enrolment | 01/06/2008 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
Department of Ophthalmology
London
SE1 7EH
United Kingdom
SE1 7EH
United Kingdom
Sponsor information
Guys and St Thomas NHS Foundation Trust (UK)
Hospital/treatment centre
Hospital/treatment centre
c/o Jackie Pullen
Clinical Quality Manager
The Joint Clinical Trials Office
3rd Floor Conybeare House
Guy's Hospital
Great Maze Pond
London
SE1 9RT
England
United Kingdom
| Website | http://www.guysandstthomas.nhs.uk/ |
|---|---|
"ROR" |
https://ror.org/00j161312 |
Funders
Funder type
Charity
Eye Hope (UK)
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 | 01/11/2010 | Yes | No |
