|
ISRCTN
|
ISRCTN65144700
|
|
ClinicalTrials.gov identifier
|
|
|
Public title
|
Selective Laser Trabeculoplasty and its effect on fluid flow out of the eyes
|
|
Scientific title
|
A randomised study of different levels of total energy delivered in Selective Laser Trabeculoplasty
|
|
Acronym
|
SLTLIM
|
|
Serial number at source
|
PROTOCOL 1
|
|
Study hypothesis
|
Different levels of total energy delivered in selective laser trabeculoplasty (SLT) will have different effects on outflow facility and intra-ocular pressure.
|
|
Ethics approval
|
Ethics approval received from the St Thomas' Hospital Local Ethics Committee in September 2005 (ref: 05/Q0702/42).
|
|
Study design
|
Randomised prospective non-controlled two armed trial
|
|
Countries of recruitment
|
United Kingdom
|
|
Disease/condition/study domain
|
Ocular hypertension (OHT) and primary open-angle glaucoma (POAG)
|
|
Participants - inclusion criteria
|
1. Participants aged 21 - 85 years, male and female
2. Newly diagnosed ocular hypertension and primary open-angle glaucoma that require treatment
|
|
Participants - exclusion criteria
|
1. Previous intraocular surgery
2. Advanced glaucoma
3. Very high presenting intra-ocular pressure (greater than 35 mmHg)
|
|
Anticipated start date
|
01/11/2006
|
|
Anticipated end date
|
01/06/2008
|
|
Status of trial
|
Completed
|
|
Patient information material
|
|
|
Target number of participants
|
46
|
|
Interventions
|
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.
|
|
Primary outcome measure(s)
|
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 measure(s)
|
Complications, measured at baseline, one month and three months.
|
|
Sources of funding
|
Eye Hope (UK)
|
|
Trial website
|
|
|
Publications
|
|
|
Contact name
|
Mr
Kin Sheng
Lim
|
|
Address
|
Department of Ophthalmology
St Thomas' Hospital
Westminster Bridge Road
|
|
City/town
|
London
|
|
Zip/Postcode
|
SE1 7EH
|
|
Country
|
United Kingdom
|
|
Sponsor
|
Guy’s and St Thomas’ NHS Foundation Trust (UK)
|
|
Address
|
c/o Jackie Pullen
Clinical Quality Manager
The Joint Clinical Trials Office
3rd Floor Conybeare House
Guy's Hospital
Great Maze Pond
|
|
City/town
|
London
|
|
Zip/Postcode
|
SE1 9RT
|
|
Country
|
United Kingdom
|
|
Sponsor website:
|
http://www.guysandstthomas.nhs.uk/
|
|
Date applied
|
23/03/2008
|
|
Last edited
|
25/04/2008
|
|
Date ISRCTN assigned
|
25/04/2008
|
