Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
PROTOCOL 1
Study information
Scientific title
A randomised study of different levels of total energy delivered in Selective Laser Trabeculoplasty
Acronym
SLTLIM
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
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Condition
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
Phase
Not Specified
Drug names
Primary outcome measures
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 trial start date
01/11/2006
Overall trial end date
01/06/2008
Reason abandoned
Eligibility
Participant inclusion criteria
1. Participants aged 21 - 85 years, male and female
2. Newly diagnosed ocular hypertension and primary open-angle glaucoma that require treatment
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
46
Participant exclusion criteria
1. Previous intraocular surgery
2. Advanced glaucoma
3. Very high presenting intra-ocular pressure (greater than 35 mmHg)
Recruitment start date
01/11/2006
Recruitment end date
01/06/2008
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Department of Ophthalmology
London
SE1 7EH
United Kingdom
Sponsor information
Organisation
Guys and St Thomas NHS Foundation Trust (UK)
Sponsor details
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
United Kingdom
Sponsor type
Government
Website
Funders
Funder type
Charity
Funder name
Eye Hope (UK)
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
1. 2010 results in http://www.ncbi.nlm.nih.gov/pubmed/20472748
Publication citations
-
Results
Goyal S, Beltran-Agullo L, Rashid S, Shah SP, Nath R, Obi A, Lim KS, Effect of primary selective laser trabeculoplasty on tonographic outflow facility: a randomised clinical trial., Br J Ophthalmol, 2010, 94, 11, 1443-1447, doi: 10.1136/bjo.2009.176024.