Selective Laser Trabeculoplasty and its effect on fluid flow out of the eyes

ISRCTN	ISRCTN65144700
DOI	https://doi.org/10.1186/ISRCTN65144700
Protocol serial number	PROTOCOL 1
Sponsor	Guys and St Thomas NHS Foundation Trust (UK)
Funder	Eye Hope (UK)

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

Department of Ophthalmology
St Thomas' Hospital
Westminster Bridge Road
London
SE1 7EH
United Kingdom

Study information

Primary study design	Interventional
Study design	Randomised prospective non-controlled two armed trial
Secondary study design	Randomised controlled trial
Study type	Participant 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(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.
Key secondary outcome measure(s)	Complications, measured at baseline, one month and three months.
Completion date	01/06/2008

Eligibility

Participant type(s)	Patient
Age group	Adult
Sex	All
Target sample size at registration	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

United Kingdom
England

Study participating centre

Department of Ophthalmology

London
SE1 7EH
United Kingdom

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	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
Participant information sheet	Participant information sheet	11/11/2025	11/11/2025	No	Yes