Condition category
Eye Diseases
Date applied
23/03/2008
Date assigned
25/04/2008
Last edited
05/04/2012
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Mr Kin Sheng Lim

ORCID ID

Contact details

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

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

Guy’s 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

http://www.guysandstthomas.nhs.uk/

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

  1. 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.

Additional files

Editorial Notes