Condition category
Eye Diseases
Date applied
28/09/2007
Date assigned
28/09/2007
Last edited
07/12/2010
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 Avinash A Kulkarni

ORCID ID

Contact details

Lambeth Road
London
SE1 7EH
United Kingdom
+44 (0)2071887188

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N0013184505

Study information

Scientific title

Acronym

Study hypothesis

At the present time, although SLT is accepted as a viable treatment for OHT / POAG, there has not been a thorough assessment of the optimum Laser power settings which enable safe and effective treatment. This study aims to scientifically compare high power settings with low power settings, investigating the efficacy of treatment in lowering intraocular pressure during the follow-up period after treatment, and the incidence of adverse events related to Laser treatment. Secondary Research Objectives: None

Ethics approval

Not provided at time of registration

Study design

Randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Condition

Eye Diseases: Ocular hypertension (OHT)

Intervention

Research participants are to be recruited from the NHS glaucoma clinic at St. Thomas' Hospital over a 6 months period, starting 1st May 2004. Eligible participants will be patients with OHT or POAG, which is uncontrolled in one or both eyes despite maximal topical medical therapy. We aim to recruit 60 patients.

Each patient will be randomized to treatment with the Laserex Solo SLT Glaucoma Laser in one of three treatment groups:
Group 1 will receive high-energy SLT (1.2mJ shots) in one or both eyes
Group 2 will receive medium energy SLT (0.8mJ shots) in one or both eyes
Group 3 will receive low-energy SLT (0.4mJ shots) in one or both eyes.

The decision to treat either one or both eyes will depend on whether the intraocular pressure is too high in one or both eyes. Therefore only eyes with uncontrolled pressure will be treated. Some patients may have both eyes treated. In these cases data for the study will only be collected for one eye. Thus, in total, 20 patients will be allocated to each of the 3 groups with 20 eyes per group (one per patient).

Intervention type

Other

Phase

Not Specified

Drug names

Primary outcome measures

1. Visual field defect progression
2. Disc cup appearances

Secondary outcome measures

Not provided at time of registration

Overall trial start date

01/08/2005

Overall trial end date

01/08/2006

Reason abandoned

Eligibility

Participant inclusion criteria

Patients with OHT or POAG, which is uncontrolled despite maximal topical medical therapy.

Participant type

Patient

Age group

Adult

Gender

Not Specified

Target number of participants

40

Participant exclusion criteria

Patients who do not meet inclusion criteria

Recruitment start date

01/08/2005

Recruitment end date

01/08/2006

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Lambeth Road
London
SE1 7EH
United Kingdom

Sponsor information

Organisation

Record Provided by the NHSTCT Register - 2007 Update - Department of Health

Sponsor details

The Department of Health
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom
+44 (0)20 7307 2622
dhmail@doh.gsi.org.uk

Sponsor type

Government

Website

http://www.dh.gov.uk/Home/fs/en

Funders

Funder type

Government

Funder name

Guy's and St. Thomas' NHS Foundation Trust

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

Own account

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

NHS R&D Support Funding

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