Condition category
Eye Diseases
Date applied
28/01/2010
Date assigned
16/03/2010
Last edited
04/10/2011
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

Dr Marcelo Ayala

ORCID ID

Contact details

Glaucoma Department
Klinik 3
St Eriks Eye Hospital
Polhemsgatan 50
Stockholm
112 82
Sweden
+46 (0)8 6723507
marcelo.ayala@sankterik.se

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

Intraocular pressure reduction after repeated selective laser trabeculoplasty (SLT): A prospective randomised clinical trial

Acronym

Study hypothesis

Is repeated laser treatment as effective as non-repeated treatment in decreasing IOP?

Glaucoma is a progressive neuropathy localised in the optic nerve that may lead to blindness. Reducing IOP seems to be the only treatment to stop progression in glaucoma. There are several methods to reduce IOP: medical treatment, laser and surgery.

Ethics approval

Local ethics committee of the Karolinska Institutet approved on the 28th of January 2009 (ref: 2009/ 1:1)

Study design

Single centre prospective randomised clinical 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 contact details below to request a patient information sheet (in Swedish)

Condition

Glaucoma

Intervention

Patients will be treated with SLT 2 and randomly divided to treatment in adjacent place (classically treated) or in the same place. Then will be checked at 1 month, 3 months, 6 months and 12 months after SLT 2.

Intervention type

Other

Phase

Not Applicable

Drug names

Primary outcome measures

IOP after repeated SLT in the same area against repeated SLT treatment in adjacent areas.
IOP will be measured with the Goldmann applanation tonometry (GAT) at base line (before treatment) and then 1, 3, 6 and 12 months after treatment.

Secondary outcome measures

1. Gender’s influence on IOP
2. Age’s influence on IOP
3. Pseudoexfoliation’s influence on IOP
4. Inflammation measurements using a slit-lamp and according to the international classification of the Standardization of Uveitis Nomenclature (SUN) Working Group

Overall trial start date

01/02/2010

Overall trial end date

01/12/2010

Reason abandoned

Eligibility

Participant inclusion criteria

1. Patients suffering from glaucoma or Ocular Hypertenstion (OHT)
1.1. Primary open angle glaucoma (POAG) - open angle defined as > grade II (Shaffer classification: scale 0-IV) assessed by gonioscopy
1.2. Pigmentary and pseudoexfoliative glaucoma
1.3. OHT to be treated with SLT 2 both with and without eye-drops.
2. If both eyes must be treated just one will be selected at random.
3. Older than 18 years, no upper age limit
4. Men and women

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

40

Participant exclusion criteria

1. Patients treated with cortisone or immunosuppressive drugs
2. Patients suffering from ocular or systemic inflammatory diseases
3. Patients with Possner-Schlossman syndrome
4. Patients that cannot be treated with SLT due to eye’s characteristics (shallow anterior chamber) or bad collaboration

Recruitment start date

01/02/2010

Recruitment end date

01/12/2010

Locations

Countries of recruitment

Sweden

Trial participating centre

Glaucoma Department
Stockholm
112 82
Sweden

Sponsor information

Organisation

St Eriks Eye Hospital (Sweden)

Sponsor details

Glaucoma Department
St Eriks Eye Hospital
Polhemsgatan 50
Stockholm
112 82
Sweden
+46 (0)8-6723507
marcelo.ayala@sankterik.se

Sponsor type

Hospital/treatment centre

Website

Funders

Funder type

Charity

Funder name

Karolinska Institute Research Foundation (Sweden)

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

Publication citations

Additional files

Editorial Notes