Is repeated laser treatment effective in intraocular pressure (IOP) reduction?

ISRCTN	ISRCTN67927615
DOI	https://doi.org/10.1186/ISRCTN67927615
Protocol serial number	N/A
Sponsor	St Eriks Eye Hospital (Sweden)
Funder	Karolinska Institute Research Foundation (Sweden)

Submission date: 28/01/2010
Registration date: 16/03/2010
Last edited: 04/10/2011

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Eye Diseases

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

Plain English summary of protocol

Not provided at time of registration

Contact information

Dr Marcelo Ayala
Scientific

Glaucoma Department
Klinik 3
St Eriks Eye Hospital
Polhemsgatan 50
Stockholm
112 82
Sweden

Phone	+46 (0)8 6723507
Email	marcelo.ayala@sankterik.se

Study information

Primary study design	Interventional
Study design	Single centre prospective randomised clinical trial
Secondary study design	Randomised controlled trial
Study type	Participant information sheet
Scientific title	Intraocular pressure reduction after repeated selective laser trabeculoplasty (SLT): A prospective randomised clinical trial
Study objectives	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(s)	Local ethics committee of the Karolinska Institutet approved on the 28th of January 2009 (ref: 2009/ 1:1)
Health condition(s) or problem(s) studied	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
Primary outcome measure(s)	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.
Key secondary outcome measure(s)	1. Genders influence on IOP 2. Ages influence on IOP 3. Pseudoexfoliations 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
Completion date	01/12/2010

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	All
Target sample size at registration	40
Key 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
Key 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 eyes characteristics (shallow anterior chamber) or bad collaboration
Date of first enrolment	01/02/2010
Date of final enrolment	01/12/2010

Locations

Countries of recruitment

Sweden

Study participating centre

Glaucoma Department

Stockholm
112 82
Sweden

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?
Participant information sheet	Participant information sheet	11/11/2025	11/11/2025	No	Yes