Condition category
Eye Diseases
Date applied
05/05/2006
Date assigned
03/07/2006
Last edited
11/08/2008
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

Prof Michael Belkin

ORCID ID

Contact details

Goldschleger Eye Research Institute
Tel Aviv University
Sheba Medical Center
Tel Hashomer
52621
Israel

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

Acronym

SLT for PACG Study

Study hypothesis

To determine whether selective laser trabeculoplasty (SLT) using a Q-switched frequency doubled neodymium-doped yttrium aluminium garnet (Nd:YAG) laser is effective in lowering intraocular pressure in patients with primary angle-closure glaucoma (PACG).

Ethics approval

Ethics approval received from:
1. Singapore Eye Research Institute (SERI-Singapore) (Ref: R424/19/2005) dated 27/10/2005
2. United Christian Hospital (Hong Kong) (Ref: KC/KE05-0073/FR-3) dated on 15/06/2005

Other ethics approval from Chulalongkorn University and Hospital (Thailand), St. Luke's Medical Centre (Philippines) and National University Hospital (Singapore).

Study design

Prospective, observational, uncontrolled, non-comparative study

Primary study design

Observational

Secondary study design

Cohort study

Trial setting

Not specified

Trial type

Treatment

Patient information sheet

Condition

Primary angle-closure glaucoma

Intervention

Selective laser trabeculoplasty (SLT)

Intervention type

Other

Phase

Not Specified

Drug names

Primary outcome measures

Intraocular pressure (IOP) at regular intervals of follow-up with the final IOP being measured at six months after the last treatment. Successful outcome defined as greater or equal to 20% reduction in IOP from pre-laser levels.

Secondary outcome measures

IOP measured on other eye if both eyes are eligible for the study.

Overall trial start date

01/07/2005

Overall trial end date

01/07/2006

Reason abandoned

Eligibility

Participant inclusion criteria

1. PACG
2. Intraocular pressure 21 - 28 mmHg on one or more topical medicine in presence of patent iridotomy
3. At least two months since last iridotomy
4. Aged over 21 years old

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

150

Participant exclusion criteria

1. Secondary causes of angle-closure
2. Corneal abnormalities
3. Advanced glaucomatous optic neuropathy
4. Patient blind in one eye

Recruitment start date

01/07/2005

Recruitment end date

01/07/2006

Locations

Countries of recruitment

Hong Kong, Philippines, Singapore, Thailand

Trial participating centre

Goldschleger Eye Research Institute
Tel Hashomer
52621
Israel

Sponsor information

Organisation

Ellex Medical Pty. Ltd. (Australia)

Sponsor details

82 Gilbert Street
Adelaide
SA
5000
Australia

Sponsor type

Industry

Website

http://www.ellex.com

Funders

Funder type

Industry

Funder name

Ellex Medical Pty Ltd (Australia)

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