Safety Study of Conventional Versus Micropulse Transscleral Cyclophotocoagulation in Treating End-Stage Glaucoma

This study is currently recruiting participants.

Verified by National University Hospital, Singapore, May 2008

First Received: July 6, 2006 Last Updated: May 13, 2008 History of Changes

Sponsored by:	National University Hospital, Singapore
Information provided by:	National University Hospital, Singapore
ClinicalTrials.gov Identifier:	NCT00349414

Purpose

The aim of this study is to compare the safety and efficacy of conventional and micropulse transscleral diode laser in the treatment of end-stage glaucoma.

Condition	Intervention	Phase
Advanced Glaucoma Refractory Glaucoma	Procedure: Micropulse Transscleral Cyclophotocoagulation Procedure: Conventional Transscleral Cyclophotocoagulation	Phase I Phase II

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Active Control, Single Group Assignment, Safety/Efficacy Study
Official Title:	A Comparison of the Safety and Efficacy of Conventional Versus Micropulse Transscleral Diode Laser Cyclophotocoagulation in Refractory Glaucoma

Resource links provided by NLM:

Genetics Home Reference related topics: early-onset glaucoma

MedlinePlus related topics: Glaucoma

U.S. FDA Resources

Further study details as provided by National University Hospital, Singapore:

Primary Outcome Measures:

Number of patients in each group that had a 30% decrease of IOP from baseline after 6 months

Secondary Outcome Measures:

Number of patients with complications, such as hypotony, phthisis, sympathetic ophthalmia, surface conjunctival burns, bulbar conjunctival swelling, decompensation of corneal grafts, hyphema and vitreous hemorrhage

Estimated Enrollment:	70
Study Start Date:	July 2006
Estimated Study Completion Date:	December 2008

Detailed Description:

End-stage glaucoma is difficult to treat, and it may sometimes be unresponsive to surgery or medications. A common treatment is the conventional transscleral cyclophotocoagulaion, but it has various side effects. This study specifically aims to compare the intraocular pressure (IOP) lowering effects and the incidence of complications such as hypotony, phthisis, sympathetic ophthalmia, surface conjunctival burns, bulbar conjunctival swelling, decompensation of corneal grafts, hyphema and vitreous hemorrhage, in conventional and the newer micropulse transscleral cyclophotocoagulation.The hypothesis is that the micropulse transscleral cyclophotocoagulation will be as good or better than the conventional transscleral cyclophotocoagulation, with less complications.

Eligibility

Ages Eligible for Study:	22 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

Criteria

Inclusion Criteria:

· More than 21 years old
- Advanced glaucoma refractory to maximum tolerated medical and surgical treatment
- Visual acuity worse than 6/60
- Poor candidates for additional filtration surgery

Exclusion Criteria:

· Any eye surgery done within 2 months of enrolment
- Any ocular infection or inflammation
- Unable to give informed consent

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00349414

Contacts

Contact: Anna Tan, MMed	6772-5317	amwttan@yahoo.com
Contact: Grace Dizon, MD	6772-5317	gengmd@yahoo.com

Locations

Singapore
National University Hospital Singapore Department of Ophthalmology	Recruiting
Singapore, Singapore, 119074
Sub-Investigator: Anna Tan, MMEd
Sub-Investigator: Grace Dizon, MD
Sub-Investigator: Anna Tan, MMed

Sponsors and Collaborators

National University Hospital, Singapore

Investigators

Principal Investigator:

Paul Chew, FRCSEd,MMed

National University Hospital,Ophthalmology Department

More Information

Publications:

Berger JW. Thermal modelling of micropulsed diode laser retinal photocoagulation. Lasers Surg Med. 1997;20(4):409-15.

Ho CL, Wong EY, Chew PT. Effect of diode laser contact transscleral pars plana photocoagulation on intraocular pressure in glaucoma. Clin Experiment Ophthalmol. 2002 Oct;30(5):343-7.

Responsible Party:	National University Hospital ( Paul Chew, FRCSEd,MMed )
Study ID Numbers:	DSRB Reference Code: A/06/164
Study First Received:	July 6, 2006
Last Updated:	May 13, 2008
ClinicalTrials.gov Identifier:	NCT00349414 History of Changes
Health Authority:	Singapore: Health Sciences Authority

Keywords provided by National University Hospital, Singapore:

Advanced glaucoma
Refractory glaucoma
Cyclophotocoagulation
Transscleral cyclophotocoagulation
Micropulse transscleral cyclophotocoagulation

Study placed in the following topic categories:

Glaucoma
Eye Diseases
Hypertension
Ocular Hypertension

Additional relevant MeSH terms:

Glaucoma
Eye Diseases
Ocular Hypertension

ClinicalTrials.gov processed this record on September 11, 2009