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

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ClinicalTrials.gov Identifier: NCT00349414
Recruitment Status : Unknown
Verified May 2008 by National University Hospital, Singapore.
Recruitment status was:  Recruiting
First Posted : July 7, 2006
Last Update Posted : May 15, 2008
Sponsor:
Information provided by:
National University Hospital, Singapore

Brief Summary:
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 or disease Intervention/treatment Phase
Advanced Glaucoma Refractory Glaucoma Procedure: Micropulse Transscleral Cyclophotocoagulation Procedure: Conventional Transscleral Cyclophotocoagulation Phase 1 Phase 2

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.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 70 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Comparison of the Safety and Efficacy of Conventional Versus Micropulse Transscleral Diode Laser Cyclophotocoagulation in Refractory Glaucoma
Study Start Date : July 2006
Estimated Study Completion Date : December 2008

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Glaucoma




Primary Outcome Measures :
  1. Number of patients in each group that had a 30% decrease of IOP from baseline after 6 months

Secondary Outcome Measures :
  1. 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


Information from the National Library of Medicine

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Ages Eligible for Study:   22 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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         
Sponsors and Collaborators
National University Hospital, Singapore
Investigators
Principal Investigator: Paul Chew, FRCSEd,MMed National University Hospital,Ophthalmology Department

Publications:
Responsible Party: Paul Chew, FRCSEd,MMed, National University Hospital
ClinicalTrials.gov Identifier: NCT00349414     History of Changes
Other Study ID Numbers: DSRB Reference Code: A/06/164
First Posted: July 7, 2006    Key Record Dates
Last Update Posted: May 15, 2008
Last Verified: May 2008

Keywords provided by National University Hospital, Singapore:
Advanced glaucoma
Refractory glaucoma
Cyclophotocoagulation
Transscleral cyclophotocoagulation
Micropulse transscleral cyclophotocoagulation

Additional relevant MeSH terms:
Glaucoma
Ocular Hypertension
Eye Diseases