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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified May 2008 by National University Hospital, Singapore.
Recruitment status was:  Recruiting
Sponsor:
Information provided by:
National University Hospital, Singapore
ClinicalTrials.gov Identifier:
NCT00349414
First received: July 6, 2006
Last updated: May 13, 2008
Last verified: May 2008
  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 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:


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   (Adult, Senior)
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Locations
Singapore
National University Hospital Singapore Department of Ophthalmology
Singapore, Singapore, 119074
Sponsors and Collaborators
National University Hospital, Singapore
Investigators
Principal Investigator: Paul Chew, FRCSEd,MMed National University Hospital,Ophthalmology Department
  More Information

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 
Study First Received: July 6, 2006
Last Updated: May 13, 2008
Health Authority: Singapore: Health Sciences Authority

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

ClinicalTrials.gov processed this record on December 02, 2016