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

Phase 1

• Conditions: Advanced Glaucoma; Refractory Glaucoma

• Registration Number: NCT00349414
• Lead Sponsor: 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.

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 Timeline

• Study Start: 2006-07
• Study First Submitted: 2006-07-06
• Study First Submitted QC: 2006-07-06
• Study First Posted: 2006-07-07
• Status Verified: 2008-05
• Last Update Submitted: 2008-05-13
• Last Update Posted: 2008-05-15
• Study Completion: 2008-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 70

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

National University Hospital Singapore Department of Ophthalmology; 🇸🇬 Singapore, Singapore