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

Sponsor

National University Hospital, Singapore (Other)

Overall Status

Unknown status

CT.gov ID

NCT00349414

Collaborator

(none)

Enrollment

Location

Duration (Months)

2.4

Patients Per Site Per Month

Study Details

Study Description

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 Design

Study Type:

Interventional

Anticipated 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 :

Jul 1, 2006

Anticipated Study Completion Date :

Dec 1, 2008

Outcome Measures

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 []

Eligibility Criteria

Criteria

Ages Eligible for Study:

22 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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