Clinical trial NCT00349414: Safety Study of Conventional Versus Micropulse Transscleral Cyclophotocoagulation in Treating End-Stage Glaucoma
Official title: A Comparison of the Safety and Efficacy of Conventional Versus Micropulse Transscleral Diode Laser Cyclophotocoagulation in Refractory Glaucoma
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
PHASE2
Conditions: Advanced Glaucoma
Refractory Glaucoma
Keywords: Advanced glaucoma
Refractory glaucoma
Cyclophotocoagulation
Transscleral cyclophotocoagulation
Micropulse transscleral cyclophotocoagulation
Lead sponsor: National University Hospital, Singapore
Sponsor class: OTHER
First posted: 2006-07-07
Enrollment: 70
Sex: ALL
Minimum age (years): 22
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Eligibility 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

Primary outcomes:
measure: Number of patients in each group that had a 30% decrease of IOP from baseline after 6 months
Secondary outcomes:
measure: 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
Other outcomes:
Locations:
city: Singapore
country: Singapore
facility: National University Hospital Singapore Department of Ophthalmology
Study officials:
affiliation: National University Hospital,Ophthalmology Department
name: Paul Chew, FRCSEd,MMed
role: PRINCIPAL_INVESTIGATOR
References:
citation: Berger JW. Thermal modelling of micropulsed diode laser retinal photocoagulation. Lasers Surg Med. 1997;20(4):409-15. doi: 10.1002/(sici)1096-9101(1997)20:43.0.co;2-u.
citation: Ho CL, Wong EY, Chew PT. Effect of diode laser contact transscleral pars plana photocoagulation on intraocular pressure in glaucoma. Clin Exp Ophthalmol. 2002 Oct;30(5):343-7. doi: 10.1046/j.1442-9071.2002.00553.x.