Clinical trial NCT01774227: the Pops-titration Versus the Slow-coagulation Cyclophotocoagulation in Treatment of Refractory Glaucoma
Official title: A Randomized Trial of the Pops-titration Versus the Slow-coagulation Energy Delivery Technique on the Outcome of Diode Laser Transcleral Cyclophotocoagulation in Treatment of Neovascular Glaucoma With Dark Iris
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Glaucoma
Intraocular Pressure
Keywords: Refractory glaucoma
Transcleral cyclophotocoagulation (TSCPC)
Dark iris
Pops-titration
Slow-coagulation
Neovascular glaucoma
Lead sponsor: Prince of Songkla University
Sponsor class: OTHER
First posted: 2013-01-23
Enrollment: 98
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: * Transcleral cyclophotocoagulation (TSCPC) has long been used as refractory glaucoma management and is very easy to learn and easy to perform.
* Recent advances in laser technology; the role of TSCPC is being expanded because it has benefits of noninvasive glaucoma procedure.
* The titration (pops), the fixed high-energy, and the fixed-low energy (slow-coagulation) are three energy delivery techniques.
* The present study would report on the outcome (efficacy and safety) of the slow-coagulation versus the titration method in treatment of refractory glaucoma with dark iris.
* The results would provide reliable evidences to supplement clinical judgment when making a decision in favor of each treatment method for glaucoma patients.

Detailed description: * Several protocols afford delivery of the "optimum" dose of laser energy per session necessary to achieve a long-term effective ocular hypotensive response balancing risks related to a high energy treatment and risks related to retreatment due to suboptimum dose delivery.
* There are two main approaches to delivering laser energy, the pops-titration method and the fixed energy method that are the fixed-high and low-energy (the Gaasterland's slow-coagulation technique).
* Of particular interest is which laser energy delivery method (slow-coagulation versus pops-titration) affords the optimal dose of photocoagulation necessary to achieve an effective long-term intraocular pressure (IOP) reduction while minimizing the risk of adverse events related to overtreatment and retreatments especially in refractory glaucomatous eyes with dark iris color.

Eligibility criteria: Inclusion Criteria:

* Refractory glaucoma (Neovascular glaucoma) with
* Eyes with no visual potential and very high intraocular pressure (on maximal medical treatment) in which the intraocular pressure will probably cause corneal complications
* Eyes with no visual potential and very high intraocular pressure (on maximal medical treatment) in which the intraocular pressure cause eye pain and need pain relief
* Eyes with minimal useful vision and intraocular pressure over the target intraocular pressure
* Eyes in which trabeculectomy with mitomycin-C and/or drainage implants have a high probability of failure
* Eyes in which trabeculectomy with mitomycin-C and/or drainage implants have previously failed
* Patient refuses to undergo more aggressive intraocular surgery
* Patients whose general medical condition precludes invasive surgery

Exclusion Criteria:

* The visual acuity in the fellow eye is no light perception
* Have previously been treated by the transcleral cyclophotocoagulation
* Allergy to anesthetic medication
* Can not measure the intraocular pressure by the applanation method

Primary outcomes:
measure: Success rate
timeFrame: 60 months
Secondary outcomes:
measure: Response rate
timeFrame: 60 months
measure: Cyclodiode efficacy index
timeFrame: 60 months
measure: Failure rate
timeFrame: 60 months
Other outcomes:
Locations:
city: Hat Yai
country: Thailand
facility: Ophthalmology Department, Prince of Songkla University
state: Songkhla
Study officials:
affiliation: Prince of Songkla University
name: Weerawat Kiddee, MD
role: STUDY_DIRECTOR
References: