the Pops-titration Versus the Slow-coagulation Cyclophotocoagulation in Treatment of Refractory Glaucoma

Prince of Songkla University

Status: Completed

Conditions: Glaucoma; Intraocular Pressure

Treatments: Procedure: The slow-coagulation group; Procedure: The pops-titration group

Study type: Interventional

Funder types: Other

Identifiers

NCT01774227

EC 56-094-02-1-2

Details and patient eligibility

About

• 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.

Full 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.

Enrollment: 98 patients

Sex: All

Ages: 18 to 85 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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98 participants in 2 patient groups

The pops-titration group

Experimental group

Description:

The titration method uses power that is titrated according to the audible "pop".

Treatment:

Procedure: The pops-titration group

The slow-coagulation group

Experimental group

Description:

The slow-coagulation group utilize the low-energy using the Gaasterland's slow-coagulation technique

Treatment:

Procedure: The slow-coagulation group