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

P

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

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

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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