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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

98 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-05-31

Study Completion Date

2020-01-31

Brief Summary

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* 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.

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Detailed Description

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* 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.

Conditions

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Glaucoma Intraocular Pressure

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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The pops-titration group

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

Group Type EXPERIMENTAL

The pops-titration group

Intervention Type PROCEDURE

The energy delivery is started at a low level and is increased in intervals till an audible pop is heard, following which the power is reduced downward until the pops are no longer audible, then the treatment is completed at these parameters

The slow-coagulation group

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

Group Type EXPERIMENTAL

The slow-coagulation group

Intervention Type PROCEDURE

The Gaasterland's slow-coagulation energy delivery technique using the lower power for the longer duration.

Interventions

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The pops-titration group

The energy delivery is started at a low level and is increased in intervals till an audible pop is heard, following which the power is reduced downward until the pops are no longer audible, then the treatment is completed at these parameters

Intervention Type PROCEDURE

The slow-coagulation group

The Gaasterland's slow-coagulation energy delivery technique using the lower power for the longer duration.

Intervention Type PROCEDURE

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No