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

Sponsor

Prince of Songkla University (Other)

Overall Status

Completed

CT.gov ID

NCT01774227

Collaborator

(none)

Enrollment

Location

Arms

Duration (Months)

1.2

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Glaucoma Intraocular Pressure	Procedure: The pops-titration group Procedure: The slow-coagulation group	N/A

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.

Study Design

Study Type:

Interventional

Actual Enrollment :

98 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Participant)

Primary Purpose:

Treatment

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 Start Date :

May 1, 2013

Actual Primary Completion Date :

Jan 1, 2020

Actual Study Completion Date :

Jan 1, 2020

Arms and Interventions

Arm	Intervention/Treatment
Experimental: The pops-titration group The titration method uses power that is titrated according to the audible "pop".	Procedure: 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
Experimental: The slow-coagulation group The slow-coagulation group utilize the low-energy using the Gaasterland's slow-coagulation technique	Procedure: The slow-coagulation group The Gaasterland's slow-coagulation energy delivery technique using the lower power for the longer duration.

Arm

Intervention/Treatment

Experimental: The pops-titration group

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

Procedure: 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

Experimental: The slow-coagulation group

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

Procedure: The slow-coagulation group

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

Outcome Measures

Primary Outcome Measures

Success rate [60 months]
Success rate defined as the proportion of eyes achieving an intraocular pressure between 6 and 21mmHg with or without topical antiglaucoma medication at the final follow up visit.

Secondary Outcome Measures

Response rate [60 months]
Response rate defined as the proportion of eyes achieving an intraocular pressure between < 22 mmHg or > 30% drop in an intraocular pressure with or without topical antiglaucoma medication at the final follow up visit.
Cyclodiode efficacy index [60 months]
Cyclodiode efficacy index defined as the ratio of response rate to the mean number of the treatment session.
Failure rate [60 months]
Failure rate defined as the proportion of eyes developed hypotony or phthisis bulbi or need to repeat treatment for more than 2 laser sessions.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 85 Years

Sexes Eligible for Study:

All

Accepts 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