the Pops-titration Versus the Slow-coagulation Cyclophotocoagulation in Treatment of Refractory Glaucoma
|ClinicalTrials.gov Identifier: NCT01774227|
Recruitment Status : Completed
First Posted : January 23, 2013
Last Update Posted : November 6, 2017
- 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||Not Applicable|
- 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 Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||60 participants|
|Intervention Model:||Parallel Assignment|
|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 Refractory Glaucoma With Dark Iris|
|Study Start Date :||May 2013|
|Actual Primary Completion Date :||October 2017|
|Actual Study Completion Date :||November 2017|
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.
- Success rate [ Time Frame: 12 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.
- Response rate [ Time Frame: 12 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 [ Time Frame: 12 months ]Cyclodiode efficacy index defined as the ratio of response rate to the mean number of the treatment session.
- Failure rate [ Time Frame: 12 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.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01774227
|Ophthalmology Department, Prince of Songkla University|
|Hat Yai, Songkhla, Thailand, 90110|
|Study Director:||Weerawat Kiddee, MD||Prince of Songkla University|