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

This study is currently recruiting participants. (see Contacts and Locations)
Verified November 2013 by Prince of Songkla University
Sponsor:
Information provided by (Responsible Party):
Weerawat Kiddee, Prince of Songkla University
ClinicalTrials.gov Identifier:
NCT01774227
First received: January 17, 2013
Last updated: November 27, 2013
Last verified: November 2013

January 17, 2013
November 27, 2013
May 2013
December 2016   (final data collection date for primary outcome measure)
Success rate [ Time Frame: 12 months ] [ Designated as safety issue: No ]
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.
Same as current
Complete list of historical versions of study NCT01774227 on ClinicalTrials.gov Archive Site
  • Response rate [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    Cyclodiode efficacy index defined as the ratio of response rate to the mean number of the treatment session.
  • Failure rate [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
    Failure rate defined as the proportion of eyes developed hypotony or phthisis bulbi or need to repeat treatment for more than 2 laser sessions.
Same as current
Not Provided
Not Provided
 
the Pops-titration Versus the Slow-coagulation Cyclophotocoagulation in Treatment of Refractory Glaucoma
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
  • 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.
  • 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.
Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
  • Glaucoma
  • Intraocular Pressure
  • 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
  • Procedure: The slow-coagulation group
    The Gaasterland's slow-coagulation energy delivery technique using the lower power for the longer duration.
  • Experimental: The pops-titration group
    The titration method uses power that is titrated according to the audible "pop".
    Intervention: Procedure: The pops-titration group
  • Experimental: The slow-coagulation group
    The slow-coagulation group utilize the low-energy using the Gaasterland's slow-coagulation technique
    Intervention: Procedure: The slow-coagulation group
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
90
December 2016
December 2016   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • 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
Both
18 Years to 85 Years
No
Contact: Weerawat Kiddee, MD +66874954626 kweerawat@hotmail.com
Thailand
 
NCT01774227
EC 56-094-02-1-2
Yes
Weerawat Kiddee, Prince of Songkla University
Prince of Songkla University
Not Provided
Study Director: Weerawat Kiddee, MD Prince of Songkla University
Prince of Songkla University
November 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP