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

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ClinicalTrials.gov Identifier: NCT01774227
Recruitment Status : Completed
First Posted : January 23, 2013
Last Update Posted : April 2, 2020
Sponsor:
Information provided by (Responsible Party):
Weerawat Kiddee, Prince of Songkla University

Tracking Information
First Submitted Date  ICMJE January 17, 2013
First Posted Date  ICMJE January 23, 2013
Last Update Posted Date April 2, 2020
Study Start Date  ICMJE May 2013
Actual Primary Completion Date January 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 31, 2020)
Success rate [ Time Frame: 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.
Original Primary Outcome Measures  ICMJE
 (submitted: January 20, 2013)
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.
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: March 31, 2020)
  • Response rate [ Time Frame: 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 [ Time Frame: 60 months ]
    Cyclodiode efficacy index defined as the ratio of response rate to the mean number of the treatment session.
  • Failure rate [ Time Frame: 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.
Original Secondary Outcome Measures  ICMJE
 (submitted: January 20, 2013)
  • 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.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE the Pops-titration Versus the Slow-coagulation Cyclophotocoagulation in Treatment of Refractory Glaucoma
Official Title  ICMJE 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
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.
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 Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Condition  ICMJE
  • Glaucoma
  • Intraocular Pressure
Intervention  ICMJE
  • 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.
Study Arms  ICMJE
  • 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
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: March 31, 2020)
98
Original Estimated Enrollment  ICMJE
 (submitted: January 20, 2013)
90
Actual Study Completion Date  ICMJE January 2020
Actual Primary Completion Date January 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 85 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Thailand
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01774227
Other Study ID Numbers  ICMJE EC 56-094-02-1-2
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Weerawat Kiddee, Prince of Songkla University
Study Sponsor  ICMJE Prince of Songkla University
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Weerawat Kiddee, MD Prince of Songkla University
PRS Account Prince of Songkla University
Verification Date March 2020

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