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

This study is currently recruiting participants.
Verified May 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: May 6, 2013
Last verified: May 2013
History of Changes
  Purpose
  • 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 Intervention
Glaucoma
Intraocular Pressure
 Procedure: The pops-titration group
Procedure: The slow-coagulation group

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
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 Refractory Glaucoma With Dark Iris

Resource links provided by NLM:

MedlinePlus related topics: Glaucoma
U.S. FDA Resources

Further study details as provided by Prince of Songkla University:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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.


Estimated Enrollment: 90
Study Start Date: May 2013
Estimated Study Completion Date: December 2016
Estimated Primary Completion Date: December 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

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.
  Eligibility

Ages Eligible for Study:   18 Years to 85 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01774227

Contacts
Contact: Weerawat Kiddee, MD +66874954626 kweerawat@hotmail.com

Locations
Thailand
Ophthalmology Department, Prince of Songkla University Recruiting
Hatyai, Songkhla, Thailand, 90110
Contact: Weerawat Kiddee, MD     +66874954626     kweerawat@hotmail.com    
Principal Investigator: Weerawat Kiddee, MD            
Sponsors and Collaborators
Prince of Songkla University
Investigators
Study Director: Weerawat Kiddee, MD Prince of Songkla University
  More Information

No publications provided

Responsible Party: Weerawat Kiddee, Dr.Weerawat Kiddee, Prince of Songkla University
ClinicalTrials.gov Identifier: NCT01774227     History of Changes
Other Study ID Numbers: EC 56-094-02-1-2
Study First Received: January 17, 2013
Last Updated: May 6, 2013
Health Authority: Thailand: Ethical Committee

Keywords provided by Prince of Songkla University:
Refractory glaucoma
Transcleral cyclophotocoagulation (TSCPC)
Dark iris
Pops-titration
Slow-coagulation

Additional relevant MeSH terms:
Glaucoma
Ocular Hypertension
Eye Diseases

ClinicalTrials.gov processed this record on May 16, 2013