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

Primary Purpose

Glaucoma, Intraocular Pressure

Status
Completed
Phase
Not Applicable
Locations
Thailand
Study Type
Interventional
Intervention
The pops-titration group
The slow-coagulation group
Sponsored by
Prince of Songkla University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Glaucoma focused on measuring Refractory glaucoma, Transcleral cyclophotocoagulation (TSCPC), Dark iris, Pops-titration, Slow-coagulation, Neovascular glaucoma

Eligibility Criteria

18 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept 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

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

Sites / Locations

  • Ophthalmology Department, Prince of Songkla University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

The pops-titration group

The slow-coagulation group

Arm Description

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

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

Outcomes

Primary Outcome Measures

Success rate
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
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
Cyclodiode efficacy index defined as the ratio of response rate to the mean number of the treatment session.
Failure rate
Failure rate defined as the proportion of eyes developed hypotony or phthisis bulbi or need to repeat treatment for more than 2 laser sessions.

Full Information

First Posted
January 17, 2013
Last Updated
March 31, 2020
Sponsor
Prince of Songkla University
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1. Study Identification

Unique Protocol Identification Number
NCT01774227
Brief Title
the Pops-titration Versus the Slow-coagulation Cyclophotocoagulation in Treatment of Refractory Glaucoma
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 Type
Interventional

2. Study Status

Record Verification Date
March 2020
Overall Recruitment Status
Completed
Study Start Date
May 2013 (undefined)
Primary Completion Date
January 2020 (Actual)
Study Completion Date
January 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Prince of Songkla University

4. Oversight

Data Monitoring Committee
Yes

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Glaucoma, Intraocular Pressure
Keywords
Refractory glaucoma, Transcleral cyclophotocoagulation (TSCPC), Dark iris, Pops-titration, Slow-coagulation, Neovascular glaucoma

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
98 (Actual)

8. Arms, Groups, and Interventions

Arm Title
The pops-titration group
Arm Type
Experimental
Arm Description
The titration method uses power that is titrated according to the audible "pop".
Arm Title
The slow-coagulation group
Arm Type
Experimental
Arm Description
The slow-coagulation group utilize the low-energy using the Gaasterland's slow-coagulation technique
Intervention Type
Procedure
Intervention Name(s)
The pops-titration group
Intervention Description
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
Intervention Type
Procedure
Intervention Name(s)
The slow-coagulation group
Intervention Description
The Gaasterland's slow-coagulation energy delivery technique using the lower power for the longer duration.
Primary Outcome Measure Information:
Title
Success rate
Description
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.
Time Frame
60 months
Secondary Outcome Measure Information:
Title
Response rate
Description
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.
Time Frame
60 months
Title
Cyclodiode efficacy index
Description
Cyclodiode efficacy index defined as the ratio of response rate to the mean number of the treatment session.
Time Frame
60 months
Title
Failure rate
Description
Failure rate defined as the proportion of eyes developed hypotony or phthisis bulbi or need to repeat treatment for more than 2 laser sessions.
Time Frame
60 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Weerawat Kiddee, MD
Organizational Affiliation
Prince of Songkla University
Official's Role
Study Director
Facility Information:
Facility Name
Ophthalmology Department, Prince of Songkla University
City
Hat Yai
State/Province
Songkhla
ZIP/Postal Code
90110
Country
Thailand

12. IPD Sharing Statement

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

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