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

Information source: Prince of Songkla University
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Glaucoma; Intraocular Pressure

Intervention: The pops-titration group (Procedure); The slow-coagulation group (Procedure)

Phase: N/A

Status: Recruiting

Sponsored by: Prince of Songkla University

Official(s) and/or principal investigator(s):
Weerawat Kiddee, MD, Study Director, Affiliation: Prince of Songkla University

Overall contact:
Weerawat Kiddee, MD, Phone: +66874954626, Email: kweerawat@hotmail.com

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.

Clinical Details

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 design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Primary outcome: Success rate

Secondary outcome:

Response rate

Cyclodiode efficacy index

Failure rate

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

Minimum age: 18 Years. Maximum age: 85 Years. Gender(s): Both.

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

Locations and Contacts

Weerawat Kiddee, MD, Phone: +66874954626, Email: kweerawat@hotmail.com

Ophthalmology Department, Prince of Songkla University, Hatyai, Songkhla 90110, Thailand; Recruiting
Weerawat Kiddee, MD, Phone: +66874954626, Email: kweerawat@hotmail.com
Weerawat Kiddee, MD, Principal Investigator
Additional Information

Starting date: May 2013
Last updated: June 11, 2015

Page last updated: August 23, 2015

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