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

Glaucoma Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01774227
• Other study ID #: EC 56-094-02-1-2
• Status: Completed
• Phase: N/A
• Start date: May 2013
• Est. completion date: January 2020

Study information

• Verified date: March 2020
• Source: Prince of Songkla University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 98
• Est. completion date: January 2020
• Est. primary completion date: January 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

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

Related Conditions & MeSH terms

• Glaucoma
• Intraocular Pressure

Intervention

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
• The slow-coagulation group
The Gaasterland's slow-coagulation energy delivery technique using the lower power for the longer duration.

Locations

Country	Name	City	State
Thailand	Ophthalmology Department, Prince of Songkla University	Hat Yai	Songkhla

Sponsors (1)

Lead Sponsor	Collaborator
Prince of Songkla University

Country where clinical trial is conducted

Thailand, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	60 months
Secondary	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.	60 months
Secondary	Cyclodiode efficacy index	Cyclodiode efficacy index defined as the ratio of response rate to the mean number of the treatment session.	60 months
Secondary	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.	60 months