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Completed

NCT Number: NCT01774227

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

* 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.

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Key information

Conditions

Glaucoma Eye Diseases Glaucoma, Neovascular Intraocular Pressure Ocular Hypertension

Age range

18 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Ophthalmology Department, Prince of Songkla University

Hat Yai, Changwat Songkhla, 90110, Thailand

About this study

  • 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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

The pops-titration group

Procedure

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

Procedure

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

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

  2. 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.

  3. 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.

Sponsors and collaborators

Lead sponsor

Prince of Songkla University

Other

Registry information

Official study 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

Important dates

Study start
2013
Primary completion
2020
Study completion
2020
First posted
Jan 23, 2013
Registry last updated
Apr 2, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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