NCT01774227

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
98

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started May 2013

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 17, 2013

Completed
6 days until next milestone

First Posted

Study publicly available on registry

January 23, 2013

Completed
3 months until next milestone

Study Start

First participant enrolled

May 1, 2013

Completed
6.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2020

Completed
Last Updated

April 2, 2020

Status Verified

March 1, 2020

Enrollment Period

6.7 years

First QC Date

January 17, 2013

Last Update Submit

March 31, 2020

Conditions

GlaucomaIntraocular Pressure

Keywords

Refractory glaucomaTranscleral cyclophotocoagulation (TSCPC)Dark irisPops-titrationSlow-coagulationNeovascular glaucoma

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (3)

  • Response rate

    60 months

  • Cyclodiode efficacy index

    60 months

  • Failure rate

    60 months

Study Arms (2)

The pops-titration group

EXPERIMENTAL

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

Procedure: The pops-titration group

The slow-coagulation group

EXPERIMENTAL

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

Procedure: The slow-coagulation group

Interventions

The pops-titration groupPROCEDURE

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 pops-titration group
The slow-coagulation groupPROCEDURE

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

The slow-coagulation group

Eligibility Criteria

Age18 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ophthalmology Department, Prince of Songkla University

Hat Yai, Changwat Songkhla, 90110, Thailand

Location

Related Publications (1)

  • Kiddee W, Kittigoonpaisan K, Leelaprasasne S, Tanjana A. Randomized clinical trial for pop titrated versus the slow coagulation cyclophotocoagulation in treating dark irises neovascular glaucoma. Sci Rep. 2025 Aug 18;15(1):30238. doi: 10.1038/s41598-025-16306-9.

    PMID: 40826269DERIVED

MeSH Terms

Conditions

GlaucomaGlaucoma, Neovascular

Condition Hierarchy (Ancestors)

Ocular HypertensionEye Diseases

Study Officials

  • Weerawat Kiddee, MD

    Prince of Songkla University

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dr.Weerawat Kiddee

Study Record Dates

First Submitted

January 17, 2013

First Posted

January 23, 2013

Study Start

May 1, 2013

Primary Completion

January 1, 2020

Study Completion

January 1, 2020

Last Updated

April 2, 2020

Record last verified: 2020-03

Locations

TH(1)