NCT02875158

Brief Summary

Transscleral cyclophotocoagulation of the ciliary body is an effective technique to reduce intraocular pressure in case of glaucoma. Due to concerns over complications, the main indications for this second-line treatment are refractory glaucoma medication / surgery and low visual prognosis. The 2000 milliwatts (mW) for 2 seconds settings are used by the majority of researchers and clinicians according to the published literature. Some have proposed using 1250 mW for 4 seconds to improve the use of this medical procedure. The aim of this study is to determine how different parameters affect the efficacy of the treatment. This is a prospective double-blinded randomized controlled trial comparing two groups, the experimental group using 1250 mW for 4 seconds and the control group using 2000 mW for 2 seconds.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
44

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Aug 2016

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

July 18, 2016

Completed
14 days until next milestone

Study Start

First participant enrolled

August 1, 2016

Completed
22 days until next milestone

First Posted

Study publicly available on registry

August 23, 2016

Completed
6.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2023

Completed
Last Updated

September 11, 2023

Status Verified

September 1, 2023

Enrollment Period

7 years

First QC Date

July 18, 2016

Last Update Submit

September 8, 2023

Conditions

Glaucoma

Outcome Measures

Primary Outcomes (1)

  • Intraocular pressure (IOP) evolution

    The intraocular pressure is measured to determine the efficacy of treatment during follow-up compared to the baseline IOP.

    1h, 1 month, 6 months, 12 months, 18 months and 24 months post-op

Secondary Outcomes (4)

  • Presence of complications

    During the intervention, 1 month, 6 months, 12 months, 18 months, 24 months post-op

  • Use of medication

    1 month, 6 months, 12 months, 18 months and 24 months post-op

  • Retreatment

    From the initial treatment up to the last visit (24 months)

  • Visual acuity

    1 month, 6 months, 12 months, 18 months and 24 months post-op

Study Arms (2)

Diode laser using conventional settings

ACTIVE COMPARATOR

The cyclophotocoagulation protocol is used with the conventional cyclophotocoagulation settings of 2000 mW for 2 seconds.

Procedure: Cyclophotocoagulation protocolProcedure: Conventional cyclophotocoagulation

Diode laser using modified settings

EXPERIMENTAL

The cyclophotocoagulation protocol is used with the modified cyclophotocoagulation settings of 1250 mW for 4 seconds.

Procedure: Cyclophotocoagulation protocolProcedure: Modified cyclophotocoagulation

Interventions

Cyclophotocoagulation protocolPROCEDURE

* Intravenous route is installed * Retrobulbar anaesthesia : 50% xylocaine (2%) + 50% bupivicaine * Parameters set for laser treatment (1250mW-4seconds or 2000mW-2 seconds depending on the assigned group) * Pars plana measurement using transillumination (if needed) * Laser treatment applied approximately 1mm post to limbus * Dexamethasone 0,5 mg subconjunctival injection * Post-op regimen: Prednisolone 1% qid x 4 weeks, Atropine 1% bid x 2 weeks + Erythromycin ointment + patch x 6h

Diode laser using conventional settingsDiode laser using modified settings
Conventional cyclophotocoagulationPROCEDURE

1250 mW for 4 seconds.

Diode laser using conventional settings
Modified cyclophotocoagulationPROCEDURE

2000 mW for 2 seconds.

Diode laser using modified settings

Eligibility Criteria

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

You may qualify if:

  • Patients with poorly controlled high pressure glaucoma
  • Cyclophotocoagulation necessary to prevent visual loss
  • Cyclophotocoagulation necessary to prevent or to reduce ocular discomfort

You may not qualify if:

  • Patient has already undergone a cyclophotocoagulation or cryotherapy treatment in the same eye for glaucoma
  • Patients receiving concomitant treatment the same day as the intervention
  • Patient not able to follow the prescribed post-operative treatment

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Centre universitaire d'ophtalmologie, Hôpital du Saint-Sacrement. CHU de Québec

Québec, G1S 4L8, Canada

Location

MeSH Terms

Conditions

Glaucoma

Condition Hierarchy (Ancestors)

Ocular HypertensionEye Diseases

Study Officials

  • Andrew Toren, Doctor

    Centre de recherche du CHU de Québec : Université Laval

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 18, 2016

First Posted

August 23, 2016

Study Start

August 1, 2016

Primary Completion

August 1, 2023

Study Completion

August 1, 2023

Last Updated

September 11, 2023

Record last verified: 2023-09

Data Sharing

IPD Sharing
Will not share

Locations

CA(1)