ClinicalTrials.gov
ClinicalTrials.gov Menu

Cyclophotocoagulation in Glaucoma

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02875158
Recruitment Status : Recruiting
First Posted : August 23, 2016
Last Update Posted : January 25, 2018
Sponsor:
Information provided by (Responsible Party):
CHU de Quebec-Universite Laval

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.


Condition or disease Intervention/treatment Phase
Glaucoma Procedure: Cyclophotocoagulation protocol Procedure: Conventional cyclophotocoagulation Procedure: Modified cyclophotocoagulation Not Applicable

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Modified Settings for Transscleral Cyclophotocoagulation of the Ciliary Body in Glaucoma : A Randomized Controlled Trial
Study Start Date : August 2016
Estimated Primary Completion Date : August 2020
Estimated Study Completion Date : August 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Glaucoma

Arm Intervention/treatment
Active Comparator: Diode laser using conventional settings
The cyclophotocoagulation protocol is used with the conventional cyclophotocoagulation settings of 2000 mW for 2 seconds.
Procedure: Cyclophotocoagulation protocol
  • 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

Procedure: Conventional cyclophotocoagulation
1250 mW for 4 seconds.

Experimental: Diode laser using modified settings
The cyclophotocoagulation protocol is used with the modified cyclophotocoagulation settings of 1250 mW for 4 seconds.
Procedure: Cyclophotocoagulation protocol
  • 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

Procedure: Modified cyclophotocoagulation
2000 mW for 2 seconds.




Primary Outcome Measures :
  1. Intraocular pressure (IOP) evolution [ Time Frame: 1h, 1 month, 6 months, 12 months, 18 months and 24 months post-op ]
    The intraocular pressure is measured to determine the efficacy of treatment during follow-up compared to the baseline IOP.


Secondary Outcome Measures :
  1. Presence of complications [ Time Frame: During the intervention, 1 month, 6 months, 12 months, 18 months, 24 months post-op ]
    Assessment of complications (if applicable).

  2. Use of medication [ Time Frame: 1 month, 6 months, 12 months, 18 months and 24 months post-op ]
    Assessment of the topical and oral glaucoma medication at baseline and after treatment

  3. Retreatment [ Time Frame: From the initial treatment up to the last visit (24 months) ]
    The clinician will assess the need for retreatment based on clinical experience.

  4. Visual acuity [ Time Frame: 1 month, 6 months, 12 months, 18 months and 24 months post-op ]
    The visual acuity will be assessed at baseline and each subsequent visit



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02875158


Contacts
Contact: Andrew Toren, Doctor 418-682-7511 andrewtoren@gmail.com

Locations
Canada
Centre universitaire d'ophtalmologie, Hôpital du Saint-Sacrement. CHU de Québec Recruiting
Québec, Canada, G1S 4L8
Contact: Andrew Toren, Doctor    418-682-7511      
Contact: Jessye Blouin, Adjointe    418-682-7511 ext 84821    cuo.recherche@fmed.ulaval.ca   
Principal Investigator: Andrew Toren, Doctor         
Sponsors and Collaborators
CHU de Quebec-Universite Laval
Investigators
Principal Investigator: Andrew Toren, Doctor Centre de recherche du CHU de Québec : Université Laval

Responsible Party: CHU de Quebec-Universite Laval
ClinicalTrials.gov Identifier: NCT02875158     History of Changes
Other Study ID Numbers: 2015-2212
First Posted: August 23, 2016    Key Record Dates
Last Update Posted: January 25, 2018
Last Verified: January 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Additional relevant MeSH terms:
Glaucoma
Ocular Hypertension
Eye Diseases