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
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|
|Intervention Model:||Parallel Assignment|
|Masking:||Triple (Participant, Investigator, Outcomes Assessor)|
|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|
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
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
Procedure: Modified cyclophotocoagulation
2000 mW for 2 seconds.
- 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.
- 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).
- 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
- 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.
- 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
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
|Contact: Andrew Toren, Doctoremail@example.com|
|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 firstname.lastname@example.org|
|Principal Investigator: Andrew Toren, Doctor|
|Principal Investigator:||Andrew Toren, Doctor||Centre de recherche du CHU de Québec : Université Laval|