Cyclophotocoagulation in Glaucoma
Study Details
Study Description
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 |
|---|---|---|
|
N/A |
Study Design
Arms and Interventions
| 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.
|
Outcome Measures
Primary Outcome Measures
- Intraocular pressure (IOP) evolution [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
- Presence of complications [During the intervention, 1 month, 6 months, 12 months, 18 months, 24 months post-op]
Assessment of complications (if applicable).
- Use of medication [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 [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 [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
Eligibility Criteria
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
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Centre universitaire d'ophtalmologie, Hôpital du Saint-Sacrement. CHU de Québec | Québec | Canada | G1S 4L8 |
Sponsors and Collaborators
- CHU de Quebec-Universite Laval
Investigators
- Principal Investigator: Andrew Toren, Doctor, Centre de recherche du CHU de Québec : Université Laval
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 2015-2212