Glaucoma
Conditions
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.
Interventions
PROCEDURECyclophotocoagulation 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
PROCEDUREConventional cyclophotocoagulation
1250 mW for 4 seconds.
PROCEDUREModified cyclophotocoagulation
2000 mW for 2 seconds.
Sponsors
CHU de Quebec-Universite Laval
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Countries
Canada
Outcome results
None listed