GlaucomaNCT02875158
Cyclophotocoagulation in Glaucoma
A study testing Cyclophotocoagulation protocol, Conventional cyclophotocoagulation and Modified cyclophotocoagulation in people with Glaucoma, run by CHU de Quebec-Universite Laval at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Glaucoma
- What is being tested?
- Cyclophotocoagulation protocol, Conventional cyclophotocoagulation and Modified cyclophotocoagulation
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 44 participants
- Where
- 1 siteCanada
- Study dates
- Aug 2016to Aug 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Patients with poorly controlled high pressure glaucoma
- Cyclophotocoagulation necessary to prevent visual loss
- Cyclophotocoagulation necessary to prevent or to reduce ocular discomfort
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Canada1 site
Centre universitaire d'ophtalmologie, Hôpital du Saint-Sacrement. CHU de Québec
Québec, G1S 4L8
About this study
Official title: Modified Settings for Transscleral Cyclophotocoagulation of the Ciliary Body in Glaucoma : A Randomized Controlled Trial
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.
- Conditions
- Glaucoma
- Being tested
- Cyclophotocoagulation protocol, Conventional cyclophotocoagulation, Modified cyclophotocoagulation
- Medical subject headings
- Glaucoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cyclophotocoagulation protocolProcedure or surgery
- 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
Conventional cyclophotocoagulationProcedure or surgery
1250 mW for 4 seconds.
Modified cyclophotocoagulationProcedure or surgery
2000 mW for 2 seconds.
| Study group | Role | What they receive |
|---|---|---|
| Diode laser using conventional settings | Active comparator | The cyclophotocoagulation protocol is used with the conventional cyclophotocoagulation settings of 2000 mW for 2 seconds. Receives: Procedure: Cyclophotocoagulation protocol; Procedure: Conventional cyclophotocoagulation |
| Diode laser using modified settings | Experimental | The cyclophotocoagulation protocol is used with the modified cyclophotocoagulation settings of 1250 mW for 4 seconds. Receives: Procedure: Cyclophotocoagulation protocol; Procedure: Modified cyclophotocoagulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Intraocular pressure (IOP) evolution
The intraocular pressure is measured to determine the efficacy of treatment during follow-up compared to the baseline IOP.
Measured: 1h, 1 month, 6 months, 12 months, 18 months and 24 months post-op
Secondary outcomes (4)
Presence of complications
Assessment of complications (if applicable).
Measured: During the intervention, 1 month, 6 months, 12 months, 18 months, 24 months post-op
Use of medication
Assessment of the topical and oral glaucoma medication at baseline and after treatment
Measured: 1 month, 6 months, 12 months, 18 months and 24 months post-op
Retreatment
The clinician will assess the need for retreatment based on clinical experience.
Measured: From the initial treatment up to the last visit (24 months)
Visual acuity
The visual acuity will be assessed at baseline and each subsequent visit
Measured: 1 month, 6 months, 12 months, 18 months and 24 months post-op
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Aug 2016 (estimated)
- Study startAug 2016
- Primary completionAug 2023
- Study completionAug 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for GlaucomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 44 participants (actual)
Sponsor and investigators
- Lead sponsor
- CHU de Quebec-Universite Laval
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Andrew Toren, Doctor, Principal investigator, Centre de recherche du CHU de Québec : Université Laval
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02875158
- Sponsor's protocol ID
- 2015-2212
- Status last verified
- Sep 2023
- First submitted
- 18 Jul 2016
- Last updated
- 11 Sep 2023
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Modified Settings for Transscleral Cyclophotocoagulation of the Ciliary Body in Glaucoma : A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT02875158
- Acronym / sponsor ID
- 2015-2212
- Conditions
- Glaucoma
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 44 participants (actual)
- Lead sponsor
- CHU de Quebec-Universite LavalUniversity, hospital or other
- Study start
- Aug 2016 (actual)
- Primary completion
- Aug 2023 (actual)
- Study completion
- Aug 2023 (actual)
- First posted
- 23 Aug 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Diode laser using conventional settings | Active comparator | Procedure: Cyclophotocoagulation protocol, Procedure: Conventional cyclophotocoagulationThe cyclophotocoagulation protocol is used with the conventional cyclophotocoagulation settings of 2000 mW for 2 seconds. |
| Diode laser using modified settings | Experimental | Procedure: Cyclophotocoagulation protocol, Procedure: Modified cyclophotocoagulationThe cyclophotocoagulation protocol is used with the modified cyclophotocoagulation settings of 1250 mW for 4 seconds. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients with poorly controlled high pressure glaucoma
- Cyclophotocoagulation necessary to prevent visual loss
- Cyclophotocoagulation necessary to prevent or to reduce ocular discomfort
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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 or surgery | Diode laser using conventional settings, Diode laser using modified settings |
| Conventional cyclophotocoagulation1250 mW for 4 seconds. | Procedure or surgery | Diode laser using conventional settings |
| Modified cyclophotocoagulation2000 mW for 2 seconds. | Procedure or surgery | Diode laser using modified settings |
Primary outcome
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.
4 secondary outcomes
Presence of complications
Time frame: During the intervention, 1 month, 6 months, 12 months, 18 months, 24 months post-op
Use of medication
Time frame: 1 month, 6 months, 12 months, 18 months and 24 months post-op
Retreatment
Time frame: From the initial treatment up to the last visit (24 months)
Visual acuity
Time frame: 1 month, 6 months, 12 months, 18 months and 24 months post-op
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Sep 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Andrew Toren, Doctor principal investigator
Centre de recherche du CHU de Québec : Université Laval
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cyclophotocoagulation protocol, Conventional cyclophotocoagulation and Modified cyclophotocoagulation in people with Glaucoma, run by CHU de Quebec-Universite Laval at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Intraocular pressure (IOP) evolution (time frame: 1h, 1 month, 6 months, 12 months, 18 months and 24 months post-op). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Sep 2023.