GlaucomaSLTNCT01058278
Impact Post-operative Treatment on Intraocular Pressure Post-SLT on Patients With Primary Open-angle Glaucoma
A study testing Selective Laser trabeculoplasty in people with Glaucoma and Inflammatory Response, run by CHU de Quebec-Universite Laval at 1 site in Canada.
Trial summary
The present study's main objective is to assess if there is a significant difference between either of the treatments frequently used in post-op, namely a topic cortisone-based treatment, an non-steroidal anti-inflammatory drug (NSAID) or simply a placebo, in order to gain the best long term (6 months) efficacy of the… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Glaucoma, Inflammatory Response
- What is being tested?
- Selective Laser trabeculoplasty
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 67 participants
- Where
- 1 siteCanada
- Study dates
- Mar 2008to Dec 2015
- 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 suffering from with primary open-angle glaucoma.
- Patients with IOP > 21 mmHg, uncontrolled with medical treatment or due to non-compliance, or to whom this is the first glaucoma treatment.
- Patients > 18 years old, able to consent.
- Patients consenting to the trial.
Who cannot join
- Patients suffering from chronic glaucoma other than primary open-angle glaucoma
- Patients who had changes done to their anti-glaucoma treatments over the last 6 weeks or following the SLT
- Patients under oral corticosteroid treatment at the time of the operation or those who have stopped during the preceding month.
- Patients suffering from an important corneal disease which interferes with the capacity to visualize the entire trabeculae.
- Monophthalmic patients.
- Patients who already underwent a glaucoma treatment to the eye requiring treatment.
Show all 9Show fewer
- Patients who already underwent a glaucoma treatment using SLT or ALT (Argon laser trabeculoplasty)
- Patients who underwent cataract surgery in the past 3 months.
- Pregnant patients.
Trial locations and contacts
1 site in 1 country.
Canada1 site
Centre universitaire d'ophtalmologie, Hôpital du Saint-Sacrement, CHU de Québec
Québec, Quebec, G1S 4L8
About this study
Official title: Impact of the Post-operative Treatment on the Intraocular Pressure Post Selective Laser Trabeculoplasty (SLT) on Patients With Primary Open-angle Glaucoma
The present study's main objective is to assess if there is a significant difference between either of the treatments frequently used in post-op, namely a topic cortisone-based treatment, an non-steroidal anti-inflammatory drug (NSAID) or simply a placebo, in order to gain the best long term (6 months) efficacy of the SLT.
Read the detailed description
The selective laser trabeculoplasty (SLT) is the laser treatment of choice for treating glaucoma. A There is however a controversy regarding the use of drops post-treatment. Indeed, some would prefer not to pharmacologically modulate the post-op inflammatory response which can be an integral part of the treatment by favouring the mobilisation of the macrophages which participate to the trabeculae "cleaning". Others will prefer to calm the inflammatory reaction and choose an anti-inflammatory drug (either steroidal or non-steroidal).
- Conditions
- Glaucoma, Inflammatory Response
- Being tested
- Selective Laser trabeculoplasty
- Keywords
- Glaucoma, Ocular Hypertension, Intraocular Pressure, Trabeculectomy
- Medical subject headings
- Glaucoma, Ocular Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Selective Laser trabeculoplastyProcedure or surgery
The Selective Laser Trabeculoplasty is done with the Latina lens after applying a drop of iopidine in the treated eye and alcaïne in both eye. Fifty spots are done over 180°. The maximal and total energy is written in the chart. After the treatment, prednisolone acetate 1% (a corticosteroid), diclofenac 0.1% (an NSAID) or a placebo is used. The three treatments were administered 4 times a day (at breakfast, lunch, dinner and at bedtime) for five days.
| Study group | Role | What they receive |
|---|---|---|
| Prednisone acetate 1% | Active comparator | A topic cortisone-based treatment Receives: Procedure: Selective Laser trabeculoplasty |
| diclofenac 0.1% | Active comparator | an non-steroidal anti-inflammatory drug Receives: Procedure: Selective Laser trabeculoplasty |
| Artificial Tears | Placebo comparator | Pharmasciences DIN: 02229570 Receives: Procedure: Selective Laser trabeculoplasty |
What is being measured
The primary outcome is the main question the study is designed to answer.
Intraocular pressure in the treated eye
Measured: 1 hour, 7 days, 1.5, 3 and 6 months
Secondary outcomes (1)
Side effects (include a slight uveitis, oculary discomfort and a spike in intraocular pressure in the immediate post-op period)
Measured: 1 hour, 7 days, 1.5 months, 3 months and 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jan 2010 (estimated)
- Study startMar 2008
- Primary completionJun 2012
- Study completionDec 2015
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, Care provider, Investigator
- Enrolment
- 67 participants (actual)
Sponsor and investigators
- Lead sponsor
- CHU de Quebec-Universite Laval
- Sponsor type
- University, hospital or other
- Collaborators
- Canadian Glaucoma Clinical Research Council, Pfizer
- Responsible party
- Principal investigator, Béatrice Des Marchais, CHU de Quebec-Universite Laval
- Investigators
- Béatrice Des Marchais, FRCSC M.Sc., Principal investigator, CHU de Quebec-Universite Laval
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01058278
- Sponsor's protocol ID
- DR-002-1213
- Acronym
- SLT
- Status last verified
- Feb 2016
- First submitted
- 27 Jan 2010
- Last updated
- 29 Feb 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Feb 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of the Post-operative Treatment on the Intraocular Pressure Post Selective Laser Trabeculoplasty (SLT) on Patients With Primary Open-angle Glaucoma
- ClinicalTrials.gov ID
- NCT01058278
- Acronym / sponsor ID
- SLT / DR-002-1213
- Conditions
- Glaucoma, Inflammatory Response
- Keywords
- Glaucoma, Ocular Hypertension, Intraocular Pressure, Trabeculectomy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 67 participants (actual)
- Lead sponsor
- CHU de Quebec-Universite LavalUniversity, hospital or other
- Collaborators
- Canadian Glaucoma Clinical Research Council, Pfizer
- Study start
- Mar 2008
- Primary completion
- Jun 2012 (actual)
- Study completion
- Dec 2015 (actual)
- First posted
- 28 Jan 2010 (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.
The present study's main objective is to assess if there is a significant difference between either of the treatments frequently used in post-op, namely a topic cortisone-based treatment, an non-steroidal anti-inflammatory drug (NSAID) or simply a placebo, in order to gain the best long term (6 months) efficacy of the SLT.
Detailed description
The selective laser trabeculoplasty (SLT) is the laser treatment of choice for treating glaucoma. A There is however a controversy regarding the use of drops post-treatment. Indeed, some would prefer not to pharmacologically modulate the post-op inflammatory response which can be an integral part of the treatment by favouring the mobilisation of the macrophages which participate to the trabeculae "cleaning". Others will prefer to calm the inflammatory reaction and choose an anti-inflammatory drug (either steroidal or non-steroidal).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Prednisone acetate 1% | Active comparator | Procedure: Selective Laser trabeculoplastyA topic cortisone-based treatment |
| diclofenac 0.1% | Active comparator | Procedure: Selective Laser trabeculoplastyan non-steroidal anti-inflammatory drug |
| Artificial Tears | Placebo comparator | Procedure: Selective Laser trabeculoplastyPharmasciences DIN: 02229570 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patients suffering from with primary open-angle glaucoma.
- Patients with IOP > 21 mmHg, uncontrolled with medical treatment or due to non-compliance, or to whom this is the first glaucoma treatment.
- Patients > 18 years old, able to consent.
- Patients consenting to the trial.
Key exclusion criteria (9 listed)
- Patients suffering from chronic glaucoma other than primary open-angle glaucoma
- Patients who had changes done to their anti-glaucoma treatments over the last 6 weeks or following the SLT
- Patients under oral corticosteroid treatment at the time of the operation or those who have stopped during the preceding month.
- Patients suffering from an important corneal disease which interferes with the capacity to visualize the entire trabeculae.
- Monophthalmic patients.
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 |
|---|---|---|
| Selective Laser trabeculoplastyThe Selective Laser Trabeculoplasty is done with the Latina lens after applying a drop of iopidine in the treated eye and alcaïne in both eye. Fifty spots are done over 180°. The maximal and total energy is written in the chart. After the treatment, prednisolone acetate 1% (a corticosteroid), diclofenac 0.1% (an NSAID) or a placebo is used. The three treatments were administered 4 times a day (at breakfast, lunch, dinner and at bedtime) for five days. | Procedure or surgery | Artificial Tears, Prednisone acetate 1%, diclofenac 0.1% |
Primary outcome
Intraocular pressure in the treated eye
Time frame: 1 hour, 7 days, 1.5, 3 and 6 months
1 secondary outcome
Side effects (include a slight uveitis, oculary discomfort and a spike in intraocular pressure in the immediate post-op period)
Time frame: 1 hour, 7 days, 1.5 months, 3 months and 6 months
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 29 Feb 2016.
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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.
Béatrice Des Marchais, FRCSC M.Sc. principal investigator
CHU de Quebec-Universite 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 Selective Laser trabeculoplasty in people with Glaucoma and Inflammatory Response, 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 4 inclusion and 9 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 29 Feb 2016. 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. Some participants in this study may receive a placebo. 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 in the treated eye (time frame: 1 hour, 7 days, 1.5, 3 and 6 months). 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 29 Feb 2016.