Exfoliation GlaucomaCOILEHNCT04635020
Comparison Of iStent to Laser in Exfoliation Glaucoma Helsinki Study Group
A study testing iStent, SLT-laser and Cataract surgery in people with Exfoliation Glaucoma and Cataract, run by Helsinki University Central Hospital at 1 site in Finland.
Trial summary
The purpose of the study is to investigate the efficacy of an iStent trabecular microbypass stent compared to selective laser trabeculoplasty in combination with cataract surgery in eyes with exfoliation glaucoma (EXF) Read more about this study
- Who is it for?
- Ages 50 to 100 years
- Conditions the study is for
- Exfoliation Glaucoma, Cataract
- What is being tested?
- iStent, SLT-laser and Cataract surgery
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 285 participants
- Where
- 1 siteFinland
- Study dates
- 1 Oct 2020to Sep 2033
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 50 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Signed consent of information
- Clinical significant cataract
- Able to attend 12 month period
- Mild to moderate exfoliation glaucoma according to European glaucoma society guidelines (EGS)
- Group I stable glaucoma (IOP within individual target IOP), and group II unstable glaucoma (IOP above individual target IOP) with baseline glaucoma medication
- Target IOP ≥16
- Able to understand Finnish, Swedish or English
Who cannot join
- Clinical set target IOP < 16 mmHg in advanced glaucoma
- Baseline IOP prior to enrolment ≥30 mmHg, and ≥3 glaucoma medications
- Closed angle
- Congenital angle anomaly
- Clinically significant corneal dystrophy or other hindering corneal condition
- Unable to use topical medical therapy
Show all 12Show fewer
- Central corneal thickness of less than 480um or more than 620um
- Active uveitis, cystic macular edema (CME), exudative age-related macular degeneration, proliferative diabetic retinopathy or clinical significant macular edema, intraocular neoplasm, intraocular injections, intraocular lens luxation, phacodonesis.
- Previous intraocular surgery, refractive surgery or cycloablation
- Two or more prior SLT or laser trabeculoplasty
- Unable to participate due to another medical disease or condition
- Participating in another clinical trial
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Finland1 site, 1 recruiting
- Recruiting
Helsinki University Hospital
Helsinki
Eeva Ojanen, MD, +358 503608589, eeva.ojanen@hus.fi
Mika Harju, MD prof
About this study
Official title: A Prospective Randomised Trial Comparing Selective Laser Trabeculoplasty (SLT) and iStent Trabecular Micro-bypass Stent Implantation Combined With Cataract Surgery in Exfoliation Glaucoma
The purpose of the study is to investigate the efficacy of an iStent trabecular microbypass stent compared to selective laser trabeculoplasty in combination with cataract surgery in eyes with exfoliation glaucoma (EXF)
Read the detailed description
Exfoliation glaucoma patients with significant cataracts are being informed about the study and potential risks, all patients giving written informed consent will undergo screening to determine eligibility for study entry. Patient´s glaucoma is classified into stable or unstable glaucoma groups with their current glaucoma medication. Patients meeting the eligibility requirements of stable glaucoma will be randomised to cataract surgery combined with iStent (65 patients), II SLT (65 patients) or III cataract surgery alone (25 patients) and patient with unstable glaucoma will be randomised to cataract surgery combined with I iStent (65 patients), II SLT (65 patients).
- Conditions
- Exfoliation Glaucoma, Cataract
- Being tested
- iStent, SLT-laser, Cataract surgery
- Keywords
- SLT, iStent
- Medical subject headings
- Exfoliation Syndrome, Cataract
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
iStentProcedure or surgery
Also called Trabecular Micro-Bypass Stent System Model G2-M-IS, Glaukos Corporation, San Clemente, California
2 trabecular Stent injected at the end of the cataract surgery to the trabecular meshwork
SLT-laserProcedure or surgery
Also called Selective laser trabeculoplasty
1 month after cataract surgery laser treatment to the trabecular meshwork (100 applications, 360 degrees)
Cataract surgeryProcedure or surgery
Conventional cataract surgery
| Study group | Role | What they receive |
|---|---|---|
| Stable glaucoma iStent | Experimental | Cataract surgery combined with iStent inject Receives: Procedure: iStent; Procedure: Cataract surgery |
| Stable glaucoma SLT-laser | Experimental | Cataract surgery combined with SLT-laser 1 month after surgery Receives: Procedure: SLT-laser; Procedure: Cataract surgery |
| Stable glaucoma | Active comparator | Cataract surgery Receives: Procedure: Cataract surgery |
| Unstable glaucoma iStent | Experimental | Cataract surgery combined with iStent inject Receives: Procedure: iStent; Procedure: Cataract surgery |
| Unstable glaucoma SLT-laser | Experimental | Cataract surgery combined with SLT-laser 1 month after surgery Receives: Procedure: SLT-laser; Procedure: Cataract surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
Group I: Change in the number of IOP lowering medications compared to baseline
Accountability of IOP lowering medications used by the patient
Measured: 12 months
Group II: Change in the IOP compared to baseline
IOP measured by Goldmann aplanation tonometry (GAT)
Measured: 12 months
Secondary outcomes (2)
Group I: Change in the IOP compared to baseline
IOP measured by GAT
Measured: 12 months
Group II: Change in the number of IOP lowering medications compared to baseline
Accountability of IOP lowering medications used by the patient
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Nov 2020
- Study start1 Oct 2020
- Primary completionSep 2023 (estimated)
- Study completionSep 2033 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Exfoliation GlaucomaStudies of the same condition, open and under way.
- More trials run by Helsinki University Central HospitalThe sponsor's other registered studies.
- 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
- None (open label)
- Enrolment
- 285 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Helsinki University Central Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Prof. Mika Harju, Helsinki University Central Hospital
- Investigators
- Mika Harju, MD, prof., Principal investigator, Helsinki University Central Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04635020
- Sponsor's protocol ID
- 123123
- Acronym
- COILEH
- Status last verified
- Nov 2020
- First submitted
- 29 Oct 2020
- Last updated
- 18 Nov 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Randomised Trial Comparing Selective Laser Trabeculoplasty (SLT) and iStent Trabecular Micro-bypass Stent Implantation Combined With Cataract Surgery in Exfoliation Glaucoma
- ClinicalTrials.gov ID
- NCT04635020
- Acronym / sponsor ID
- COILEH / 123123
- Conditions
- Exfoliation Glaucoma, Cataract
- Keywords
- SLT, iStent
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 285 participants (estimated)
- Lead sponsor
- Helsinki University Central HospitalUniversity, hospital or other
- Study start
- 1 Oct 2020 (actual)
- Primary completion
- Sep 2023 (estimated)
- Study completion
- Sep 2033 (estimated)
- First posted
- 18 Nov 2020 (actual)
- 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 purpose of the study is to investigate the efficacy of an iStent trabecular microbypass stent compared to selective laser trabeculoplasty in combination with cataract surgery in eyes with exfoliation glaucoma (EXF)
Detailed description
Exfoliation glaucoma patients with significant cataracts are being informed about the study and potential risks, all patients giving written informed consent will undergo screening to determine eligibility for study entry. Patient´s glaucoma is classified into stable or unstable glaucoma groups with their current glaucoma medication. Patients meeting the eligibility requirements of stable glaucoma will be randomised to cataract surgery combined with iStent (65 patients), II SLT (65 patients) or III cataract surgery alone (25 patients) and patient with unstable glaucoma will be randomised to cataract surgery combined with I iStent (65 patients), II SLT (65 patients).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Stable glaucoma iStent | Experimental | Procedure: iStent, Procedure: Cataract surgeryCataract surgery combined with iStent inject |
| Stable glaucoma SLT-laser | Experimental | Procedure: SLT-laser, Procedure: Cataract surgeryCataract surgery combined with SLT-laser 1 month after surgery |
| Stable glaucoma | Active comparator | Procedure: Cataract surgeryCataract surgery |
| Unstable glaucoma iStent | Experimental | Procedure: iStent, Procedure: Cataract surgeryCataract surgery combined with iStent inject |
| Unstable glaucoma SLT-laser | Experimental | Procedure: SLT-laser, Procedure: Cataract surgeryCataract surgery combined with SLT-laser 1 month after surgery |
Who may qualify
- Ages
- 50 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Signed consent of information
- Clinical significant cataract
- Able to attend 12 month period
- Mild to moderate exfoliation glaucoma according to European glaucoma society guidelines (EGS)
- Group I stable glaucoma (IOP within individual target IOP), and group II unstable glaucoma (IOP above individual target IOP) with baseline glaucoma medication
Key exclusion criteria (12 listed)
- Clinical set target IOP < 16 mmHg in advanced glaucoma
- Baseline IOP prior to enrolment ≥30 mmHg, and ≥3 glaucoma medications
- Closed angle
- Congenital angle anomaly
- Clinically significant corneal dystrophy or other hindering corneal condition
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 |
|---|---|---|
| iStentAlso: Trabecular Micro-Bypass Stent System Model G2-M-IS, Glaukos Corporation, San Clemente, California2 trabecular Stent injected at the end of the cataract surgery to the trabecular meshwork | Procedure or surgery | Stable glaucoma iStent, Unstable glaucoma iStent |
| SLT-laserAlso: Selective laser trabeculoplasty1 month after cataract surgery laser treatment to the trabecular meshwork (100 applications, 360 degrees) | Procedure or surgery | Stable glaucoma SLT-laser, Unstable glaucoma SLT-laser |
| Cataract surgeryConventional cataract surgery | Procedure or surgery | Stable glaucoma, Stable glaucoma SLT-laser, Stable glaucoma iStent, Unstable glaucoma SLT-laser, Unstable glaucoma iStent |
Primary outcome
Group I: Change in the number of IOP lowering medications compared to baseline
Time frame: 12 months
Accountability of IOP lowering medications used by the patient
Group II: Change in the IOP compared to baseline
Time frame: 12 months
IOP measured by Goldmann aplanation tonometry (GAT)
2 secondary outcomes
Group I: Change in the IOP compared to baseline
Time frame: 12 months
Group II: Change in the number of IOP lowering medications compared to baseline
Time frame: 12 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Nov 2020.
- 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.
Mika Harju, MD, prof. principal investigator
Helsinki University Central Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing iStent, SLT-laser and Cataract surgery in people with Exfoliation Glaucoma and Cataract, run by Helsinki University Central Hospital at 1 site in Finland.
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 7 inclusion and 12 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: looking for participants now, as of the sponsor's last update on 18 Nov 2020. 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 Finland. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Eeva Ojanen, MD (+358503608589, eeva.ojanen@hus.fi), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Group I: Change in the number of IOP lowering medications compared to baseline (time frame: 12 months). The study lists 2 primary outcomes in all. 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 18 Nov 2020.