Open Angle GlaucomaSMIGSNCT05035394
Swedish Microinvasive Glaucoma Surgery Study (SMIGS)
A study testing Cataract surgery, KDB and Istent in people with Open Angle Glaucoma and Cataract, run by Umeå University at 1 site in Sweden.
Trial summary
The purpose of the study is to investigate the efficacy of Cataract Surgery as stand-alone compared to Cataract Surgery in combination with Kahook Dual Blade Glide goniotomy (KDB) or iStent Inject W Trabecular Microbypass Stent (Istent) in eyes with Open-angle glaucoma. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Open Angle Glaucoma, Cataract, Kahook Dual Blade Glide
- What is being tested?
- Cataract surgery, KDB and Istent
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteSweden
- Study dates
- 16 Sep 2021to Sep 2027
- 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Only one eye per participant
- Clinically significant cataract
- Glaucoma or intraocular hypertension treated with one to four medications and no need for filtering glaucoma surgery at the time of study enrollment.
- Open chamber angle with Schaffer grading three to four in at least two quadrants
Who cannot join
- Previous glaucoma surgery, including cyclodestructive procedures.
- Selective Laser Trabeculoplasty (SLT) within 90 days prior to planned surgery.
- Exudative age-related macular degeneration, proliferative diabetic retinopathy, clinically significant corneal dystrophy, other eye disease that affect intraocular eye pressure or visual field.
- Unable to participate and make written consent due to another medical condition.
Trial locations and contacts
1 site in 1 country.
Sweden1 site
Eye clinic at the hospital of Ostersund
Östersund, Östersund, 83183
About this study
Official title: A Prospective Randomized Trial Comparing Cataract Surgery as Stand Alone and Cataract Surgery Combined With Kahook Dual Blade Glide Goniotomy or Istent Inject W Trabecular Micro-Bypass Stent in Open-Angle Glaucoma.
The purpose of the study is to investigate the efficacy of Cataract Surgery as stand-alone compared to Cataract Surgery in combination with Kahook Dual Blade Glide goniotomy (KDB) or iStent Inject W Trabecular Microbypass Stent (Istent) in eyes with Open-angle glaucoma.
Read the detailed description
Glaucoma patients with significant cataract are being informed about the study and potential risks, all participants giving written informed consent and meeting the criteria will become eligibility for study entry. Participants meeting the eligible requirements will be randomized to Cataract Surgery as stand-alone (40 patients) or Cataract Surgery combined with Kahook Dual Blade Glide (40 patients) or iStent Inject W (40 patients).
- Conditions
- Open Angle Glaucoma, Cataract, Kahook Dual Blade Glide, Istent Inject W, MIGS, Goniotomy
- Being tested
- Cataract surgery, KDB, Istent
- Medical subject headings
- Glaucoma, Open-Angle, Cataract
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cataract surgeryProcedure or surgery
Also called Phacoemulsification, Cataract Surgery as stand-alone
Cataract Surgery in a standardized fashion
KDBProcedure or surgery
Also called Kahook Dual Blade Glide, New World Medical, Inc, Rancho Cucamonga, CA, KDB glide
Goniotomy with KDB glide will be performed at the end of Cataract Surgery
IstentProcedure or surgery
Also called iStent inject W, Trabecular Micro-Bypass Stent System Model G2-W, Glaukos Corporation, San Clemente, California
Two iStent inject W will be injected into Schlemms Canal at the end of Cataract Surgery
| Study group | Role | What they receive |
|---|---|---|
| Cataract surgery as stand alone | Active comparator | Cataract surgery as stand alone. Cataract surgery will be performed in a standardized fashion. Receives: Procedure: Cataract surgery |
| Cataract surgery in combination with Kahook Dual Blade glide goniotomy | Active comparator | Cataract surgery combined with Kahook Dual Blade Glide goniotomy. The goniotomy will be performed at the end of cataract surgery through the temporal cataract incision. Receives: Procedure: KDB |
| Cataract surgery in combination with iStent Inject W implantation | Active comparator | Cataract surgery combined with iStent Inject W. The two stents will be injected in Schlemms canal at the end of cataract surgery through the temporal cataract incision. Receives: Procedure: Istent |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in the number of intraocular pressure lowering medications compared to baseline
Accountability of intraocular pressure lowering medications used by the patient
Measured: 12 to 24 months
Number of participants with ≥20 percent intraocular pressure reduction or reduction with ≥1 medication compared to baseline
Intraocular pressure measured by Goldmann applanation tonometry (GAT)
Measured: 12 to 24 months
Secondary outcomes (1)
Number of participants with intraocular pressure ≤21 mm Hg, ≤18 mm Hg, ≤15 mm Hg and ≤12mm Hg
Intraocular pressure measured by Goldmann applanation tonometry (GAT)
Measured: 12 to 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Sep 2021
- Study start16 Sep 2021
- Primary completionSep 2026 (estimated)
- Study completionSep 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Open Angle 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
- None (open label)
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- Umeå University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Anna Barkander, Umeå University
- Investigators
- Anna Barkander, MD, Principal investigator, Hospital of Ostersund, department of Ophtalmology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05035394
- Sponsor's protocol ID
- 2021-02970
- Acronym
- SMIGS
- Status last verified
- Jun 2025
- First submitted
- 27 Aug 2021
- Last updated
- 5 Jun 2025
- Results posted
- No
- Data monitoring committee
- No
- 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 5 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Randomized Trial Comparing Cataract Surgery as Stand Alone and Cataract Surgery Combined With Kahook Dual Blade Glide Goniotomy or Istent Inject W Trabecular Micro-Bypass Stent in Open-Angle Glaucoma.
- ClinicalTrials.gov ID
- NCT05035394
- Acronym / sponsor ID
- SMIGS / 2021-02970
- Conditions
- Open Angle Glaucoma, Cataract, Kahook Dual Blade Glide, Istent Inject W, MIGS, Goniotomy
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Umeå UniversityUniversity, hospital or other
- Study start
- 16 Sep 2021 (actual)
- Primary completion
- Sep 2026 (estimated)
- Study completion
- Sep 2027 (estimated)
- First posted
- 5 Sep 2021 (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 Cataract Surgery as stand-alone compared to Cataract Surgery in combination with Kahook Dual Blade Glide goniotomy (KDB) or iStent Inject W Trabecular Microbypass Stent (Istent) in eyes with Open-angle glaucoma.
Detailed description
Glaucoma patients with significant cataract are being informed about the study and potential risks, all participants giving written informed consent and meeting the criteria will become eligibility for study entry. Participants meeting the eligible requirements will be randomized to Cataract Surgery as stand-alone (40 patients) or Cataract Surgery combined with Kahook Dual Blade Glide (40 patients) or iStent Inject W (40 patients).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Cataract surgery as stand alone | Active comparator | Procedure: Cataract surgeryCataract surgery as stand alone. Cataract surgery will be performed in a standardized fashion. |
| Cataract surgery in combination with Kahook Dual Blade glide goniotomy | Active comparator | Procedure: KDBCataract surgery combined with Kahook Dual Blade Glide goniotomy. The goniotomy will be performed at the end of cataract surgery through the temporal cataract incision. |
| Cataract surgery in combination with iStent Inject W implantation | Active comparator | Procedure: IstentCataract surgery combined with iStent Inject W. The two stents will be injected in Schlemms canal at the end of cataract surgery through the temporal cataract incision. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Only one eye per participant
- Clinically significant cataract
- Glaucoma or intraocular hypertension treated with one to four medications and no need for filtering glaucoma surgery at the time of study enrollment.
- Open chamber angle with Schaffer grading three to four in at least two quadrants
Key exclusion criteria (4 listed)
- Previous glaucoma surgery, including cyclodestructive procedures.
- Selective Laser Trabeculoplasty (SLT) within 90 days prior to planned surgery.
- Exudative age-related macular degeneration, proliferative diabetic retinopathy, clinically significant corneal dystrophy, other eye disease that affect intraocular eye pressure or visual field.
- Unable to participate and make written consent due to another medical 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 |
|---|---|---|
| Cataract surgeryAlso: Phacoemulsification, Cataract Surgery as stand-aloneCataract Surgery in a standardized fashion | Procedure or surgery | Cataract surgery as stand alone |
| KDBAlso: Kahook Dual Blade Glide, New World Medical, Inc, Rancho Cucamonga, CA, KDB glideGoniotomy with KDB glide will be performed at the end of Cataract Surgery | Procedure or surgery | Cataract surgery in combination with Kahook Dual Blade glide goniotomy |
| IstentAlso: iStent inject W, Trabecular Micro-Bypass Stent System Model G2-W, Glaukos Corporation, San Clemente, CaliforniaTwo iStent inject W will be injected into Schlemms Canal at the end of Cataract Surgery | Procedure or surgery | Cataract surgery in combination with iStent Inject W implantation |
Primary outcome
Change in the number of intraocular pressure lowering medications compared to baseline
Time frame: 12 to 24 months
Accountability of intraocular pressure lowering medications used by the patient
Number of participants with ≥20 percent intraocular pressure reduction or reduction with ≥1 medication compared to baseline
Time frame: 12 to 24 months
Intraocular pressure measured by Goldmann applanation tonometry (GAT)
1 secondary outcome
Number of participants with intraocular pressure ≤21 mm Hg, ≤18 mm Hg, ≤15 mm Hg and ≤12mm Hg
Time frame: 12 to 24 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 5 Jun 2025.
- 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.
Anna Barkander, MD principal investigator
Hospital of Ostersund, department of Ophtalmology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cataract surgery, KDB and Istent in people with Open Angle Glaucoma and Cataract, run by Umeå University at 1 site in Sweden.
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 4 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: under way, not looking for participants, as of the sponsor's last update on 5 Jun 2025. 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 Sweden. 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?
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?
Change in the number of intraocular pressure lowering medications compared to baseline (time frame: 12 to 24 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 5 Jun 2025.