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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.
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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cataract surgery as stand alone | Active Comparator | Cataract 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 | 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. |
|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cataract surgery | Procedure | Cataract Surgery in a standardized fashion |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in the number of intraocular pressure lowering medications compared to baseline | Accountability of intraocular pressure lowering medications used by the patient | 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) | 12 to 24 months |
| Measure | Description | Time Frame |
|---|---|---|
| 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) | 12 to 24 months |
| Measure | Description | Time Frame |
|---|---|---|
| Number of participants that need further surgery | Arm comparison of future need for microinvasive surgery, filtering surgery or cyclodestructive laser | 12 to 24 months |
| Number of participants that need additional medical therapy |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Anna Barkander, MD | Hospital of Ostersund, department of Ophtalmology | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Eye clinic at the hospital of Ostersund | Östersund | Östersund | 83183 | Sweden |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Oct 18, 2022 | Oct 26, 2022 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D005902 | Glaucoma, Open-Angle |
| D002386 | Cataract |
| ID | Term |
|---|---|
| D005901 | Glaucoma |
| D009798 | Ocular Hypertension |
| D005128 | Eye Diseases |
| D007905 | Lens Diseases |
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| ID | Term |
|---|---|
| D002387 | Cataract Extraction |
| D018918 | Phacoemulsification |
| ID | Term |
|---|---|
| D054140 | Refractive Surgical Procedures |
| D013508 | Ophthalmologic Surgical Procedures |
| D013514 | Surgical Procedures, Operative |
| D059708 | Ultrasonic Surgical Procedures |
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| KDB | Procedure | Goniotomy with KDB glide will be performed at the end of Cataract Surgery |
|
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| Istent | Procedure | Two iStent inject W will be injected into Schlemms Canal at the end of Cataract Surgery |
|
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Assessment of the need for future medical therapy in the study groups
| 12 to 24 months |