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| Name | Class |
|---|---|
| Glaukos Corporation | INDUSTRY |
| Center for Eye Research Australia | OTHER |
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This study aims to recruit patients of the Glaucoma Investigative and Research Unit (GIRU) of Royal Victorian Eye and Ear Hospital (RVEEH) with mild to moderate glaucoma who are due to undergo cataract surgery and randomise each to either cataract surgery or combined cataract surgery with iStent Inject® insertion. Only patients who meet the inclusion criteria and none of the exclusion criteria will be recruited. The outcomes measures of the study will be a comparison of: 1) extent of IOP reduction; 2) reduction in number of topical glaucoma medications; 3) patient treatment satisfaction - between the two treatment groups.
Glaucoma is the commonest cause of irreversible blindness in the world. Treatment centres around lowering intraocular pressure (IOP) and typically includes medication (least invasive), laser, to surgery (most invasive). The gold-standard glaucoma operation is the trabeculectomy. Whilst it is effective at lowering IOP, it is associated with potentially devastating complications including bleb leak, hypotonous maculopathy, blebitis and endophthalmitis. In recent years, minimally- invasive glaucoma surgery (MIGS) has become an increasingly popular option of treating mild to moderate glaucoma. It is usually performed in conjunction with cataract surgery. The iStent (Glaukos Corporation, California, USA) is one of the most commonly utilised MIGS devices in the world and one of two Therapeutic Goods Administration (TGA)- approved MIGS devices in Australia. The iStent Inject® is the second generation iStent device and Australia is one of the first countries in the world to have access to this. So far there are no published randomised controlled trials comparing the effect of cataract surgery alone to combined cataract surgery with insertion of iStent Inject®.
This study aims to recruit patients of the Glaucoma Investigative and Research Unit (GIRU) of Royal Victorian Eye and Ear Hospital (RVEEH) with mild to moderate glaucoma who are due to undergo cataract surgery and randomise each to either cataract surgery or combined cataract surgery with iStent Inject® insertion. Only patients who meet the inclusion criteria and none of the exclusion criteria will be recruited. The outcomes measures of the study will be a comparison of: 1) extent of IOP reduction; 2) reduction in number of topical glaucoma medications; 3) patient treatment satisfaction - between the two treatment groups.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cataract surgery | Active Comparator | Conventional phacoemulsification cataract surgery and intraocular lens implantation |
|
| Cataract surgery plus iStent inject® | Experimental | Conventional phacoemulsification cataract surgery and lens implantation plus insertion of iStent inject® |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| iStent inject® | Device | Insertion of iStent inject® |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Intraocular pressure | Intraocular pressure reduction | Up to 2 years |
| Glaucoma medications | Number of glaucoma medications | Up to 2 years |
| Measure | Description | Time Frame |
|---|---|---|
| Treatment satisfaction | Patient treatment satisfaction | Up to 2 years |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jennifer Fan Gaskin, FRANZCO | Royal Victoria Eye and Ear Hospital | Principal Investigator |
| Brian Ang, FRANZCO | Royal Victoria Eye and Ear Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Royal Victorian Eye and Ear Hospital | East Melbourne | Victoria | 3002 | Australia |
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| ID | Term |
|---|---|
| D005902 | Glaucoma, Open-Angle |
| ID | Term |
|---|---|
| D005901 | Glaucoma |
| D009798 | Ocular Hypertension |
| D005128 | Eye Diseases |
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| ID | Term |
|---|---|
| D018918 | Phacoemulsification |
| D019654 | Lens Implantation, Intraocular |
| ID | Term |
|---|---|
| D002387 | Cataract Extraction |
| D054140 | Refractive Surgical Procedures |
| D013508 | Ophthalmologic Surgical Procedures |
| D013514 | Surgical Procedures, Operative |
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| Phacoemulsification and intraocular lens implant |
| Procedure |
Conventional phacoemulsification cataract surgery and intraocular lens implant |
|
| D059708 | Ultrasonic Surgical Procedures |