Glaucoma, Open-AngleNCT03106181
A Comparison of Cataract Surgery Alone and Cataract Surgery With iStent
A study testing iStent inject® and Phacoemulsification and intraocular lens implant in people with Glaucoma, Open-Angle, run by Royal Victoria Eye and Ear Hospital at 1 site in Australia.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Glaucoma, Open-Angle
- What is being tested?
- iStent inject® and Phacoemulsification and intraocular lens implant
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 93 participants
- Where
- 1 siteAustralia
- Study dates
- 1 Feb 2018to 31 Dec 2022
- 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
- >18 years of age
- Diagnosis of mild-to-moderate open angle glaucoma
- Presence of cataract requiring surgery
- Good understanding of both verbal and written English
- Able to provide informed consent
Who cannot join
- Recent intraocular surgery within last 3 months
- Other ocular pathology affecting vision
- Inability to complete the elements of the study, eg: coma, hemodynamic instability, ventilator dependence, that could be of concern in the investigator's judgment.
- Non-elective hospitalisation within the past 60 days that could be of concern in the investigator's judgment.
- Medical illness that in the judgment of the investigator would jeopardise the safe completion of the study. Examples include cancer, chronic inflammatory disease, chronic liver insufficiency, epilepsy, thrombocytosis.
Trial locations and contacts
1 site in 1 country.
Australia1 site
Royal Victorian Eye and Ear Hospital
East Melbourne, Victoria, 3002
About this study
Official title: A Randomised Controlled Trial of Cataract Surgery Versus 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.
Read the detailed description
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.
- Conditions
- Glaucoma, Open-Angle
- Being tested
- iStent inject®, Phacoemulsification and intraocular lens implant
- Medical subject headings
- Glaucoma, Open-Angle
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
iStent inject®Device
Insertion of iStent inject®
Phacoemulsification and intraocular lens implantProcedure or surgery
Conventional phacoemulsification cataract surgery and intraocular lens implant
| Study group | Role | What they receive |
|---|---|---|
| Cataract surgery | Active comparator | Conventional phacoemulsification cataract surgery and intraocular lens implantation Receives: Procedure: Phacoemulsification and intraocular lens implant |
| Cataract surgery plus iStent inject® | Experimental | Conventional phacoemulsification cataract surgery and lens implantation plus insertion of iStent inject® Receives: Device: iStent inject®; Procedure: Phacoemulsification and intraocular lens implant |
What is being measured
The primary outcome is the main question the study is designed to answer.
Intraocular pressure
Intraocular pressure reduction
Measured: Up to 2 years
Glaucoma medications
Number of glaucoma medications
Measured: Up to 2 years
Secondary outcomes (1)
Treatment satisfaction
Patient treatment satisfaction
Measured: Up to 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Apr 2017
- Study start1 Feb 2018
- Primary completion31 Mar 2022
- Study completion31 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Glaucoma, Open-AngleStudies 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
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 93 participants (actual)
Sponsor and investigators
- Lead sponsor
- Royal Victoria Eye and Ear Hospital
- Sponsor type
- Other government
- Collaborators
- Glaukos Corporation, Center for Eye Research Australia
- Responsible party
- Principal investigator, Jennifer Fan Gaskin, Royal Victoria Eye and Ear Hospital
- Investigators
- Jennifer Fan Gaskin, FRANZCO, Principal investigator, Royal Victoria Eye and Ear HospitalBrian Ang, FRANZCO, Principal investigator, Royal Victoria Eye and Ear Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03106181
- Sponsor's protocol ID
- iStent RCT
- Status last verified
- Aug 2023
- First submitted
- 4 Apr 2017
- Last updated
- 9 Aug 2023
- 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 9 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomised Controlled Trial of Cataract Surgery Versus Combined Cataract Surgery With Insertion of iStent Inject®
- ClinicalTrials.gov ID
- NCT03106181
- Acronym / sponsor ID
- iStent RCT
- Conditions
- Glaucoma, Open-Angle
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 93 participants (actual)
- Lead sponsor
- Royal Victoria Eye and Ear HospitalOther government
- Collaborators
- Glaukos Corporation, Center for Eye Research Australia
- Study start
- 1 Feb 2018 (actual)
- Primary completion
- 31 Mar 2022 (actual)
- Study completion
- 31 Dec 2022 (actual)
- First posted
- 10 Apr 2017 (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.
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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cataract surgery | Active comparator | Procedure: Phacoemulsification and intraocular lens implantConventional phacoemulsification cataract surgery and intraocular lens implantation |
| Cataract surgery plus iStent inject® | Experimental | Device: iStent inject®, Procedure: Phacoemulsification and intraocular lens implantConventional phacoemulsification cataract surgery and lens implantation plus insertion of iStent inject® |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- >18 years of age
- Diagnosis of mild-to-moderate open angle glaucoma
- Presence of cataract requiring surgery
- Good understanding of both verbal and written English
- Able to provide informed consent
Key exclusion criteria (5 listed)
- Recent intraocular surgery within last 3 months
- Other ocular pathology affecting vision
- Inability to complete the elements of the study, eg: coma, hemodynamic instability, ventilator dependence, that could be of concern in the investigator's judgment.
- Non-elective hospitalisation within the past 60 days that could be of concern in the investigator's judgment.
- Medical illness that in the judgment of the investigator would jeopardise the safe completion of the study. Examples include cancer, chronic inflammatory disease, chronic liver insufficiency, epilepsy, thrombocytosis.
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 |
|---|---|---|
| iStent inject®Insertion of iStent inject® | Device | Cataract surgery plus iStent inject® |
| Phacoemulsification and intraocular lens implantConventional phacoemulsification cataract surgery and intraocular lens implant | Procedure or surgery | Cataract surgery, Cataract surgery plus iStent inject® |
Primary outcome
Intraocular pressure
Time frame: Up to 2 years
Intraocular pressure reduction
Glaucoma medications
Time frame: Up to 2 years
Number of glaucoma medications
1 secondary outcome
Treatment satisfaction
Time frame: Up to 2 years
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 9 Aug 2023.
- 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.
Jennifer Fan Gaskin, FRANZCO principal investigator
Royal Victoria Eye and Ear Hospital
Brian Ang, FRANZCO principal investigator
Royal Victoria Eye and Ear 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 inject® and Phacoemulsification and intraocular lens implant in people with Glaucoma, Open-Angle, run by Royal Victoria Eye and Ear Hospital at 1 site in Australia.
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 5 inclusion and 5 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 9 Aug 2023. 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 Australia. 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?
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 (time frame: Up to 2 years). 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 9 Aug 2023.