Primary Open Angle Glaucoma and CataractsNCT00847158
A Clinical Trial of Phacoemulsification Versus Phacoemulsification & the iStent Implantation in POAG Patients
A study testing phacoemulsification alone and iStent Trabecular Micro-Bypass Stent in people with Primary Open Angle Glaucoma and Cataracts, run by University of Turin, Italy.
Trial summary
This was a prospective, double-masked, 15-month clinical trial comparing efficacy of phacoemulsification alone to combined phacoemulsification and implantation of the iStent® trabecular micro-bypass stent in patients with primary open-angle glaucoma. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Primary Open Angle Glaucoma and Cataracts
- What is being tested?
- phacoemulsification alone and iStent Trabecular Micro-Bypass Stent
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- No sites listed yet
- Study dates
- Dec 2006to Mar 2008
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- a previous diagnosis of POAG
- an IOP of > 18 mm Hg at three separate visits if on one medication, or subjects on at least two medications with uncontrolled IOP on three separate visits.
- all patients were deemed likely to follow surgeon instructions and were able to give informed consent.
Who cannot join
- any glaucoma diagnosis other than POAG
- the presence of peripheral anterior synechiae (PAS)
- a cloudy cornea likely to inhibit gonioscopic view of the angle
- any previous ocular surgery
- history of trauma or ocular surface disease
- the presence of peripheral anterior synechiae (PAS)
- a cloudy cornea likely to inhibit gonioscopic view of the angle
About this study
Official title: A Randomized, Double-Masked Clinical Trial of Phacoemulsification Compared With Phacoemulsification and Micro-Bypass Stent Implantation in Patients With POAG
This was a prospective, double-masked, 15-month clinical trial comparing efficacy of phacoemulsification alone to combined phacoemulsification and implantation of the iStent® trabecular micro-bypass stent in patients with primary open-angle glaucoma.
Read the detailed description
This was a prospective, randomized open-label study of 36 patients with POAG scheduled to undergo phacoemulsification with intraocular lens implantation ("cataract surgery"). Patients were randomized 2:1 to receive either cataract surgery alone (control group) or cataract surgery and iStent implantation (combined surgery group).
Implantation of the study stent occurred after cataract extraction and IOL insertion using the same small, temporal, clear-corneal incision (approximately 3 mm) used to perform phacoemulsification and IOL placement. The study stent was guided into Schlemm's canal using ab-interno gonioscopy (using a Swan-Jacobs gonioscope). (Figure 1) If no complications occurred during phacoemulsification, acetylcholine was injected in the anterior chamber after the IOL implantation to constrict the pupil. The anterior chamber was then filled with a viscoelastic agent to reform the anterior chamber and provide more clearance in the angle.
The anterior chamber was traversed with the applicator (the implant was on the tip of applicator) and the trabecular meshwork located. The leading edge of the device was gently slid through the trabecular meshwork and into Schlemm's canal at the nasal position (3 to 4 o'clock for the right eye; 9 to 8 o'clock for the left eye) with the tip of the implant directed inferiorly. If difficulty was encountered with the insertion at the primary location, we tried inserting about 0.5 clock hour inferiorly; and continued to move inferiorly as needed for subsequent attempts. Next, the device was released by pushing the button on the applicator, position of the stent was verified and the applicator was withdrawn.
The patients were instructed to discontinue all glaucoma medications after surgery. Standard post cataract extraction antibiotic and anti-inflammatory drug regimen was prescribed. Target pressure for each patient was determined prior to study entry. Following the assigned procedure, any patient with an IOP (as measured between 8 and 10 AM) that was greater than 2 mm Hg over their target was instructed to return twice in the following three days for re-measurement of their IOP. If the patient's IOP was > 2 mm Hg over their target pressure, ocular hypotensive agents were added. The medications were added in a pre-set schedule, with beta-blockers first, angiotensin-converting enzyme (ACE) inhibitors second, and prostaglandins third. If, however, on the third consecutive visit the patient's IOP was within 2 mm Hg of target, patient re-entered the normal visit schedule. Investigators were masked to treatment assignment both when measuring IOP and when determining when or if to add medications.
- Being tested
- phacoemulsification alone, iStent Trabecular Micro-Bypass Stent
- Keywords
- POAG, Combination glaucoma & cataract procedure, trabecular micro-bypass stent, 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.
phacoemulsification aloneProcedure or surgery
Also called cataract surgery, Phaco
phacoemulsification alone
iStent Trabecular Micro-Bypass StentDevice
Also called iStent, Trabecular micro-bypass stent, GTS100L, GTS100R
phacoemulsification and implantation of the iStent® trabecular micro-bypass stent
| Study group | Role | What they receive |
|---|---|---|
| 1 | Active comparator | phacoemulsification alone Receives: Procedure: phacoemulsification alone |
| 2 | Active comparator | phacoemulsification and implantation of the iStent® trabecular micro-bypass stent Receives: Device: iStent Trabecular Micro-Bypass Stent |
What is being measured
The primary outcome is the main question the study is designed to answer.
Primary outcomes included IOP and reduction in medication use.
Measured: 15 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Feb 2009 (estimated)
- Study startDec 2006
- Primary completionMar 2008
- Study completionMar 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Primary Open Angle Glaucoma and CataractsStudies 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
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Turin, Italy
- Sponsor type
- University, hospital or other
- Investigators
- Antonio Fea, MD, Principal investigator, University of Torino
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00847158
- Sponsor's protocol ID
- iStent Washout study
- Status last verified
- Feb 2009
- First submitted
- 18 Feb 2009
- Last updated
- 19 Feb 2009
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Fea AM, Consolandi G, Zola M, Pignata G, Cannizzo P, Lavia C, Rolle T, Grignolo FM. Micro-Bypass Implantation for Primary Open-Angle Glaucoma Combined with Phacoemulsification: 4-Year Follow-Up. J Ophthalmol. 2015;2015:795357. doi: 10.1155/2015/795357. Epub 2015 Oct 26.
PubMed 26587282
Study at a glance
From the registry record, last updated by the sponsor on 19 Feb 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-Masked Clinical Trial of Phacoemulsification Compared With Phacoemulsification and Micro-Bypass Stent Implantation in Patients With POAG
- ClinicalTrials.gov ID
- NCT00847158
- Acronym / sponsor ID
- iStent Washout study
- Keywords
- POAG, Combination glaucoma & cataract procedure, trabecular micro-bypass stent, iStent
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- University of Turin, ItalyUniversity, hospital or other
- Study start
- Dec 2006
- Primary completion
- Mar 2008 (actual)
- Study completion
- Mar 2008 (actual)
- First posted
- 19 Feb 2009 (estimated)
- 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 was a prospective, double-masked, 15-month clinical trial comparing efficacy of phacoemulsification alone to combined phacoemulsification and implantation of the iStent® trabecular micro-bypass stent in patients with primary open-angle glaucoma.
Detailed description
This was a prospective, randomized open-label study of 36 patients with POAG scheduled to undergo phacoemulsification with intraocular lens implantation ("cataract surgery"). Patients were randomized 2:1 to receive either cataract surgery alone (control group) or cataract surgery and iStent implantation (combined surgery group).
Implantation of the study stent occurred after cataract extraction and IOL insertion using the same small, temporal, clear-corneal incision (approximately 3 mm) used to perform phacoemulsification and IOL placement. The study stent was guided into Schlemm's canal using ab-interno gonioscopy (using a Swan-Jacobs gonioscope). (Figure 1) If no complications occurred during phacoemulsification, acetylcholine was injected in the anterior chamber after the IOL implantation to constrict the pupil. The anterior chamber was then filled with a viscoelastic agent to reform the anterior chamber and provide more clearance in the angle.
The anterior chamber was traversed with the applicator (the implant was on the tip of applicator) and the trabecular meshwork located. The leading edge of the device was gently slid through the trabecular meshwork and into Schlemm's canal at the nasal position (3 to 4 o'clock for the right eye; 9 to 8 o'clock for the left eye) with the tip of the implant directed inferiorly. If difficulty was encountered with the insertion at the primary location, we tried inserting about 0.5 clock hour inferiorly; and continued to move inferiorly as needed for subsequent attempts. Next, the device was released by pushing the button on the applicator, position of the stent was verified and the applicator was withdrawn.
The patients were instructed to discontinue all glaucoma medications after surgery. Standard post cataract extraction antibiotic and anti-inflammatory drug regimen was prescribed. Target pressure for each patient was determined prior to study entry. Following the assigned procedure, any patient with an IOP (as measured between 8 and 10 AM) that was greater than 2 mm Hg over their target was instructed to return twice in the following three days for re-measurement of their IOP. If the patient's IOP was > 2 mm Hg over their target pressure, ocular hypotensive agents were added. The medications were added in a pre-set schedule, with beta-blockers first, angiotensin-converting enzyme (ACE) inhibitors second, and prostaglandins third. If, however, on the third consecutive visit the patient's IOP was within 2 mm Hg of target, patient re-entered the normal visit schedule. Investigators were masked to treatment assignment both when measuring IOP and when determining when or if to add medications.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Active comparator | Procedure: phacoemulsification alonephacoemulsification alone |
| 2 | Active comparator | Device: iStent Trabecular Micro-Bypass Stentphacoemulsification and implantation of the iStent® trabecular micro-bypass stent |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- a previous diagnosis of POAG
- an IOP of > 18 mm Hg at three separate visits if on one medication, or subjects on at least two medications with uncontrolled IOP on three separate visits.
- all patients were deemed likely to follow surgeon instructions and were able to give informed consent.
Key exclusion criteria (7 listed)
- any glaucoma diagnosis other than POAG
- the presence of peripheral anterior synechiae (PAS)
- a cloudy cornea likely to inhibit gonioscopic view of the angle
- any previous ocular surgery
- history of trauma or ocular surface disease
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 |
|---|---|---|
| phacoemulsification aloneAlso: cataract surgery, Phacophacoemulsification alone | Procedure or surgery | 1 |
| iStent Trabecular Micro-Bypass StentAlso: iStent, Trabecular micro-bypass stent, GTS100L, GTS100Rphacoemulsification and implantation of the iStent® trabecular micro-bypass stent | Device | 2 |
Primary outcome
Primary outcomes included IOP and reduction in medication use.
Time frame: 15 month
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 19 Feb 2009.
- Derived from this study: PubMed 26587282Fea AM, Consolandi G, Zola M, Pignata G, Cannizzo P, Lavia C, Rolle T, Grignolo FM. Micro-Bypass Implantation for Primary Open-Angle Glaucoma Combined with Phacoemulsification: 4-Year Follow-Up. J Ophthalmol. 2015;2015:795357. doi: 10.1155/2015/795357. Epub 2015 Oct 26.
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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.
Antonio Fea, MD principal investigator
University of Torino
Questions about this trial
What is this clinical trial studying?
A study testing phacoemulsification alone and iStent Trabecular Micro-Bypass Stent in people with Primary Open Angle Glaucoma and Cataracts, run by University of Turin, Italy.
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 3 inclusion and 7 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 19 Feb 2009. Status can change between updates, so confirm with the study contact before making plans.
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?
Primary outcomes included IOP and reduction in medication use. (time frame: 15 month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00847158, which also lists 1 linked publication.
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 19 Feb 2009.