GlaucomaPhase 4OptonolNCT00597181
A Clinical Study Comparing the Inflammatory Response of the Ex-Press Mini Shunt to Trabeculectomy
A Phase 4 study testing Trabeculectomy with mitomycin c and Ex-Press mini shunt with mitomycin c in people with Glaucoma, run by Indiana University at 1 site in United States.
Trial summary
The less invasive nature of the Ex-Press Mini shunt with mitomycin C induces less post-operative inflammation than trabeculectomy with mitomycin c. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Glaucoma
- What is being tested?
- Trabeculectomy with mitomycin c and Ex-Press mini shunt with mitomycin c
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2007to Aug 2010
- Phase
- Phase 4
- 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
- All subjects must:
- Be willing and able to provide written Informed Consent.
- Be able and willing to follow instructions on the use of post- operative medication and likely to complete the entire course of the study.
- Be male or female of any race at least 18 years of age.
- Have medically uncontrolled glaucoma for which they have elected to undergo surgery.
- Diagnosed with primary open angle glaucoma, pigmentary or pseudoexfoliation glaucoma.
Who cannot join
- No subject may:
- Have any contraindication to intraocular surgery.
- Diagnosed with: primary angle closure glaucoma, normal tension glaucoma, secondary glaucoma, neovascular glaucoma.
- Have any active ocular disease other than glaucoma that would interfere with study parameters (such as: uveitis, ocular infection, or severe dry eye). Subjects with mild chronic blepharitis, age-related macular degeneration and background diabetic retinopathy may be enrolled at the discretion of the investigator.
- Have laser ALT or SLT within the past 3 months or cataract surgery within the last six months.
- Require use of ocular NSAID or systemic steroids.
Show all 11Show fewer
- Have known allergy or sensitivity to mitomycin C
- Have corneal abnormalities that would interfere with the ability to obtain an adequate laser flare measurement.
- Be concurrently enrolled in an investigational drug or device study or participation within the last 30 days in any investigational drug or device study.
- Be pregnant, nursing, planning a pregnancy, or be of childbearing potential and not using a reliable form of contraception (a woman is considered of childbearing potential unless she is postmenopausal, has had a uterus and/or both ovaries removed, or has had a bilateral tubal ligation).
- Have a situation or condition that in the investigator's opinion may put the subject at significant risk, may confound the study results, or may interfere significantly with participation in the study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Clinical Study Comparing the Inflammatory Response of the Ex-Press Mini Glaucoma Shunt to Trabeculectomy in Subjects With Open-Angle Glaucoma
The less invasive nature of the Ex-Press Mini shunt with mitomycin C induces less post-operative inflammation than trabeculectomy with mitomycin c.
Read the detailed description
The purpose of this study is to quantify the degree of post-operative inflammation in eyes which have undergone either trabeculectomy filtering surgery or Ex-Press mini shunt insertion. Early intraocular pressure control and postoperative complications will also be noted.
- Conditions
- Glaucoma
- Being tested
- Trabeculectomy with mitomycin c, Ex-Press mini shunt with mitomycin c
- Keywords
- Inflammatory response
- Medical subject headings
- Glaucoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Trabeculectomy with mitomycin cProcedure or surgery
mitomycin c 0.2 mg/cc for 2 minutes
Ex-Press mini shunt with mitomycin cProcedure or surgery
mitomycin c 0.2 mg/cc for 2 minutes
| Study group | Role | What they receive |
|---|---|---|
| 1 | Active comparator | Trabeculectomy with Mitomycin C 0.2 mg/cc for 2 minutes Receives: Procedure: Trabeculectomy with mitomycin c |
| 2 | Active comparator | Ex-Press mini shunt; Model R50 with mitomycin C 0.2 mg/cc for 2 minutes Receives: Procedure: Ex-Press mini shunt with mitomycin c |
What is being measured
The primary outcome is the main question the study is designed to answer.
Aqueous humor flare
Measured: 2 months
Secondary outcomes (1)
Aqueous humor cell
Measured: 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jan 2008 (estimated)
- Study startNov 2007
- Primary completionJan 2009
- Study completionAug 2010
Why it stopped: Patient population limited
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for GlaucomaStudies of the same condition, open and under way.
- More trials run by Indiana UniversityThe sponsor's other registered studies.
- 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Indiana University
- Sponsor type
- University, hospital or other
- Collaborators
- Optonol
- Investigators
- Louis B Cantor, MD, Principal investigator, Indiana University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00597181
- Sponsor's protocol ID
- 0710-28
- Acronym
- Optonol
- Status last verified
- Sep 2010
- First submitted
- 7 Jan 2008
- Last updated
- 17 Sep 2010
- Results posted
- No
- Data monitoring committee
- No
Publications
Hille K, Hans J, Manderscheid T, Spang S, Ruprecht KW. [Laser flare in combined cataract and glaucoma surgery]. Ophthalmologe. 2001 Jan;98(1):47-53. doi: 10.1007/s003470170199. German.
PubMed 11220271Maris PJ Jr, Ishida K, Netland PA. Comparison of trabeculectomy with Ex-PRESS miniature glaucoma device implanted under scleral flap. J Glaucoma. 2007 Jan;16(1):14-9. doi: 10.1097/01.ijg.0000243479.90403.cd.
PubMed 17224744Shah SM, Spalton DJ, Allen RJ, Smith SE. A comparison of the laser flare cell meter and fluorophotometry in assessment of the blood-aqueous barrier. Invest Ophthalmol Vis Sci. 1993 Oct;34(11):3124-30.
PubMed 8407220Dahan E, Carmichael TR. Implantation of a miniature glaucoma device under a scleral flap. J Glaucoma. 2005 Apr;14(2):98-102. doi: 10.1097/01.ijg.0000151688.34904.b7.
PubMed 15741808Shields, MB Textbook of Glaucoma. Fourth Edition; Williams & Wilkins, Baltimore, 1998.
Guyer DR, Yannuzzi LA, Chang S, Shields JA, Green WR Retina-Vitreous-Macula. W.B. Saunders Company, Philadelphia, 1999.
Study at a glance
From the registry record, last updated by the sponsor on 17 Sep 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Clinical Study Comparing the Inflammatory Response of the Ex-Press Mini Glaucoma Shunt to Trabeculectomy in Subjects With Open-Angle Glaucoma
- ClinicalTrials.gov ID
- NCT00597181
- Acronym / sponsor ID
- Optonol / 0710-28
- Conditions
- Glaucoma
- Keywords
- Inflammatory response
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Patient population limited
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Indiana UniversityUniversity, hospital or other
- Collaborators
- Optonol
- Study start
- Nov 2007
- Primary completion
- Jan 2009 (actual)
- Study completion
- Aug 2010 (actual)
- First posted
- 17 Jan 2008 (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.
The less invasive nature of the Ex-Press Mini shunt with mitomycin C induces less post-operative inflammation than trabeculectomy with mitomycin c.
Detailed description
The purpose of this study is to quantify the degree of post-operative inflammation in eyes which have undergone either trabeculectomy filtering surgery or Ex-Press mini shunt insertion. Early intraocular pressure control and postoperative complications will also be noted.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Active comparator | Procedure: Trabeculectomy with mitomycin cTrabeculectomy with Mitomycin C 0.2 mg/cc for 2 minutes |
| 2 | Active comparator | Procedure: Ex-Press mini shunt with mitomycin cEx-Press mini shunt; Model R50 with mitomycin C 0.2 mg/cc for 2 minutes |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Be willing and able to provide written Informed Consent.
- Be able and willing to follow instructions on the use of post- operative medication and likely to complete the entire course of the study.
- Be male or female of any race at least 18 years of age.
- Have medically uncontrolled glaucoma for which they have elected to undergo surgery.
- Diagnosed with primary open angle glaucoma, pigmentary or pseudoexfoliation glaucoma.
Key exclusion criteria (11 listed)
- Have any contraindication to intraocular surgery.
- Diagnosed with: primary angle closure glaucoma, normal tension glaucoma, secondary glaucoma, neovascular glaucoma.
- Have any active ocular disease other than glaucoma that would interfere with study parameters (such as: uveitis, ocular infection, or severe dry eye). Subjects with mild chronic blepharitis, age-related macular degeneration and background diabetic retinopathy may be enrolled at the discretion of the investigator.
- Have laser ALT or SLT within the past 3 months or cataract surgery within the last six months.
- Require use of ocular NSAID or systemic steroids.
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 |
|---|---|---|
| Trabeculectomy with mitomycin cmitomycin c 0.2 mg/cc for 2 minutes | Procedure or surgery | 1 |
| Ex-Press mini shunt with mitomycin cmitomycin c 0.2 mg/cc for 2 minutes | Procedure or surgery | 2 |
Primary outcome
Aqueous humor flare
Time frame: 2 months
1 secondary outcome
Aqueous humor cell
Time frame: 2 months
Results and safety
The study was stopped early (reason given: Patient population limited). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Sep 2010.
- Background: PubMed 11220271Hille K, Hans J, Manderscheid T, Spang S, Ruprecht KW. [Laser flare in combined cataract and glaucoma surgery]. Ophthalmologe. 2001 Jan;98(1):47-53. doi: 10.1007/s003470170199. German.
- Background: PubMed 17224744Maris PJ Jr, Ishida K, Netland PA. Comparison of trabeculectomy with Ex-PRESS miniature glaucoma device implanted under scleral flap. J Glaucoma. 2007 Jan;16(1):14-9. doi: 10.1097/01.ijg.0000243479.90403.cd.
- Background: PubMed 8407220Shah SM, Spalton DJ, Allen RJ, Smith SE. A comparison of the laser flare cell meter and fluorophotometry in assessment of the blood-aqueous barrier. Invest Ophthalmol Vis Sci. 1993 Oct;34(11):3124-30.
- Background: PubMed 15741808Dahan E, Carmichael TR. Implantation of a miniature glaucoma device under a scleral flap. J Glaucoma. 2005 Apr;14(2):98-102. doi: 10.1097/01.ijg.0000151688.34904.b7.
- BackgroundShields, MB Textbook of Glaucoma. Fourth Edition; Williams & Wilkins, Baltimore, 1998.
- BackgroundGuyer DR, Yannuzzi LA, Chang S, Shields JA, Green WR Retina-Vitreous-Macula. W.B. Saunders Company, Philadelphia, 1999.
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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.
Louis B Cantor, MD principal investigator
Indiana University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Trabeculectomy with mitomycin c and Ex-Press mini shunt with mitomycin c in people with Glaucoma, run by Indiana University at 1 site in United States.
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 6 inclusion and 11 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: stopped early, as of the sponsor's last update on 17 Sep 2010. 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 United States. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: Patient population limited). Results are not available in the source record.
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?
Aqueous humor flare (time frame: 2 months). 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 NCT00597181, which also lists 6 linked publications.
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 17 Sep 2010.