Refractory GlaucomaPhase 3NCT00971061
Ahmed Glaucoma Valve and Single-Plate Molteno Implants in Treatment of Refractory Glaucoma
A Phase 3 study testing Ahmed valve implant and Molteno single-plate implant (MSPI) in people with Refractory Glaucoma, run by Vanak Eye Surgery Center at 1 site in Iran.
Trial summary
The purpose of this study is to investigate the efficacy and safety of the Ahmed valve implant (AVI) and the Molteno single-plate implant (MSPI) in eyes with refractory glaucoma during a follow-up period of 24 months. Read more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- Refractory Glaucoma
- What is being tested?
- Ahmed valve implant and Molteno single-plate implant (MSPI)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 72 participants
- Where
- 1 siteIran
- Study dates
- Jan 2003to Aug 2005
- Phase
- Phase 3
- 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 40 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- refractory glaucoma, defined as uncontrolled IOP despite maximal anti-glaucoma medication, previously failed nonseton surgical treatment, or a combination thereof.
Who cannot join
- age less than 40 years
- a visual acuity of no light perception
- lens opacity
- elevated IOP associated with silicone oil previous glaucoma drainage device implantation in the same eye
- previous cyclodestructive treatment
- increased risk of endophthalmitis posterior segment disorders
- pre-existing ocular comorbidities.
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of this study is to investigate the efficacy and safety of the Ahmed valve implant (AVI) and the Molteno single-plate implant (MSPI) in eyes with refractory glaucoma during a follow-up period of 24 months.
- Conditions
- Refractory Glaucoma
- Being tested
- Ahmed valve implant, Molteno single-plate implant (MSPI)
- Keywords
- Ahmed valve, single-plate Molteno implant, refractory glaucoma, surgical treatment
- Medical subject headings
- Glaucoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ahmed valve implantDevice
184 mm2 surface area Ahmed Glaucoma Valve (AGV Model FP7; New World Medical Inc., Rancho Cucamonga, California, USA)
Molteno single-plate implant (MSPI)Device
134 mm2 surface area single-plate Molteno implant (Molteno Ophthalmic Limited, Dunedin, New Zealand)
| Study group | Role | What they receive |
|---|---|---|
| MSPI | Experimental | Molteno single-plate implant Receives: Device: Molteno single-plate implant (MSPI) |
| AVI | Active comparator | Ahmed valve implant Receives: Device: Ahmed valve implant |
What is being measured
The primary outcome is the main question the study is designed to answer.
Intra Ocular pressure (IOP)
Measured: Month 24
Secondary outcomes (5)
Intra Ocular pressure (IOP)
Measured: day 1,week 1, and months 1, 3, 6, 9, 12 and 18
Changes in visual acuity
Measured: day 1,week 1, and months 1, 3, 6, 9, 12, 18, and 24.
Number of anti-glaucoma medications
Measured: week 1, and months 1, 3, 6, 9, 12, 18, and 24
Mean deviation of visual field,
Measured: week 1, and months 1, 3, 6, 9, 12, 18, and 24
Rate of intra- and postoperative complications
Measured: week 1, and months 1, 3, 6, 9, 12, 18, and 24
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Sep 2009 (estimated)
- Study startJan 2003
- Primary completionAug 2005
- Study completionAug 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Refractory GlaucomaStudies 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 72 participants (actual)
Sponsor and investigators
- Lead sponsor
- Vanak Eye Surgery Center
- Sponsor type
- University, hospital or other
- Investigators
- Nader Nassiri, MD, Principal investigator, Assistant Professor, Department of Ophthalmology, Imam Hussein Medical Center, Shaheed Beheshti University of Medical Sciences, Tehran, IranNariman Nassiri, MD, Principal investigator, Medical Researcher, Vanak Eye Surgery Center, Tehran, IranGhazal Kamali, MD, Principal investigator, 4th-year Resident, Department of Ophthalmology, Imam Hussein Medical Center, Shaheed Beheshti University of Medical Sciences, Tehran, Iran
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00971061
- Sponsor's protocol ID
- 1465087
- Status last verified
- Sep 2009
- First submitted
- 2 Sep 2009
- Last updated
- 4 Sep 2009
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 4 Sep 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ahmed Glaucoma Valve and Single-Plate Molteno Implants in Treatment of Refractory Glaucoma
- ClinicalTrials.gov ID
- NCT00971061
- Acronym / sponsor ID
- 1465087
- Conditions
- Refractory Glaucoma
- Keywords
- Ahmed valve, single-plate Molteno implant, refractory glaucoma, surgical treatment
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 72 participants (actual)
- Lead sponsor
- Vanak Eye Surgery CenterUniversity, hospital or other
- Study start
- Jan 2003
- Primary completion
- Aug 2005 (actual)
- Study completion
- Aug 2005 (actual)
- First posted
- 3 Sep 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.
The purpose of this study is to investigate the efficacy and safety of the Ahmed valve implant (AVI) and the Molteno single-plate implant (MSPI) in eyes with refractory glaucoma during a follow-up period of 24 months.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| MSPI | Experimental | Device: Molteno single-plate implant (MSPI)Molteno single-plate implant |
| AVI | Active comparator | Device: Ahmed valve implantAhmed valve implant |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- refractory glaucoma, defined as uncontrolled IOP despite maximal anti-glaucoma medication, previously failed nonseton surgical treatment, or a combination thereof.
Key exclusion criteria (7 listed)
- age less than 40 years
- a visual acuity of no light perception
- lens opacity
- elevated IOP associated with silicone oil previous glaucoma drainage device implantation in the same eye
- previous cyclodestructive treatment
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 |
|---|---|---|
| Ahmed valve implant184 mm2 surface area Ahmed Glaucoma Valve (AGV Model FP7; New World Medical Inc., Rancho Cucamonga, California, USA) | Device | AVI |
| Molteno single-plate implant (MSPI)134 mm2 surface area single-plate Molteno implant (Molteno Ophthalmic Limited, Dunedin, New Zealand) | Device | MSPI |
Primary outcome
Intra Ocular pressure (IOP)
Time frame: Month 24
5 secondary outcomes
Intra Ocular pressure (IOP)
Time frame: day 1,week 1, and months 1, 3, 6, 9, 12 and 18
Changes in visual acuity
Time frame: day 1,week 1, and months 1, 3, 6, 9, 12, 18, and 24.
Number of anti-glaucoma medications
Time frame: week 1, and months 1, 3, 6, 9, 12, 18, and 24
Mean deviation of visual field,
Time frame: week 1, and months 1, 3, 6, 9, 12, 18, and 24
Rate of intra- and postoperative complications
Time frame: week 1, and months 1, 3, 6, 9, 12, 18, and 24
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 4 Sep 2009.
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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.
Nader Nassiri, MD principal investigator
Assistant Professor, Department of Ophthalmology, Imam Hussein Medical Center, Shaheed Beheshti University of Medical Sciences, Tehran, Iran
Nariman Nassiri, MD principal investigator
Medical Researcher, Vanak Eye Surgery Center, Tehran, Iran
Ghazal Kamali, MD principal investigator
4th-year Resident, Department of Ophthalmology, Imam Hussein Medical Center, Shaheed Beheshti University of Medical Sciences, Tehran, Iran
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Ahmed valve implant and Molteno single-plate implant (MSPI) in people with Refractory Glaucoma, run by Vanak Eye Surgery Center at 1 site in Iran.
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 1 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 4 Sep 2009. 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 Iran. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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 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?
Intra Ocular pressure (IOP) (time frame: Month 24). 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 4 Sep 2009.