GlaucomaPhase 4AADINCT01401088
Evaluation of Safety and Efficacy of Glaucoma Shunt (Aurolab Artificial Drainage Implant) in Refractory Glaucoma
A Phase 4 study testing Artificial drainage implant in people with Glaucoma, run by Aurolab at 1 site in India.
Trial summary
The purpose of this study is to evaluate the efficacy and safety of Aurolab Artificial Drainage Implant (AADI) on intraocular pressure reduction in patients with refractory glaucoma. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Glaucoma
- What is being tested?
- Artificial drainage implant
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteIndia
- Study dates
- Jul 2011to Dec 2013
- 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
- 18 years of age or older
- Significant optic nerve damage and visual field loss due to glaucoma in eligible eyes
- Eligible eyes is considered at high risk of failure/complication following conventional filtering surgery
- Eyes with uncontrolled glaucoma with prior history of Filtering surgery/Uveitic/ Neovascular/Developmental glaucomas
- IOP≥18 mm of Hg with or without anti glaucoma medications
- If taking glaucoma medications, stable dose for 6 weeks
Who cannot join
- Age<18 years
- Eyes with uncontrolled glaucoma expected to have favorable post-operative outcome by conventional trabeculectomy
- Corneal abnormalities that would preclude accurate IOP readings
- Uncontrolled systemic diseases
- Endothelial cell count<1800cells/mm
- Any other active ocular disease,(active uveitis, ocular infection)
Trial locations and contacts
1 site in 1 country.
India1 site, 1 recruiting
- Recruiting
Aravind Eye Hospital
Madurai, Tamil Nadu, 625020
Mr. S.Karthi Kumar, M. Pharmacy, +91 452 3096100 ext. 229, crd@aurolab.com
Ms. Sophia, M.Sc, +91 452 4356100 ext. 364, clinicaltrials@aravind.org
About this study
The purpose of this study is to evaluate the efficacy and safety of Aurolab Artificial Drainage Implant (AADI) on intraocular pressure reduction in patients with refractory glaucoma.
Read the detailed description
Aurolab Artificial Drainage Implant is a non resistant tube device based on Baerveldt implant. It reduces intra ocular pressure by draining aqueous from anterior chamber into sub-conjunctival space formed around base of the implant. Reduction of intraocular pressure prevents further damage to optic nerve and functional visual field loss in advanced refractory glaucoma.
- Conditions
- Glaucoma
- Being tested
- Artificial drainage implant
- Keywords
- patient with refractory glaucoma
- Medical subject headings
- Glaucoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Artificial drainage implantDevice
Also called AADI
Artificial drainage implant is used for intra ocular pressure reduction in patient with refractory glaucoma
| Study group | Role | What they receive |
|---|---|---|
| Artificial drainage implant | Experimental | Aurolab Artificial Drainage Implant (AADI) on intraocular pressure reduction will be implanted in patients with refractory glaucoma. Receives: Device: Artificial drainage implant |
What is being measured
The primary outcome is the main question the study is designed to answer.
Intra Ocular Pressure (IOP)
Mean Intraocular pressure (IOP) reduction from pre operative IOP
Measured: One year
Secondary outcomes (2)
Success rate
Success rate (defined as Inraocular pressure (IOP) of 5mmHg to 20 mmHg and at least a 20% reduction in IOP without visually devastating complications or additional glaucoma surgery)
Measured: one year
Number of patients with adverse events as a measure of safety
to assess the incidence of post operative adverse events
Measured: one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jul 2011 (estimated)
- Study startJul 2011
- Primary completionNov 2013 (estimated)
- Study completionDec 2013 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Aurolab
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Dr. Prashanth Ranganath, MBBS., MS.,, Principal investigator, Aravind Eye Hospital, Madurai
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01401088
- Sponsor's protocol ID
- 1PN1011049
- Acronym
- AADI
- Status last verified
- Jan 2013
- First submitted
- 20 Jul 2011
- Last updated
- 3 Jan 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Jan 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Safety and Efficacy of Glaucoma Shunt (Aurolab Artificial Drainage Implant) in Refractory Glaucoma
- ClinicalTrials.gov ID
- NCT01401088
- Acronym / sponsor ID
- AADI / 1PN1011049
- Conditions
- Glaucoma
- Keywords
- patient with refractory glaucoma
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- AurolabUniversity, hospital or other
- Study start
- Jul 2011
- Primary completion
- Nov 2013 (estimated)
- Study completion
- Dec 2013 (estimated)
- First posted
- 25 Jul 2011 (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 evaluate the efficacy and safety of Aurolab Artificial Drainage Implant (AADI) on intraocular pressure reduction in patients with refractory glaucoma.
Detailed description
Aurolab Artificial Drainage Implant is a non resistant tube device based on Baerveldt implant. It reduces intra ocular pressure by draining aqueous from anterior chamber into sub-conjunctival space formed around base of the implant. Reduction of intraocular pressure prevents further damage to optic nerve and functional visual field loss in advanced refractory glaucoma.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Artificial drainage implant | Experimental | Device: Artificial drainage implantAurolab Artificial Drainage Implant (AADI) on intraocular pressure reduction will be implanted in patients with refractory glaucoma. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 18 years of age or older
- Significant optic nerve damage and visual field loss due to glaucoma in eligible eyes
- Eligible eyes is considered at high risk of failure/complication following conventional filtering surgery
- Eyes with uncontrolled glaucoma with prior history of Filtering surgery/Uveitic/ Neovascular/Developmental glaucomas
- IOP≥18 mm of Hg with or without anti glaucoma medications
Key exclusion criteria (6 listed)
- Age<18 years
- Eyes with uncontrolled glaucoma expected to have favorable post-operative outcome by conventional trabeculectomy
- Corneal abnormalities that would preclude accurate IOP readings
- Uncontrolled systemic diseases
- Endothelial cell count<1800cells/mm
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 |
|---|---|---|
| Artificial drainage implantAlso: AADIArtificial drainage implant is used for intra ocular pressure reduction in patient with refractory glaucoma | Device | Artificial drainage implant |
Primary outcome
Intra Ocular Pressure (IOP)
Time frame: One year
Mean Intraocular pressure (IOP) reduction from pre operative IOP
2 secondary outcomes
Success rate
Time frame: one year
Number of patients with adverse events as a measure of safety
Time frame: one year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jan 2013.
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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.
Dr. Prashanth Ranganath, MBBS., MS., principal investigator
Aravind Eye Hospital, Madurai
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 Artificial drainage implant in people with Glaucoma, run by Aurolab at 1 site in India.
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 6 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: status not confirmed, as of the sponsor's last update on 3 Jan 2013. 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 India. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Dr. Prashanth Ranganath, MBBS., MS., (+91 452 4356100 ext. 118, loweriop@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Intra Ocular Pressure (IOP) (time frame: One year). 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 3 Jan 2013.