Corneal TransplantationPhase 4AuroKProNCT01018888
Safety and Efficacy Study of Artificial Cornea
A Phase 4 study testing Auro KPro (Keratoprosthesis) in people with Corneal Transplantation, run by Aurolab at 1 site in India.
Trial summary
The purpose of this study is to evaluate the stability of artificial cornea manufactured by Aurolab and to assess its visual outcomes. Read more about this study
- Who is it for?
- Ages 20 to 80 years
- Conditions the study is for
- Corneal Transplantation
- What is being tested?
- Auro KPro (Keratoprosthesis)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteIndia
- Study dates
- Aug 2010to Jul 2014
- 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 20 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age more than 20 years
- Willing to participate and review on schedule
- Multiple failed grafts with poor prognosis for regrafting
- Adequate tear film and lid function
- Projection of light in all quadrants
- Bilateral blind
Who cannot join
- Reasonable chance of success with keratoplasty
- Autoimmune disease such as Stevens Johnson Syndrome, Pemphigoid
- End stage glaucoma
- Retinal detachment
Trial locations and contacts
1 site in 1 country.
India1 site, 1 recruiting
- Recruiting
Aravind Eye Hospital
Madurai, Tamil Nadu, 625 020
Mr. Gobinath, B.Pharm, 0452-4356100 ext. 364, clinicalresearch@aravind.org
Muthu Selvi, BA., BBE, 0452-4356100 ext. 364, clinicaltrials@aravind.org
About this study
Official title: Clinical Assessment of Auro KPro
The purpose of this study is to evaluate the stability of artificial cornea manufactured by Aurolab and to assess its visual outcomes.
Read the detailed description
The keratoprosthesis, also know as an artificial cornea plays a significant role in combating corneal blindness in patients who are no longer candidates for penetrating keratoplasty.The global incidence of corneal blindness is estimated to be 6-8 million. In India there are approximately 6.8 million cases of unilateral corneal blindness and 1.3 million people with bilateral corneal pathology.
Eligible subjects after getting informed consent will be included in this study. All the subjects will have pre-operative evaluation which includes history, visual acuity, Intraocular pressure (IOP), evaluation of tear film and ultrasound A and B scan. Ocular inflammation will be controlled prior to surgery. Keratoplasty will be performed with keratoprosthesis under local anesthesia. Patients will be followed up at regular interval to assess the outcome variables.
- Conditions
- Corneal Transplantation
- Being tested
- Auro KPro (Keratoprosthesis)
- Keywords
- Cornea, Transplantation, Cornea, Keratoplasty, Grafting, Corneal
- Medical subject headings
- Corneal Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Auro KPro (Keratoprosthesis)Device
Also called Auro KPro
Front plate with optical cylinder, a back plate and a titanium ring to hold the complex together
| Study group | Role | What they receive |
|---|---|---|
| Keratoprosthesis | Experimental | Not described Receives: Device: Auro KPro (Keratoprosthesis) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Visual Acuity
Measured: 1st Month, 2nd Month, 3rd Month,5th Month, 7th Month, 9th Month and 12th Month
Secondary outcomes (1)
Retention of the device
Measured: 1st Month, 2nd Month, 3rd Month,5th Month, 7th Month, 9th Month and 12th Month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Nov 2009 (estimated)
- Study startAug 2010
- Primary completionJun 2014 (estimated)
- Study completionJul 2014 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Corneal TransplantationStudies 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
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Aurolab
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Dr. Jeena Mascarenhas, MBBS, MS, Principal investigator, Aravind Eye Hospital, Madurai
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01018888
- Sponsor's protocol ID
- 1PN1010941
- Acronym
- AuroKPro
- Status last verified
- Jul 2011
- First submitted
- 24 Nov 2009
- Last updated
- 8 Jan 2013
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 8 Jan 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Assessment of Auro KPro
- ClinicalTrials.gov ID
- NCT01018888
- Acronym / sponsor ID
- AuroKPro / 1PN1010941
- Conditions
- Corneal Transplantation
- Keywords
- Cornea, Transplantation, Cornea, Keratoplasty, Grafting, Corneal
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- AurolabUniversity, hospital or other
- Study start
- Aug 2010
- Primary completion
- Jun 2014 (estimated)
- Study completion
- Jul 2014 (estimated)
- First posted
- 25 Nov 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 evaluate the stability of artificial cornea manufactured by Aurolab and to assess its visual outcomes.
Detailed description
The keratoprosthesis, also know as an artificial cornea plays a significant role in combating corneal blindness in patients who are no longer candidates for penetrating keratoplasty.The global incidence of corneal blindness is estimated to be 6-8 million. In India there are approximately 6.8 million cases of unilateral corneal blindness and 1.3 million people with bilateral corneal pathology.
Eligible subjects after getting informed consent will be included in this study. All the subjects will have pre-operative evaluation which includes history, visual acuity, Intraocular pressure (IOP), evaluation of tear film and ultrasound A and B scan. Ocular inflammation will be controlled prior to surgery. Keratoplasty will be performed with keratoprosthesis under local anesthesia. Patients will be followed up at regular interval to assess the outcome variables.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Keratoprosthesis | Experimental | Device: Auro KPro (Keratoprosthesis) |
Who may qualify
- Ages
- 20 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Age more than 20 years
- Willing to participate and review on schedule
- Multiple failed grafts with poor prognosis for regrafting
- Adequate tear film and lid function
- Projection of light in all quadrants
Key exclusion criteria (4 listed)
- Reasonable chance of success with keratoplasty
- Autoimmune disease such as Stevens Johnson Syndrome, Pemphigoid
- End stage glaucoma
- Retinal detachment
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 |
|---|---|---|
| Auro KPro (Keratoprosthesis)Also: Auro KProFront plate with optical cylinder, a back plate and a titanium ring to hold the complex together | Device | Keratoprosthesis |
Primary outcome
Visual Acuity
Time frame: 1st Month, 2nd Month, 3rd Month,5th Month, 7th Month, 9th Month and 12th Month
1 secondary outcome
Retention of the device
Time frame: 1st Month, 2nd Month, 3rd Month,5th Month, 7th Month, 9th Month and 12th Month
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 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. Jeena Mascarenhas, 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 Auro KPro (Keratoprosthesis) in people with Corneal Transplantation, 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 4 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 8 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 Mr.Karthikumar S, M.Pharm (0452-3096100 ext. 229, crd@aurolab.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Visual Acuity (time frame: 1st Month, 2nd Month, 3rd Month,5th Month, 7th Month, 9th Month and 12th Month). 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 8 Jan 2013.