Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE4
20 participants
INTERVENTIONAL
2010-08-31
2014-07-31
Brief Summary
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Detailed Description
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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
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Keratoprosthesis
Auro KPro (Keratoprosthesis)
Front plate with optical cylinder, a back plate and a titanium ring to hold the complex together
Interventions
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Auro KPro (Keratoprosthesis)
Front plate with optical cylinder, a back plate and a titanium ring to hold the complex together
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
Exclusion Criteria
* Autoimmune disease such as Stevens Johnson Syndrome, Pemphigoid
* End stage glaucoma
* Retinal detachment
20 Years
80 Years
ALL
No
Sponsors
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Aurolab
OTHER
Responsible Party
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Principal Investigators
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Dr. Jeena Mascarenhas, MBBS, MS
Role: PRINCIPAL_INVESTIGATOR
Aravind Eye Hospital, Madurai
Locations
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Aravind Eye Hospital
Madurai, Tamil Nadu, India
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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1PN1010941
Identifier Type: -
Identifier Source: org_study_id
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