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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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CTRI |
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Last refreshed on:
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24 November 2021 |
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Main ID: |
CTRI/2014/10/005114 |
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Date of registration:
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16-10-2014 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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A study to compare the efficacy of artificial cornea in restoring vision in comparison to human cornea transplant.
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Scientific title:
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A Clinical Trial to evaluate the safety and effectiveness of the RHCIII-MPC biosynthetic cornea in patients requiring deep anterior lamerllar keratoplasty |
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Date of first enrolment:
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05-09-2014 |
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Target sample size:
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10 |
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Recruitment status: |
Suspended |
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URL:
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http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=9854 |
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Study type:
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Interventional |
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Study design:
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Single Arm Trial
Method of generating randomization sequence:Not Applicable Method of allocation concealment:Not Applicable Blinding and masking:Open Label
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Phase:
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Phase 1/ Phase 2
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Countries of recruitment
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India
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Contacts
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Name:
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Dr Virender S Sangwan
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Address:
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L V Prasad Eye Institute
Kallam Anji Reddy Campus
L.V.Prasad Marg, Banjara Hills, Hyderabad - 500 034
L V Prasad Eye Institute
Kallam Anji Reddy Campus
L.V.Prasad Marg, Banjara Hills, Hyderabad - 500 034
500034
Hyderabad, ANDHRA PRADESH
India |
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Telephone:
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040-30612632 |
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Email:
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vsangwan@lvpei.org |
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Affiliation:
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L V Prasad Eye Institute |
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Name:
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Dr Virender S Sangwan
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Address:
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L V Prasad Eye Institute
Kallam Anji Reddy Campus
L.V.Prasad Marg, Banjara Hills, Hyderabad - 500 034
L V Prasad Eye Institute
Kallam Anji Reddy Campus
L.V.Prasad Marg, Banjara Hills, Hyderabad - 500 034
500034
Hyderabad, ANDHRA PRADESH
India |
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Telephone:
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040-30612632 |
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Email:
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vsangwan@lvpei.org |
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Affiliation:
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L V Prasad Eye Institute |
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Key inclusion & exclusion criteria
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Inclusion criteria: 1. Subjects must sign and be given a copy of the written Informed Consent form.
2. Subjects with CDVA 20/200 or worse as a result of corneal scar due to injury or infection in the operative eye or from progressive keratoconus or Dystrophies or any other causes requiring DALK.
3. Subjects must be>=18 and <= 60 years of age at the time of subject eligibility visit.
4. Subjects must be willing and able to return for scheduled follow-up examinations for 12 months after surgery.
Exclusion criteria: 1.Subjects with severe or life-threatening systemic disease.
2.Subjects with uncontrolled hypertension.
3. Subjects with autoimmune disease.
4. Subjects with uncontrolled diabetes or insulin-dependent diabetes.
5. Subjects with an ocular infection.
6. Subjects with any anterior segment pathology (chronic uveitis, iritis, iridocyclitis, rubeosis, iritis, corneal dystrophy, pseudoexfoliation, etc. in the operative eye.
7. Subjects with glaucoma in either eye.
8.Subjects with previous retinal detachment or retinal pathology in the operative eye.
9.Subjects with congenital bilateral cataracts.
10.Subjects with marked microphthalmos or aniridia in either eye.
11.Subjects who have had previous ocular surgery in the operative eye, except pterygium or strabismus surgeries which may be allowed based on clinical evaluation.
12.Subjects who are or lactating or who plan to become pregnant over the course of the clinical investigation.
13.Subjects with any other serious ocular pathology,serious ocular complications at the time of corneal transplant underlying serious medical conditions,based on the Investigator medical judgement.
Age minimum:
Age maximum:
Gender:
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Health Condition(s) or Problem(s) studied
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Intervention(s)
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Intervention1: Biosynthetic RHC III Biosynthetic Cornea: Anterior lamellar Keratoplasty
Control Intervention1: Human donar Cornea: Anterior lamellar Keratoplasty
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Primary Outcome(s)
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Visual Acuity
Clarity of Implant
Timepoint: Preoperative Evaluation (Day -60 to Day -1)
Operative Evaluation (Day 0)
Day 1(24 to 36 hours post-op)
Week 1 (5 to 9 days post-op)
Month 1(3 to 5 weeks post-op)
Month 6(21 to 26 weeks post-op)
Month 9
Month 12
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Secondary Outcome(s)
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1. Manifest refraction Preoperative
2. Uncorrected visual acuity (ETDRS)
3. Distance-corrected visual acuity without add (ETDRS)
4. Distance-corrected near visual acuity with add (ETDRS)
5. Slit lamp examination
6. Central keratometry
7. Computerized corneal topography
8. Specular microscopy of the corneal endothelium on both eyes
9. Central applanation intraocular pressure
10. Dilated fundus examination
11. Anterior segment OCT
12. Subject questionnaire
Timepoint: Preoperative Evaluation (Day -60 to Day -1)
Operative Evaluation (Day 0)
Day 1 (24 to 36 hours post-op)
Week 1(5 to 9 days post-op)
Month 1 (3 to 5 weeks post-op)
Month 6 (21 to 26 weeks post-op)
Month 9
Month 12
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Secondary ID(s)
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LVPEI-RHCIII-MPCBIOSYNTHETIC CORNEA
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Source(s) of Monetary Support
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Linkoping University
Department of Clinical and Experimental Medicine
Division of Cell Biology
S-581 85 Linköping
Sweden
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Ethics review
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Status: Approved
Approval date: 24/01/2014
Contact:
Hyderabad Eye Research Foundation
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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