A study to compare the efficacy of artificial cornea in restoring vision in comparison to human cornea transplant.

Phase 1

Suspended

• Registration Number: CTRI/2014/10/005114
• Lead Sponsor: Dr May Griffith

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 24 November 2021

Recruitment & Eligibility

• Status: Suspended
• Sex: Not specified
• Target Recruitment: 0

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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Visual Acuity <br/ ><br> <br/ ><br>Clarity of Implant <br/ ><br>Timepoint: Preoperative Evaluation (Day -60 to Day -1) <br/ ><br>Operative Evaluation (Day 0) <br/ ><br>Day 1(24 to 36 hours post-op) <br/ ><br>Week 1(5 to 9 days post-op) <br/ ><br>Month 1(3 to 5 weeks post-op) <br/ ><br>Month 6(21 to 26 weeks post-op) <br/ ><br>Month 9 <br/ ><br> Month 12 <br/ ><br> <br/ ><br> <br/ ><br>

Secondary Outcome Measures

Name	Time	Method
1. Manifest refraction Preoperative <br/ ><br>2. Uncorrected visual acuity (ETDRS) <br/ ><br>3. Distance-corrected visual acuity without add (ETDRS) <br/ ><br>4. Distance-corrected near visual acuity with add (ETDRS) <br/ ><br>5. Slit lamp examination <br/ ><br>6. Central keratometry <br/ ><br>7. Computerized corneal topography <br/ ><br>8. Specular microscopy of the corneal endothelium on both eyes <br/ ><br>9. Central applanation intraocular pressure <br/ ><br>10. Dilated fundus examination <br/ ><br>11. Anterior segment OCT <br/ ><br>12. Subject questionnaire <br/ ><br>Timepoint: Preoperative Evaluation (Day -60 to Day -1) <br/ ><br>Operative Evaluation (Day 0) <br/ ><br>Day 1(24 to 36 hours post-op) <br/ ><br>Week 1(5 to 9 days post-op) <br/ ><br>Month 1 (3 to 5 weeks post-op) <br/ ><br>Month 6 (21 to 26 weeks post-op) <br/ ><br>Month 9 <br/ ><br>Month 12 <br/ ><br>