A COMPARITIVE STUDY OF TWO DIFFERENT O.1 % VITAMIN B12 DYE FOR STRENGTHENING OF CORNEA IN THIN AND CONICAL CORNEAS

Not Applicable

Conditions: Health Condition 1: null- keratoconusHealth Condition 2: H186- Keratoconus

Recruitment & Eligibility

Inclusion Criteria

1.Unilateral/bilateral

2.A diagnosis of keratoconus.

3.Progressing keratoconus.

4.Patients with Keratometric readings <= 55 D

5.Patients >= 18 years of age

6.Patients with clear central cornea, without apical scarring.

7.Patients with corneal thickness >= 400 microns at the thinnest point.

8.Patient willing to participate and sign informed consent

9.Patient willing to come for all post-operative follow-up procedures as defined in study protocol.

Exclusion Criteria

1.Eyes classified as either normal, atypical normal (except corneal ectasia), or keratoconus suspect on the severity grading scheme.

2.A history of previous corneal surgery or the insertion of intrastromal ring implantation in the eye(s) to be treated.

3.Previous corneal or Intraocular surgery

4.Pellucid marginal corneal degeneration

5.Eyes which are aphakic or pseudophakic and do not have a UV blocking lens implanted.

6.A history of delayed epithelial healing.

7.Patients with nystagmus or any other condition that would have prevented a steady gaze during the CXL treatment or other diagnostic tests.

8.Pregnancy & Lactation

9.Concurrent participation in another drug or device Study.

Primary Outcome Measures

Name	Time	Method
â?¢Progression of Keratoconus [Time Frame: Pre-operative visit, 1,3, 6 & 12 Months Follow-up] <br/ ><br>â?¢Best Corrected Visual acuity [Time Frame: Pre-operative visit, 1,3, 6 & 12 Months Follow-up] <br/ ><br>Visual Acuity (VA) is measured in logMAR. LogMAR is the logarithm of the minimum angle of resolution. A lower logMAR value indicates better visual acuity. <br/ ><br>â?¢Endothelial Cell Count [Time Frame: Pre-operative visit, 1,3, 6 & 12 Months Follow-up] <br/ ><br>As measured by Specular Microscope <br/ ><br>Timepoint: Pre-operative visit, 1,3, 6 & 12 Months Follow-up

Secondary Outcome Measures

Name	Time	Method
Refraction <br/ ><br>Corneal Demarcation Line Depth (DLD) <br/ ><br>Corneal Haze <br/ ><br>Uncorrected Visual acuity <br/ ><br>Corneal Thickness Change in K1, K2 and Kmean Value <br/ ><br>Timepoint: Pre-operative visit, 1,3, 6 & 12 Months Follow-up