Health Condition 1: null- keratoconus Health Condition 2: H186- Keratoconus
Conditions
Interventions
Intervention1: 0.1% Riboflavin (Flavin solution): 0.1% Flavin dye will be used for conventional cross linking and the safety and efficacy will be compared with the 0.1% riboflavin formulation from an
Sponsors
BIOTECH HEALTHCARE PVT LTD
Eligibility
Inclusion criteria
Inclusion criteria: 1. Unilateral/bilateral 2. A diagnosis of keratoconus. 3. Progressing keratoconus. 4. Patients with Keratometric readings 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
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| â?¢Progression of Keratoconus [Time Frame: Pre-operative visit, 1,3, 6 & 12 Months Follow-up] â?¢Best Corrected Visual acuity [Time Frame: Pre-operative visit, 1,3, 6 & 12 Months Follow-up] 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. â?¢Endothelial Cell Count [Time Frame: Pre-operative visit, 1,3, 6 & 12 Months Follow-up] As measured by Specular Microscope Timepoint: Pre-operative visit, 1,3, 6 & 12 Months Follow-up | — |
Secondary
| Measure | Time frame |
|---|---|
| Refraction Corneal Demarcation Line Depth (DLD) Corneal Haze Uncorrected Visual acuity Corneal Thickness Change in K1, K2 and Kmean Value Timepoint: Pre-operative visit, 1,3, 6 & 12 Months Follow-up | — |
Countries
India
Contacts
Public Contactdr sri ganesh
nethradhama super speciality eye hospital
Outcome results
None listed