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

Not yet recruiting

• Conditions: Keratoconus,

• Registration Number: CTRI/2019/11/021841
• Lead Sponsor: BIOTECH HEALTHCARE PVT LTD

Brief Summary

This is a prospective, comparative, open label, clinical study aimed  to evaluate the safety and efficay of two different 0.1% Riboflavin solutions used in corneal cross-linking treatment for patients with keratoconus.

Flavin Isotonic Riboflavin Ophthalmic Solution 0.1%- Flavin (Biotech Ophthalmics Pvt. Ltd., India) will be compared with  Peschke® D Standard Riboflavin Solution (PESCHKE Trade GmbH, Switzerland). 100 Eyes of patients with unilateral or bilateral keratoconus will be randomized to receive treatment with either  Flavin or Peschke isotonic riboflavin 0.1% solutions, with 50 eyes in each group. 

Post operative follow up  will be conducted at  1,3, 6 & 12 Months and the clinical parameters evaluated between the two groups will be - uncorrected and best corrected visual acuity, refraction,  change in keratometry and corneal thickness  & endothelial cell count. Any adverse effects or post operative complications such as haze, corneal oedema, infection etc, will be immediately  reported to ethics committee and necessary steps  will be taken.

Detailed Description

Not available

Study Timeline

• Study Start: 2019-10-11
• Last Update Posted: 2019-10-31

Recruitment & Eligibility

• Status: Not Yet Recruiting
• Sex: All
• Target Recruitment: 100

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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
•Progression of Keratoconus [Time Frame: Pre-operative visit, 1,3, 6 & 12 Months Follow-up]	Pre-operative visit, 1,3, 6 & 12 Months Follow-up
•Best Corrected Visual acuity [Time Frame: Pre-operative visit, 1,3, 6 & 12 Months Follow-up]	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.	Pre-operative visit, 1,3, 6 & 12 Months Follow-up
•Endothelial Cell Count [Time Frame: Pre-operative visit, 1,3, 6 & 12 Months Follow-up]	Pre-operative visit, 1,3, 6 & 12 Months Follow-up
As measured by Specular Microscope	Pre-operative visit, 1,3, 6 & 12 Months Follow-up

Secondary Outcome Measures

Name	Time	Method
Refraction	Corneal Demarcation Line Depth (DLD)

Trial Locations

Locations (1)

nethradhama super speciality eye hospital; 🇮🇳 Bangalore, KARNATAKA, India

nethradhama super speciality eye hospital

🇮🇳Bangalore, KARNATAKA, India

dr sri ganesh

Principal investigator

9845129740

phacomaverick@gmail.com