Cyanocobalamin as Photosensitizing Agent

Cyanocobalamin as Photosensitizing Agent Using to Make Cross-linking to Cornea Collagen in Treatment of Progressive Keratoconus

is cyanocobalamin active as Photosensitizing Agent instead of riboflavin ? using cyanocobalamin with mix of external collagen to make crosslinking with cornea collagen to make rigid of cornea

Study Overview

• Status: Not yet recruiting
• Conditions: Keratoconus

• Study Type: Observational
• Enrollment (Anticipated): 1

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 40 years (Adult)
• Accepts Healthy Volunteers: N/A
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

primary care

Description

Inclusion Criteria:

• - Is 20 years or older Has been diagnosed with Keratoconus; Has no other active ocular disease; Is not pregnant or nursing;

Exclusion Criteria:

• Is under the age of 20 Has best corrected visual acuity outside 20/400; Pregnant or nursing at the time of enrollment in the study;

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
PRESERVATION of presence of red flare by using slit lamb	Cyanocobalamin react with cornea collagen and format red flare	Base line

Collaborators and Investigators

• Sponsor: EL Romany Ophthalmics Factory

Study record dates

Study Major Dates

• Study Start (Anticipated): September 1, 2023
• Primary Completion (Anticipated): October 1, 2023
• Study Completion (Anticipated): December 1, 2023

Study Registration Dates

• First Submitted: May 25, 2022
• First Submitted That Met QC Criteria: May 25, 2022
• First Posted (Actual): May 27, 2022

Study Record Updates

• Last Update Posted (Actual): February 15, 2023
• Last Update Submitted That Met QC Criteria: February 14, 2023
• Last Verified: February 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases; Eye Diseases; Corneal Diseases; Dermatitis; Skin Diseases, Eczematous; Dermatitis, Irritant; Dermatitis, Contact; Photosensitivity Disorders; Keratoconus; Dermatitis, Phototoxic
• Other Study ID Numbers: CYHEMG

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No