Identification and Validation of Functional Biomarkers for Keratoconus

NCT01746823 | Unknown

• 1 other identifier: NNKC-2011
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 1

Brief Summary

There is currently no medication for containing KC, nor any adequate biomarkers to predict the disease. Furthermore, there is considerable confusion in the field regarding the pathophysiology of the disease and involvement of inflammation. To that end, this study is designed to address some of these questions by determining the proteomic profiles of KC patients with different clinical grades. This relatively large cohort study is expected to yield significant information regarding the molecules that are deregulated during progression of KC and may provide a framework to assign diagnostic biomarkers and therapeutic intervention points.

Conditions

Keratoconus

Keywords

Keratoconus; Proteomics

Outcome Measures

Primary Outcomes (1)

• Keratoconus grade specific biomarker identification

  1 year

Secondary Outcomes (1)

• Onlabel use of anti-allergic topical treatment for inhibition of specific biomarkers to modify keratoconus disease progression

  2 years

Study Arms (1)

Controls, Keratoconus

Sub group of Keratoconus to be treated with anti-inflammatory agents ie Cyclosporine-A

Drug: Cyclosporins

Interventions

Cyclosporins DRUG

Also known as: Restasis

Controls, Keratoconus

Eligibility Criteria

• Age: 10 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients detected with corneal thinning by keratometry at a tertiary level hospital

You may qualify if:

• Evidence of corneal thinning by any type of keratometry

You may not qualify if:

• Corneal inflammation without evidence of ectasia
• Retinal disorder subjects excluded

Sponsors & Collaborators

• Narayana Nethralaya: lead
• Singapore Eye Research Institute: collaborator

Study Sites (1)

Narayana Nethralaya

Bangalore, Karnataka, 560010, India

RECRUITING

Related Publications (2)

• Gontier J, Fisch U. Schirmer's test: its normal values and clinical significance. ORL J Otorhinolaryngol Relat Spec. 1976;38(1):1-10. doi: 10.1159/000275252.

  PMID: 943747 BACKGROUND

• Shetty R, Ghosh A, Lim RR, Subramani M, Mihir K, Reshma AR, Ranganath A, Nagaraj S, Nuijts RM, Beuerman R, Shetty R, Das D, Chaurasia SS, Sinha-Roy A, Ghosh A. Elevated expression of matrix metalloproteinase-9 and inflammatory cytokines in keratoconus patients is inhibited by cyclosporine A. Invest Ophthalmol Vis Sci. 2015 Feb 3;56(2):738-50. doi: 10.1167/iovs.14-14831.

  PMID: 25648341 DERIVED

Biospecimen

Retention: SAMPLES WITHOUT DNA

Tear samples and discarded epithelium from Keratoplasty surgeries.

MeSH Terms

Conditions

Keratoconus

Interventions

Cyclosporins

Condition Hierarchy (Ancestors)

Corneal Diseases; Eye Diseases

Intervention Hierarchy (Ancestors)

Peptides, Cyclic; Macrocyclic Compounds; Polycyclic Compounds; Peptides; Amino Acids, Peptides, and Proteins

Study Officials

• Rohit Shetty, MBBS,DNB, FRCS

  Narayana Nethralaya

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Target Duration: 6 Months
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Consultant, Cornea and Refractive Services

Study Record Dates

• First Submitted: December 7, 2012
• First Posted: December 11, 2012
• Study Start: April 1, 2013
• Primary Completion: December 1, 2015
• Study Completion: December 1, 2015
• Last Updated: March 6, 2014

Record last verified: 2012-12

Locations

IN (1)