Riboflavin Corneal Crosslinking for Brittle Cornea Syndrome and Ehlers-Danlos Syndrome Type VI

Brittle Cornea Syndrome Clinical Trial

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT01307527
• Other study ID #: BTL-CXL-HMO-CTIL
• Status: Enrolling by invitation
• Phase: N/A
• First received: March 1, 2011
• Last updated: March 2, 2011

Study information

• Verified date: February 2011
• Source: Hadassah Medical Organization
• Contact: n/a
• Is FDA regulated: No
• Health authority: Israel: Ministry of Health - Director General
• Study type: Interventional

Clinical Trial Summary

Brittle Cornea Syndrome and Ehlers-Danlos Syndrome (EDS) type VI are rare collagen-connective tissue disorders that predispose affected individuals to the development of perforated corneas from the mildest of eye trauma or even spontaneously. Clinical studies evaluating riboflavin-corneal crosslinking have found that it dramatically increases corneal rigidity. Given the success and safety of riboflavin crosslinking, the investigators believe that it can increase the corneal stability in patients affected these disseases, preventing perforation. It is furthermore possible, that riboflavin crosslinking will allow corneal transplants to successfully be performed on blind eyes that have already perforated and opacified. The purpose of the study is to determine whether corneal crosslinking can be safely performed on individuals with Brittle Cornea Syndrome or Ehlers-Danlos Syndrome type VI.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 1
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

Adult Patient with:

1. Genetic diagnosis of either Brittle Cornea Syndrome or EDS-VI, and

2. Either:

• Personal History of either spontaneous corneal perforation or corneal perforation due to minor ocular mechanical trauma or

• Immediate family member with history of either spontaneous corneal perforation or corneal perforation due to minor ocular mechanical trauma

Exclusion Criteria:

• Any patient that is deemed to be unable to fully cooperate during the crosslinking procedure

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Brittle Cornea Syndrome
• Ehlers-Danlos Syndrome
• Ehlers-Danlos Syndrome Type 6
• Syndrome

Intervention

Drug:
• Riboflavin
0.1%, applied every 5 minutes for 60 minutes

Device:
• Kera-X
3 mW/cm2, to the central 7.5 mm of the cornea, for 30 minutes

Locations

Country	Name	City	State
Israel	Hadassah Medical Organization	Jerusalem

Sponsors (1)

Lead Sponsor	Collaborator
Hadassah Medical Organization

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Adverse Events from Cornea Riboflavin Crosslinking in Brittle Cornea Syndrome or Ehlers Danlos Type VI		3 Months	Yes