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

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

study id #: NCT01307527

condition: Brittle Cornea Syndrome, Ehlers-Danlos Syndrome Type 6

status: unknown

purpose:

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.

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

last updated: March 3, 2011

phase of development: N/A

size / enrollment: 1

study design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Prevention

primary outcomes:

  • Adverse Events from Cornea Riboflavin Crosslinking in Brittle Cornea Syndrome or Ehlers Danlos Type VI [ Time Frame:3 Months ]

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

sponsor: Hadassah Medical Organization

locations: Israel