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

Status

UNKNOWN

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01307527

Enrollment

Registered

2011-03-03

Start date

Unknown

Completion date

Unknown

Last updated

2011-03-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Brittle Cornea Syndrome, Ehlers-Danlos Syndrome Type 6

Brief 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.

Interventions

DRUGRiboflavin

0.1%, applied every 5 minutes for 60 minutes

DEVICEKera-X

3 mW/cm2, to the central 7.5 mm of the cornea, for 30 minutes

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

PREVENTION

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
Adverse Events from Cornea Riboflavin Crosslinking in Brittle Cornea Syndrome or Ehlers Danlos Type VI	3 Months

Countries

Israel

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026