ClinicalTrials.gg
Status unknownNCT01307527Updated Mar 3, 2011

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

An interventional study of Riboflavin and Kera-X in Brittle Cornea Syndrome and Ehlers-Danlos Syndrome Type 6, sponsored by Hadassah Medical Organization. Status unknown at 1 site in Israel. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2011-03-03.

Sponsored by Hadassah Medical Organization · Not applicable, Interventional, and Prevention

The sponsor has not verified this record recently (last verified Feb 2011), so the status shown — last known as Enrolling by invitation — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
1
Allocation
Not applicable
Ages
18 Years and older
Sex
All
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Study 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.

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Conditions studied

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

Lead sponsor

Hadassah Medical Organization is the lead sponsor of 675 studies on the registry; 54 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

Exclusion Criteria:

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

Phase
Not applicable
Primary purpose
Prevention
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
1 participant (estimated)

Interventions

  • 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

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What researchers measure

Primary outcomes

  1. Adverse Events from Cornea Riboflavin Crosslinking in Brittle Cornea Syndrome or Ehlers Danlos Type VI

    Time frame: 3 Months

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Study locations

1 site
  • Hadassah Medical Organization
    Jerusalem, Israel
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 3, 2011, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT01307527
First posted
Mar 3, 2011
Last update
Mar 3, 2011
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Feb 2011. You cannot join it, but the record below documents what was studied.

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Studies of the drug tested here: Riboflavin

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