Status:

UNKNOWN

CHED - Congenital Hereditary Endothelial Dystrophy: New Paradigm Shift in Therapy Using Topical Eye Drops

Lead Sponsor:

L.V. Prasad Eye Institute

Collaborating Sponsors:

Allergan

Conditions:

Congenital Hereditary Endothelial Dystrophy of Cornea

Eligibility:

All Genders

Up to 6 years

Phase:

PHASE2

Brief Summary

CHED- Congenital Endothelial Endothelial Dystrophy is a condition that causes corneal cloudiness. Since, currently only surgery is being done to cure this condition, we are taking up the research of ...

Detailed Description

Introduction: Corneal endothelial cell loss is often associated with blinding endothelial corneal dystrophies: relatively seen more frequently dominantly inherited (5%) FECD (Fuchs Endothelial Cornea...

Eligibility Criteria

Inclusion

  • Children upto 9 years of age diagnosed with CHED (Congenital Hereditary Endothelial Dystrophy) with bilaterally equal corneal involvement
  • Patients agreeing on a regular monthly follow-up for a minimum of 6 months

Exclusion

  • Patient undergone any other surgery like Penetrating keratoplasty (PK), Descemet stripping automated endothelial keratoplasty (DSEK) and Descemet's membrane endothelial keratoplasty (DMEK), Glaucoma surgeries, in one of both eyes
  • Patients with concomitant ophthalmic pathologies like glaucoma, poor corneal surface, dry eye disease, corneal ulcers, systemic inflammatory conditions, cataract, nystagmus, Reduced corneal sensation etc.
  • Patients not able to come for follow-ups
  • Asymmetrical corneal involvement
  • Patients with known allergy to ophthalmic NSAID's
  • Patients with asthma or bleeding dyscrasias
  • Non-cooperative children

Key Trial Info

Start Date :

December 15 2020

Trial Type :

INTERVENTIONAL

Allocation :

ESTIMATED

End Date :

December 15 2022

Estimated Enrollment :

30 Patients enrolled

Trial Details

Trial ID

NCT04843839

Start Date

December 15 2020

End Date

December 15 2022

Last Update

April 14 2021

Active Locations (1)

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1

L V Prasad Eye Institute

Hyderabad, Banjara Hills, India, 500034