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Status:

UNKNOWN

Intacs for Keratoconus

Lead Sponsor:

Singapore National Eye Centre

Conditions:

Keratoconus

Eligibility:

All Genders

21+ years

Phase:

NA

Brief Summary

To study the effects Intacs intracorneal ring segments(Addition Technology, Inc) insertion in the treatment of keratoconus

Detailed Description

The purpose of this evaluation is to study the effects of implanting INTACS inserts, identical to those commercially available to correct myopia, into the corneal stroma of patients with keratoconus (...

Eligibility Criteria

Inclusion

  • Patients must have keratoconus (mild to moderate).
  • Visual acuity with contact lenses must be better than or equal to (20/40).
  • Patients must be intolerant of contact lenses, i.e., they must be unable to wear contact lenses for a whole day.
  • Patients will have a corneal thickness of 425 microns at the site of ICRS (INTACS inserts) placement (the thinnest region of the cornea).
  • In terms of general health, patients must not have any illnesses posing an immediate threat to life.
  • Patients must have provided written informed consent at least one week prior to surgery.
  • Patients must over 21 years of age.
  • Patients' contact lenses must have been removed at least one week prior to surgery for soft lenses and two weeks prior to surgery for hard lenses.

Exclusion

  • Positive pregnancy test.
  • Breast-feeding.
  • History of previous ophthalmologic surgery on the operative eye.
  • Patients with corneal stromal disorders.
  • Patients with history of herpetic keratitis.
  • Patients with retinal disorders.
  • Corneal grafts.
  • Patients refusing to remove contact lenses one week before surgery for soft lenses and two weeks before surgery for hard lenses.
  • Patients with amblyopia (VA \<1110 for the contralateral eye).
  • Patients with corneal thickness \<425 microns.
  • Patients with TOP \<10 mmHg or \>21 mmHg.
  • Patients taking part in other biomedical research in the 30 days prior to the start of this study.
  • Patients with an uncooperative disposition.

Key Trial Info

Start Date :

October 1 2005

Trial Type :

INTERVENTIONAL

End Date :

Estimated Enrollment :

20 Patients enrolled

Trial Details

Trial ID

NCT00347230

Start Date

October 1 2005

Last Update

July 7 2006

Active Locations (1)

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1

Singapore National Eye Centre

Singapore, Singapore, 168751