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Photorefractive Keratectomy and Corneal Cross-linking in Keratoconus

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ClinicalTrials.gov Identifier: NCT02189447
Recruitment Status : Completed
First Posted : July 14, 2014
Last Update Posted : July 14, 2014
Sponsor:
Information provided by (Responsible Party):
The Eye Center and The Eye Foundation for Research in Ophthalmology

Brief Summary:
Evaluation of the safety and efficacy of surface ablation followed by Collagen Cross-linking in patients with keratoconus

Condition or disease Intervention/treatment Phase
Keratoconus Procedure: Simultaneous Photorefractive Keratectomy and Collagen Cross-linking in patients with keratoconus Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 44 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Study Start Date : January 2011
Actual Primary Completion Date : September 2013
Actual Study Completion Date : September 2013


Arm Intervention/treatment
Experimental: Refractive surgery
Patients with keratoconus treated with simultaneous photorefractive keratectomy and Corneal collagen cross-linking.
Procedure: Simultaneous Photorefractive Keratectomy and Collagen Cross-linking in patients with keratoconus
Photorefractive Keratectomy followed by Collagen Cross-linking in patients with keratoconus in the same surgical setting




Primary Outcome Measures :
  1. The change of visual acuity following Photorefractive Keratectomy and Corneal Collagen Cross-linking in patients with Keratoconus [ Time Frame: 6 months ]
    The change of visual acuity from baseline in patients suffering from keratoconus following treatment with Photorefractive Keratectomy and Corneal Collagen Cross-linking.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • contact lens intolerance
  • corneal thickness > 450 micrometers
  • Keratometry < 56 diopters
  • Astigmatism < 6 diopters

Exclusion Criteria:

  • corneal thickness < 450 micrometers
  • Keratometry > 56 diopters
  • Astigmatism > 6 diopters
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Responsible Party: The Eye Center and The Eye Foundation for Research in Ophthalmology
ClinicalTrials.gov Identifier: NCT02189447    
Other Study ID Numbers: TEC 126
First Posted: July 14, 2014    Key Record Dates
Last Update Posted: July 14, 2014
Last Verified: July 2014
Keywords provided by The Eye Center and The Eye Foundation for Research in Ophthalmology:
Keratoconus
Ectasia
Corneal Cross-linking
Additional relevant MeSH terms:
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Keratoconus
Corneal Diseases
Eye Diseases