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Corneal Changes After Crosslinking in Keratoconus Patients Compared to the Untreated Fellow Eye

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ClinicalTrials.gov Identifier: NCT02428166
Recruitment Status : Completed
First Posted : April 28, 2015
Last Update Posted : December 13, 2017
Sponsor:
Information provided by (Responsible Party):
Prof. Dr. med. Mike P. Holzer, Heidelberg University

Brief Summary:
The purpose of this retrospective study is to assess corneal changes (keratometry, pachymetry) and change in visual acuity (VA) in keratoconus patients after unilateral crosslinking treatment compared to the untreated fellow eye. The corneal measurements obtained preoperatively and 2 to 14 months postoperatively using a Pentacam rotating scheimpflug camera are analyzed. Furthermore, pre-existing or actual ocular pathology or/and ocular surgeries as potential factors involved in treatment outcome are also evaluated.

Condition or disease
Keratoconus

Study Type : Observational
Actual Enrollment : 66 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Corneal Changes After Crosslinking in Keratoconus Patients Compared to the Untreated Fellow Eye
Study Start Date : February 2015
Actual Primary Completion Date : March 31, 2017
Actual Study Completion Date : March 31, 2017

Resource links provided by the National Library of Medicine





Primary Outcome Measures :
  1. Change in maximum keratometry (Kmax) as measured by the Pentacam HR [ Time Frame: after completion of data collection based on the measurements preoperatively and 2-14 months postoperative ]

Secondary Outcome Measures :
  1. Change in corneal thickness as measured by the Pentacam HR [ Time Frame: retrospective analysis from preoperatively to 2-14 months postoperatively ]
  2. Change in visual acuity (VA) [ Time Frame: retrospective analysis from preoperatively to 2-14 months postoperatively ]
  3. Evaluation of pre-existing ocular pathology or/and ocular surgery as potential factors involved in treatment outcome [ Time Frame: retrospective analysis from preoperatively to 2-14 months postoperatively ]


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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Eligible keratoconus patients aged 18-50 years who underwent unilateral crosslinking treatment in our ophthalmology department and completed a postoperative follow-up of 2-14 months
Criteria

Inclusion Criteria:

  • Keratoconus patients after unilateral crosslinking treatment

Exclusion Criteria:

  • Morphological changes of the cornea caused be ocular infection or trauma (e.g. corneal scarring)
  • Other pre-existing corneal surgery (e.g. corneal transplantation, implantation of intrastromal corneal ring segments)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02428166


Locations
Germany
Department of ophthalmology, University of Heidelberg
Heidelberg, Baden-Wuerttemberg, Germany, 69120
Sponsors and Collaborators
Heidelberg University
Investigators
Principal Investigator: Mike P Holzer, MD, FEBO Department of ophthalmology, University of Heidelberg

Responsible Party: Prof. Dr. med. Mike P. Holzer, Ophthalmologist, FEBO, Heidelberg University
ClinicalTrials.gov Identifier: NCT02428166     History of Changes
Other Study ID Numbers: S-004/2015
First Posted: April 28, 2015    Key Record Dates
Last Update Posted: December 13, 2017
Last Verified: December 2017

Keywords provided by Prof. Dr. med. Mike P. Holzer, Heidelberg University:
crosslinking
keratoconus
keratometry
pachymetry
pentacam

Additional relevant MeSH terms:
Keratoconus
Corneal Diseases
Eye Diseases