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Clinical Trials/NCT02428166
NCT02428166
Completed
Not Applicable

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

Heidelberg University1 site in 1 country66 target enrollmentFebruary 2015
ConditionsKeratoconus

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Keratoconus
Sponsor
Heidelberg University
Enrollment
66
Locations
1
Primary Endpoint
Change in maximum keratometry (Kmax) as measured by the Pentacam HR
Status
Completed
Last Updated
8 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
February 2015
End Date
March 31, 2017
Last Updated
8 years ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Prof. Dr. med. Mike P. Holzer

Ophthalmologist, FEBO

Heidelberg University

Eligibility 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)

Outcomes

Primary Outcomes

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 Outcomes

  • Change in corneal thickness as measured by the Pentacam HR(retrospective analysis from preoperatively to 2-14 months postoperatively)
  • Change in visual acuity (VA)(retrospective analysis from preoperatively to 2-14 months postoperatively)
  • Evaluation of pre-existing ocular pathology or/and ocular surgery as potential factors involved in treatment outcome(retrospective analysis from preoperatively to 2-14 months postoperatively)

Study Sites (1)

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