Overview

This trial is active, not recruiting.

Condition keratoconus
Sponsor Heidelberg University
Start date February 2015
End date December 2016
Trial size 50 participants
Trial identifier NCT02428166, S-004/2015

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Observational model cohort
Time perspective retrospective

Primary Outcomes

Measure
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

Measure
Change in corneal thickness as measured by the Pentacam HR
time frame: retrospective analysis from preoperatively to 2-14 months postoperatively
Change in visual acuity (VA)
time frame: 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
time frame: retrospective analysis from preoperatively to 2-14 months postoperatively

Eligibility Criteria

Male or female participants from 18 years up to 50 years old.

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)

Additional Information

Official title Corneal Changes After Crosslinking in Keratoconus Patients Compared to the Untreated Fellow Eye
Principal investigator Mike P Holzer, MD, FEBO
Trial information was received from ClinicalTrials.gov and was last updated in June 2016.
Information provided to ClinicalTrials.gov by Heidelberg University.