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

Completed

• Conditions: Keratoconus

• Registration Number: NCT02428166
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2015-02
• Study First Submitted: 2015-04-23
• Study First Submitted QC: 2015-04-23
• Study First Posted: 2015-04-28
• Primary Completion: 2017-03-31
• Study Completion: 2017-03-31
• Status Verified: 2017-12
• Last Update Submitted: 2017-12-11
• Last Update Posted: 2017-12-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 66

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)

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Change in maximum keratometry (Kmax) as measured by the Pentacam HR	after completion of data collection based on the measurements preoperatively and 2-14 months postoperative

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Department of ophthalmology, University of Heidelberg; 🇩🇪 Heidelberg, Baden-Wuerttemberg, Germany