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

Keratoconus Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02428166
• Other study ID #: S-004/2015
• Status: Completed
• Phase: N/A
• First received: April 23, 2015
• Last updated: December 11, 2017
• Start date: February 2015
• Est. completion date: March 31, 2017

Study information

• Verified date: December 2017
• Source: Heidelberg University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 66
• Est. completion date: March 31, 2017
• Est. primary completion date: March 31, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 50 Years

Eligibility

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)

Related Conditions & MeSH terms

• Keratoconus

Locations

Country	Name	City	State
Germany	Department of ophthalmology, University of Heidelberg	Heidelberg	Baden-Wuerttemberg

Sponsors (1)

Lead Sponsor	Collaborator
Heidelberg University

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Change in corneal thickness as measured by the Pentacam HR		retrospective analysis from preoperatively to 2-14 months postoperatively
Secondary	Change in visual acuity (VA)		retrospective analysis from preoperatively to 2-14 months postoperatively
Secondary	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