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

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.

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Key information

Conditions

Keratoconus Corneal Diseases Eye Diseases

Age range

18 year–50 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Department of ophthalmology, University of Heidelberg

Heidelberg, Baden-Wurttemberg, 69120, Germany

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

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

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

Sponsors and collaborators

Lead sponsor

Heidelberg University

Other

Registry information

Important dates

Study start: 2015
Primary completion: 2017
Study completion: 2017
First posted: Apr 28, 2015
Registry last updated: Dec 13, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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Completed