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

NCT02428166 | Completed

• 1 other identifier: S-004/2015
• Study Type: observational
• Target: 66
• Locations: 1 country
• Sites: 1

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.

Conditions

Keratoconus

Keywords

crosslinking; keratoconus; keratometry; pachymetry; pentacam

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• 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

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Eligible keratoconus patients aged 18-50 years who underwent unilateral crosslinking treatment in our ophthalmology department and completed a postoperative follow-up of 2-14 months

You may qualify if:

• Keratoconus patients after unilateral crosslinking treatment

You may not qualify if:

• 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)

Sponsors & Collaborators

• Heidelberg University: lead

Study Sites (1)

Department of ophthalmology, University of Heidelberg

Heidelberg, Baden-Wurttemberg, 69120, Germany

Location

MeSH Terms

Conditions

Keratoconus

Condition Hierarchy (Ancestors)

Corneal Diseases; Eye Diseases

Study Officials

• Mike P Holzer, MD, FEBO

  Department of ophthalmology, University of Heidelberg

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Ophthalmologist, FEBO

Study Record Dates

• First Submitted: April 23, 2015
• First Posted: April 28, 2015
• Study Start: February 1, 2015
• Primary Completion: March 31, 2017
• Study Completion: March 31, 2017
• Last Updated: December 13, 2017

Record last verified: 2017-12

Locations

DE (1)