Corneal Changes After Crosslinking in Keratoconus Patient... | NCT02428166

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

NCT02428166

Sponsor

Heidelberg University

Status

Completed

Last Update Posted

Dec 13, 2017Actual

Enrollment

66Actual

Phase

Not provided

Conditions

Keratoconus

Interventions

Not provided

Countries

Germany

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Dec 2017

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Feb 2015

Primary Completion Date

Mar 31, 2017Actual

Completion Date

Mar 31, 2017Actual

First Submitted Date

Apr 23, 2015

First Submission Date that Met QC Criteria

Apr 23, 2015

First Posted Date

Apr 28, 2015Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Dec 11, 2017

Last Update Posted Date

Dec 13, 2017Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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 provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

66Actual

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Measure	Description	Time Frame
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

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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)

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

50 Years

Standard Ages

Adult

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

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Mike P Holzer, MD, FEBO	Department of ophthalmology, University of Heidelberg	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Department of ophthalmology, University of Heidelberg		Heidelberg	Baden-Wurttemberg	69120	Germany

Condition Browse Module

MeSH Terms

ID	Term
D007640	Keratoconus

Ancestor Terms

ID	Term
D003316	Corneal Diseases
D005128	Eye Diseases

Browse Leaves

Not provided

Browse Branches

Not provided