NCT02023619

Brief Summary

The purpose of the study was to identify corneal epithelial- and stromal-thickness distribution patterns in keratoconic eyes using spectral-domain-optical coherence tomography (SD-OCT). Study Hypothesis: SD-OCT provides necessary details about the distribution of corneal epithelial and stromal thicknesses for identification of a pattern characteristic for early keratoconus.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jul 2013

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2013

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2013

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

December 12, 2013

Completed
18 days until next milestone

First Posted

Study publicly available on registry

December 30, 2013

Completed
Last Updated

April 4, 2019

Status Verified

April 1, 2019

Enrollment Period

2 months

First QC Date

December 12, 2013

Last Update Submit

April 2, 2019

Conditions

KeratoconusAstigmatism

Keywords

KeratoconusAstigmatismCorneaSD-OCT

Outcome Measures

Primary Outcomes (1)

  • Cornea epithelial thickness distribution

    A single non-invasive measurement by OCT evaluated up to 24 weeks after the examination

    Up to 24 weeks

Secondary Outcomes (1)

  • Cornea stromal thickness distribution

    Up to 24 weeks

Study Arms (2)

Keratoconus

Eyes with confirmed keratoconus diagnosis

Astigmatism >2.0 D

Healthy eyes with astigmatism \>2.0 D

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

20 eyes with diagnosed keratoconus and 20 healthy eyes with astigmatism \>2.0 D

You may qualify if:

  • Keratoconus group: Confirmed diagnosis of keratoconus
  • Astigmatism group: Healthy eyes with astigmatism of \>2.0 D

You may not qualify if:

  • Keratoconus group: Keratoconus \> stage 3 on Krumeich scale
  • Astigmatism group: No signs of keratoconus

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

SynsLaser Kirurgi AS

Tromsø, Troms, 9008, Norway

Location

Related Publications (1)

  • Zhou W, Stojanovic A. Comparison of corneal epithelial and stromal thickness distributions between eyes with keratoconus and healthy eyes with corneal astigmatism >/= 2.0 D. PLoS One. 2014 Jan 28;9(1):e85994. doi: 10.1371/journal.pone.0085994. eCollection 2014.

    PMID: 24489687RESULT

MeSH Terms

Conditions

KeratoconusAstigmatismCorneal Diseases

Condition Hierarchy (Ancestors)

Eye DiseasesRefractive Errors

Study Officials

  • Aleksandar Stojanovic, MD

    SynsLaser Kirurgi AS

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CROSSOVER
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Medical director of SynsLaser Surgery AS

Study Record Dates

First Submitted

December 12, 2013

First Posted

December 30, 2013

Study Start

July 1, 2013

Primary Completion

September 1, 2013

Study Completion

September 1, 2013

Last Updated

April 4, 2019

Record last verified: 2019-04

Data Sharing

IPD Sharing
Will not share

Locations

NO(1)