NCT01272271

Brief Summary

This retrospective chart review study compares the incidence of corneal inflammation due to infection in children vs. adult patients wearing overnight corneal reshaping lenses.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
1,317

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Feb 2008

Typical duration for all trials

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

February 1, 2008

Completed
2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2010

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

January 6, 2011

Completed
1 day until next milestone

First Posted

Study publicly available on registry

January 7, 2011

Completed
Last Updated

April 29, 2024

Status Verified

April 1, 2024

Enrollment Period

2.7 years

First QC Date

January 6, 2011

Last Update Submit

April 26, 2024

Conditions

KeratitisMyopia

Keywords

Contact lensInfectionCornea

Outcome Measures

Primary Outcomes (1)

  • Microbial keratitis incidence

    Incidence of microbial keratitis in children vs. adults with the use of two brands of corneal reshaping lenses.

    1 year

Study Arms (2)

Children

Adults

Eligibility Criteria

Age5 Years - 69 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Randomized sample of optometry and ophthalmology patients seen by 200 practitioners in various practice settings, stratified on manufacturer, practitioner volume.

You may qualify if:

  • Patients completing at least 3 months of wearing corneal reshaping lenses

You may not qualify if:

  • Less than 3 months of wearing corneal reshaping lenses

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

KeratitisMyopiaInfectionsCorneal Diseases

Condition Hierarchy (Ancestors)

Eye DiseasesRefractive Errors

Study Officials

  • Mark A Bullimore, PhD

    Ohio State University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER

Study Record Dates

First Submitted

January 6, 2011

First Posted

January 7, 2011

Study Start

February 1, 2008

Primary Completion

October 1, 2010

Study Completion

October 1, 2010

Last Updated

April 29, 2024

Record last verified: 2024-04