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CompletedNCT01272271Updated Apr 29, 2024

Safety of Overnight Corneal Reshaping Lenses

An observational study in Keratitis and Myopia, sponsored by Ohio State University. Completed. Open to participants aged 5 Years to 69 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-04-29.

Sponsored by Ohio State University · Observational

Study type
Observational
Model
Cohort
Time perspective
Retrospective
Enrollment
1,317
Ages
5 Years to 69 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Keratitis
  • Myopia

Keywords

  • Contact lens
  • Infection
  • Cornea
03

In context

Keratitis

129 studies on the registry are indexed under Keratitis; 14 are open to participants now.

This study's enrollment of 1,317 is above the median of 100 across 38 observational studies indexed under Keratitis.

Browse Keratitis studies →

Lead sponsor

Ohio State University is the lead sponsor of 658 studies on the registry; 145 are open to participants now.

Of its 66 completed or terminated interventional studies of FDA-regulated products, 49 (74%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
5 Years to 69 Years
Sexes eligible
All
Accepts healthy volunteers
Yes
Sampling method
Probability sample

Study population

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

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  • Less than 3 months of wearing corneal reshaping lenses
05

Study design

Observational model
Cohort
Time perspective
Retrospective
Enrollment
1,317 participants (actual)

Groups and cohorts

  • Children
  • Adults
06

What researchers measure

Primary outcomes

  1. Microbial keratitis incidence

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

    Time frame: 1 year

07

Study locations

No study locations are listed for this record.

08

Timeline

Tracking since Sep 25, 2026
Not marked actual or estimatedDates not marked actual or estimated

The record gives a start of Feb 2008, a primary completion of Oct 2010 and a completion of Oct 2010. It does not say whether these dates are actual or estimated.

How these figures are worked out, and which studies are left out of them.

Registered
Jan 6, 2011
First posted
Jan 7, 2011
Start
Feb 2008
Primary completionActual
Oct 2010
CompletionActual
Oct 2010
Last update
Apr 29, 2024
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Apr 29, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT01272271
First posted
Jan 7, 2011
Start date
Feb 2008
Primary completion
Oct 2010
Completion
Oct 2010
Last update
Apr 29, 2024

Study contacts

Mark A Bullimore, PhD
principal investigator · Ohio State University

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Apr 2024. You cannot join it, but the record below documents what was studied.

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Discussion

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