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CompletedNCT00713856Updated Oct 19, 2010

Comparison of Conventional and Custom Photorefractive Keratectomy (PRK)

An interventional study of Custom PRK with iris registration and Conventional PRK in Myopia, sponsored by University of Utah. Completed at 1 site in United States. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2010-10-19.

Sponsored by University of Utah · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
44
Allocation
Randomized
Ages
18 Years to 80 Years
Sex
All
01

Study summary

The study objective is to compare the clinical outcomes using wavefront guided PRK with iris registration and conventional laser PRK using FDA-approved laser technology on the same patient.

Read the detailed description

Patients undergoing bilateral PRK on the same day will have one eye randomly assigned to custom wavefront guided PRK and the fellow eye treated with conventional PRK.

02

Conditions studied

  • Myopia

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03

In context

Myopia

1,007 studies on the registry are indexed under Myopia; 210 are open to participants now.

This study's enrollment of 44 is below the median of 80 across 803 interventional studies indexed under Myopia.

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Lead sponsor

University of Utah is the lead sponsor of 991 studies on the registry; 177 are open to participants now.

Of its 111 completed or terminated interventional studies of FDA-regulated products, 64 (58%) have results posted.

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

04

Who can participate

Ages eligible
18 Years to 80 Years
Sexes eligible
All
Accepts healthy volunteers
No

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 deemed to be suitable candidates for bilateral PRK

Exclusion criteria

Exclusion Criteria:

  • Patients desiring monovision correction rather than bilateral distance correction
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
44 participants (actual)

Study arms

  • Active comparator
    1

    Procedure: Custom PRK with iris registration

  • Active comparator
    2

    Procedure: Conventional PRK

Interventions

  • ProcedureCustom PRK with iris registration

    PRK

  • ProcedureConventional PRK

    PRK

06

What researchers measure

Primary outcomes

  1. Visual acuity

    Time frame: 6 months

Secondary outcomes

  1. Manifest refraction

    Time frame: 6 months

  2. Wavefront aberration value

    Time frame: 6 months

07

Study locations

1 site
  • University of Utah, John Moran Eye Center
    Salt Lake City, Utah 84132, United States
08

Timeline

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

The record gives a start of Nov 2007, a primary completion of Dec 2009 and a completion of May 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
Jul 8, 2008
First posted
Jul 14, 2008
Start
Nov 2007
Primary completionActual
Dec 2009
CompletionActual
May 2010
Last update
Oct 19, 2010
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 Oct 19, 2010, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00713856
Lead sponsor
University of Utah
First posted
Jul 14, 2008
Start date
Nov 2007
Primary completion
Dec 2009
Completion
May 2010
Last update
Oct 19, 2010

Study contacts

Mark Mifflin, MD
principal investigator · University of Utah

Oversight

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

Not currently enrolling

This study is completed, as verified in Oct 2010. You cannot join it, but the record below documents what was studied.

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