ClinicalTrials.gg
Status unknownNCT02623543Updated Dec 7, 2015

Effectiveness of Orthokeratology in Decreasing Myopic Progression in a Young Adult Population Enrolled in a Professional Optometric Curriculum

A Phase 2 interventional study of OrthoK in Myopia Progression, sponsored by Illinois College of Optometry. Status unknown at 1 site in United States. Open to participants aged 20 Years to 40 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2015-12-07.

Sponsored by Illinois College of Optometry · Phase 2, Interventional, and Prevention

The sponsor has not verified this record recently (last verified Dec 2015), so the status shown — last known as Recruiting — may be out of date.
Phase
Phase 2
Study type
Interventional
Enrollment
80
Allocation
Randomized
Ages
20 Years to 40 Years
Sex
All
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Study summary

The high prevalence of myopia - especially in Asian countries - is well documented, as are the sight-threatening complications of high or degenerative myopia. Retinal detachment, glaucoma, vitreal degeneration and focal retinal changes occur secondary to the progressive axial elongation of the eye with age. Specialty rigid lenses have long been shown to lessen this progression in the pediatric population; orthokeratology (ortho-k) lenses are worn at night and change the corneal topography to correct low to moderate amounts of myopia. This same axial elongation has also been shown to occur in young adults with high near demands, however to our knowledge, there are no studies examining the effect of ortho-k lenses in this population. Our project seeks to investigate the efficacy of ortho-k in slowing axial elongation and myopic progression in subjects between the ages of 21-30. Results will help elucidate what role these specialty lenses may have in the management of the myopic patient throughout their development, as well as what potential they have in prevention of associated degenerative changes.

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Conditions studied

  • Myopia Progression

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03

In context

Myopia

1,159 studies on the registry are indexed under Myopia; 225 are open to participants now.

This study's planned enrollment of 80 is close to the median of 78 across 923 interventional studies indexed under Myopia.

Browse Myopia studies →

Lead sponsor

Illinois College of Optometry is the lead sponsor of 4 studies on the registry; 1 is open to participants now.

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

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Who can participate

Ages eligible
20 Years to 40 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

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

  • The subject must be in the incoming first year optometry class, with a myopic prescription between -0.50D and -5.00D in at least one eye with refractive astigmatism \<1.50D. Visual acuity must be at least logMAR 0.10 (Snellen 20/25) or better at baseline examination in both eyes. Ocular examination must not reveal any strabismus, ocular pathology or for orthokeratology lens wear. Subjects must be in good general health with no systemic conditions that might impact their ocular health or refractive error. They must be willing to sleep a minimum of six hours per night. Finally, subjects must be willing and able to present to clinic for all necessary follow-up care.

Exclusion criteria

Exclusion Criteria:

  • Prescription falls outside the refractive guidelines, have a history of any type of trauma or ocular surgery, have a history of prior experience with myopia control treatment, are amblyopic or if they are current gas permeable lens wearers. They will be discontinued from the study if they are non-compliant with the treatment protocol or do not achieve a desirable subjective result,
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Contraindication

A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.

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Study design

Phase
Phase 2
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Investigator)
Enrollment
80 participants (estimated)

Study arms

  • Experimental
    OrthoK

    OrthoK lenses will be prescribed for subjects randomly and followed for 2yrs throughout wearing the lenses. There will be an enrollment appointment, dispense appointment, 1-day, 1-week, 1-month, 6-month, 12-month, and 24-month follow-ups.

    Device: OrthoK

  • Placebo comparator
    Control

    Subjects in the randomly assigned control will continue to wear their glasses throughout the 2yr follow-up period. There will be an enrollment appointment, 6-month, 12-month, and 24-month follow-ups.

    Device: OrthoK

Interventions

  • DeviceOrthoK
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What researchers measure

Primary outcomes

  1. Myopia Progression

    Time frame: 2 years

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Study locations

1 of 1 sites recruiting
  • Illinois College of Optometry
    Chicago, Illinois 60616, United States
    Recruiting
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 7, 2015, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT02623543
Lead sponsor
Illinois College of Optometry
Responsible party
Sponsor
First posted
Dec 7, 2015
Start date
Nov 2013
Primary completion
Dec 2017 (estimated)
Last update
Dec 7, 2015

Study contacts

Yi Pang, O.D. PhD
Contact
ypang@ico.edu
312-949-7287

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Dec 2015. You cannot join it, but the record below documents what was studied.

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