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

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ClinicalTrials.gov Identifier: NCT02623543
Recruitment Status : Unknown
Verified December 2015 by Illinois College of Optometry.
Recruitment status was:  Recruiting
First Posted : December 7, 2015
Last Update Posted : December 7, 2015
Sponsor:
Information provided by (Responsible Party):
Illinois College of Optometry

Brief 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.

Condition or disease Intervention/treatment Phase
Myopia Progression Device: OrthoK Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 80 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Primary Purpose: Prevention
Official Title: Effectiveness of Orthokeratology in Decreasing Myopic Progression in a Young Adult Population Enrolled in a Professional Optometric Curriculum
Study Start Date : November 2013
Estimated Primary Completion Date : December 2017

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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



Primary Outcome Measures :
  1. Myopia Progression [ Time Frame: 2 years ]


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Ages Eligible for Study:   20 Years to 40 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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 contraindications 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:

  • 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,

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02623543


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

Locations
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United States, Illinois
Illinois College of Optometry Recruiting
Chicago, Illinois, United States, 60616
Contact: Elyse Nylin, BS    312-949-7298    enylin@ico.edu   
Sponsors and Collaborators
Illinois College of Optometry

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Responsible Party: Illinois College of Optometry
ClinicalTrials.gov Identifier: NCT02623543     History of Changes
Other Study ID Numbers: OK-ICO
First Posted: December 7, 2015    Key Record Dates
Last Update Posted: December 7, 2015
Last Verified: December 2015
Additional relevant MeSH terms:
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Disease Progression
Disease Attributes
Pathologic Processes