Effectiveness of Orthokeratology in Myopia Control

NCT03465748 | Completed Results FDA Device

• 1 other identifier: 15021
• Study Type: interventional
• Target: 45
• Locations: 1 country
• Sites: 1

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 may 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. Most of the studies on orthokeratology were conducted on Asian children. To the best of the investigators knowledge, no study has been done on African American (AA) children. The investigators' project seeks to investigate the efficacy of ortho-k in slowing axial elongation and myopic progression in AA children compared to that in other races.

Conditions

Myopia

Outcome Measures

Primary Outcomes (1)

• Axial Length

  Axial Length was measured at baseline and again at the 2 year mark. Units are given in mm. The average of axial length at the 2 year period is provided.

  2 years

Study Arms (2)

Experimental-OrthoK

EXPERIMENTAL

The study will be a randomized control study using a single-masked design to investigate axial elongation and myopic progression in children wearing ortho-k lenses (study group) versus single-vision spectacles or soft contact lenses (control group) for a period of 24 months. A minimum of 40 and a maximum of 60 subjects will be recruited from patients at Illinois Eye Institute. Once eligibility has been determined by an unmasked observer, patients will be randomly assigned to either the orthokeratology group or the single-vision contact lens /spectacle group

Device: OrthoK

Control

NO INTERVENTION

The study will be a randomized control study using a single-masked design to investigate axial elongation and myopic progression in children wearing ortho-k lenses (study group) versus single-vision spectacles (control group) for a period of 24 months. A minimum of 40 and a maximum of 60 subjects will be recruited from patients at Illinois Eye Institute. Once eligibility has been determined by an unmasked observer, patients will be randomly assigned to either the orthokeratology group or the single-vision contact lens /spectacle group

Interventions

OrthoK DEVICE

orthok (orthokeratology) is the science of changing the curvature or shape of the cornea to change how light is focused on the retina at the back of one's eye. Specially designed molding retainer contact lenses are placed on the eye at night and are removed upon awakening.

Experimental-OrthoK

Eligibility Criteria

• Age: 6 Years - 13 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• myopia progression more than -1.00D in one year
• myopic prescription between -1.00D and -6.00D in at least one eye with refractive astigmatism \<1.50D
• Best corrected VA 20/25 or better
• subjects willing to present to clinic for all necessary follow up care
• willing to be randomized to either group

You may not qualify if:

• non-compliance with treatment protocol
• contraindications for orthok as per company guidelines
• history of refractive surgery
• current gas permeable contact lens wearers

Sponsors & Collaborators

• Illinois College of Optometry: lead
• Wesley Research Institute: collaborator

Study Sites (1)

Illinois Eye Institute

Chicago, Illinois, 60616, United States

Location

Related Publications (8)

• Charm J, Cho P. High myopia-partial reduction ortho-k: a 2-year randomized study. Optom Vis Sci. 2013 Jun;90(6):530-9. doi: 10.1097/OPX.0b013e318293657d.

  PMID: 23645372 BACKGROUND

• Cho P, Cheung SW, Edwards M. The longitudinal orthokeratology research in children (LORIC) in Hong Kong: a pilot study on refractive changes and myopic control. Curr Eye Res. 2005 Jan;30(1):71-80. doi: 10.1080/02713680590907256.

  PMID: 15875367 BACKGROUND

• Walline JJ, Jones LA, Sinnott LT. Corneal reshaping and myopia progression. Br J Ophthalmol. 2009 Sep;93(9):1181-5. doi: 10.1136/bjo.2008.151365. Epub 2009 May 4.

  PMID: 19416935 BACKGROUND

• Kakita T, Hiraoka T, Oshika T. Influence of overnight orthokeratology on axial elongation in childhood myopia. Invest Ophthalmol Vis Sci. 2011 Apr 6;52(5):2170-4. doi: 10.1167/iovs.10-5485.

  PMID: 21212181 BACKGROUND

• Loman J, Quinn GE, Kamoun L, Ying GS, Maguire MG, Hudesman D, Stone RA. Darkness and near work: myopia and its progression in third-year law students. Ophthalmology. 2002 May;109(5):1032-8. doi: 10.1016/s0161-6420(02)01012-6.

  PMID: 11986114 BACKGROUND

• Kinge B, Midelfart A. Refractive changes among Norwegian university students--a three-year longitudinal study. Acta Ophthalmol Scand. 1999 Jun;77(3):302-5. doi: 10.1034/j.1600-0420.1999.770311.x.

  PMID: 10406150 BACKGROUND

• Walline JJ, Rah MJ, Jones LA. The Children's Overnight Orthokeratology Investigation (COOKI) pilot study. Optom Vis Sci. 2004 Jun;81(6):407-13. doi: 10.1097/01.opx.0000135093.77007.18.

  PMID: 15201713 BACKGROUND

• Santodomingo-Rubido J, Villa-Collar C, Gilmartin B, Gutierrez-Ortega R. Myopia control with orthokeratology contact lenses in Spain: refractive and biometric changes. Invest Ophthalmol Vis Sci. 2012 Jul 31;53(8):5060-5. doi: 10.1167/iovs.11-8005.

  PMID: 22729437 BACKGROUND

MeSH Terms

Conditions

Myopia

Condition Hierarchy (Ancestors)

Refractive Errors; Eye Diseases

Limitations and Caveats

Many subjects withdrew from the study due to scheduling conflicts. There was also a pause towards the end of the study follow up due to COVID. Some subjects withdrew from the study due to not being able to tolerate the lenses. Some subjects lost many lenses and had to re-order repeatedly throughout the study, limiting their success in completing the study. Remote learning during COVID may have impacted myopia progression.

Results Point of Contact

• Title: Dr. Yi Pang
• Organization: Illinois College of Optometry

YPang@ico.edu

3129497287

Study Officials

• Yi Pang, OD

  Illinois College of Optometry

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief, Cornea Center for Clinical Excellence

Study Record Dates

• First Submitted: March 6, 2018
• First Posted: March 14, 2018
• Study Start: May 1, 2017
• Primary Completion: January 31, 2021
• Study Completion: December 1, 2021
• Last Updated: September 28, 2023
• Results First Posted: September 28, 2023

Record last verified: 2023-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)