The Berkeley Orthokeratology Study

NCT00000123 | Completed Phase 3

• 1 other identifier: NEI-22
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief Summary

To evaluate the relative efficacy of orthokeratology, primarily by assessment of changes in central corneal thickness, astigmatism, visual acuity, endothelial cell density, and corneal curvature. To evaluate the relative safety of orthokeratology, primarily by assessment of changes in central corneal thickness, astigmatism, visual acuity, endothelial cell density, induced corneal edema, and epithelial staining. To assess the duration of any orthokeratology treatment effect. To study the mechanisms by which refractive error and visual acuity changes occur, in particular the contribution that comes from changes in corneal curvature and shape. To determine whether there were any predisposing ocular factors that could be used to predict which subjects will experience changes or complications.

Conditions

Astigmatism; Myopia

Interventions

Polymethyl Methacrylate-Silicone Contact Lenses DEVICE

Polymethyl Methacrylate Contact Lenses DEVICE

Eligibility Criteria

• Age: 20 Years - 35 Years
• Sex: all
• Age Groups: Adult (18-64)

Myopic volunteers, ages 20 to 35, who had not worn contact lenses were eligible to participate in the study if they were free of ocular disease, were in good physical health, and were not taking systemic medications that could have ocular side effects. In addition, eligibility was limited to persons with corneal curvature between 40.50 and 47.00 D (flatter keratometry reading), corrected visual acuity of 6/6 (20/20) or better in each eye, astigmatism less than 0.75 D, anisometropia less than 1 D, and myopia between 1 and 4 D.

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• National Eye Institute (NEI): lead

Related Publications (6)

• Polse KA, Brand RJ. Contact lens effects on ametropia: a current example of the clinical trial. Am J Optom Physiol Opt. 1981 Apr;58(4):281-8.

  PMID: 7282852 BACKGROUND

• Brand RJ, Polse KA, Schwalbe JS. The Berkeley Orthokeratology Study, Part I: General conduct of the study. Am J Optom Physiol Opt. 1983 Mar;60(3):175-86. doi: 10.1097/00006324-198303000-00005.

  PMID: 6342407 BACKGROUND

• Polse KA, Brand RJ, Keener RJ, Schwalbe JS, Vastine DW. The Berkeley Orthokeratology Study, part III: safety. Am J Optom Physiol Opt. 1983 Apr;60(4):321-8. doi: 10.1097/00006324-198304000-00011.

  PMID: 6344645 BACKGROUND

• Polse KA, Brand RJ, Schwalbe JS, Vastine DW, Keener RJ. The Berkeley Orthokeratology Study, Part II: Efficacy and duration. Am J Optom Physiol Opt. 1983 Mar;60(3):187-98. doi: 10.1097/00006324-198303000-00006.

  PMID: 6342408 BACKGROUND

• Polse KA, Brand RJ, Vastine DW, Schwalbe JS. Corneal change accompanying orthokeratology. Plastic or elastic? Results of a randomized controlled clinical trial. Arch Ophthalmol. 1983 Dec;101(12):1873-8. doi: 10.1001/archopht.1983.01040020875008.

  PMID: 6360111 BACKGROUND

• Lawrenson JG, Shah R, Huntjens B, Downie LE, Virgili G, Dhakal R, Verkicharla PK, Li D, Mavi S, Kernohan A, Li T, Walline JJ. Interventions for myopia control in children: a living systematic review and network meta-analysis. Cochrane Database Syst Rev. 2023 Feb 16;2(2):CD014758. doi: 10.1002/14651858.CD014758.pub2.

  PMID: 36809645 DERIVED

MeSH Terms

Conditions

Astigmatism; Myopia

Condition Hierarchy (Ancestors)

Refractive Errors; Eye Diseases

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Purpose: TREATMENT
• Sponsor Type: NIH

Study Record Dates

• First Submitted: September 23, 1999
• First Posted: September 24, 1999
• Study Start: January 1, 1978
• Study Completion: February 1, 1979
• Last Updated: September 17, 2009

Record last verified: 2009-09