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Orthokeratology Rigid Gas Permeable Contact Lenses - Premarket Submissions and Clinical Testing Requirements

This guidance provides recommendations for manufacturers submitting premarket applications (510(k) or PMA) for orthokeratology rigid gas permeable (RGP) contact lenses. It covers both daily wear and overnight wear lenses intended for temporary reduction of myopia. The guidance focuses on clinical and labeling requirements, with preclinical aspects referenced to previous contact lens guidance documents.

What You Need to Know? 👇

What are the key clinical study requirements for orthokeratology contact lens submissions?

For daily wear studies, FDA recommends 50-60 completed subjects from 3-5 clinical sites with minimum 3-month follow-up. Overnight wear requires 150-200 subjects for 12 months due to significant risk classification requiring IDE approval.

What specific data tables must be included in orthokeratology submissions?

Submissions must include supplemental tables beyond standard contact lens data: keratometry changes stratified by dioptric groups, corneal cylinder changes, refractive parameter demographics, accuracy of intended vs achieved correction, and stability of manifest refraction analyses.

How should manufacturers define success criteria for orthokeratology devices?

Success should be defined using objective, quantifiable parameters including specific uncorrected visual acuity levels, corneal topographic eccentricity stability, and proportions of subjects achieving targeted refractive error reduction within ±0.50, ±1.00, and ±2.00 diopters.

What are the main safety endpoints FDA requires for orthokeratology studies?

Key safety parameters include loss of 2+ lines best corrected visual acuity, increase in corneal/refractive astigmatism ≥1D and ≥2D, signs/symptoms with grading scales, slit lamp findings, and comprehensive adverse event documentation with associated criteria.

What labeling components are mandatory for orthokeratology contact lenses?

Required labeling includes shipping container label, package insert, professional fitting guide, and two-part patient booklet. Each must contain specific warnings about non-sterile shipping, contraindications, wearing restrictions, and detailed care instructions per FDA template.

How does FDA classify daily wear versus overnight wear orthokeratology studies?

Daily wear orthokeratology studies are considered non-significant risk requiring only IRB approval, while overnight wear studies are significant risk requiring both IRB approval and FDA IDE approval before initiating clinical testing.


What You Need to Do 👇

  1. Develop comprehensive clinical study protocol addressing all required parameters
  2. Create detailed patient selection criteria and documentation
  3. Establish stability criteria and measurement methods
  4. Prepare complete labeling package including all required components
  5. Document fitting procedures and problem-solving guidance
  6. Develop detailed patient instructions and care procedures
  7. Create professional training materials
  8. Establish adverse event monitoring and reporting procedures
  9. Submit IDE application if overnight wear is intended
  10. Prepare comprehensive clinical data analysis and presentation
  11. Document maintenance lens/retainer lens protocols
  12. Create risk analysis and mitigation strategies

Key Considerations

Clinical testing

  • Minimum 50-60 completed subjects from 3-5 clinical sites for daily wear
  • Minimum 150-200 completed subjects for overnight wear studies
  • Follow-up period of minimum 3 months for daily wear, 12 months for overnight wear
  • Define stability through quantifiable measures (eccentricity value, corneal topography, refractive error changes)
  • Collect data on uncorrected visual acuity, refractive error changes, keratometry/topography changes
  • Monitor safety parameters including adverse events and loss of best corrected visual acuity
  • Document wearing time and regression patterns

Human Factors

  • Patient selection criteria must be defined
  • Document patient training requirements
  • Provide detailed wearing schedules and instructions

Labelling

  • Include shipping container label
  • Package insert with detailed safety information
  • Patient information booklet in two parts
  • Professional fitting and information guide
  • Clear warnings and precautions
  • Detailed care and handling instructions

Safety

  • Monitor for adverse events including corneal edema, staining, infections
  • Document any loss of best corrected visual acuity
  • Track increases in corneal/refractive astigmatism
  • Monitor intraocular pressure

Other considerations

  • IDE required for overnight wear studies
  • Document maintenance lens/retainer lens requirements
  • Provide detailed fitting procedures and problem-solving guidance
  • Include clinical study results in labeling

Relevant Guidances 🔗

  • 510(K) Guidance Document for Daily Wear Contact Lenses (May 12, 1994)

Original guidance

  • Orthokeratology Rigid Gas Permeable Contact Lenses - Premarket Submissions and Clinical Testing Requirements
  • HTML / PDF
  • Issue date: 2000-04-09
  • Last changed date: 2023-08-17
  • Status: FINAL
  • Official FDA topics: Medical Devices, Premarket
  • ReguVirta ID: 09e0d9bf76e5817a5fdf6cf6db786652
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