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.
Recommended Actions
- Develop comprehensive clinical study protocol addressing all required parameters
- Create detailed patient selection criteria and documentation
- Establish stability criteria and measurement methods
- Prepare complete labeling package including all required components
- Document fitting procedures and problem-solving guidance
- Develop detailed patient instructions and care procedures
- Create professional training materials
- Establish adverse event monitoring and reporting procedures
- Submit IDE application if overnight wear is intended
- Prepare comprehensive clinical data analysis and presentation
- Document maintenance lens/retainer lens protocols
- 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
- Adding Lens Finishing Laboratories to Class III Rigid Gas Permeable Contact Lens PMAs
- Testing and Performance Requirements for Soft Daily Wear Contact Lenses
Related references and norms
- 510(K) Guidance Document for Daily Wear Contact Lenses (May 12, 1994)
Original guidance
This post is licensed under CC BY 4.0 by the author.