Porous PFPE Lenticule Implantation in Human Corneal Stroma
No, porous perfluoropolyether (PFPE) lenticule implantation in the corneal stroma has not been tested or used in humans based on the available evidence.
Current Status of Lenticule Implantation Technology
Types of Lenticules Used in Clinical Practice
Current evidence indicates that corneal lenticule implantation has been explored using several materials, but specifically porous PFPE lenticules have not been documented in human clinical applications:
Human Stromal Lenticules: Extracted during SMILE (Small Incision Lenticule Extraction) procedures, these autologous or allogenic lenticules have been used in various applications 1.
Decellularized Human Lenticules: These are processed from SMILE-extracted lenticules to remove cellular material while preserving the extracellular matrix 2.
Acellular Porcine Corneal Stroma (APCS): Animal-derived lenticules have been used, though with reported complications including ulcerative keratopathy 3.
Current Applications of Lenticule Implantation
Lenticule implantation has been investigated for several clinical scenarios:
- Correction of refractive errors: Primarily hyperopia and presbyopia
- Treatment of corneal ectasia and keratoconus
- Management of corneal perforations 4
- Corneal tissue engineering
Evidence from Animal Studies
Animal studies have demonstrated the feasibility of allogenic lenticule implantation:
Monkey studies: Femtosecond laser-assisted corneal small incision allogenic intrastromal lenticule implantation showed promising results with approximately 82% of intended refractive correction achieved at 6 months 5.
Rabbit studies: Decellularized human stromal lenticules have been implanted into rabbit stromal pockets, showing biocompatibility without short or long-term rejection 2.
Preservation Methods for Lenticules
Several preservation methods have been investigated for corneal lenticules:
- Hypothermic storage: Similar to conventional corneal preservation
- Cryopreservation: For longer-term storage
- Decellularization: Using agents like 0.1% sodium dodecylsulfate (SDS) 2, 6
Potential Complications of Lenticule Implantation
Based on existing evidence with other lenticule materials, potential complications include:
- Ulcerative keratopathy: Reported with acellular porcine corneal stroma implants 3
- Interface complications: Including debris and inflammation
- Corneal edema: Particularly in early postoperative period
- Refractive unpredictability
Clinical Considerations for Future Development
If porous PFPE lenticules were to be developed for human use, several factors would need consideration:
- Optical properties: Must maintain corneal transparency and light transmittance
- Biocompatibility: Need for extensive testing to ensure no rejection or inflammation
- Stromal integration: Ability to support keratocyte migration and integration
- Refractive predictability: Consistent and stable refractive outcomes
Surgical Approaches for Lenticule Implantation
Current lenticule implantation techniques that might be adapted for porous PFPE include:
- Stromal pocket creation: Using femtosecond laser technology 1
- Small incision techniques: Similar to SMILE procedure
- Lamellar keratoplasty approaches: Including DALK techniques 1
Conclusion
While various lenticule materials and implantation techniques have been investigated for corneal applications, there is no evidence in the available literature that porous perfluoropolyether (PFPE) lenticules have been tested or used in human corneal stroma. Any future development would require extensive preclinical testing before human trials could be considered.