Research on Ophthalmic Devices: IOL design and materials, OVDs and IOL injectors.
The David J Apple International Laboratory for Ocular Pathology provides a confidential, professional service of optical, physical, chemical and other analyses on ophthalmic devices using input from the following sources:
▪ The Apple Lab’s own staff and resources at the main Heidelberg Germany site.
▪ Staff and resources of the IVCRC (International Vision Correction Research Center) at the University of Heidelberg.
▪ Contractual services from Intramural relations at the University of Heidelberg: typically with departments of the university faculties of Medicine and Science.
▪ Extramural sub-contractors within the region of the city of Heidelberg.
We study implant devices before they are launched on the market and the follow-up with vigilance studies on the device performance after it is marketed.
- Development research on device design and materials: outsourcing Test-House Services to implant manufacturers.
- Post-market surveillance analyses of ophthalmic devices
- Development research on device design and materials including OVDs and IOL injectors.
In the developmental phase before a new device is tested in clinical trials there are a number of physical and chemical measurements and tests which can be conducted on the lens material to check its safety and efficacy. These activities are typically conducted by the lens polymer manufacturer and the IOL manufacturer. The Apple Lab may be contracted to conduct matching parallel measurements and tests to confirm and independently corroborate the manufacturer’s results.
- physical testing
- chemical testing
- optical purity
- IOL metrology and power measurement
- MTF measurement
- predictive modelling of IOL safety and efficacy
- Observation of IOL behaviour during and after injection in cadaver eyes, using Miyake-Apple and Miyake-Apple-Choi techniques
Further information on these services is available from the laboratory.
Post-market surveillance analyses of ophthalmic devices.
The laboratory provides a General Report on the Structural and Ultrastructural analysis of explanted IOLs. This comprises:
- The history of the device as it is known to the surgeon who explanted it, giving the reason for explantation.
- A Medical History of Patient – when provided by the explanting surgeon.
- A Device Manufacturing History – when provided by the manufacturer.
- Procedural Results
- Results of gross examination of explant material – identification of changed morphology (lesions, inclusions, discolorations, etc.) and the location of opacifications whether these are in central /peripheral /superficial /”cortical”/ or pervasive positions in or on the device.
- Light microscopy results – usually accompanied by a photographic record.
- Results of detailed gross examination of explant material – with photographic record
- Results of Histological Staining analysis, e.g. with Alizarin Red stain.
- Results of scanning electron microscopy (SEM) – at different levels of magnification and using different sectional samples – with a photographic record.
- Results of EDX (energy dispersive x-ray fluorescence) spectroscopy.
- Further analysis, when appropriate – for example lens power measurement or MTF measurement. Whether this is done will be determined in earlier stages of the analysis of explant material and it may entail extra charges
- Discussion of results – with cross reference, if appropriate, to peer-review publications.
- Recommendations to the manufacturer to improve the device.
- Concluding remarks by an ophthalmic surgeon of professorial standing at the University of Heidelberg.
- In addition, if it is appropriate, the laboratory may secure commentary from a correspondent physician – this will be done only after consultation with the client.
- Bibliographic references to peer-review papers.
The laboratory charges an all-in fee that fully covers the multi-disciplinary nature of each report. Please register at our Contact page for a quotation on these services.