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A Spanish research group and a Spanish company have developed a new multifocal scleral contact lens to compensate presbyopia which has the peculiarity of being optically customizable according to the specific needs of each patient. Some prototypes have been manufactured at laboratory level and they have been validated successfully in patients. Currently, CE marking is being processed. Companies interested in licensing agreement or commercial agreement with technical assistance are sought.
Presbyopia is a widespread problem in the population over 45 years which causes difficulty in seeing up close. Nowadays, there is a wide variety of multifocal contact lenses designs to compensate the presbyopia, both in hydrogel material and oxygen permeable rigid material. All of these designs are based on the induction of fixed amounts of primary spherical aberration for different levels of near vision.
A Spanish university and a Spanish company have developed a novel multifocal contact lenses to compensate presbyopia, based on the optimization of depth of focus through combining different types of optical aberrations, with an easy fitting, with significant positional stability, and customizable according to the specific needs of each patient.
This technology solves the main limitations of multifocal contact lenses that are currently available on the market, among others:
1. The induction of spherical aberration is fixed and it does not take into account the specific aberrometric defects inherent to each patient's eye.
2. The fitting guides are empirical and do not always operate properly.
3. In most of these fitting guides, refraction is used as the only selection criterion for the selection of the trial lens.
4. These types of lenses experience decentrations, which minimize the increase in depth of focus.
5. Corneal multifocal contact lenses only induce different levels of positive primary spherical aberration without the possibility of modifying it according to specific peculiarities of the patient's eye. Likewise, rigid lenses cause discomfort during the beginning of the contact lens wearing, which can lead to its rejection.
6. Practically all current multifocal contact lenses induce primary spherical aberration, but do not consider the combination of other types of optical aberrations that have been shown to be highly effective to induce significant increases in depth of focus without deteriorating the visual quality.
The developed contact lenses are made of oxygen permeable rigid material, with scleral bearing (that is, the outermost and white layer of the eyeball), which is fully customizable according to the specific anatomical properties of the eye of each patient, such as:
• Zernike's third to sixth order aberrations.
• Pupil dynamics.
• Position of the visual axis with respect to the pupillary center.
This novel contact lens, which allows an aligned and adequate fitting to the corneal-conjunctival profile of the patient, comprise three different areas: corneal, limbar and scleral. In turn, each of these areas has two surfaces: anterior (which is in contact with the environment), and posterior (which is the one that configures the tear meniscus retained between the cornea and the contact lens). See Figures 1 and 2.
1) Corneal area (3): it has a variable diameter with a fixed rear surface geometry (3a) and an anterior surface shape (3b) which is modified during the manufacturing process according to the specific needs of the patient and the aberrometric induction required.
2) Limbar area (2): it has both a diameter and a variable asphericity. Also, this area is the responsible for the control of the sagittal height of the contact lens.
3) Scleral area (1): it is the area of the contact lens that rests on conjunctiva. It has a spherical geometry and a variable diameter. The radius of curvature of the temporal portion and the nasal portion is different to consider the naso-temporal asymmetry of the corneo-scleral profile.
These contact lenses are already on the market. The manufacturing process is reliable and reproducible. The CE marking process has been applied for. The company expects to obtain it in September-October 2018.
Companies in the contactology sector, either manufacturers or distributors, are sought for:
- licensing agreements for the multifocal scleral contact lens to compensate presbyopia and/or their design.
- Commercial agreements with technical assistance.
The new multifocal scleral contact lens made of oxygen permeable rigid material and with optical personalization for each patient, offers the following advantages over the designs currently on the market:
1. It rests only on the conjunctival-scleral surface (this lens does not bear at any point on the surface of the cornea), minimizing the risk for continuous friction between the lens and the cornea, allowing a fitting providing maximum comfort.
2. It presents a great variety of options to induce stable optical aberrations according to the needs and the optical peculiarities of the patient's eye.
3. It allows an optimization of the depth of focus leading to excellent levels of visual quality.
4. In the case of patients with peculiar pupil dynamics, the contact lens can be modified to achieve an even greater optimization of the results.
5. The scleral support in the 360º confers a greater stability to the lens, minimizing the movement and the decentration, and therefore contributing to an optimum vision for both near and far.
6. It takes into account the naso-temporal asymmetry of the profile of the corneo-scleral junction, which minimizes both the decentration and the movement of the lens.
7. The fitting of the contact lens is easy, personalized and specific for each patient, providing great levels of comfort and excellent visual quality.
8. The high failure rates provided of current multifocal contact lenses are overcome with this lens.
The most innovative aspect of the developed contact lens to compensate presbyopia is the fact that they are optically customizable according to the specific needs of each patient's eye.
Additionally, a wide variety of Zernike third to sixth order optical aberration induction options has been used not only according to the patient's near addition, but also according to the patient's kappa angle as well as the pupil size under different lighting conditions.
Before introducing these lenses on the market, a batch of prototypes were manufactured and successfully validated in different patients.
Spanish and PCT patent application.
- Type of partner sought: Companies
- Specific area of activity of the partner: Manufacturer or distributor of contact lenses.
- Task to be performed:
* To commercially exploit the multifocal scleral contact lens and/or their design through a licensing agreement, or;
* To distribute the multifocal scleral contact lens through a commercial agreement with technical assistance.