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(119 days)
The GPA (hexafocon A) Rigid Gas Permeable Contact Lens is indicated for daily wear for the correction of refractive error in aphakic and not aphakic persons with non-diseased eyes with myopia or hyperopia and/or possesses refractive astigmatism not exceeding 0.75 diopters.
The GPA-AT (hexafocon A) Rigid Gas Permeable Contact Lens is indicated for daily wear for the correction of refractive error in aphakic and not aphakic persons with non-diseased eyes with myopia or hyperopia and/or possesses refractive astigmatism not exceeding 6.00 diopters.
The GPA-M, GPA-PN and GPA-PD (hexafocon A) Rigid Gas Permeable Contact Lenses are indicated for daily wear for the correction of refractive error in aphakic and not aphakic persons with non-diseased eyes with myopia or hyperopia and/or possesses refractive astigmatism not exceeding 0.75 diopters.
The GPA-PDT, GPA-MT, and GPA-PNT (hexafocon A) Rigid Gas Permeable Contact Lenses are indicated for daily wear for the correction of refractive error in aphakic and not aphakic persons with non-diseased eyes with myopia or hyperopia and/or possesses refractive astigmatism not exceeding 6.00 diopters and are presbyopic requiring add power of up to +4.00 diopters.
The GPA-K (hexafocon A) Rigid Gas Permeable Contact Lens may be prescribed in otherwise non-diseased eyes that require a rigid gas permeable lens for the management of irregular corneal conditions such as; keratoconus, pellucid marginal degeneration or following penetrating keratoplasty or refractive (e.g. LASIK) surgery.
Eyecare practitioners may prescribe the lenses for frequent/planned replacement wear, with cleaning, disinfection and scheduled replacement. When prescribed for frequent/planned replacement wear, the lens may be cleaned and disinfected using a chemical (not heat) lens care system.
The GPA (hexafocon A) Rigid Gas Permeable Contact Lenses are lathe manufactured from the lens blank material hexafocon A, which is blue-tinted for visibility and may include an ultraviolet (UV) light absorber. The contact lens material name hexafocon A has been adopted by the United States Adopted Names (USAN) Council.
The GPA (hexafocon A) Rigid Gas Permeable Contact Lenses are a family of rigid gas permeable contact lenses available in the following design configurations:
| Model | Description |
|---|---|
| GPA-A | Rigid gas permeable contact lens with double aspherical design on both the front and back surfaces. |
| GPA-K | Rigid gas permeable contact lens with double aspherical design on both the front and back surfaces, specifically designed for keratoconus. |
| GPA-M | Progressive multifocal rigid gas permeable contact lens with double aspherical design on both the front and back surfaces. |
| GPA-PN | Multifocal rigid gas permeable contact lens with an aspherical back surface and a concentric multi-zone front surface where the center zone is for near vision, specifically designed for presbyopia correction. |
| GPA-PD | Multi-focal rigid gas permeable contact lens with an aspherical back surface and a concentric multi-zone front surface where the center zone is for distance vision, specifically designed for presbyopia correction. |
| GPA-AT | Rigid gas permeable contact lens with double toric design on both the front and back surfaces. |
| GPA-MT | Progressive multifocal rigid gas permeable contact lens with a toric back surface and an aspherical front surface. |
| GPA-PNT | Multifocal rigid gas permeable contact lens with a toric back surface and a concentric multi-zone front surface where the center zone is for near vision, specifically designed for correcting presbyopia in patients with large corneal astigmatism. |
| GPA-PDT | Multi-focal rigid gas permeable contact lens with an aspherical back surface and a concentric multi-zone front surface where the center zone is for distance vision, specifically designed for correcting presbyopia in patients with large corneal astigmatism. |
The GPA (hexafocon A) Rigid Gas Permeable Contact Lenses are in the following lens parameters:
| Parameter | Abbr. | Range (mm) | Step (mm) | Tolerance | ||||
|---|---|---|---|---|---|---|---|---|
| GPA-A | GPA-K | GPA-M | GPA-PN | GPA-PD | ||||
| BC radius /mm | BC | 6.50~9.50 | 4.50~7.50 | 6.50~9.50 | 6.50~9.50 | 6.50~9.50 | 0.05 | ± 0.05 mm |
| Total diameter /mm | TD | 8.50~11.50 | 7.00~11.00 | 8.00~12.00 | 8.00~12.00 | 8.00~12.00 | 0.10 | ± 0.10mm |
| Spherical power /D | SPH | -20.00~+20.00 | -20.00~+20.00 | -20.00~0.00 | -20.00~+6.00 | -20.00~+6.00 | 0.25 | ± 0.12 (0 to </= 5D)± 0.18 (5 to </= 10.0D)± 0.25 (10 to </= 15D)± 0.37 (15 to </= 20D)± 0.50 (over 20D) |
| Additional power /D | Add | N/A | N/A | -5.00~+5.00 | 0~+4.00 | 0~+4.00 | 0.25 | ± 0.38D |
| Center thickness /mm | CT | 0.11~0.60 | 0.11~0.60 | 0.11~0.60 | 0.11~0.60 | 0.11~0.60 | - | ± 0.02 mm |
| Optional back toric design | - | GPA-AT | N/A | GPA-MT | GPA-PNT | GPA-PDT | - | - |
| Optional back toric diopters /D | TOR | 0.00~-6.00 | N/A | 0.00~-6.00 | 0.00~-6.00 | 0.00~-6.00 | 0.25 | ± 0.25 (0 to </= 2D)± 0.37 (2 to </= 4D)± 0.50 (over 4D) |
| Surface Appearance | - | Lenses should be clear with no surface defect |
The physical properties of the GPA (hexafocon A) Rigid Gas Permeable Contact Lenses are as follows:
| Hexafocon A Rigid Gas Permeable Contact Lens |
|---|
| Refractive Index: 1.415 |
| Modulus (MPa): 1269 |
| Hardness (Shore D): 81 |
| Specific Gravity: 1.27 |
| Oxygen Permeability (Dk): 100 x 10⁻¹¹(cm²/sec) (ml O₂/ml x mm Hg @ 35°C) |
| Color Additive(s): D&C Green #6 |
GPA (hexafocon A) Rigid Gas Permeable Contact Lenses are distributed in a dry state, without immersion in solution. The primary packaging consists of a polycarbonate plastic screw-top vial equipped with a lens clamp to secure the product during transit. All accompanying documentation—including the case, packing slip, and invoice—identifies lens specifications: base curve, dioptric power, cylindrical power, cylindrical axis, additional power, diameter, central thickness, color, and lot number.
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