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Progressive Boston Diamond Orthokeratology (Oprifocon A) Shaping Lenses for Overnight Wear

TFDA approval# 023221

Description

Progressive Boston Diamond Orthokeratology (oprifocon A) Shaping Lenses for Overnight Wear are lathe cut contact lenses with spherical posterior surfaces in blue, green, red and yellow tinted versions. The posterior curve is selected to properly fit an individual eye for orthokeratology and the anterior curve is selected to provide the necessary optical power for a temporary reduction of myopia. A peripheral curve system on the posterior surface allows tear exchange between the lens and the cornea.

Progressive Boston Diamond Orthokeratology (oprifocon A) Shaping Lenses for Overnight Wear are made from Boston Equalens II (oprifocon A) polymer with a water content of less than 1 percent. The material is available with or without an ultraviolet absorber, Uvinul D-49. The blue tinted lenses contain D&C Green #6 as a color additive. The green tinted lenses contain D&C Green #6 and C.I. Solvent #18. The red tinted lenses contain D&C Red #17 as a color additive. The yellow tinted lenses contain C.I. Solvent #18 as a color additive.

Feature

The Progressive Boston Diamond Orthokeratology (oprifocon A) Shaping Lenses for Overnight Wear produces a temporary reduction of myopia by changing the shape (flattening of the cornea, which is elastic in nature. Flattening the cornea reduces the focusing power of the eye, and if the amount of corneal flattening is properly controlled, it is possible to bring the eye into correct focus and completely compensate for myopia.

The posterior surface of regular contact lenses generally aligns with the central cornea and rests directly on the corneal tear layer. Regular contact lenses are designed to cause little or no effect on the cornea but Progressive Boston Diamond Orthokeratology (oprifocon A) Shaping Lenses for Overnight Wear are designed to purposely flatten the shape of the cornea by applying slight pressure to the center of the cornea when the patient is asleep.

After the lens is removed, the cornea retains its altered shape for all or most of one’s waking hours. The lenses are designed to be worn overnight with removal during the following day.

The Progressive Boston Diamond Orthokeratology (oprifocon A) Shaping Lenses for Overnight Wear must be worn at night on a regular schedule to maintain the orthokeratology effect, or the myopia will revert to the pretreatment level.

Application range

Progressive Boston Diamond Orthokeratology (oprifocon A) Shaping Lenses for Overnight Wear are indicated for use in the reduction of myopia refractive error in non-diseased eyes. The lenses are indicated for overnight wear as part of the Bausch & Lomb Vision Shaping Treatment VSTTM process(and known as Orthofocus in the USA) for the temporary reduction of myopia up to 5.00 diopters with eyes having astigmatism up to 1.50 diopters for children of 12 years or older. The lenses are also indicated for overnight wear for the temporary reduction of myopia up to 4.00 diopters with eyes having astigmatism up to 1.50 diopters for children of age 9 through 12.

The lenses may only be disinfected using a chemical disinfection system.

Operation & Precautions

Precautions:

  1. This device is intended for use by an ophthalmologist.
  2. To maintain the orthokeratology effect of myopia reduction, overnight wear must be continued on a prescribed schedule. Failure to do so can affect daily activities (e.g., night driving), visual fluctuations and changes in intend correction.
Lens Specification
Chord Diameter9.6mm to 11.6mm
Base Curve7.30mm to 10.15mm
Center Thickness For low minus lens Far plus lenses0.20mm to 0.32mm 0.20mm to 0.32mm
Reverse Curve Steeper than the base curve in proportion to the amount of correction5.0mm to 9.0mm
Alignment Curve 1 Steeper than the base curve but flatter than the Reverse curve. Generally equal to the Flat K of the cornea being fit.7.0mm to 9.0mm
Alignment Curve 2 Steeper than the base curve but flatter than AC1 and Reverse curve.7.25mm to 9.25mm
Peripheral curve9.00mm to 15.00mm
Back Vertex Power+1.50 to -5.00 Diopters
Physical Properties
Specific Gravity1.24
Refractive Index1.423
Light Absorbance10.0 Blue 4.8 Green 10.3 Yellow 2.5 Red
Wetting Angle30 degrees by CaptiveBubble
Water Contact<1%
Oxygen Permeability127*(85**) {x10-11 (cm2/sec)/(ml O2 x mmHg) @ 35°} *gas to gas method **polarographic method (ISO/Fatt)
Hardness114 Rockwell

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