Contact Lens RX Release Policy

Document Sample
Contact Lens RX Release Policy Powered By Docstoc
					                                                    STATE OF NEW MEXICO                                 Bill Richardson
                                          REGULATION & LICENSING DEPARTMENT
                                    BOARD OF EXAMINERS IN OPTOMETRY                                   Arturo L. Jaramillo
                                       PO BOX 25101, SANTA FE, NM 87504                                 Superintendent
                                        505-476-4660, FAX: 505-476-4620
                                      E-MAIL:                                  Kathleen O’Dea
                              INTERNET ADDRESS:                   Boards & Commissions

                                                      Revised June 14, 2004

Contact lenses are classified as a medical prosthetic device under FDA regulations, 21 CFR
886.5916, Rigid gas permeable contact lenses and 21 CFR 886.5925, Soft (hydrophilic)
contact lenses. If lenses are intended for daily wear use only, they are Class II devices. If
they are intended for extended wear, they are Class III devices. Both daily wear and
extended wear contact lenses are restricted to prescription use. The prescription labeling
requirements in 21 CFR 801.109 state that prescription devices are to be sold by or on the
order of a licensed practitioner. Any sale or provision of contact or corneal lenses, including
those without dioptric power (plano power), without a current/valid prescription from a
licensed practitioner is a violation of the restriction for prescription that was placed on the
device when it was cleared for marketing by the FDA. Distributors or dispensers, including
mail order dispensers or distributors, that do not adhere to that regulation misbrand the
device. [This information is taken from 6/2/99 letter to the Board from the Food and Drug Administration. Author: James
F. Saviola, O.D., F.A.A.O. and Chief of Vitreoretinal & Extraocular Devices Branch of the Division of Ophthalmic Devices,
Office of Device Evaluation, Center for Devices and Radiological Health.]

The cornea is the only tissue in the human body that actually gets its oxygen supply from the
atmosphere. Since a contact or corneal lens fits over the cornea, it creates a barrier between
the eye and its oxygen supply. An improperly fitted contact or corneal lens can painlessly cut
off the oxygen to the cornea leading to conditions such as infection, bacterial conjunctivitis,
corneal abrasions, corneal vascularization (blood vessels growing from the white of the eye
into the clear cornea), corneal ulcers, and corneal scarring. These conditions can cause
permanent, irreversible damage to the eye and, in some cases, blindness. Furthermore,
severe infections into the inner tissues of the eye can require surgical removal of the entire

As medical prosthetic devices, contact or corneal lenses must be designed and prescribed to
fit each individual eye. A prescription for contact or corneal lenses is different from a
prescription for glasses. Because contact or corneal lenses touch the eye surface, they
cannot be fit without additional measurements and evaluation of the eye. Otherwise, serious
eye health problems can develop. All contact or corneal lenses have a specific shape ground

Page 1, Contact Lens Prescription Release Policy, Revised June 14, 2004
New Mexico Board of Examiners in Optometry
or formed into the back surface of the lens to allow it to “fit” the front surface of the eye called
the cornea.

Contact or corneal lens and eyeglass prescriptions can differ significantly. In fact, they have
few, if any similarities. The important differences in a contact or corneal lens prescription can
only be determined through special measurements and evaluation of the eyes for contact or
corneal lenses. The testing necessary to determine a contact or corneal lens prescription is
not done as part of a routine eye examination.

The initial personal history driven battery of tests in a contact or corneal lens fit and the vision
analysis are designed to measure the refractive state of the eyes, best correctable visual
acuities, extraocular muscle imbalances, and focusing ranges. An ocular examination to
screen and test for ocular diseases is then performed with an external biomicroscopic
examination and an internal ophthalmoscopic inspection.

Contact or corneal lens fitting procedures may proceed in the absence of contraindications
with a corneal curvature measurement. The instrumentation used for this provides a rough
estimate of lens curvature requirements. From refractive and curvature measurements, trial
lenses are selected to evaluate lens parameters necessary for proper alignment, centration,
movement, and coverage. The lenses dispensed for the first few days of wear represent a
tentative fit that may be adjusted on follow-up visits. Until contact or corneal lenses have
been worn for a trial period and monitored, the lens specifications for fit are considered
tentative. If this evaluation period is not completed with indicated fitting modifications and
monitoring of ocular response to the lenses and lens care system, there are NO releasable
specifications! The goals of a contact or corneal lens fitting are maximum comfort, good
vision, and ocular health that is not compromised.

All corneas are not the same size, shape, or curvature. This is why optometric physicians
use sophisticated equipment to precisely measure the corneal curvature to within one
hundredth of a millimeter before choosing a lens to fit the patient. In addition to the optical
correction of the eye, a contact lens prescription contains detailed information about the
design features of the contact lenses, including the specific lens material and fitting
parameters. The ultimate goal is for the contact lens wearer to see well, be comfortable, and
not experience harm to the eyes by wearing the lenses.

A thorough diagnostic fitting with contact lenses on the eyes and appropriate follow-up
evaluations to determine that the prescribed lenses are optimal for the patient are required
before a contact lens prescription can be finalized. After a patient receives his or her first
lenses from the doctor, he or she returns for follow-up visits and the doctor uses a slit lamp
microscope to assess whether there is corneal injury or oxygen compromise. If there is
evidence of compromise, the doctor changes the parameters of the lens to improve the
relationship of the lens to the eye and has the patient return until a satisfactory fit has been
achieved. Several follow-up examinations may be necessary to ensure that a successful fit

Page 2, Contact Lens Prescription Release Policy, Revised June 14, 2004
New Mexico Board of Examiners in Optometry
has been achieved. With some patients, the contact lenses first prescribed may require lens
design modification or changes before there is a complete or final contact lens prescription.
Again, There is no final prescription until after the doctor has evaluated the lens fit in follow-
up exams and has made all modifications or changes as needed.

We hope that this short explanation will help you understand why an eyeglass prescription is
not the same as a contact lens prescription and why contact lenses are different from
glasses. if you have any questions, please feel free to ask your Doctor or the Doctor’s clinic

In accordance with in the Board’s rule, 16.16.19 NMAC - “Contact Lenses”, a contact or
corneal lens prescription may only be released to the patient after a trial fitting period of
successful wear to determine the parameters of the prescription has been complete. In the
event the patient requests the prescription after the initial contact or corneal lens fitting was
finalized, the prescription must be released provided, of course, that the prescription has not
expired. The prescription for contact or corneal lenses expires two years from the date the
patient’s prescription parameters are determined, unless a shorter prescription period is
clinically indicated by the patient’s ocular health or by potential harm to the patient’s ocular

The New Mexico licensed optometrist may exclude categories of contact or corneal lenses
from the prescription if the exclusion is clinically indicated. The optometrist may refuse to
provide a contact or corneal lens prescription to a patient if the patient’s ocular health
presents a contraindication for contact or corneal lenses; or the refusal is warranted due to
potential harm to the patient’s ocular health; or the patient has a medical condition indicating
that the patient’s ocular health would be damaged if the prescription were released to the
patient; or further monitoring of the patient is needed.

Page 3, Contact Lens Prescription Release Policy, Revised June 14, 2004
New Mexico Board of Examiners in Optometry

Shared By: