| Criteria: |
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Inclusion Criteria:
- Enrollment is limited to subjects who satisfy the following inclusion criteria:
- Male or Female
- Any race
- Patient is at least 40 years old.
- Patient has bilateral sight with at least one eye with low hyperopia [with +1.0
to +2.75 D spherical component of manifest refraction, less than or equal to
0.75 D cylindrical component of manifest refraction (minus cylinder format) and
manifest refraction, spherical equivalent of +1.0 to +2.5 D].
- Patient has documented stable refraction defined as a change in baseline MRSE of
≤ 0.5 D for the 12 month period prior to primary Opti-K Tx as verified by
consecutive refractions, medical records or prescription history.
- Patient is able to tolerate full cycloplegic refraction while not under
cycloplegia.
- Patient has distance uncorrected visual acuity (D-UCVA) less than 20/40 and
better than or equal to 20/80 in both eyes.
- Patient has stable D-UCVA as documented by a change of ≤ 1 line of D-UCVA for
the 12 month period prior to baseline measurements.
- Patient has distance and near best spectacle corrected visual acuity (D-BSCVA
and N-BSCVA) of 20/40 or better in both eyes.
- Patient has normal videokeratography (i.e., without distorted or unclear corneal
mires).
- Contacts lens wearers must:
1. discontinue use of soft or gas permeable contact lenses at least two weeks
prior to baseline measurements or discontinue use of hard or rigid gas
permeable contact lenses at least three weeks prior to baseline
measurements and
2. have two central keratometry readings and two manifest refractions taken at
least one week apart that do not differ by more than 0.5 D in either
meridian; mires should be regular.
- Patient is willing and able to comply with all pre-treatment and follow-up
requirements, including the ability to read English to complete the NEI-RQL
questionnaire.
- Patient understands the nature of the procedure, as well as potential\ risks or
limitations of the treatment, and provides informed consent
Exclusion Criteria:
- Patients are not permitted to enroll in the study if they meet any of the following
exclusion criteria:
- Patients with latent hyperopia > 1.0 D (i.e., baseline MRSE and CRSE should not
differ by more than 1.0 D)
- Patients with nystagmus
- Patients with previous intraocular or corneal surgery
- Patients with any residual, recurrent or active ocular disease or corneal
abnormality, including any of the following: corneal diameter < 9 mm; central
corneal thickness < 500 µm; mild to severe dry eye disease; uncontrolled
uveitis; severe blepharitis; lagophthalmos; glaucoma; intraocular pressure > 21
mm Hg; cataract; history of uveitis;corneal shape disorders (keratoconus,
keratoglobus, pellucid marginal degeneration, significant irregular corneal
astigmatism, etc.);history of herpes zoster/simplex keratitis
- Patients with cloudy cornea or cloudy anterior chamber
- Patients with allergy to anesthetics or postoperative medications
- Patients with chronic allergic reactions, tearing and/or ocular irritation
- Patients who are hypersensitive to pain stimulus
- Patients taking systemic medications (NSAIDs, etc.) that affect wound healing
- Patients taking amiodarone, isotretinoin and/or sumatriptan
- Patients requiring administration of topical or systemic ophthalmic medications
other than the study medications - use of corticosteroids or antimetabolites is
specifically contraindicated.
- Patients with a recent history (within one week prior to treatment) of using
ophthalmic medications containing preservatives (benzalkonium chloride,etc.)
and/or other ocular drugs that are cytotoxic
- Patients who are immunocompromised (by, for example, infectious diseases such as
HIV, herpes, etc. and/or by immunosuppressive medications) or who have
autoimmune diseases such as lupus, rheumatoid arthritis, etc.
- Patients with diabetes
- Pregnant, planning to be pregnant or lactating women
- Patients with unusual hormonal status due to, for example, hormone replacement
therapy
- Patients who have taken or who plan to take oral contraceptives within one year
prior to, or following, treatment
- Patients with unrealistic expectations
- Patients participating in other ophthalmic clinical trials during this clinical
investigation
- Persons who, in the determination of the investigator, are not competent to
understand the procedure or the actions asked of them as research subjects
- Persons who may not be able to complete the requirements of returning to the
investigator's clinic over the period of the study, or who may be difficult to
locate or contact on short notice. This does not preclude vacations or travel.
- Persons who cannot achieve corneal applanation using the SAWSR device or cannot
tolerate application of the SAWSR device or who cannot remain motionless for at
least 5 seconds after verifying proper SAWSR mounting.
- Patients who are likely to be exposed to high levels of ultraviolet
radiation(from sunlight, tanning lights, etc.) without protective eyewear during
the one year period following Opti-K treatment
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