Safety and Effectiveness of the TENEO 317 Model 2 (1.28 US) Excimer Laser for Laser In Situ Keratomileusis (LASIK) Surgery to Treat Hyperopia With or Without Astigmatism

Inclusion Criteria:

1. Subjects 22 years of age or older at the time of the pre-operative examination.

2. Manifest, distance corrected visual acuity (CDVA) 20/25 (logMAR 0.10) or better inan operative eye

3. Pre-operative refractive error of hyperopia with spherical component of +1.00 D to +4.00 D with or without cylinder up to +2.00 D, based on the manifest refraction inthe study eye(s).

4. Difficulty maintaining uncorrected distance visual acuity (UDVA) of 20/40 or better,as evidenced by need for constant contact lens or spectacle wear.

5. Difference between manifest refractive and cycloplegic spherical equivalent ≤ 0.75D, difference between manifest and cycloplegic cylinder ≤ ± 0.50 D and differencebetween manifest and cycloplegic cylinder axis ≤ ± 15 degrees.

6. Stable refraction (i.e., a change of ≤ ± 0.50 D in MRSE) for a minimum of 12 monthsprior to surgery, as verified by consecutive refractions, medical records, orprescription history.

7. Agree to discontinue use of contact lenses for at least 2 weeks (for rigid or toriclenses) or 3 days (for soft contact lenses) prior to the first refraction used toestablish stability and through the day of surgery.

8. All contact lens wearers must demonstrate a stable refraction in an eye to betreated, as follows: two consecutive examinations at least 1 week apart within ± 0.50 D manifest refractive spherical equivalent and within ± 15 degrees cylinderaxis.

9. Agree to emmetropia correction for each treated eye.

10. Anticipated postoperative stromal bed thickness of at least 250 microns.

11. Can lie flat without difficulty.

12. Willing and able to read, understand, and sign a written informed consent form (ICF).

13. Willing and able to comply with the schedule for all post-surgery follow-up visits.

Exclusion Criteria:

1. Acute or chronic disease or illness that would increase operative risk or confoundthe results of the study (e.g., dry eye disease, cataract, glaucoma,immuno-compromised, rheumatoid arthritis, clinically significant atopic disease,acne rosacea, autoimmune disease, endocrine disorders, lupus, systemic connectivetissue disease, diabetes, or severe atopic disease).

2. Use of medications by any administration route that may increase risk to the subjector may confound the outcome of the study, including those known to affect woundhealing (e.g., systemic corticosteroids, antimetabolites).

3. Ocular conditions, other than hyperopia with or without astigmatism that maypredispose the subject to future complications including but not limited to:

4. Evidence or history of retinal vascular disease

5. Evidence or history of active or inactive corneal disease or infection (e.g.,recurrent corneal erosion syndrome, herpes simplex or herpes zoster keratitis)in either eye.

6. Evidence or history of glaucoma or glaucoma suspect (IOP > 24 mmHg) by examfindings and/or family history.

7. Previous intraocular or corneal surgery in an eye considered for eligibility thatmight confound the outcome of the study or increase the risk to the subject.

8. An increased risk for developing strabismus post-treatment or an ocular muscledisorder (e.g., strabismus or nystagmus) affecting fixation.

9. Known sensitivity to any study medications (e.g., used during LASIK procedure andpostoperative care).

10. Have central corneal scars affecting visual acuity.

11. Presence of keratoconus, keratoconus suspect, subclinical or forme frustekeratoconus, corneal dystrophy, or other corneal irregularity (e.g., irregularastigmatism) or abnormal corneal topography

12. Presence of visually significant or progressive cataract in an eye considered foreligibility.

13. Actively taking medications contraindicated with LASIK such as isotretinoin (Accutane) or amiodarone hydrochloride (Cordarone).

14. Have a cardiac pacemaker, implanted defibrillator, or other implanted electronicdevice.

15. Pregnant, lactating, or subjects who plan to become pregnant during the course ofthe study.

16. Are participating in any other trial within 30 days of screening or during thisclinical trial.

17. Eyes with mesopic pupil size > 7.0 mm.

18. Have a Schirmer's pre-operative test without anesthesia < 4 mm after 5 minutes.