Primary Outcome Measures:
- At the point of stability, a minimum of 75% of eyes should have an achieved refraction within ± 1.00 D of the intended outcome, and at least 50% of eyes should be within ± 0.50 D of the intended outcome. [ Time Frame: Point of stability ] [ Designated as safety issue: No ]
- A minimum of 85% of eyes targeted for emmetropia should have an uncorrected visual acuity of 20/40 or better at the postoperative interval at which stability has been established. [ Time Frame: Point of stability ] [ Designated as safety issue: No ]
- A minimum of 95% of eyes should have a change of < 1.00 D in manifest refraction spherical equivalent (MRSE) between 2 refractions performed at least 3 months apart, and the mean rate of MRSE change per month should be < 0.04 D. [ Time Frame: Point of stability ] [ Designated as safety issue: No ]
- 75% of eyes undergoing astigmatic treatment should be within ± 1.00 D of the attempted astigmatism correction by the point of stability. [ Time Frame: Point of stability ] [ Designated as safety issue: No ]
- Distance BSCVA of worse than 20/40 at the postoperative interval at which stability has been established should occur in less than 1.0% of eyes that had a BSCVA of 20/20 or better before surgery. [ Time Frame: Point of stability ] [ Designated as safety issue: Yes ]
- Loss of more than 2 lines of BSCVA should occur in less than 5.0% of eyes. [ Time Frame: Point of stability ] [ Designated as safety issue: Yes ]
- Less than 5% of eyes treated for sphere only should have a magnitude of postoperative manifest refractive astigmatism that varies from baseline cylinder by greater than 2.00 D at the postoperative interval at which stability has been established. [ Time Frame: Point of stability ] [ Designated as safety issue: Yes ]
- Incidence of Adverse Events to occur in less 1% of eyes [ Time Frame: Postoperative visits ] [ Designated as safety issue: Yes ]
Secondary Outcome Measures:
- Subject Satisfaction: As measured by a subjective questionnaire, and will be considered as a secondary efficacy variable. [ Time Frame: Postoperative visits 3, 6, 9, 12, 18 and 24 months ] [ Designated as safety issue: No ]
- Incidence of Complications [ Time Frame: Postoperative visits ] [ Designated as safety issue: Yes ]
- Patient Symptoms: As measured by a subjective questionnaire, will be considered as a secondary safety variable. [ Time Frame: Preoperative and Postoperative visits 3, 6, 9, 12, 18 and 24 months ] [ Designated as safety issue: Yes ]
Intervention Details:
Device: MEL 80 Hyperopic LASIK Treatment
Treatment of Hyperopic corrections ≤ +6.0 D with or without Astigmatism of +0.50 to +3.50 D and MRSE ≤ +6.50 D.
LASIK has become one of the most common refractive eye procedures performed in the country. In the hyperopia procedure, a steepening occurs on the corneal surface, rather than the flattening procedure (myopic treatment). The surgeon will produce a standard keratomileusis flap using a microkeratome, exposing the corneal stroma. Recontouring under the flap is then accomplished by the removal of tissue from the stroma with the laser. This recontouring results in an altering of effective lens power of the central cornea, measured in diopters (D). The MEL 80 Excimer Laser System will be evaluated for its ability to create accurate and stable hyperopic refractive correction results.