Safety and Efficacy Study to Evaluate the Treatment of Both Near and Distance Vision in a Simulta… (NCT01322919) | Clinical Trial Compass
CompletedPhase 3
Safety and Efficacy Study to Evaluate the Treatment of Both Near and Distance Vision in a Simultaneous Laser Procedure
Mexico61 participantsStarted 2010-04
Plain-language summary
By using a new software two consecutive laser treatments have been combined to correct the distance vision and to provide a near vision component in addition to the first treatment.
This study will help us to answer 2 questions:
1. How accurately this combined technique corrects distance and near vision
2. Whether the correction is adequate to remove the complete need for supplementary near spectacles
Who can participate
Age range45 Years – 85 Years
SexALL
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Inclusion Criteria:
* Subjects must be at least 45 years old and not older than 85 years
* Subjects must read, understand, and sign an Informed Consent Form (ICF).
* Subjects must be willing and able to return for scheduled follow up examinations through 6 months after surgery.
* Subjects must be willing to have both eyes treated with the laser during the same visit.
* Subjects for study arm-I must have up to +4 diopters (D) of absolute spherical hyperopia (not spherical equivalent), with up to +2.5 D of refractive astigmatism (NOT corneal astigmatism) by manifest subjective refraction in both eyes. The spherical equivalent must be no more than +5.25 D. Subjects for study arm-II must have up to -7 diopters (D) of absolute spherical myopia (not spherical equivalent), with up to -4.0 D of refractive astigmatism (NOT corneal astigmatism) by manifest subjective refraction in both eyes. The spherical equivalent must be no more than -9.00 D.
* Subjects must have presbyopia as determined by an age-related need for optical aid (\> +1.50 D) for reading with their best distance correction.
* Subjects who have been screened successfully for acceptance of the PresbyLasik simulation
* Subjects who are contact lens wearers must have gas permeable (GP) lenses discontinued for at least 3 weeks and soft lenses discontinued for at least 1 week prior to the preoperative evaluation in the eye to be treated. Contact lens wearers who wear their contact lenses for any amount of time between the pr…
What they're measuring
1
The percentage of treated patients with an uncorrected monocular high contrast Near VA of 20/40 or better