Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 5:38 PM
Ignite Modification Date:
2025-12-24 @ 5:38 PM
NCT ID:
NCT01166568
Eligibility Criteria:
Inclusion Criteria:
* Subject must be between 50-60 years old
* Subject must have a best corrected distance visual acuity of 20/20 or better
* Subject must have SLOAN distance corrected near visual acuity @ 40cm in the operative eye/eyes of 20/50 to 20/100 (inclusive).
* Subject should have a manifest distance spherical equivalent refractive correction in the operative eye/eyes of from -0.50 to +0.75 diopters with no more than 1.00 diopter of astigmatism and should require at least a +1.50 diopter add. The distance manifest refraction spherical equivalent and the distance cycloplegic refraction spherical equivalent must be within 0.50 diopters of each other.
* Subject must be phakic in the study eye
* Subject must be mentally competent to understand and comply with the requirements of the study.
* Subject must be able to provide written informed consent.
Exclusion Criteria:
* Chronic uveitis or other recurrent anterior or posterior segment inflammation in either eye.
* Scleral thickness less than 530 μm in the operative eye/eyes.
* Any previous eye surgeries including cataract, LASIK, or Muscle surgery
* Any history of prior extraocular muscle surgery, specifically the recti or oblique muscles.
* Any chronic systemic diseases such as diabetes, heart disease, Lupus, etc.
* Any eye diseases such as eye inflammation, infection, cataract, or retinal diseases
* Allergic to any medications used in the study.
* The patient may not have participated in a device clinical study for the operative eye within the last 3 months and may not have been implanted with PSI devices in this or any other study.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
50 Years
Maximum Age:
60 Years
Study:
NCT01166568
Study Brief:
Protocol Section:
NCT01166568