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 @ 11:40 PM
Ignite Modification Date:
2025-12-24 @ 11:40 PM
NCT ID:
NCT02028351
Eligibility Criteria:
General Exclusion Criteria:
those individuals whom the examiner determines cannot read the ETDRS letter chart to define vision and those individuals whom the examiner determines cannot respond to the computer presentation of the tumbled Landolt C by pressing one of the 4 buttons arranged in a diamond or by deflecting the joystick on the response pad held in the lap.
Normals:
Systemic Disease Exclusion Criteria: Persons with systemic disease that would interfere with vision will be excluded under the normal classification. Such diseases that would exclude a subject from this category would include diabetes, and other systemic diseases such as neurological disorders that the examiner determines may interfere with the vision of an eye.
Ocular Inclusion criteria:
For inclusion in the normal group an eye would have an ocular examination within three months that, in the least, included the following:
A visual acuity measured of 20/30 or better for which on examination the refractive error alone is determined to define the vision.
For individuals 65 years or greater, lens nuclear opalescence and brunescence that is less than or equal to NO3, NC3 according to the LOCS III grading system.
For individuals less than 65 years, lens nuclear opalescence and brunescence that is less than or equal to NO2, NC2, according to the LOCS III grading system.
Ocular Exclusion Criteria:
Media opacity or retinal or optic nerve pathology that the examiner determines would affect the measured vision.
For individuals aged 65 or greater, eyes with nuclear opalescence and brunescence, according to the LOCS III grading system greater than NO3, NC3 or with other opacities will be excluded.
Eyes with Cataracts:
General Inclusion Criteria:
Persons without systemic disease that would interfere with vision will be enrolled. Such diseases that would exclude a subject from this category would include diabetes, and other systemic diseases such as neurological disorders that the examiner determines may interfere with the vision of an eye.
Ocular Inclusion Criteria:
For inclusion an eye would have had an ocular examination within three months as per the stated protocol.
A visual acuity worse than 20/30. The determination on examination by the examiner that the lens opacity alone defines the vision. For individuals less than age 65 the nuclear cataract will be denser than NO2, NC2 or contain other components (posterior cortical or posterior sub capsular) that will be documented. For individuals 65 years of age or older, the nuclear cataract will be greater than NO3, NC3 or contain other components that define the vision.
Ocular Exclusion Criteria:
Eyes in which retinal or optic nerve pathology that the examiner determines would affect the measured vision.
Eyes with a best refracted chart acuity of 20/100 or worse because in such eyes the examiner will be prevented by the media opacity from adequately examining the fundus to determine if there is co-existent macular pathology.
Eyes with Maculopathy:
General Inclusion Criteria:
It is recognized that many individuals within this group will have diabetes or hypertension that may be the cause of the maculopathy or aggravate the maculopathy. However, such systemic diseases will not necessarily exclude such persons, unless the examiner determines that such diseases cause reduced vision in the eye that is not defined by the maculopathy.
Ocular Inclusion Criteria:
For inclusion an eye would have had an ocular examination within three months with components according to the protocol as stated.
A visual acuity with chart testing worse than 20/30 for which on examination the maculopathy alone is determined to define the vision.
Ocular Exclusion Criteria:
Eyes with a chart acuity of 20/400 or worse. Eyes having lens or optic nerve pathology that the examiner determines would affect the measured vision.
Eyes with dense cataract in which an adequate examination of the macula is prevented.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT02028351
Study Brief:
Protocol Section:
NCT02028351