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 @ 2:54 PM
Ignite Modification Date:
2025-12-24 @ 2:54 PM
NCT ID:
NCT02466659
Eligibility Criteria:
Inclusion Criteria:
* Intermittent exotropia (manifest deviation) meeting all of the following criteria:
* Intermittent exotropia at distance OR constant exotropia at distance and either intermittent exotropia or exophoria at near
* Exodeviation at least 15PD at distance OR near measured by prism and alternate cover test (PACT)
* Exodeviation at least 10PD at distance measured by PACT
* No previous surgical or non-surgical treatment for IXT (other than refractive correction)
* Visual acuity in the worse eye 0.3 logMAR or better (20/40 on ATS HOTV or 70 letters on E-ETDRS) for children ≥ 3 years of age
* No interocular difference of visual acuity more than 0.2 logMAR (2 lines on ATS HOTV or 10 letters on E-ETDRS) for children ≥ 7 years of age
* Investigator not planning to initiate amblyopia treatment
* No hyperopia greater than +3.50 D spherical equivalent in either eye
* No myopia greater than -6.00 D spherical equivalent in either eye
* No prior strabismus, intraocular, or refractive surgery
* No abnormality of the cornea, lens, or central retina
* Investigator willing to observe the IXT untreated for 3 years unless specific criteria for deterioration are met.
Exclusion Criteria:
* N/A
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
3 Years
Maximum Age:
11 Years
Study:
NCT02466659
Study Brief:
Protocol Section:
NCT02466659