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:
2025-12-25 @ 12:56 AM
Ignite Modification Date:
2025-12-25 @ 12:56 AM
NCT ID:
NCT06079593
Eligibility Criteria:
Inclusion Criteria:
* Requiring PPV to treat idiopathic (primary) FTMH.
* 18 years or older
* ETDRS BCVA letter score of 1 or better in the study eye
* Able to provide written informed consent
Exclusion Criteria:
General:
* Hypersensitivity to hyaluronate or other components of Healon Pro® viscoelastic
* Any major illness or major surgical procedure within 4 weeks
* Any other condition that, in the opinion of the investigator, would prevent the participant from granting informed consent or complying with the protocol
Study eye
* Previous vitreoretinal surgery, retinopexy, open-globe injury, or endophthalmitis
* Presence of fibrotic retinal proliferation or central epiretinal membrane (within 1 disc diameter of the fovea)
* Aphakia
* Current or former myopia greater than 6 dioptres
* Current or previous posterior uveitis or choroiditis
* Presence of other ocular co-morbidity that, in the opinion of the investigator, is likely to impair BCVA postoperatively or affect FTMH closure
* Current ocular or periocular infection, other than mild or moderate blepharitis
* Lens or media opacity that preclude adequate retinal assessment and imaging
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
100 Years
Study:
NCT06079593
Study Brief:
Protocol Section:
NCT06079593