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 @ 10:53 PM
Ignite Modification Date:
2025-12-24 @ 10:53 PM
NCT ID:
NCT02332369
Eligibility Criteria:
Inclusion Criteria:
* The patient is in good general and ocular health, having a vision-reducing cataract in the intended operative eye.
* The intended operative eye has a Snellen best corrected visual of 20/40 or worse for distance or the refraction worsens to this level with glare testing.
* The patients' worse seeing Eye is 20/70 or better.
* The patient is willing and able to complete all required postoperative visits.
* The patient is willing to sign a statement of informed consent.
* The patient is at least 21 years old.
* The patient requires cataract surgery with IOL implantation.
* The patient has observed or suspected weakened, torn, missing or otherwise compromised zonules (torn or missing estimated not to exceed one-third of the capsular bag diameter) due to Pseudoexfoliation Syndrome, Marfans Syndrome, trauma or other zonular compromising condition.
* The capsule is intact during insertion.
Exclusion Criteria:
* Only one functional eye
* Capsular bag tearing beyond the point where the surgeon thinks it is in the best interest of the patient to have a capsular ring implanted
* Significant zonular didlysis during surgery
* Preoperative ocular infection
* Ocular inflammation or uveitis
* Amblyopia
* Aniridia
* Congenital cataracts
* Cataracts due to rubella
* Corneal disease
* Diabetes
* Preoperative intraocular pressure over 21 mm Hg
* Iritis
* Iris atrophy
* Pseudophakic lens exchange
* Microphthalmia
* Optic atrophy
* Macular degeneration
* Retinal detachment
* Retinal degeneration
* Vitritis
* Flat anterior chamber
* Other conditions as noted by the surgeon which may compromise the safety of the patient or the accuracy of the study
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT02332369
Study Brief:
Protocol Section:
NCT02332369