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 @ 3:28 AM
Ignite Modification Date:
2025-12-25 @ 3:28 AM
NCT ID:
NCT04622605
Eligibility Criteria:
Inclusion Criteria:
Pre-Operative Inclusion Criteria
1. Male and Female patients at least 40 years of age.
2. An operable age-related cataract with visual impairment or glare, eligible for phacoemulsification.
3. Subjects with diagnosed primary angle-closure (PAC; defined as appositional or synechial irido-trabecular contact of 90 degrees or more on gonionscopy) OR primary angle-closure glaucoma (PACG; defined as PAC with documented glaucomatous optic neuropathy and/or reproducible glaucomatous visual field defect), and on \> or = 1 glaucoma medication with IOP \> or = 21mmHg at both preoperative visits.
4. PAC or PACG subjects that are newly diagnosed, or unmedicated (newly diagnosed or non-compliant patient not using medication for \> 30 days), with IOP \> or = 24mmHg at both preoperative visits.
The subject is able to understand the requirements of the study and is willing to provide written informed consent, follow study instructions, and comply with all study procedures.
Intraoperative Inclusion Critera
1. An intact and centered capsulorhexis.
2. An intact posterior capsular bag.
3. A well-centered IOL implant placed in the capsular bag.
4. A clear view and visualization of the angle with direct gonioscopy.
5. No evidence of zonular dehiscence/rupture (uncomplicated cataract extraction)
Exclusion Criteria:
1. Pseudophakia in the intended study eye
2. All forms of glaucoma other than primary angle-closure (i.e. all open-angle glaucoma including primary open-angle, pseudoexfoliative, or pigmentary glaucoma; neovascular, uveitic, traumatic, steroid induced, lens induced, or glaucoma associated with increased episcleral venous pressure; congenital or developmental glaucoma).
3. Secondary angle-closure glaucoma
4. Advanced glaucoma, defined as visual field mean deviation worse than -15 dB, or cup-to-disc ration \> or = 0.9.
5. Visual field depression within the central 5 degrees of fixation, on pattern deviation probability plot.
6. Eyes with an anticipated need for incisional glaucoma surgery (e.g. trabeculectomy or tube shunt) within the 12-month follow-up period.
7. Central corneal thickness \>620 or \<490 microns.
8. Axial length \< or = 19 mm (nanophthalmos).
9. Previous incisional glaucoma surgery in the study eye, including trabeculectomy, tube shunt, and non-penetrating procedures such as deep sclerectomy, viscocanalostomy or canaloplasty.
10. Plateau iris syndrome.
11. History of complicated intraocular surgery.
12. Previous MIGS surgery in the study eye.
13. Proliferative diabetic retinopathy.
14. Previous surgery for retinal detachment.
15. Clinically significant corneal dystrophy (e.g. Fuch's Dystrophy).
16. Best-corrected visual acuity in the fellow eye worse than 20/200.
17. Previous corneal surgery.
18. Previous refractive surgery.
19. Degenerative visual disorders such as exudative age-related macular degeneration.
20. Clinically significant ocular inflammation or infection within thirty days prior to screening.
21. Uncontrolled systemic disease that in the opinion of the investigator would put the subject's health at risk and/or prevent the subject from completing all study visits.
22. Pregnant or nursing females.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
40 Years
Study:
NCT04622605
Study Brief:
Protocol Section:
NCT04622605