Ignite Creation Date:
2025-12-25 @ 3:28 AM
Ignite Modification Date:
2025-12-26 @ 2:09 AM
Study NCT ID:
NCT04622605
Status:
COMPLETED
Last Update Posted:
2022-02-16
First Post:
2020-11-05
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Hydrus Microstent and Lens Extraction for the Treatment of Primary Angle-Closure Glaucoma
Sponsor:
Asian Eye Institute
Organization:
Study Overview
Official Title:
Hydrus Microstent and Lens Extraction for the Treatment of Primary Angle-Closure Glaucoma
Status:
COMPLETED
Status Verified Date:
2022-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This study is a prospective evaluation of the Hydrus Microstent for the treatment of Primary Angle Closure (PAC) and Primary Angle Closure Glaucoma (PACG) with adjunctive cataract. A total of 20 subjects will be successfully treated with one Hydrus device after completion of cataract extraction with phacoemulsification followed by IOL replacement (HMS cohort), and 10 eyes will be treated with phacoemulsification cataract extraction and IOL replacement only (PCS group). Since cataract surgery is standard of care for this condition, eligible fellow eyes from the HMS cohort may be enrolled into the PCS group. To avoid selection bias in this non-randomized study, the first 20 consecutive qualifying subjects will be treated with Hydrus and the next 10 consecutive qualifying eyes will be treated with cataract surgery only.
Detailed Description:
The objective of this study is to assess the effectiveness of the Hydrus Microstent for lowering intraocular pressure in patients with PAC or PACG. The addition of the Hydrus is expected to lower IOP and medication dependency, and thus reduce the risk of progression of glaucoma. The PCS group will provide a control group to assess the magnitude of the Hydrus treatment effect on IOP, medications, and safety.
Upon successfully meeting the study inclusion/exclusion criteria at both the screening and baseline visits, the subject will be scheduled for surgery. Follow up will be continued for 1 year post surgery, and will include assessments of the subject's IOP, ocular health, and visual acuity status. Visits will be conducted at 1, 7, 30, 90, 180, and 365 days.
A 20% drop in IOP in response to therapy is considered clinically meaningful. The study treatment will be considered successful if a patient can obtain this response in IOP using the same or a fewer number of medications as pre-operative baseline.
Upon successfully meeting the study inclusion/exclusion criteria at both the screening and baseline visits, the subject will be scheduled for surgery. Follow up will be continued for 1 year post surgery, and will include assessments of the subject's IOP, ocular health, and visual acuity status. Visits will be conducted at 1, 7, 30, 90, 180, and 365 days.
A 20% drop in IOP in response to therapy is considered clinically meaningful. The study treatment will be considered successful if a patient can obtain this response in IOP using the same or a fewer number of medications as pre-operative baseline.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: