Hydrus Microstent and Lens Extraction for the Treatment of Primary Angle-Closure Glaucoma

NCT04622605 | Completed

• 1 other identifier: 2017-004
• Study Type: interventional
• Target: 31
• Locations: 1 country
• Sites: 1

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.

Conditions

Primary Angle Closure Glaucoma; Primary Angle Closure

Outcome Measures

Primary Outcomes (1)

• Reduction in IOP

  Proportion of subjects with \> or = 20% reduction of IOP while maintaining the same or fewer number of glaucoma medications compared with baseline, measured by Goldmann applanation tonometry

  12 months

Secondary Outcomes (1)

• Change in IOP

  12 months

Study Arms (1)

Treatment Group

EXPERIMENTAL

Cataract extraction and intraocular lens placement with combined placement of glaucoma microstent

Device: Trabecular bypass and Schlemm's canal stent

Interventions

Trabecular bypass and Schlemm's canal stent DEVICE

ab interno Microstent placement after cataract surgery

Also known as: Hydrus Microstent

Treatment Group

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male and Female patients at least 40 years of age.
• An operable age-related cataract with visual impairment or glare, eligible for phacoemulsification.
• 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.
• 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.
• An intact and centered capsulorhexis.
• An intact posterior capsular bag.
• A well-centered IOL implant placed in the capsular bag.
• A clear view and visualization of the angle with direct gonioscopy.
• No evidence of zonular dehiscence/rupture (uncomplicated cataract extraction)

You may not qualify if:

• Pseudophakia in the intended study eye
• 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).
• Secondary angle-closure glaucoma
• Advanced glaucoma, defined as visual field mean deviation worse than -15 dB, or cup-to-disc ration \> or = 0.9.
• Visual field depression within the central 5 degrees of fixation, on pattern deviation probability plot.
• Eyes with an anticipated need for incisional glaucoma surgery (e.g. trabeculectomy or tube shunt) within the 12-month follow-up period.
• Central corneal thickness \>620 or \<490 microns.
• Axial length \< or = 19 mm (nanophthalmos).
• Previous incisional glaucoma surgery in the study eye, including trabeculectomy, tube shunt, and non-penetrating procedures such as deep sclerectomy, viscocanalostomy or canaloplasty.
• Plateau iris syndrome.
• History of complicated intraocular surgery.
• Previous MIGS surgery in the study eye.
• Proliferative diabetic retinopathy.
• Previous surgery for retinal detachment.
• Clinically significant corneal dystrophy (e.g. Fuch's Dystrophy).

Sponsors & Collaborators

• Asian Eye Institute: lead
• Ivantis, Inc.: collaborator

Study Sites (1)

Asian Eye Institute

Makati City, National Capital Region, 1200, Philippines

Location

MeSH Terms

Conditions

Glaucoma, Angle-Closure

Condition Hierarchy (Ancestors)

Glaucoma; Ocular Hypertension; Eye Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: November 5, 2020
• First Posted: November 10, 2020
• Study Start: June 13, 2017
• Primary Completion: September 1, 2021
• Study Completion: December 23, 2021
• Last Updated: February 16, 2022

Record last verified: 2022-02

Locations

PH (1)