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

NCT04622605 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 31

Last updated 2022-02-16

No results posted yet for this study

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

Interventions

DEVICE

Trabecular bypass and Schlemm's canal stent

ab interno Microstent placement after cataract surgery

Sponsors & Collaborators

  • Ivantis, Inc.

    collaborator INDUSTRY

  • Asian Eye Institute

    lead INDUSTRY

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
40 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-06-13
Primary Completion
2021-09-01
Completion
2021-12-23

Countries

  • Philippines

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04622605 on ClinicalTrials.gov