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A Comparison of Cataract Surgery Alone and Cataract Surgery With iStent

NCT03106181 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 93

Last updated 2023-08-09

No results posted yet for this study

Summary

This study aims to recruit patients of the Glaucoma Investigative and Research Unit (GIRU) of Royal Victorian Eye and Ear Hospital (RVEEH) with mild to moderate glaucoma who are due to undergo cataract surgery and randomise each to either cataract surgery or combined cataract surgery with iStent Inject® insertion. Only patients who meet the inclusion criteria and none of the exclusion criteria will be recruited. The outcomes measures of the study will be a comparison of: 1) extent of IOP reduction; 2) reduction in number of topical glaucoma medications; 3) patient treatment satisfaction - between the two treatment groups.

Conditions

  • Glaucoma, Open-Angle

Interventions

DEVICE

iStent inject®

Insertion of iStent inject®

PROCEDURE

Phacoemulsification and intraocular lens implant

Conventional phacoemulsification cataract surgery and intraocular lens implant

Sponsors & Collaborators

  • Glaukos Corporation

    collaborator INDUSTRY

  • Center for Eye Research Australia

    collaborator OTHER

  • Royal Victoria Eye and Ear Hospital

    lead OTHER_GOV

Principal Investigators

  • Jennifer Fan Gaskin, FRANZCO · Royal Victoria Eye and Ear Hospital

  • Brian Ang, FRANZCO · Royal Victoria Eye and Ear Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2018-02-01
Primary Completion
2022-03-31
Completion
2022-12-31

Countries

  • Australia

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 NCT03106181 on ClinicalTrials.gov