A Comparison of Cataract Surgery Alone and Cataract Surgery With iStent

A Randomised Controlled Trial of Cataract Surgery Versus Combined Cataract Surgery With Insertion of iStent Inject®

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.

Study Overview

• Status: Completed
• Conditions: Glaucoma, Open-Angle
• Intervention / Treatment: Procedure: Phacoemulsification and intraocular lens implant; Device: iStent inject®

Detailed Description

Glaucoma is the commonest cause of irreversible blindness in the world. Treatment centres around lowering intraocular pressure (IOP) and typically includes medication (least invasive), laser, to surgery (most invasive). The gold-standard glaucoma operation is the trabeculectomy. Whilst it is effective at lowering IOP, it is associated with potentially devastating complications including bleb leak, hypotonous maculopathy, blebitis and endophthalmitis. In recent years, minimally- invasive glaucoma surgery (MIGS) has become an increasingly popular option of treating mild to moderate glaucoma. It is usually performed in conjunction with cataract surgery. The iStent (Glaukos Corporation, California, USA) is one of the most commonly utilised MIGS devices in the world and one of two Therapeutic Goods Administration (TGA)- approved MIGS devices in Australia. The iStent Inject® is the second generation iStent device and Australia is one of the first countries in the world to have access to this. So far there are no published randomised controlled trials comparing the effect of cataract surgery alone to combined cataract surgery with insertion of iStent Inject®.

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.

• Study Type: Interventional
• Enrollment (Actual): 93
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Australia
  • Victoria
    • East Melbourne, Victoria, Australia, 3002
      • Royal Victorian Eye and Ear Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• >18 years of age
• Diagnosis of mild-to-moderate open angle glaucoma
• Presence of cataract requiring surgery
• Good understanding of both verbal and written English
• Able to provide informed consent

Exclusion Criteria:

• Recent intraocular surgery within last 3 months
• Other ocular pathology affecting vision
• Inability to complete the elements of the study, eg: coma, hemodynamic instability, ventilator dependence, that could be of concern in the investigator's judgment.
• Non-elective hospitalisation within the past 60 days that could be of concern in the investigator's judgment.
• Medical illness that in the judgment of the investigator would jeopardise the safe completion of the study. Examples include cancer, chronic inflammatory disease, chronic liver insufficiency, epilepsy, thrombocytosis.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Cataract surgery; Conventional phacoemulsification cataract surgery and intraocular lens implantation	Procedure: Phacoemulsification and intraocular lens implant; Conventional phacoemulsification cataract surgery and intraocular lens implant
Experimental: Cataract surgery plus iStent inject®; Conventional phacoemulsification cataract surgery and lens implantation plus insertion of iStent inject®	Procedure: Phacoemulsification and intraocular lens implant; Conventional phacoemulsification cataract surgery and intraocular lens implant; Device: iStent inject®; Insertion of iStent inject®

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Intraocular pressure	Intraocular pressure reduction	Up to 2 years
Glaucoma medications	Number of glaucoma medications	Up to 2 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Treatment satisfaction	Patient treatment satisfaction	Up to 2 years

Collaborators and Investigators

• Sponsor: Royal Victoria Eye and Ear Hospital
• Collaborators: Glaukos Corporation; Centre for Eye Research Australia
• Investigators: Principal Investigator: Jennifer Fan Gaskin, FRANZCO, Royal Victoria Eye and Ear Hospital; Principal Investigator: Brian Ang, FRANZCO, Royal Victoria Eye and Ear Hospital

Study record dates

Study Major Dates

• Study Start (Actual): February 1, 2018
• Primary Completion (Actual): March 31, 2022
• Study Completion (Actual): December 31, 2022

Study Registration Dates

• First Submitted: April 4, 2017
• First Submitted That Met QC Criteria: April 7, 2017
• First Posted (Actual): April 10, 2017

Study Record Updates

• Last Update Posted (Actual): August 9, 2023
• Last Update Submitted That Met QC Criteria: August 7, 2023
• Last Verified: August 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Eye Diseases; Ocular Hypertension; Lens Diseases; Glaucoma; Glaucoma, Open-Angle; Cataract
• Other Study ID Numbers: iStent RCT

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No