A Comparison of Cataract Surgery Alone and Cataract Surgery With iStent

NCT ID: NCT03106181

Last Updated: 2023-08-09

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 93 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-02-01
• Study Completion Date: 2022-12-31

Brief 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.

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.

Conditions

Glaucoma, Open-Angle

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Cataract surgery

Conventional phacoemulsification cataract surgery and intraocular lens implantation

Group Type: ACTIVE_COMPARATOR

Phacoemulsification and intraocular lens implant

Intervention Type: PROCEDURE

Conventional phacoemulsification cataract surgery and intraocular lens implant

Cataract surgery plus iStent inject®

Conventional phacoemulsification cataract surgery and lens implantation plus insertion of iStent inject®

Group Type: EXPERIMENTAL

iStent inject®

Intervention Type: DEVICE

Insertion of iStent inject®

Phacoemulsification and intraocular lens implant

Intervention Type: PROCEDURE

Conventional phacoemulsification cataract surgery and intraocular lens implant

Interventions

iStent inject®

Insertion of iStent inject®

Intervention Type: DEVICE

Phacoemulsification and intraocular lens implant

Conventional phacoemulsification cataract surgery and intraocular lens implant

Intervention Type: PROCEDURE

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Glaukos Corporation

INDUSTRY

Sponsor Role: collaborator

Center for Eye Research Australia

OTHER

Sponsor Role: collaborator

Royal Victoria Eye and Ear Hospital

OTHER_GOV

Sponsor Role: lead

Responsible Party

Jennifer Fan Gaskin

Ophthalmologist

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Jennifer Fan Gaskin, FRANZCO

Role: PRINCIPAL_INVESTIGATOR

Royal Victoria Eye and Ear Hospital

Brian Ang, FRANZCO

Role: PRINCIPAL_INVESTIGATOR

Royal Victoria Eye and Ear Hospital

Locations

Royal Victorian Eye and Ear Hospital

East Melbourne, Victoria, Australia

Countries

Australia

Other Identifiers

iStent RCT

Identifier Type: -

Identifier Source: org_study_id