A Comparison of Cataract Surgery Alone and Cataract Surgery With iStent

Glaucoma, Open-Angle Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03106181
• Other study ID #: iStent RCT
• Status: Completed
• Phase: N/A
• Start date: February 1, 2018
• Est. completion date: December 31, 2022

Study information

• Verified date: August 2023
• Source: Royal Victoria Eye and Ear Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 93
• Est. completion date: December 31, 2022
• Est. primary completion date: March 31, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Cataract
• Glaucoma, Open-Angle

Intervention

Device:
• iStent inject®
Insertion of iStent inject®

Procedure:
• Phacoemulsification and intraocular lens implant
Conventional phacoemulsification cataract surgery and intraocular lens implant

Locations

Country	Name	City	State
Australia	Royal Victorian Eye and Ear Hospital	East Melbourne	Victoria

Sponsors (3)

Lead Sponsor	Collaborator
Royal Victoria Eye and Ear Hospital	Centre for Eye Research Australia, Glaukos Corporation

Country where clinical trial is conducted

Australia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Intraocular pressure	Intraocular pressure reduction	Up to 2 years
Primary	Glaucoma medications	Number of glaucoma medications	Up to 2 years
Secondary	Treatment satisfaction	Patient treatment satisfaction	Up to 2 years