RecruitingACTRN12622000492752

Cost Effectiveness and Efficacy of Standalone Stents as Second-Stage Surgery Study: SUCCESSES

Cost Effectiveness and Efficacy of Standalone Stents as Second-Stage Surgery in Glaucoma Patients Undergoing Cataract Surgery: SUCCESSES

Sponsor

Dr Jesse Gale

Enrollment

97 participants

Start Date

Apr 13, 2022

Study Type

Interventional

Conditions

Cataract Glaucoma Cataract Surgery

Summary

This study is based on the concept of staging cataract and iStent surgery (a minimally invasive glaucoma device). In patients with both cataracts and glaucoma, we would perform the cataract surgery first (which is standard of care) and delay the insertion of an iStent. The iStent would only be inserted (as a second stage procedure) if it is still required at any point from 3 months after the cataract surgery i.e. the intraocular pressure remains uncontrolled or there are side effects from the eye drops. The hypothesis is that if iStent insertion is not usually required after cataract surgery, then two-stage insertion would save money and unnecessary implantation of stents, but if iStent insertion is required after most cataract operations in glaucoma patients, then two-stage insertion would cost more money in additional theatre visits.

Eligibility

Sex: Both males and femalesMin Age: 19 Yearss

Plain Language Summary

Simplified for easier understanding

This study is for people who have both cataracts and glaucoma, two common eye conditions that often occur together as people age. The standard approach is to remove the cataract first and, if needed, also insert a tiny device called an iStent to help lower eye pressure from glaucoma at the same time. This study takes a different approach: do the cataract surgery first, then wait to see whether the iStent is actually needed before deciding to implant it. Researchers believe that for many people, cataract surgery alone may lower eye pressure enough so that the iStent is not necessary. If that is true, staging the procedures could save money and avoid unnecessary implants. If most people still need the iStent after cataract surgery, then doing two separate procedures would cost more and the current combined approach would remain better. You may be eligible if you are over 18 years old, have a visually significant cataract, have been diagnosed with ocular hypertension or mild to moderate open-angle glaucoma, are taking at least one type of eye drop for glaucoma, and your eye pressure is either above your target level or your drops are causing side effects. People with certain other types of glaucoma or who have had previous glaucoma surgery are not eligible.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

An iStent (Glaukos Corporation, Laguna Hills, CA, USA) is a minimally invasive glaucoma surgery device, used widely for glaucoma and ocular hypertension. It is an ab-interno (i.e. inserted from inside the eye) trabecular bypass stent (i.e. crosses the trabecular meshwork, the point of maximum resistance in most glaucoma). The iStent is made of non-ferromagnetic, heparin-coated, surgical grade titanium. This study is based on the concept of staging iStents. In patients with both cataracts and glaucoma, who would meet criteria for iStent with cataract surgery, we would perform only cataract surgery (which is standard of care) and delay the insertion of an iStent (which is still an emerging technology, not offered in all public hospital departments). Then, three months after surgery, if the same indications for iStent are still met, a second-stage standalone iStent insertion would be performed. The surgeries will be performed by ophthalmologists, specifically- glaucoma specialists Prof Tony Wells, Dr Jesse Gale and Dr Nicole Lim. The approximate surgical time is 20 minutes for cataract surgery (first stage) and 10 minutes for iStent surgery. The indications for iStent placement that must be met for insertion include: Either a) IOP over target; OR b) at least one recognisable side effect of drops Target IOP will be standardised (as is usual in our clinical practice) based on the Mean deviation (MD) of visual field: 1) if there is no glaucoma (ocular hypertension requiring treatment), target IOP equal to 21 mmHg, 2) if glaucoma is mild (MD greater than -6 dB), target IOP equal to 18 mmHg 3) if glaucoma is moderate (MD between -6 dB and -12 dB), target IOP equal to 15 mmHg 4) if glaucoma is advanced (MD less than -12 dB), target IOP equal to 12 mmHg all of these categories and targets are modified by the clinician as appropriate, such as when progression is known to occur despite achieving target IOP . Adherence to the intervention will be monitored by the lead investigator, who will audit participant records and operation reports at regular intervals (every 3 months) throughout the study period.