iDose TR + Cataract Surgery for Glaucoma

Overseen By Study Director

Age: 18+

Sex: Any

Trial Phase: Phase 4

Sponsor: Glaukos Corporation

Disqualifiers: Corneal inflammation, Retinal disorders, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 1

Duration: 1 day

132 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests whether a small implant called iDose TR, which releases medication, can help lower eye pressure when used with cataract surgery for people with glaucoma. Researchers aim to determine if this combination treatment is safer and more effective than cataract surgery alone. The trial seeks participants diagnosed with significant cataracts and either open-angle glaucoma (a common type of glaucoma) or ocular hypertension (higher-than-normal eye pressure). As a Phase 4 trial, this research involves an FDA-approved treatment and aims to understand its benefits for more patients.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What is the safety track record for iDose TR?

Research has shown that the iDose TR, a small implant releasing the medication travoprost, has undergone safety testing in people with glaucoma. One study found the most common side effects included eye inflammation (iritis) in 0.5% to 5.1% of patients and eye redness (ocular hyperemia) in about 2.6% to 3% of patients. Some patients also experienced reduced visual acuity.

The implant is designed to lower eye pressure, a crucial aspect of glaucoma treatment. It has already received approval for this use, indicating a level of safety confidence. However, discussing potential side effects with a doctor is always important to understand their impact on health. ^{1 2 3 4 5}

Why are researchers enthusiastic about this study treatment?

Unlike most treatments for glaucoma, which often involve daily eye drops, iDose TR is an intracameral implant that delivers the medication travoprost directly into the eye over an extended period. This innovative delivery method reduces the burden of daily administration and ensures consistent dosing. Researchers are excited because this could improve adherence to treatment and potentially enhance long-term outcomes for patients undergoing cataract surgery, offering a more convenient and reliable option compared to traditional therapies.

What evidence suggests that iDose TR is effective for glaucoma?

Studies have shown that the iDose TR, a small implant that releases medication, effectively lowers eye pressure in people with open-angle glaucoma or high eye pressure. Research indicates that this tiny implant gradually releases medicine, reducing the need for daily eye drops. Specifically, previous patients experienced significant drops in eye pressure, comparable to other common treatments like timolol. In this trial, some participants will receive the iDose TR implant alongside cataract surgery to test its effectiveness in this context. The iDose TR offers a continuous, long-term method to manage eye pressure, potentially providing convenience and effective control for those with glaucoma. ^{2 3 6 7 8}

Who Is on the Research Team?

Luis Vargas

Principal Investigator

Glaukos Corporation

Are You a Good Fit for This Trial?

This trial is for individuals with ocular conditions like glaucoma or cataract, who require cataract surgery. Specific eligibility criteria are not provided, but typically participants must meet certain health standards and have a diagnosis relevant to the study.

Inclusion Criteria

I have a significant cataract in one eye eligible for surgery.

My eye diagnosed with glaucoma or high eye pressure is having cataract surgery.

Exclusion Criteria

I have active inflammation or swelling in my cornea.

I have a retinal disorder not related to glaucoma.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo cataract surgery with or without the iDose TR implant

1 day

1 visit (in-person)

Follow-up

Participants are monitored for safety and IOP-lowering efficacy after treatment

3 months

Monthly visits (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• iDose TR

Trial Overview

The trial is testing the safety and effectiveness of iDose TR (a travoprost intracameral implant) used during cataract surgery versus just having the cataract surgery without the implant.

How Is the Trial Designed?

Group I: iDose TR (travoprost intracameral implant) 75 µg in conjunction with cataract surgery Active Control 1 Intervention

iDose TR (travoprost intracameral implant) 75 µg in conjunction with cataract surgery

Group II: Sham procedure in conjunction with cataract surgery Placebo Group 1 Intervention

Sham procedure in conjunction with cataract surgery

Who Is Running the Clinical Trial?

Glaukos Corporation

Lead Sponsor

Trials

69

Recruited

9,500+

Thomas Burns

Glaukos Corporation

Chief Executive Officer since 2002

B.A. from Yale University

Dr. Tomas Navratil

Glaukos Corporation

Chief Medical Officer since 2022

MD from Harvard Medical School

Published Research Related to This Trial

In a study of 93 eyes undergoing a triple procedure for cataract and glaucoma, the average follow-up of 32.4 months showed a significant reduction in intraocular pressure (IOP) post-surgery, with fewer medications needed.

One year after surgery, 60% of patients achieved a best corrected visual acuity of 20/40 or better, but long-term follow-up indicated that IOP control worsened over time, particularly in patients who had surgery more than four years prior.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Combined procedure for glaucoma and cataract: a retrospective study. Menezo, JL., Maldonado, MJ., Muñoz, G., et al.[2019]

In a study of 47 patients (49 eyes) with secondary glaucoma caused by intumescent senile cataract, surgical methods like extracapsular cataract extraction (ECCE) combined with various iridectomies or trabeculectomy led to improved corrected visual acuity in most cases.

All treated eyes achieved normal intraocular pressure post-surgery, demonstrating that these surgical interventions are effective in managing secondary glaucoma, especially in challenging cases requiring a five-combined-operation approach.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[A study on the treatment of secondary glaucoma due to intumescent senile cataract]. Zhang, J., Guo, L., Wang, L.[2006]

Cataract surgery in glaucomatous eyes that had previously undergone successful trabeculectomy resulted in significantly higher intraocular pressure (IOP) postoperatively, with mean IOP increasing from 11.0 mm Hg preoperatively to 19.0 mm Hg by 9 months after surgery.

Patients required more glaucoma medications after cataract surgery, increasing from an average of 3 medications preoperatively to 27 postoperatively, indicating a decline in IOP control following the procedure.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cataract surgery after trabeculectomy. Seah, SK., Jap, A., Prata, JA., et al.[2022]

The combined cataract and glaucoma procedure, which includes small-incision phacoemulsification and inferior pupilloplasty, has been successfully performed on 42 patients, leading to excellent visual outcomes and early rehabilitation.

While the procedure has shown minimal complications, some issues such as adhesions and hyphema were noted, indicating that while generally safe, careful monitoring is necessary.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A new technique for combined cataract/glaucoma procedures in patients on chronic miotics. Whitsett, JC., Stewart, RH.[2004]

Trabeculectomy is the most common procedure for glaucoma during cataract surgery, but it often leads to complications like fibrin exudation in the anterior chamber, suggesting that separate surgeries may be preferable when urgent combined surgery is not necessary.

Alternative glaucoma procedures, such as trabeculotomy and deep sclerectomy, may be less effective in lowering intraocular pressure but have a lower complication rate, making them safer options for patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Combined glaucoma-cataract surgery]. Grehn, F., Klink, T.[2018]

Phacotrabeculectomy combined with mitomycin C is the most effective surgical option for lowering intraocular pressure (IOP) in patients with both cataract and glaucoma, but it carries a risk of serious complications that could threaten vision.

For patients without a need for low target IOP, alternatives like phacotrabeculotomy or combining phacoemulsification with deep sclerectomy may be safer and still effective options.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Surgical strategies in patients with combined cataract and glaucoma. Vass, C., Menapace, R.[2019]

In a study of 55 patients with exfoliation glaucoma and cataracts, combined cataract surgery with Trabectome significantly reduced intraocular pressure (IOP) more effectively than combined cataract surgery with trabecular aspiration, particularly noticeable at 1 day, 6 months, and 1 year post-surgery.

Both surgical methods led to a significant decrease in IOP, but there was no difference in the number of antiglaucoma eyedrops needed postoperatively, indicating that while Trabectome is more effective for IOP reduction, both methods are safe and beneficial.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Combined clear cornea phacoemulsification in the treatment of pseudoexfoliative glaucoma associated with cataract: significance of trabecular aspiration and ab interno trabeculectomy. Klamann, MK., Gonnermann, J., Maier, AK., et al.[2021]

In a study of 137 eyes undergoing combined trabectome-cataract surgery, the refractive and visual outcomes were similar to those of 1,704 eyes that had cataract surgery alone, indicating that the combination is effective.

Although there was a slightly higher rate of postoperative cystoid macular edema in the combined surgery group (2.2% vs. 1.9%), the overall results suggest that combining these procedures is a safe and feasible option for patients with both glaucoma and cataracts.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Refractive and visual outcomes after combined cataract and trabectome surgery: a report on the possible influences of combining cataract and trabectome surgery on refractive and visual outcomes. Luebke, J., Boehringer, D., Neuburger, M., et al.[2022]

In a study of 60 patients with advanced glaucoma and cataracts, combined phaco-trabeculectomy resulted in a significant reduction in intraocular pressure (1.7 mmHg) and an improvement in visual field mean deviation (1.4 dB) compared to phacoemulsification alone, indicating enhanced efficacy for managing both conditions.

The procedure was safe, with no major adverse events reported, and the best predictors for visual field improvement included factors like the degree of nuclear sclerosis and preoperative cup-disc ratio, suggesting that careful patient selection could optimize outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Phaco-trabeculectomy in controlled, advanced, open-angle glaucoma and cataract: parallel, randomized clinical study of efficacy and safety. Liaska, A., Papaconstantinou, D., Georgalas, I., et al.[2015]

The combined procedure of Phacoemulsification and Intraocular Lens Implantation with Trabeculectomy (Phaco & IOL & T) showed significantly better outcomes than Extra Capsule Cataract Extraction with Intraocular Lens Implantation and Trabeculectomy (ECCE & IOL & T), with lower average intraocular pressure (2.08 kPa vs. 2.78 kPa) and higher visual acuity (84% vs. 67.5%) after three months.

Phaco & IOL & T demonstrated a safer profile, with no severe complications reported, while the ECCE & IOL & T group experienced complications such as flat filtration pads in 9 cases.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Result of phacoemulsification and intraocular lens implantation combined with trabeculectomy in the treatment of glaucoma with cataract]. Zhou, H.[2016]

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Glaukos Announces Positive Clinical Updates for its iDose ...

Indication for Use: iDose TR (travoprost intracameral implant) is indicated for the reduction of intraocular pressure (IOP) in patients with ...