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

Trial Summary

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 data supports the effectiveness of the treatment iDose TR when used with cataract surgery for glaucoma?

The research shows that combining cataract surgery with procedures like trabeculectomy or trabectome can effectively lower intraocular pressure (IOP) in glaucoma patients, which is a key goal of glaucoma treatment. This suggests that combining cataract surgery with treatments targeting IOP, like iDose TR, could be beneficial. ^{1 2 3 4 5}

How does the iDose TR + Cataract Surgery treatment for glaucoma differ from other treatments?

The iDose TR + Cataract Surgery treatment is unique because it combines a novel drug delivery system with cataract surgery, potentially offering a more integrated approach to managing both glaucoma and cataracts simultaneously. This differs from traditional methods that often involve separate procedures or more invasive surgeries, aiming to improve patient outcomes and reduce complications. ^{6 7 8 9 10}

What is the purpose of this trial?

This trial will evaluate the safety and IOP -lowering efficacy of administering an iDose TR (travoprost intracameral implant) in conjunction with cataract surgery compared to cataract surgery alone

Research Team

Luis Vargas

Principal Investigator

Glaukos Corporation

Eligibility Criteria

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

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)

Treatment Details

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.

Participant Groups

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

Findings from Research

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]

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]

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]

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]

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]

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]

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 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]

References

1. Germany 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. [2022]

2. England pubmed.ncbi.nlm.nih.gov

Phaco-trabeculectomy in controlled, advanced, open-angle glaucoma and cataract: parallel, randomized clinical study of efficacy and safety. [2015]

3. United States pubmed.ncbi.nlm.nih.gov

Combined procedure for glaucoma and cataract: a retrospective study. [2019]

4. United States pubmed.ncbi.nlm.nih.gov

Cataract surgery after trabeculectomy. [2022]

5. Germany 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. [2021]

6. United States pubmed.ncbi.nlm.nih.gov

A new technique for combined cataract/glaucoma procedures in patients on chronic miotics. [2004]

7. China pubmed.ncbi.nlm.nih.gov

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

8. Germany pubmed.ncbi.nlm.nih.gov

[Combined glaucoma-cataract surgery]. [2018]

9. United States pubmed.ncbi.nlm.nih.gov

Surgical strategies in patients with combined cataract and glaucoma. [2019]

10. China pubmed.ncbi.nlm.nih.gov

[A study on the treatment of secondary glaucoma due to intumescent senile cataract]. [2006]