Glaucoma Drainage Techniques for Glaucoma

(DECLARE Trial)

Recruiting at 7 trial locations

Overseen By Gui-shuang Ying, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Pennsylvania

Disqualifiers: Corneal condition, Previous GDD, others

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

Compensation: Varies

Number of Visits: 25

Duration: 1 day (surgery)

226 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

Glaucoma Drainage Device and Endothelial Cell Loss Compare Trial (DECLARE) is a multi-center, outcome-masked, randomized clinical trial. The purpose of this study is to compare glaucoma drainage device implantation in the anterior chamber (front part of the eye) and sulcus (small space between iris and front chamber of the eye) in efforts to minimize cell loss in the eye.

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.

How does the treatment of anterior chamber and sulcus tube placement for glaucoma differ from other treatments?

This treatment involves placing a tube in the eye to help drain fluid and reduce pressure, which is different from other methods like medication or laser treatments. The sulcus tube placement may result in fewer complications compared to the traditional anterior chamber placement, while maintaining similar effectiveness. ^{1 2 3 4 5}

What data supports the effectiveness of this treatment for glaucoma?

Research shows that placing glaucoma drainage devices in the sulcus (a groove in the eye) may result in fewer complications compared to traditional placement in the anterior chamber, while maintaining similar effectiveness in reducing eye pressure. ^{1 2 3 4 6}

Who Is on the Research Team?

Ying Han, MD, PhD

Principal Investigator

University of California, San Francisco

Jennifer Rose-Nussbaumer, MD

Principal Investigator

Stanford University

Thuy Doan, MD, PhD

Principal Investigator

University of California San Fransicso

Are You a Good Fit for This Trial?

This trial is for adults over 18 with medically uncontrolled glaucoma needing a Glaucoma Drainage Device (GDD) or GDD with phacoemulsification. Candidates must be suitable for GDD implantation in the ciliary sulcus and anterior chamber, able to consent, accept randomization, and attend scheduled visits.

Inclusion Criteria

I have glaucoma that needs surgery not controlled by medication.

I am a candidate for a specific eye implant surgery.

Exclusion Criteria

Presence of nanophthalmos, uncontrolled uveitis, silicone oil, Sturge-Weber syndrome or other conditions associated with elevated episcleral venous pressure

I had glaucoma surgery within the last 6 months.

Previous GDD implantation or Xen Gel Stent or placement of Cypass Micro-stent or Preserflo MicroShunt

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo glaucoma drainage device implantation with tube placement in either the anterior chamber or ciliary sulcus

1 day (surgery)

1 visit (in-person)

Follow-up

Participants are monitored for endothelial cell density, intraocular pressure, and other outcomes

24 months

Regular visits (in-person) over 24 months

What Are the Treatments Tested in This Trial?

Interventions

• Anterior chamber (AC) tube placement
• Sulcus tube placement

Trial Overview The DECLARE study compares two ways of placing a glaucoma drainage device: either in the front part of the eye (anterior chamber) or between the iris and front chamber (sulcus). The goal is to see which method better minimizes cell loss in the eye.

How Is the Trial Designed?

Group I: Anterior chamber (AC) tube placement Active Control 1 Intervention

Glaucoma drainage device (GDD) implantation with tube placement in the anterior chamber

Group II: Sulcus tube placement Active Control 1 Intervention

Glaucoma drainage device (GDD) implantation with tube placement in the ciliary sulcus

Anterior chamber (AC) tube placement is already approved in United States, European Union for the following indications:

Approved in United States as Glaucoma Drainage Device for:

• Glaucoma
• Primary Open-Angle Glaucoma
• Mixed-Mechanism Glaucoma

Approved in European Union as Glaucoma Drainage Device for:

• Glaucoma
• Primary Open-Angle Glaucoma
• Mixed-Mechanism Glaucoma

Who Is Running the Clinical Trial?

University of Pennsylvania

Lead Sponsor

Trials

2,118

Recruited

45,270,000+

Stanford University

Collaborator

Trials

2,527

Recruited

17,430,000+

National Eye Institute (NEI)

Collaborator

Trials

572

Recruited

1,320,000+

University of California, San Francisco

Collaborator

Trials

2,636

Recruited

19,080,000+

Published Research Related to This Trial

In a study of 40 glaucoma patients who underwent glaucoma drainage device (GDD) insertion, the pars plana (PP) group showed a significantly lower medication burden compared to those with anterior chamber (AC) or sulcus GDDs, indicating better management of glaucoma symptoms post-surgery.

All three GDD locations (AC, sulcus, and PP) had similar success rates in lowering intraocular pressure (IOP), and no significant differences in complication rates were observed after 3 months, suggesting that PP GDDs are a safe and effective option for glaucoma treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Outcomes of Anterior Chamber, Sulcus, and Pars Plana Glaucoma Drainage Device Placement in Glaucoma Patients. Samuel, S., Chang, EK., Gupta, S., et al.[2022]

In a study of 105 patients, those who had glaucoma drainage devices (GDD) placed in the sulcus experienced significantly fewer complications, including lower rates of postoperative hyphaema and severe complications compared to those with devices placed in the anterior chamber.

Both groups achieved similar reductions in intraocular pressure (IOP), but the sulcus group required fewer medications during follow-up, indicating that sulcus placement is a safe and effective option for managing glaucoma.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Comparison of surgical outcomes between sulcus and anterior chamber implanted glaucoma drainage devices. Alobaida, IA., Malik, R., Ahmad, S.[2021]

In a study of 67 eyes from 66 patients, the insertion of glaucoma drainage devices (GDD) through the ciliary sulcus (CS) showed no significant difference in intraocular pressure (IOP) or best corrected visual acuity (BCVA) compared to anterior chamber (AC) placement after a follow-up of up to 69 months.

CS placement resulted in significantly lower rates of corneal decompensation compared to AC placement, making it a safer option for pseudophakic or aphakic patients, particularly those with postpenetrating keratoplasty glaucoma.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Clinical and surgical outcomes of glaucoma drainage device tube in ciliary sulcus versus anterior chamber in North Indian glaucoma patients. Jha, UP., Kumar, S., Jindal, V., et al.[2023]

A novel technique for implanting glaucoma drainage devices (GDD) in the posterior chamber of pseudophakic eyes was successfully performed on 10 patients without any intra-operative complications, such as bleeding or improper tube placement.

This method reduces the risk of corneal complications and ensures that the GDD tube is safely positioned away from the vitreous, enhancing the safety and efficacy of the procedure.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Ab interno implantation of glaucoma drainage devices tubes in the posterior chamber. Moreno-Montañés, J., Guirao-Navarro, C., Argüeso, F.[2020]

A new technique using a transcameral suture effectively corrected the position of a glaucoma drainage device tube that was touching the corneal endothelium, ensuring it was at a safe distance from both the cornea and iris.

This method proved to be safe, quick, and minimally invasive, with successful results maintained over a follow-up period of 20 months.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Transcameral suture to prevent tube-corneal touch after glaucoma drainage device implantation: a new surgical technique. Bochmann, F., Azuara-Blanco, A.[2021]

In a study of 33 patients with glaucoma drainage devices inserted into the pars plana, the mean intraocular pressure significantly decreased from 33.06 mmHg preoperatively to 13.4 mmHg postoperatively over an average follow-up of 30.2 months.

The procedure resulted in a notable reduction in the need for pressure-lowering medications, with nearly half of the eyes achieving complete success, indicating that pars plana insertion can be an effective alternative when anterior chamber insertion is not suitable.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Pars plana insertion of glaucoma drainage devices for refractory glaucoma. de Guzman, MH., Valencia, A., Farinelli, AC.[2022]

Citations

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

Outcomes of Anterior Chamber, Sulcus, and Pars Plana Glaucoma Drainage Device Placement in Glaucoma Patients. [2022]

2. India pubmed.ncbi.nlm.nih.gov

Comparison of surgical outcomes between sulcus and anterior chamber implanted glaucoma drainage devices. [2021]

3. India pubmed.ncbi.nlm.nih.gov

Clinical and surgical outcomes of glaucoma drainage device tube in ciliary sulcus versus anterior chamber in North Indian glaucoma patients. [2023]

4. England pubmed.ncbi.nlm.nih.gov

Ab interno implantation of glaucoma drainage devices tubes in the posterior chamber. [2020]

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

Transcameral suture to prevent tube-corneal touch after glaucoma drainage device implantation: a new surgical technique. [2021]

6. Australia pubmed.ncbi.nlm.nih.gov

Pars plana insertion of glaucoma drainage devices for refractory glaucoma. [2022]