AquaLumen Filtration Procedure for Glaucoma

Overseen By Carlos A Urrea, MD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: PLU Ophthalmic

Disqualifiers: Corneal opacities, Failed trabeculectomy, others

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

Compensation: Varies

Number of Visits: 1

10 Participants Needed

Trial Summary

What is the purpose of this trial?

The study will follow a group of patients with glaucoma disease that undergo a surgical procedure intended to reduce the intra-ocular pressure (IOP) for a period of one year.

Do I need to stop taking my current medications for the trial?

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 AquaLumen treatment for glaucoma?

The AquaFlow collagen implant, used in non-penetrating glaucoma surgery, is similar to AquaLumen and has shown benefits like reduced complications and sustained control of eye pressure, although its overall effectiveness and cost-efficiency are not fully established. ^{1 2 3 4 5}

How does the AquaLumen treatment for glaucoma differ from other treatments?

The AquaLumen treatment for glaucoma is unique because it involves a filtration procedure that may use a novel implant or device to regulate eye pressure, unlike traditional surgeries like trabeculectomy or drug therapies. This approach might offer a new way to manage intraocular pressure by potentially bypassing obstructions in the eye's drainage system. ^{1 6 7 8 9}

Eligibility Criteria

This clinical trial is for individuals with a condition called Open Angle Glaucoma, which increases pressure inside the eye. Participants should be those who require treatment to lower this pressure and are willing to undergo surgery.

Inclusion Criteria

Central corneal thickness between 480 and 610 microns

I have moderate to severe open angle glaucoma.

Exclusion Criteria

I have cloudy areas on my cornea.

I have had a corneal transplant surgery.

I had a trabeculectomy that did not work.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Surgical Treatment

Participants undergo a surgical procedure intended to reduce intra-ocular pressure (IOP)

1 day

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after the surgical procedure

1 year

Regular visits (in-person)

Treatment Details

Interventions

• AquaLumen

Trial Overview The study is testing a new surgical procedure called AquaLumen designed to reduce intra-ocular pressure in patients with Open Angle Glaucoma. The effectiveness and safety of this procedure will be monitored over one year.

Participant Groups

Group I: This is the group that will undergo the surgical treatment Experimental Treatment 1 Intervention

Who Is Running the Clinical Trial?

PLU Ophthalmic

Lead Sponsor

Trials

1

Recruited

10+

References

1. Germany pubmed.ncbi.nlm.nih.gov

[Surgical therapy of glaucoma]. [2006]

2. China pubmed.ncbi.nlm.nih.gov

Complications and management of the filtration bleb. [2016]

3. Canada pubmed.ncbi.nlm.nih.gov

Non-penetrating glaucoma surgery using AquaFlow(TM)collagen implants. [2010]

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

Co-treatment of suberoylanilide hydroxamic acid and mitomycin-C induces the apoptosis of rabbit tenon's capsule fibroblast and improves the outcome of glaucoma filtration surgery. [2022]

5. France pubmed.ncbi.nlm.nih.gov

[Glaucoma treatment]. [2019]

6. England pubmed.ncbi.nlm.nih.gov

The Ex-PRESS Glaucoma Filtration Device Implantation in Uveitic Glaucoma. [2018]

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

A new glaucoma filter implant. [2003]

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

Technique for removal of malpositioned Ex-PRESS glaucoma device. [2018]

9. Germany pubmed.ncbi.nlm.nih.gov

[Implant in Schlemm's canal. A new method for regulating intraocular pressure in patients with primary open-angle glaucoma?]. [2019]