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Refractory GlaucomaNCT07907055

PAUL® Glaucoma Implant Safety and Effectiveness Study

A study testing PAUL® Glaucoma Implant in people with Refractory Glaucoma, run by Clinical Research Consultants, Inc..

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
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Trial summary

This prospective, multicenter clinical study is designed to evaluate the safety and effectiveness of the PAUL® Glaucoma Implant in adult patients with refractory glaucoma. Effectiveness will be assessed by measuring the reduction in intraocular pressure (IOP). Read more about this study

Who is it for?
Ages 22 years and older
Conditions the study is for
Refractory Glaucoma
What is being tested?
PAUL® Glaucoma Implant
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
65 participants
Where
No sites listed yet
Study dates
1 Nov 2026to 1 Aug 2028
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 22 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Adult subjects of any gender or ethnicity and 22 years of age or older at the time of the PAUL® Glaucoma Implant surgery.
  • Presenting with refractory primary open angle glaucoma failing maximally tolerated medical therapy (MTMT) for ≥4 medication classes, or fewer in cases where certain medication classes cannot be tolerated or are contraindicated, that can be treated with a PAUL® Glaucoma Implant, and the refractory glaucoma meets one or more of the following:
  • Having failed one or more traditional incisional intraocular glaucoma surgeries such as tube shunt or glaucoma filtering surgery (except procedures with minimally invasive glaucoma surgery (MIGS) devices, e.g., i-Stent, EX-PRESS, XEN devices)
  • Having failed one or more cilioablative procedures (e.g., cryotherapy or cyclodiode therapy except endocyclophotocoagulation (ECP) or micropulse cyclophotocoagulation (μCPC))
  • Having any other condition (e.g. conjunctival scarring, uveitis) in which conventional incisional glaucoma surgery such as trabeculectomy is likely to fail
  • Having a Qualifying IOP (mean IOP from 2 visits at least 4 days apart) that is between ≥ 20 mm Hg and ≤ 35 mm Hg.
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  • Presence of healthy, free, and mobile conjunctiva in the target quadrant.
  • CDVA of light perception or better.
  • Clinical findings consistent with glaucoma:
  • Glaucomatous visual field defects with optic nerve abnormalities that, in the investigator's clinical judgment, are consistent with a diagnosis of moderate stage glaucoma or advanced/late/severe stage glaucoma as per ICD-10 staging as follows:
  • Moderate Stage Glaucoma:
  • Optic nerve abnormalities consistent with glaucoma (see 6.c); and,
  • Glaucomatous visual field abnormalities in ONE hemifield and not within the central 5 degrees of fixation (note: 5 degrees = involvement of spots nearest fixation)
  • Advanced, Late, Severe Stage Glaucoma
  • Optic nerve abnormalities consistent with glaucoma (see 6.c); and,
  • Glaucomatous visual field abnormalities in BOTH hemifields and/or loss within 5 degrees of fixation in at least one hemifield
  • Visual field mean deviation score that is -3 decibels (dB) or worse, if CDVA is better than 20/100
  • Optic nerve abnormalities consistent with glaucomatous damage include but are not limited to:
  • VCDR ≥ 0.7 in one or both eyes, or an asymmetry of ≥ 0.2 between eyes. ii. Thinning or notching of the neuroretinal rim ≥ 0.2 mm. iii. Retinal nerve fiber layer (RNFL) thinning ≥ 20 microns. iv. Presence of optic disc hemorrhages. d. Shaffer Angle Grade ≥ 3.
  • Provide written informed consent and a signed Health Insurance Portability and Accountability Act (HIPAA) form.
  • Availability, willingness, ability, and sufficient cognitive awareness to comply with study examination procedures and the schedule for study visits and evaluations.

Who cannot join

  • Eyes with the glaucoma that is not primary open angle glaucoma such as the following types of glaucoma: neovascular, pseudoexfoliative, pigmentary, congenital, traumatic, or angle closure glaucoma, or open angle glaucoma resulting from aphakia or uveitis.
  • Previous glaucoma shunt/valve in the target quadrant.
  • Planned combined PAUL® Glaucoma Implant/cataract surgery.
  • Anticipated need for a combined glaucoma procedure, additional ocular surgery, or retinal laser procedure within the 12-month follow-up period.
  • CDVA worse than 20/200 in the fellow eye.
  • Prior cataract extraction surgery was performed within 12 months of the PAUL® Glaucoma Implant surgery.
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  • Any Argon laser trabeculoplasty (ALT) or selective laser trabeculoplasty (SLT) performed within 6 months of the PAUL® Glaucoma Implant surgery (all other prior glaucoma surgeries are permitted).
  • Other prior intraocular surgery.
  • History of corneal opacity or corneal transplant.
  • Central corneal thickness < 460 µm or > 620 µm.
  • Anticipated need for ocular surgery or retinal photocoagulation during the study.
  • Presence of any other ophthalmic disease or disorder that could confound the study results, including, but not limited to one or more of the following:
  • Active or recent corneal or intraocular inflammation; ocular or oral steroid use within 30 days of the operative visit
  • Known corticosteroid responder (due to the IOP spike risk from the postoperative corticosteroid regimen)
  • Current prescribed use of an oral carbonic anhydrase inhibitor or other systemic lowering medication for glaucoma treatment of one or both eyes which cannot be discontinued preoperatively
  • Presence of intraocular silicone oil or vitreous in the anterior chamber
  • Use of Latisse for hypotrichosis of the eyelashes (must be discontinued prior to operative day).
  • Inability to discontinue contact lens wear postoperatively.
  • Known allergy or sensitivity to any drugs required for the study or any device components.
  • Females who are pregnant or lactating. [NOTE: Pregnancy testing in females of childbearing potential may be performed at the investigator's discretion, or in conformity with the surgery clinic's standard procedures. Test results will be recorded in the subject's medical records but will not be recorded on the electronic case report forms (eCRFs).]
  • Presence or history or any other condition or finding that, in the investigator's opinion, makes the subject unsuitable as a candidate for study participation, may increase the operative risk (e.g., uncontrolled hypertension, diabetes, immunocompromised status, autoimmune disease, blood clotting disorders), or may confound the outcome of the study.
  • Current participation in another ophthalmic clinical trial.

Trial locations and contacts

No sites are listed yet. Contact the study team or a site near you to ask about taking part.

Jodi Pitcher Vice President, Clinical Operations contact

513-961-8200

JLPITCHER@CRC-REGULATORY.COM

About this study

Official title: PROSPECTIVE MULTICENTER STUDY OF THE SAFETY AND EFFECTIVENESS OF THE PAUL® GLAUCOMA IMPLANT

This prospective, multicenter clinical study is designed to evaluate the safety and effectiveness of the PAUL® Glaucoma Implant in adult patients with refractory glaucoma. Effectiveness will be assessed by measuring the reduction in intraocular pressure (IOP). Study results will support regulatory submissions to the U.S. Food and Drug Administration (FDA) and may also be used to support regulatory submissions and postmarketing surveillance activities in other countries.

Being tested
PAUL® Glaucoma Implant
Medical subject headings
Glaucoma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • PAUL® Glaucoma ImplantDevice

    The PAUL® Glaucoma Implant is an aqueous drainage device surgically implanted to facilitate aqueous humor drainage and reduce intraocular pressure in patients with refractory glaucoma.

Study groups in NCT07907055
Study groupRoleWhat they receive
PAUL® Glaucoma ImplantExperimentalParticipants with refractory glaucoma will undergo surgical implantation of the PAUL® Glaucoma Implant to reduce intraocular pressure (IOP). Participants will be followed for 12 months to evaluate the safety and effectiveness of the device.
Receives: Device: PAUL® Glaucoma Implant

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Proportion of Subjects Achieving ≥20% Reduction in Mean Diurnal Intraocular Pressure (DIOP)

    Proportion of subjects achieving a ≥20% reduction in mean DIOP from baseline at 12 months postoperatively while using the same or fewer glaucoma medication classes compared with baseline.

    Measured: Baseline to 12 months postoperatively

  2. Percentage Change in Mean Diurnal Intraocular Pressure (DIOP) From Baseline

    Percentage change in mean DIOP from baseline to 12 months postoperatively following implantation of the PAUL® Glaucoma Implant.

    Measured: Baseline to 12 months postoperatively

  3. Proportion of Subjects With Loss of ≥2 Lines of Corrected Distance Visual Acuity (CDVA)

    Proportion of subjects experiencing a loss of two or more lines (≥10 letters) of CDVA from baseline at 12 months postoperatively.

    Measured: Baseline to 12 months postoperatively

  4. Proportion of Subjects Requiring PAUL® Glaucoma Implant Removal

    Proportion of subjects requiring surgical removal of the PAUL® Glaucoma Implant at or before 12 months postoperatively.

    Measured: Through 12 months postoperatively

Secondary outcomes (4)

  1. Proportion of Subjects Achieving Target DIOP Range

    Proportion of subjects with mean DIOP between 6 and 18 mmHg and a ≥20% reduction from baseline at 12 months postoperatively.

    Measured: Baseline to 12 months

  2. Change in Number of Ocular Hypotensive Medication Classes

    Mean change in the number of ocular hypotensive medication classes used from baseline to 12 months postoperatively.

    Measured: Baseline to 12 months

  3. Incidence of Ocular Adverse Events

    Number and proportion of subjects experiencing ocular adverse events and procedure-related complications following implantation of the PAUL® Glaucoma Implant.

    Measured: Through 12 months

  4. Incidence of Elevated Intraocular Pressure Complications

    Proportion of subjects experiencing protocol-defined postoperative IOP complications, including IOP increases requiring medical or surgical management and IOP spikes greater than 35 mmHg at 3 months or later.

    Measured: Through 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted30 Oct 2026
  2. Study start1 Nov 2026 (estimated)
  3. Primary completion1 May 2028 (estimated)
  4. Study completion1 Aug 2028 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
65 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07907055
Sponsor's protocol ID
PGI-001
Status last verified
Oct 2026
First submitted
26 Oct 2026
Last updated
30 Oct 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
Yes
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing PAUL® Glaucoma Implant in people with Refractory Glaucoma, run by Clinical Research Consultants, Inc..

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 21 inclusion and 22 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: opening soon, as of the sponsor's last update on 30 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Jodi Pitcher Vice President, Clinical Operations (513-961-8200, JLPITCHER@CRC-REGULATORY.COM), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Proportion of Subjects Achieving ≥20% Reduction in Mean Diurnal Intraocular Pressure (DIOP) (time frame: Baseline to 12 months postoperatively). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07907055.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Oct 2026.

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