Assessing the Helix Surgical System for treating glaucoma and cataracts

A Pilot Study of the Helix Surgical System in Subjects With Primary Open-Angle Glaucoma (POAG) and Cataract.

This study tests if the Helix Surgical System is safe and effective for treating cataracts and lowering eye pressure in people aged 45 and older with mild to moderate glaucoma.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 25 (estimated)
• Ages: 45 Years and up
• Sex: All
• Sponsor: Sight Sciences, Inc. (Industry-sponsored)
• Locations: 1 site (Panama City)
• Trial ID: NCT06948773 on ClinicalTrials.gov

What this trial studies

This study evaluates the safety of the Helix Surgical System during cataract surgery while also investigating its effectiveness in reducing intraocular pressure (IOP) in patients with mild to moderate primary open-angle glaucoma (POAG) and cataracts. Participants will undergo cataract surgery using the Helix system, and their IOP will be monitored to gather early evidence of the system's performance. The study aims to include individuals aged 45 and older who meet specific criteria related to their eye conditions.

Who should consider this trial

Good fit: Ideal candidates are individuals aged 45 and older with visually significant age-related cataracts and mild to moderate primary open-angle glaucoma.

Not a fit: Patients who have had recent ocular procedures or implanted glaucoma devices may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide a new surgical option that effectively lowers IOP in patients with glaucoma while addressing cataracts.

How similar studies have performed: While there have been studies on various surgical systems for glaucoma and cataracts, the Helix Surgical System's specific application is relatively novel.

Eligibility criteria

Inclusion Criteria:

* Male or female subjects, 45 years or older
* Visually significant age-related cataract.
* Intraocular pressure (IOP) at the Screening visit not exceeding 33 mmHg and at least 21 mmHg for unmedicated eyes or 16 mmHg if medicated (1 to 4 ocular hypotensive medications - fixed combinations count as the number of components), with a stable medication regimen for ≥2 months.
* Diagnosed with mild to moderate primary open angle glaucoma (POAG).

Exclusion Criteria:

* Any of the following prior ocular procedures:

  * Laser trabeculoplasty ≤180 days prior to baseline
  * Durysta ≤12 months prior to baseline
  * Any implanted glaucoma device
  * Prior canaloplasty, goniotomy, trabeculotomy, trabeculectomy
  * Ciliary ablation including endoscopic cyclophotocoagulation (ECP), Cyclophotocoagulation or CPC (G probe), high intensity focused ultrasound (HIFU),

    * 180 days prior to baseline
  * Retinal laser procedure ≤3 months prior to baseline
* Any form of glaucoma other than POAG
* Use of topical ocular steroids.
* Clinically significant concurrent ocular pathology or systemic medical condition which, in the Investigator's judgment, would either place the subject at increased risk of complications, contraindicate surgery, place the subject at risk of significant vision loss during the study period or interfere with compliance to elements of the study protocol
* History of penetrating keratoplasty or another corneal transplant
* Endothelial cell density \< 2200 cells/mm2 (age 45), \< 2000 cells/mm2 (age 46 to 55), \< 1800 cells/mm2 (age 56 to 65), \< 1600 cells/mm2 (age \> 65).
* Retrobulbar tumor, thyroid eye disease, Sturge-Weber Syndrome or any other type of condition that may cause elevated episcleral venous pressure.
* BCVA of logMAR 0.4 (20/50) or worse in the study eye not due to cataract
* BCVA of logMAR 0.6 (20/80) or worse in the non-study eye not due to cataract.

Where this trial is running

Panama City

• Panama Eye Center — Panama City, Panama (Recruiting)

Study contacts

• Study coordinator: Jaime Dickerson, PhD

Conditions Primary Open Angle Glaucoma; Cataract