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RecruitingNCT05696561Updated Feb 27, 2026

Clinical Trial to Evaluate the Safety and Effectiveness of a Canaloplasty Device in Subjects With Open-Angle Glaucoma

An interventional study of Canaloplasty Device in OAG - Open-Angle Glaucoma, sponsored by New World Medical, Inc.. Recruiting at 3 sites in 3 countries. Open to participants aged 22 Years and older. Per ClinicalTrials.gov, last updated 2026-02-27.

Sponsored by New World Medical, Inc. · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Started Sep 2025; still recruiting 1 year 2 months later.
Phase
Not applicable
Study type
Interventional
Enrollment
70
Allocation
Not applicable
Ages
22 Years and older
Sex
All
01

Study summary

Clinical Trial to Evaluate the Safety and Effectiveness of a Canaloplasty Device in Subjects with Open-Angle Glaucoma

02

Conditions studied

  • OAG - Open-Angle Glaucoma

Browse trials for

03

In context

Glaucoma, Open-Angle

924 studies on the registry are indexed under Glaucoma, Open-Angle; 117 are open to participants now.

This study's planned enrollment of 70 is below the median of 80 across 692 interventional studies indexed under Glaucoma, Open-Angle.

Browse Glaucoma, Open-Angle studies →

Lead sponsor

New World Medical, Inc. is the lead sponsor of 7 studies on the registry; 1 is open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
22 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  1. Subjects qualifying for cataract surgery
  2. Subjects with diagnosis of open-angle glaucoma in at least one eye with unmedicated IOP of 22-34 mmHg.

Exclusion criteria

Exclusion Criteria:

1. Patients who cannot be washed-out of IOP-lowering medications.

05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
70 participants (estimated)

Study arms

  • Other
    Treatment with a Canaloplasty Device

    US. FDA Approved Canaloplasty Device

    Device: Canaloplasty Device

Interventions

  • DeviceCanaloplasty Device

    Canaloplasty

06

What researchers measure

Primary outcomes

  1. IOP change

    Reduction in unmedicated IOP

    Time frame: Month12

Secondary outcomes

  1. IOP

    Percentage Change in unmedicated IOP

    Time frame: Month12

  2. IOP meds

    Change in number of IOP lowering medications

    Time frame: Month12

07

Study locations

2 of 3 sites recruiting
  • Centro de la Vision
    Santiago, Chile
    Recruiting
    • Edison Villagran · Contact
  • Clínica 20/20
    San José, Costa Rica
    Recruiting
    • Nadja Dodero · Contact+506 8375-8263
    • Claudio Orlich, MD · Principal investigator
  • Centro Oftalmologico Robles
    Santa Rosa de Copán, Honduras
    Not yet recruiting
    • Gricelda Ortiz · Contact
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Sep 2025 (actual). Primary completion is estimated for Sep 2027, 24 months after the start.

Of 70 industry-sponsored interventional studies with no phase under Glaucoma, Open-Angle, half reached primary completion within 33 months of starting (the median), counting those still running; a quarter within 19 and three quarters within 64. This study's planned 24 months is below that.

Counting every sponsor, half of 170 studies reached it within 35 months; a quarter within 19 and three quarters within 61.

How these figures are worked out, and which studies are left out of them.

Registered
Jan 13, 2023
First posted
Jan 25, 2023
StartActual
Sep 9, 2025
Primary completionEst.
Sep 2027
CompletionEst.
Oct 2027
Last update
Feb 27, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Feb 27, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05696561
Lead sponsor
New World Medical, Inc.
Responsible party
Sponsor
First posted
Jan 25, 2023
Start date
Sep 9, 2025
Primary completion
Sep 2027 (estimated)
Completion
Oct 2027 (estimated)
Last update
Feb 27, 2026

Study contacts

Swetha Mandava, MS
Contact
smandava@newworldmedical.com
9732049467
Elysia Ison, OD,FAAO
Contact
eison@newworldmedical.com
4083487408
Mini Balaram, MD
study director · New World Medical, Inc.

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
Yes
View the source record on ClinicalTrials.gov ↗

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New World Medical, Inc.

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