Dilation of Schlemm's Canal during Glaucoma Surgery

Dilation of Schlemm?s Canal during Glaucoma Surgery: A muticenter, single arm, non-randomized interventional trial

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN12425531

Enrollment

157

Registered

2010-10-07

Start date

2005-09-08

Completion date

Unknown

Last updated

2015-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Open-angle glaucoma Eye Diseases Glaucoma

Interventions

Canaloplasty, a procedure involving circumferential viscodilation and tensioning of the inner wall of Schlemm?s canal for the treatment of open-angle glaucoma This is a single-arm study. The total du

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. At minimum 18 years of age 2. Scheduled for glaucoma surgery or combined cataract and glaucoma surgery 3. Diagnosis or primary open-angle glaucoma (POAG), pigmentary glaucoma, exfoliative glaucoma, or POAG mixed with another included mechanism 4. Baseline intraocular pressure of 16 mm Hg or higher and a historical IOP of 21 mm Hg or higher 5. Either sex

Exclusion criteria

Exclusion criteria: 1. Neovascular disease 2. Uveitis 3. Peripheral anterior synechiae 4. Angle recession 5. Developmental or secondary glaucoma with the exception of pigmentary and exfoliative glaucoma 6. Previous ocular surgeries that would interfere with complete circumferential catheterization of Schlemm?s canal 7. Patients with more than two laser trabeculoplasty procedures

Design outcomes

Primary

Measure	Time frame
1. Intraocular pressure in mm Hg, measured at baseline, 1 day, 1 week, and then at 1, 3, 6, 12, 18, 24, 30, and 36 months using tonometry. 2. Number of glaucomatous medications, obtained during patient visits and recorded via case report forms.	—

Secondary

Measure	Time frame
1. Nature and frequency of surgical and post-surgical complications 2. Number of secondary interventions Obtained during patient visits and recorded via case report forms.	—

Countries

Germany, United States of America

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026