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Efficacy and safety of trabeculectomy ab interno with Kahook DualBlade

Efficacy and safety of trabeculectomy ab interno with Kahook DualBlade

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
DRKS
Registry ID
DRKS00025194
Enrollment
30
Registered
2021-05-06
Start date
2021-05-16
Completion date
Unknown
Last updated
2025-04-07

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

Conditions

primary open angle glaucoma

Interventions

Group 1: Trabeculectomy ab interno using Kahook DualBlade Surgical procedure The operation is performed in accordance with generally accepted hygiene and surgical standards under local anesthesia acc

Sponsors

Universitätsklinikum Ulm; Augenheilkunde
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: Patients with primary open-angle glaucoma with intraocular pressure higher than 18 mmHg and less than 30 mmHg under therapy, who are likely to have sufficient pressure reduction by trabeculectomy ab interno.

Exclusion criteria

Exclusion criteria: active inflammation; marked opacity of the optic media; chamber angle < Shaffer 2° in the nasal half; alterations of the chamber angle preventing excision of the trabecular meshwork; intraocular pressure level that is not expected to provide adequate pressure reduction; Age < 18 years; YAG-iridotomy, selective laser trabeculoplasty, vitrectomy or other glaucoma surgery within 3 months prior to surgery; previous chamber angle surgery or incisional glaucoma surgery; pseudophakia with anterior chamber lens; lens status that makes lens surgery likely within the next 6 months

Design outcomes

Primary

MeasureTime frame
Intraocular pressure (Goldmann applanation tonometry [mmHg]) 1 day, 1 week, 1 month, 3 month and 6 months after surgery.

Secondary

MeasureTime frame
Number of pressure-lowering agents (eye drops); adverse events 1 day, 1 week, 1 month, 3 months, 6 months after surgery.

Countries

Germany

Contacts

Public ContactJens Ulrich Werner

Universitätsklinikum Ulm; Augenheilkunde

sekretariat.augenklinik@uniklinik-ulm.de+4973159207

Outcome results

None listed

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