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Efficacy and Safety of ab Interno Trabeculectomy With the Kahook Dual Blade

NCT04202562 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 42

Last updated 2019-12-20

No results posted yet for this study

Summary

The Kahook Dual Blade is a single-use device specially designed to create a clean cut in the trabecular meshwork. This ablation in the trabecular meshwork allows a better outflow of the aqueous humor, thus reducing the intraocular pressure (IOP), theoretically beyond the IOP reduction achieved by other minimally invasive glaucoma surgery (MIGS) devices.

Studies already published showed good results in terms of the reduction of the number of glaucoma medications and the reduction in the IOP, but not a single study has been performed prospectively comparing the efficacy of the technique, not even with the cataract surgery.

Conditions

Interventions

PROCEDURE

Ab interno trabeculectomy

Ab interno trabeculectomy performed after pupil contraction and 90 degrees ablation of the nasal trabecular meshwork

PROCEDURE

Cataract

Cataract surgery with minimal clear cornea incision and phacoemulsification

Sponsors & Collaborators

  • Hospital San Carlos, Madrid

    lead OTHER

Principal Investigators

  • Julian Garcia Feijoo, Professor · Hospital San Carlos

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
85 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-02-02
Primary Completion
2017-11-29
Completion
2018-11-30

Countries

  • Spain

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04202562 on ClinicalTrials.gov