NCT03894631Completed
Effect of Intra-subject Phaco/Trabectome vs. Phaco/Kahook Dual Blade on Intraocular Pressure
Intra-subject Comparison Between the Effect of Combined Phaco/Trabectome vs. Phaco/Kahook Dual Blade on Intra Ocular Pressure and Other Surgical Outcomes
Source: ClinicalTrials.gov · Last updated 30 Jul 2024
Brief summary (registry, in English)
To determine the safety and efficacy of Kahook dual blade over Trabectome in lowering intraocular pressure in glaucoma patients. Glaucoma surgery will be performed in conjunction with cataract surgery. The investigators hypothesize that the Kahook dual blade is as effective as Trabectome in lowering intra-ocular pressure (IOP), and as safe with a similar rate of post-operative complications such as hyphema.
- Status (registry)
- Completed
- Study type
- Interventional
- Enrollment
- 80 (actual)
- First submitted
- 25 Mar 2019
- Start date
- 6 Mar 2019
- Primary completion date
- 9 Nov 2023
- Lead sponsor
- State University of New York at Buffalo
- Diseases
- Glaucoma
- NCT number
- NCT03894631
What you commit to
- Study type: Interventional
- Participants enrolled: 80
- From 6 Mar 2019 to the primary completion date, 9 Nov 2023
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Patients with primary open angle glaucoma with previously failed trabeculectomy or other glaucoma aqueous drainage surgical procedures
Age
- Patients age less than 18 years
- Women of child bearing age
Other
- Patients unable or unwilling to provide informed consent to participate in the study
- Aphakic and Pseudophakic patients
- Patients with a closed angle, angle neovascularization (NVG), traumatic glaucoma, or any other angle abnormality in either eye
- Patients potentially unavailable for follow up visits for the length of the study
Who the study is looking for
- Patients age ≥18 years old
- Patients already diagnosed with Glaucoma and Cataract in both eyes
- Patients with Primary open angle glaucoma (POAG), Low-tension glaucoma (LTG), Pseudoexfoliation glaucoma (PSXF), pigmentary glaucoma and other glaucoma types with a structurally-normal looking open angle in both eyes
- Glaucoma that is inadequately controlled on medical therapy or with the need to reduce the glaucoma medication burden
- Patients with a visually-significant cataract in both eyes
- Patients that could benefit from cataract removal combined with MIGS surgery in both eyes
Age in the registry: 18 years to 95 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| The Ira G. Ross Eye Institute Coordinator of this site? Confirm its status | Buffalo | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.