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

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Glaucoma
• Intervention / Treatment: Procedure: KDB/Phacoemulsification; Procedure: Trabectome/Phacoemulsification

Detailed Description

Trabectome is a type of Minimally Invasive Glaucoma Surgery (MIGS) where the Trabectome handpiece tip uses electrical current to cauterized and remove a strip of trabecular meshwork and the roof of Schlemm's canal to ease the outflow of aqueous. Kahook Dual Blade (KDB) procedure is another type of MIGS where the dual blade is used to remove the trabecular meshwork and Schlemm's canal roof to increase the aqueous outflow but without any cauterization.

Preclinical studies have evaluated the clinical outcome of Trabectome over KDB. Though Trabectome helps to lower IOP, it may remove only a portion of trabecular meshwork and possibly cause damage to surrounding tissue with leaflets of residual remaining tissue that may cause blockage of aqueous drainage. Unlike Trabectome, the KDB removes blocks of trabecular meshwork with no residual tissue leaflets, low rate of fibrosis, no damage to the surrounding tissue and lower cost. However, research studies have shown that although the Trabectome and KDB have different surgical techniques and both have surgical related risks as in any glaucoma surgery, the post-surgical clinical outcome and safety profile of Trabectome could be favorable to the KDB technique.

Few studies have evaluated the clinical outcome of Trabectome over Trabeculectomy, while few other studies evaluated Trabectome over phaco-trabectome. Some studies evaluated the clinical outcome of Trabectome alone while other studies assessed the outcome of KDB alone. Some other studies compared KDB with iStent while another study compared Trabectome versus KDB in porcine eye perfusion model. Studies have also shown that Trabectome, when combined with phaco has a higher success rate than Trabectome alone. However, due to the infancy of KDB procedure, there are no robust prospective comparison studies comparing the clinical outcome of KDB over Trabectome when combined with phacoemulsification. The aim of the study is to systematically compare the clinical outcomes of KDB over Trabectome in treating glaucoma

• Study Type: Interventional
• Enrollment (Actual): 80
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • New York
    • Buffalo, New York, United States, 14209
      • The Ira G. Ross Eye Institute

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 93 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 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

Exclusion Criteria:

• Patients age less than 18 years
• Women of child bearing age
• Patients unable or unwilling to provide informed consent to participate in the study
• Aphakic and Pseudophakic patients
• Patients with primary open angle glaucoma with previously failed trabeculectomy or other glaucoma aqueous drainage surgical procedures
• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Phaco/KDB; Eyes needing glaucoma and cataract extraction will receive combined KDB and phacoemulsification in one eye of a patient	Procedure: KDB/Phacoemulsification; 50 eyes of 50 patients will receive combined KDB/phaco surgery
Active Comparator: Phaco/Trabectome; Contralateral eyes needing glaucoma and cataract extraction will receive combined Trabectome and phacoemulsification in contralateral eye of the same patient	Procedure: Trabectome/Phacoemulsification; The contralateral 50 eyes of the same 50 patients will receive combined Trabectome /phaco surgery

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Changes in intraocular pressure measurements between baseline and postoperative followup visits	Baseline (pre-operative condition) and post operative intraocular pressure will be measured on Day1, Week1, Months 1, 3, 6, 12, 18 and 24.	2 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Changes in visual acuity measurements measured using a Snellen Vision Chart between baseline and postoperative followup visits	Baseline (pre-operative condition) and post operative visual acuity will be measured on Day1, Week1, Months 1, 3, 6, 12, 18 and 24.	2 years
Changes in number of medications between baseline and postoperative followup visits	Baseline (pre-operative condition) and post operative number of medications list will be measured on Day1, Week1, Months 1, 3, 6, 12, 18 and 24.	2 years
Rate of post surgical complications	Rate of post surgical complications such as Hypotony, Corneal Edema, Hyphema, Iritis, Vitreous Hemorrhage and Cystoid Macular Edema.	2 years

Collaborators and Investigators

• Sponsor: State University of New York at Buffalo
• Investigators: Principal Investigator: Asher Weiner, MD, State University of New York at Buffalo

Study record dates

Study Major Dates

• Study Start (Actual): March 6, 2019
• Primary Completion (Anticipated): January 31, 2024
• Study Completion (Anticipated): January 31, 2024

Study Registration Dates

• First Submitted: March 25, 2019
• First Submitted That Met QC Criteria: March 27, 2019
• First Posted (Actual): March 28, 2019

Study Record Updates

• Last Update Posted (Actual): April 18, 2023
• Last Update Submitted That Met QC Criteria: April 13, 2023
• Last Verified: April 1, 2023

More Information

Terms related to this study

• Keywords: Intraocular Pressure; Trabectome; Kahook dual blade
• Additional Relevant MeSH Terms: Eye Diseases; Ocular Hypertension; Glaucoma
• Other Study ID Numbers: STUDY00002910

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No