NCT03894631

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
80

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Mar 2019

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 6, 2019

Completed
19 days until next milestone

First Submitted

Initial submission to the registry

March 25, 2019

Completed
3 days until next milestone

First Posted

Study publicly available on registry

March 28, 2019

Completed
4.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 9, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 9, 2023

Completed
Last Updated

July 30, 2024

Status Verified

July 1, 2024

Enrollment Period

4.7 years

First QC Date

March 25, 2019

Last Update Submit

July 28, 2024

Conditions

Glaucoma

Keywords

Kahook dual bladeTrabectomeIntraocular Pressure

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (3)

  • Changes in visual acuity measurements measured using a Snellen Vision Chart between baseline and postoperative followup visits

    2 years

  • Changes in number of medications between baseline and postoperative followup visits

    2 years

  • Rate of post surgical complications

    2 years

Study Arms (2)

Phaco/KDB

ACTIVE COMPARATOR

Eyes needing glaucoma and cataract extraction will receive combined KDB and phacoemulsification in one eye of a patient

Procedure: KDB/Phacoemulsification

Phaco/Trabectome

ACTIVE COMPARATOR

Contralateral eyes needing glaucoma and cataract extraction will receive combined Trabectome and phacoemulsification in contralateral eye of the same patient

Procedure: Trabectome/Phacoemulsification

Interventions

KDB/PhacoemulsificationPROCEDURE

50 eyes of 50 patients will receive combined KDB/phaco surgery

Phaco/KDB
Trabectome/PhacoemulsificationPROCEDURE

The contralateral 50 eyes of the same 50 patients will receive combined Trabectome /phaco surgery

Phaco/Trabectome

Eligibility Criteria

Age18 Years - 95 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The Ira G. Ross Eye Institute

Buffalo, New York, 14209, United States

Location

MeSH Terms

Conditions

Glaucoma

Interventions

Phacoemulsification

Condition Hierarchy (Ancestors)

Ocular HypertensionEye Diseases

Intervention Hierarchy (Ancestors)

Cataract ExtractionRefractive Surgical ProceduresOphthalmologic Surgical ProceduresSurgical Procedures, OperativeUltrasonic Surgical Procedures

Study Officials

  • Asher Weiner, MD

    State University of New York at Buffalo

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Clinical Associate Professor

Study Record Dates

First Submitted

March 25, 2019

First Posted

March 28, 2019

Study Start

March 6, 2019

Primary Completion

November 9, 2023

Study Completion

November 9, 2023

Last Updated

July 30, 2024

Record last verified: 2024-07

Data Sharing

IPD Sharing
Will not share

Locations

US(1)