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Effect of Intra-subject Phaco/Trabectome vs. Phaco/Kahook Dual Blade on Intraocular Pressure

Primary Purpose

Glaucoma

Status
Active
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
KDB/Phacoemulsification
Trabectome/Phacoemulsification
Sponsored by
State University of New York at Buffalo
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Glaucoma focused on measuring Kahook dual blade, Trabectome, Intraocular Pressure

Eligibility Criteria

18 Years - 95 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • The Ira G. Ross Eye Institute

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Phaco/KDB

Phaco/Trabectome

Arm Description

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

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
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.
Rate of post surgical complications
Rate of post surgical complications such as Hypotony, Corneal Edema, Hyphema, Iritis, Vitreous Hemorrhage and Cystoid Macular Edema.

Full Information

First Posted
March 25, 2019
Last Updated
April 13, 2023
Sponsor
State University of New York at Buffalo
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1. Study Identification

Unique Protocol Identification Number
NCT03894631
Brief Title
Effect of Intra-subject Phaco/Trabectome vs. Phaco/Kahook Dual Blade on Intraocular Pressure
Official Title
Intra-subject Comparison Between the Effect of Combined Phaco/Trabectome vs. Phaco/Kahook Dual Blade on Intra Ocular Pressure and Other Surgical Outcomes
Study Type
Interventional

2. Study Status

Record Verification Date
April 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
March 6, 2019 (Actual)
Primary Completion Date
January 31, 2024 (Anticipated)
Study Completion Date
January 31, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
State University of New York at Buffalo

4. Oversight

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
Data Monitoring Committee
No

5. Study Description

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.
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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Glaucoma
Keywords
Kahook dual blade, Trabectome, Intraocular Pressure

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
80 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Phaco/KDB
Arm Type
Active Comparator
Arm Description
Eyes needing glaucoma and cataract extraction will receive combined KDB and phacoemulsification in one eye of a patient
Arm Title
Phaco/Trabectome
Arm Type
Active Comparator
Arm Description
Contralateral eyes needing glaucoma and cataract extraction will receive combined Trabectome and phacoemulsification in contralateral eye of the same patient
Intervention Type
Procedure
Intervention Name(s)
KDB/Phacoemulsification
Intervention Description
50 eyes of 50 patients will receive combined KDB/phaco surgery
Intervention Type
Procedure
Intervention Name(s)
Trabectome/Phacoemulsification
Intervention Description
The contralateral 50 eyes of the same 50 patients will receive combined Trabectome /phaco surgery
Primary Outcome Measure Information:
Title
Changes in intraocular pressure measurements between baseline and postoperative followup visits
Description
Baseline (pre-operative condition) and post operative intraocular pressure will be measured on Day1, Week1, Months 1, 3, 6, 12, 18 and 24.
Time Frame
2 years
Secondary Outcome Measure Information:
Title
Changes in visual acuity measurements measured using a Snellen Vision Chart between baseline and postoperative followup visits
Description
Baseline (pre-operative condition) and post operative visual acuity will be measured on Day1, Week1, Months 1, 3, 6, 12, 18 and 24.
Time Frame
2 years
Title
Changes in number of medications between baseline and postoperative followup visits
Description
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.
Time Frame
2 years
Title
Rate of post surgical complications
Description
Rate of post surgical complications such as Hypotony, Corneal Edema, Hyphema, Iritis, Vitreous Hemorrhage and Cystoid Macular Edema.
Time Frame
2 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
95 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Asher Weiner, MD
Organizational Affiliation
State University of New York at Buffalo
Official's Role
Principal Investigator
Facility Information:
Facility Name
The Ira G. Ross Eye Institute
City
Buffalo
State/Province
New York
ZIP/Postal Code
14209
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Effect of Intra-subject Phaco/Trabectome vs. Phaco/Kahook Dual Blade on Intraocular Pressure

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