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Long Term Outcome of Combined Phacoemulsification and Excisional Goniotomy With the Kahook Dual Blade

Primary Purpose

Glaucoma, Glaucoma, Open-Angle, Cataract

Status
Completed
Phase
Not Applicable
Locations
Saudi Arabia
Study Type
Interventional
Intervention
kahook dual blade
Sponsored by
Ahmed Al Habash
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Glaucoma focused on measuring glaucoma, goniotomy, Kahook Dual Blade, combined phacoemulsification, MIGS, Schlemm's Canal

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

inclusion criteria:

  • adults 18 years or older
  • medically-managed glaucoma
  • visually significant cataract

Exclusion Criteria:

  • Patients undergoing any other combined procedures
  • active uveitis
  • coexisting retinopathy that limits visual acuity potential
  • active neovascularization
  • angle dysgenesis
  • those with less than 6 months of follow-up, were excluded.

Sites / Locations

  • Imam Abdulrahman Bin Faisal University Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

combined (phaco-kdb)

Arm Description

Prospective, non-comparative, uncontrolled, non-randomized interventional case series. Consecutive patients with medically-treated glaucoma and visually-significant cataract underwent combined surgery. Subgroup analysis of glaucoma subtypes was performed.

Outcomes

Primary Outcome Measures

Intraocular pressure
Characterize changes in intraocular pressure (IOP) in mmHg goldmann applanation tonometry each visit in the clinic after the combined phacoemulsification and excisional goniotomy with the kahook dual blade.
Intraocular pressure lowering medications
count the change in number of Intraocular pressure lowering medications each visit in the clinic after the combined phacoemulsification and excisional goniotomy with the kahook dual blade

Secondary Outcome Measures

Visual acuity
Characterize visual acuity (VA) using logMAR chart, each visit in clinic post undergoing combined phacoemulsification and excisional goniotomy with the kahook dual blade.

Full Information

First Posted
July 10, 2020
Last Updated
July 28, 2020
Sponsor
Ahmed Al Habash
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1. Study Identification

Unique Protocol Identification Number
NCT04476810
Brief Title
Long Term Outcome of Combined Phacoemulsification and Excisional Goniotomy With the Kahook Dual Blade
Official Title
Long Term Outcome of Combined Phacoemulsification and Excisional Goniotomy With the Kahook Dual Blade
Study Type
Interventional

2. Study Status

Record Verification Date
July 2020
Overall Recruitment Status
Completed
Study Start Date
January 1, 2017 (Actual)
Primary Completion Date
January 30, 2020 (Actual)
Study Completion Date
January 30, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Ahmed Al Habash

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief Summary
Purpose: Characterize changes in intraocular pressure (IOP), IOP-lowering medications, and visual acuity (VA) through 3 years in patients undergoing combined phacoemulsification and excisional goniotomy with the Kahook Dual Blade (phaco-KDB), with simultaneous goniosynechialysis in cases of angle-closure glaucoma, by a single surgeon (A.H.) in King Fahd Hospital of the University, Dammam, Saudi Arabia. Methods: Prospective, non-comparative, uncontrolled, non-randomized interventional case series. Consecutive patients with medically-treated glaucoma and visually-significant cataract underwent combined surgery. Subgroup analysis of glaucoma subtypes was performed.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Glaucoma, Glaucoma, Open-Angle, Cataract, Angle Closure Glaucoma, Surgery
Keywords
glaucoma, goniotomy, Kahook Dual Blade, combined phacoemulsification, MIGS, Schlemm's Canal

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
Prospective, non-comparative, uncontrolled, non-randomized interventional case series. Consecutive patients with medically-treated glaucoma and visually-significant cataract underwent combined surgery. Subgroup analysis of glaucoma subtypes was performed.
Masking
None (Open Label)
Allocation
N/A
Enrollment
57 (Actual)

8. Arms, Groups, and Interventions

Arm Title
combined (phaco-kdb)
Arm Type
Experimental
Arm Description
Prospective, non-comparative, uncontrolled, non-randomized interventional case series. Consecutive patients with medically-treated glaucoma and visually-significant cataract underwent combined surgery. Subgroup analysis of glaucoma subtypes was performed.
Intervention Type
Device
Intervention Name(s)
kahook dual blade
Other Intervention Name(s)
phacoemulsification
Intervention Description
Combined Phacoemulsification and Excisional Goniotomy with the Kahook Dual Blade
Primary Outcome Measure Information:
Title
Intraocular pressure
Description
Characterize changes in intraocular pressure (IOP) in mmHg goldmann applanation tonometry each visit in the clinic after the combined phacoemulsification and excisional goniotomy with the kahook dual blade.
Time Frame
36 months
Title
Intraocular pressure lowering medications
Description
count the change in number of Intraocular pressure lowering medications each visit in the clinic after the combined phacoemulsification and excisional goniotomy with the kahook dual blade
Time Frame
36 months
Secondary Outcome Measure Information:
Title
Visual acuity
Description
Characterize visual acuity (VA) using logMAR chart, each visit in clinic post undergoing combined phacoemulsification and excisional goniotomy with the kahook dual blade.
Time Frame
36 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
inclusion criteria: adults 18 years or older medically-managed glaucoma visually significant cataract Exclusion Criteria: Patients undergoing any other combined procedures active uveitis coexisting retinopathy that limits visual acuity potential active neovascularization angle dysgenesis those with less than 6 months of follow-up, were excluded.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ahmed Al habash, MD
Organizational Affiliation
assistant professor
Official's Role
Principal Investigator
Facility Information:
Facility Name
Imam Abdulrahman Bin Faisal University Hospital
City
Dammam
Country
Saudi Arabia

12. IPD Sharing Statement

Plan to Share IPD
Undecided

Learn more about this trial

Long Term Outcome of Combined Phacoemulsification and Excisional Goniotomy With the Kahook Dual Blade

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