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

July 28, 2020 updated by: Ahmed Al Habash

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

57

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Saudi Arabia
      • Dammam, Saudi Arabia
        • Imam Abdulrahman Bin Faisal University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: combined (phaco-kdb)
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.
Device: kahook dual blade
Combined Phacoemulsification and Excisional Goniotomy with the Kahook Dual Blade
Other Names:
  • phacoemulsification

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Intraocular pressure
Time Frame: 36 months
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.
36 months
Intraocular pressure lowering medications
Time Frame: 36 months
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
36 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Visual acuity
Time Frame: 36 months
Characterize visual acuity (VA) using logMAR chart, each visit in clinic post undergoing combined phacoemulsification and excisional goniotomy with the kahook dual blade.
36 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ahmed Al Habash

Investigators

  • Principal Investigator: Ahmed Al habash, MD, Assistant Professor

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2017

Primary Completion (Actual)

January 30, 2020

Study Completion (Actual)

January 30, 2020

Study Registration Dates

First Submitted

July 10, 2020

First Submitted That Met QC Criteria

July 14, 2020

First Posted (Actual)

July 20, 2020

Study Record Updates

Last Update Posted (Actual)

July 29, 2020

Last Update Submitted That Met QC Criteria

July 28, 2020

Last Verified

July 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IRB -2020-01-169

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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