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

Overview

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 Type

  • Study Type: Interventional
  • Study Design
    • Allocation: N/A
    • Intervention Model: Single Group Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: January 30, 2020

Interventions

  • Device: kahook dual blade
    • Combined Phacoemulsification and Excisional Goniotomy with the Kahook Dual Blade

Arms, Groups and Cohorts

  • 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.

Clinical Trial Outcome Measures

Primary Measures

  • 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.
  • 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

Secondary Measures

  • 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.

Participating in This Clinical Trial

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.

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

  • Lead Sponsor
    • Ahmed Al Habash
  • Provider of Information About this Clinical Study
    • Sponsor-Investigator: Ahmed Al Habash, Dr. Ahmed Al Habash, MD assistant professor, consultant cataract and glaucoma – Imam Abdulrahman Bin Faisal University
  • Overall Official(s)
    • Ahmed Al habash, MD, Principal Investigator, assistant professor

Clinical trials entries are delivered from the US National Institutes of Health and are not reviewed separately by this site. Please see the identifier information above for retrieving further details from the government database.

At TrialBulletin.com, we keep tabs on over 200,000 clinical trials in the US and abroad, using medical data supplied directly by the US National Institutes of Health. Please see the About and Contact page for details.