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

Sponsor
Ahmed Al Habash (Other)
Overall Status
Completed
CT.gov ID
NCT04476810
Collaborator
(none)
57
Enrollment
1
Location
1
Arm
36.9
Actual Duration (Months)
1.5
Patients Per Site Per Month

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Device: kahook dual blade
 N/A

Study Design

Study Type:
Interventional
Actual Enrollment :
57 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Intervention 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.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)
Primary Purpose:
Treatment
Official Title:
Long Term Outcome of Combined Phacoemulsification and Excisional Goniotomy With the Kahook Dual Blade
Actual Study Start Date :
Jan 1, 2017
Actual Primary Completion Date :
Jan 30, 2020
Actual Study Completion Date :
Jan 30, 2020

Arms and Interventions

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

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Intraocular pressure [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.

    2. Intraocular pressure lowering medications [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 Outcome Measures

    1. Visual acuity [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.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes

    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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Imam Abdulrahman Bin Faisal University Hospital Dammam Saudi Arabia

    Sponsors and Collaborators

    • Ahmed Al Habash

    Investigators

    • Principal Investigator: Ahmed Al habash, MD, assistant professor

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Ahmed Al Habash, Dr. Ahmed Al Habash, MD assistant professor, consultant cataract and glaucoma, Imam Abdulrahman Bin Faisal University
    ClinicalTrials.gov Identifier:
    NCT04476810
    Other Study ID Numbers:
    • IRB -2020-01-169
    First Posted:
    Jul 20, 2020
    Last Update Posted:
    Jul 29, 2020
    Last Verified:
    Jul 1, 2020
    Individual Participant Data (IPD) Sharing Statement:
    Undecided
    Plan to Share IPD:
    Undecided
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Ahmed Al Habash, Dr. Ahmed Al Habash, MD assistant professor, consultant cataract and glaucoma, Imam Abdulrahman Bin Faisal University
    glaucoma
    goniotomy
    Kahook Dual Blade
    combined phacoemulsification
    MIGS
    Schlemm's Canal
    Additional relevant MeSH terms:
    Glaucoma
    Cataract
    Glaucoma, Open-Angle
    Glaucoma, Angle-Closure

    Study Results

    No Results Posted as of Jul 29, 2020