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

Not Applicable

Completed

• Conditions: Surgery; Angle Closure Glaucoma; Glaucoma; Cataract; Glaucoma, Open-Angle
• Interventions: Device: kahook dual blade

• Registration Number: NCT04476810
• Lead Sponsor: Ahmed Al Habash

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2017-01-01
• Primary Completion: 2020-01-30
• Study Completion: 2020-01-30
• Status Verified: 2020-07
• Study First Submitted: 2020-07-10
• Study First Submitted QC: 2020-07-14
• Study First Posted: 2020-07-20
• Last Update Submitted: 2020-07-28
• Last Update Posted: 2020-07-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 57

Inclusion Criteria

Not provided

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
combined (phaco-kdb)	kahook dual blade	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.

Primary Outcome Measures

Name	Time	Method
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.
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

Name	Time	Method
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.

Trial Locations

Locations (1)

Imam Abdulrahman Bin Faisal University Hospital; 🇸🇦 Dammam, Saudi Arabia