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

Surgery Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04476810
• Other study ID #: IRB -2020-01-169
• Status: Completed
• Phase: N/A
• Start date: January 1, 2017
• Est. completion date: January 30, 2020

Study information

• Verified date: July 2020
• Source: Imam Abdulrahman Bin Faisal University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 57
• Est. completion date: January 30, 2020
• Est. primary completion date: January 30, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Angle Closure Glaucoma
• Cataract
• Glaucoma
• Glaucoma, Angle-Closure
• Glaucoma, Open-Angle
• Surgery

Intervention

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

Locations

Country	Name	City	State
Saudi Arabia	Imam Abdulrahman Bin Faisal University Hospital	Dammam

Sponsors (1)

Lead Sponsor	Collaborator
Ahmed Al Habash

Country where clinical trial is conducted

Saudi Arabia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	36 months
Primary	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	36 months
Secondary	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.	36 months