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

NCT04476810 | Completed

• 1 other identifier: IRB -2020-01-169
• Study Type: interventional
• Target: 57
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

glaucoma; goniotomy; Kahook Dual Blade; combined phacoemulsification; MIGS; Schlemm's Canal

Outcome Measures

Primary Outcomes (2)

• 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

• 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 Outcomes (1)

• Visual acuity

  36 months

Study Arms (1)

combined (phaco-kdb)

EXPERIMENTAL

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

Interventions

kahook dual blade DEVICE

Combined Phacoemulsification and Excisional Goniotomy with the Kahook Dual Blade

Also known as: phacoemulsification

combined (phaco-kdb)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• adults 18 years or older
• medically-managed glaucoma
• visually significant cataract

You may not qualify if:

• 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.

Sponsors & Collaborators

• Ahmed Al Habash: lead

Study Sites (1)

Imam Abdulrahman Bin Faisal University Hospital

Dammam, Saudi Arabia

Location

MeSH Terms

Conditions

Glaucoma; Glaucoma, Open-Angle; Cataract; Glaucoma, Angle-Closure

Interventions

Phacoemulsification

Condition Hierarchy (Ancestors)

Ocular Hypertension; Eye Diseases; Lens Diseases

Intervention Hierarchy (Ancestors)

Cataract Extraction; Refractive Surgical Procedures; Ophthalmologic Surgical Procedures; Surgical Procedures, Operative; Ultrasonic Surgical Procedures

Study Officials

• Ahmed Al habash, MD

  assistant professor

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Dr. Ahmed Al Habash, MD assistant professor, consultant cataract and glaucoma

Model Details: 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 Record Dates

• First Submitted: July 10, 2020
• First Posted: July 20, 2020
• Study Start: January 1, 2017
• Primary Completion: January 30, 2020
• Study Completion: January 30, 2020
• Last Updated: July 29, 2020

Record last verified: 2020-07

Locations

SA (1)