Kahook Dual Blade Ab-interno Trabeculotomy Versus ab Externo Viscotrabeculotomy in Primary Congenital Glaucoma

This prospective study aims to compare KDB ab-interno trabeculotomy to ab externo rigid probe viscotrabeculotomy in patients with PCG.

Study Overview

• Status: Not yet recruiting
• Conditions: Glaucoma; Congenital Glaucoma
• Intervention / Treatment: Procedure: The Kahook dual blade® (KDB) assisted ab-interno trabeculotomy; Procedure: ab externo viscotrabeculotomy

Detailed Description

Introduction:

Ab externo viscotrabeculotomy is known as an effective surgical procedure used for managing primary congenital glaucoma (PCG) in which the Schlemm's canal (SC) is identified and a metal probe is inserted into the canal and rotated into the anterior chamber (AC) to perforate the SC inner wall.

Recently, Kahook dual blade (KDB) have been developed as one of the micro-invasive glaucoma surgical tools which removes a strip of the trabecular meshwork(TM) at the angle with superiority to simple goniotomy in treating the angle pathology in PCG.

The Kahook dual blade® (KDB) assisted ab-interno trabeculotomy is a simple procedure usually performed at the time of cataract surgery. It doesn't require sutures, and it carries no risk of bleb leaks or infections. It has a a quicker postoperative visual recovery than most other glaucoma treatments. The KDB device is specifically designed to produce targeted and fine tuned parallel incisions in the trabecular meshwork tissue for a quick and effective glaucoma treatment. The KDB's unique design enables precise excision of diseased trabecular meshwork (TM) to access multiple collector channels.

The KDB's unique design enables the operator to perform excisional goniotomy both during cataract surgery and as a stand alone procedure. The Kahook Dual Blade is a precise, intuitive surgical instrument utilized to perform excisional goniotomy.

Purpose:

This prospective study aims to compare KDB ab-interno trabeculotomy to ab externo rigid probe viscotrabeculotomy in patients with PCG.

Methods:

Sixty eyes of with PCG underwent ab-interno trabeculotomy using a KDB or ab externo viscotrabeculotomy. The study will be conducted at Mansoura university ophthalmic Center. Follow-up visits were scheduled at these post-operative dates: first day, first week, first month, 3rd month and then every 3 months for 2 years. Complete success was defined as an IOP from 6 to 17 mmHg at the 2-year follow-up visit, without AGM or further surgical interventions, without any sign of glaucoma progression (increasing corneal diameter, axial length or cup/disc ratio) and without visual devastating complications. Qualified success was defined as fulfilling the same criteria but with the use of AGM.

Preoperative data including age, sex, laterality, type of glaucoma, ocular history, number of glaucoma medications, IOP, cup to disc ratio, and central corneal thickness (CCT) were record. Postoperative data included follow-up durations.

Statistical analysis:

All statistical analysis will be accomplished using IBM SPSS version 20. Assessment of the data normality will be done using both Histogram plot and Shapiro-Wilk's test. Wilcoxon test was used to compare the preoperative and postoperative variables in each group. The comparison between the two groups will be done using Mann-Whitney test for numerical variables and Chi-square test for categorical variables. Kaplan-Meier survival curve will be plotted to estimate the mean survival time and probabilities of failure at different follow-up stages in the both groups. For all tests, P value of less than 0.05 will be considered significant.

• Study Type: Interventional
• Enrollment (Anticipated): 60
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Amr M Abdelkader, MD, FRCS; Phone Number: 01004314242; Email: dramrabdelkader@gmail.com
• Study Contact Backup: Name: Ahmed s Elwehidy, MD; Phone Number: +20 1009922107; Email: aselwehidy@yahoo.com

Study Locations

• Egypt
  • Mansoura, Egypt, 35516
    • Mansoura university ophthalmic center
    • Contact: Amr Abdelkader, MD, FRCS; Phone Number: 020 01004314242; Email: dramrabdelkader@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 month to 10 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

primary congenital glaucoma

Exclusion Criteria:

secondary congenital glaucoma

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Kahook dual blade ab-interno Trabeculotomy; The Kahook dual blade® (KDB) assisted ab-interno trabeculotomy	Procedure: The Kahook dual blade® (KDB) assisted ab-interno trabeculotomy; The Kahook dual blade® (KDB) assisted ab-interno trabeculotomy
Active Comparator: ab externo viscotrabeculotomy; In brief, a fornix-based conjunctival incision is followed by fashioning and dissection of a triangular scleral flap. Radial incisions at the limbus followed to identify Schlemm's canal. viscotrabeculotomy, is performed by injection of high-viscosity sodium hyaluronate (Healon GV, Pfizer, NY) into Schlemm's canal prior to completion of the procedure with the metal trabeculotome. while a Nylon 10/0 suture in inserted into schlemm's canal in visco-circumferential-suture trabeculotomy group.	Procedure: ab externo viscotrabeculotomy; In brief, a fornix-based conjunctival incision is followed by fashioning and dissection of a triangular scleral flap. Radial incisions at the limbus followed to identify Schlemm's canal. viscotrabeculotomy, is performed by injection of high-viscosity sodium hyaluronate (Healon GV, Pfizer, NY) into Schlemm's canal prior to completion of the procedure with the metal trabeculotome. while a Nylon 10/0 suture in inserted into schlemm's canal in visco-circumferential-suture trabeculotomy group

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
IOP	Complete success was defined as an IOP from 6 to 17 mmHg at the 2-year follow-up visit, without AGM or further surgical interventions, without any sign of glaucoma progression (increasing corneal diameter, axial length or cup/disc ratio) and without visual devastating complications. Qualified success was defined as fulfilling the same criteria but with the use of AGM.	2 years

Collaborators and Investigators

• Sponsor: Mansoura University
• Investigators: Study Chair: Ahmed S Elwehidy, DM, Mansoura faculty of Medicine

Study record dates

Study Major Dates

• Study Start (Anticipated): November 1, 2021
• Primary Completion (Anticipated): November 1, 2023
• Study Completion (Anticipated): November 1, 2024

Study Registration Dates

• First Submitted: October 30, 2021
• First Submitted That Met QC Criteria: November 9, 2021
• First Posted (Actual): November 10, 2021

Study Record Updates

• Last Update Posted (Actual): November 10, 2021
• Last Update Submitted That Met QC Criteria: November 9, 2021
• Last Verified: October 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Eye Diseases; Congenital Abnormalities; Ocular Hypertension; Eye Abnormalities; Glaucoma, Open-Angle; Infant, Newborn, Diseases; Glaucoma; Hydrophthalmos
• Other Study ID Numbers: R.21.10.1477

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Yes
• IPD Plan Description: share primitive data as supplementary digital content
• IPD Sharing Supporting Information Type: Study Protocol; Statistical Analysis Plan (SAP); Informed Consent Form (ICF)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No