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

NCT05115708 | Unknown

• 1 other identifier: R.21.10.1477
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Glaucoma; Congenital Glaucoma

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

Kahook dual blade ab-interno Trabeculotomy

ACTIVE COMPARATOR

The Kahook dual blade® (KDB) assisted ab-interno trabeculotomy

Procedure: The Kahook dual blade® (KDB) assisted ab-interno trabeculotomy

ab externo viscotrabeculotomy

ACTIVE COMPARATOR

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

Interventions

ab externo viscotrabeculotomy PROCEDURE

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

ab externo viscotrabeculotomy

The Kahook dual blade® (KDB) assisted ab-interno trabeculotomy PROCEDURE

The Kahook dual blade® (KDB) assisted ab-interno trabeculotomy

Kahook dual blade ab-interno Trabeculotomy

Eligibility Criteria

• Age: 1 Month - 10 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• primary congenital glaucoma

You may not qualify if:

• secondary congenital glaucoma

Sponsors & Collaborators

• Mansoura University: lead

Study Sites (1)

Mansoura university ophthalmic center

Al Mansurah, 35516, Egypt

Location

MeSH Terms

Conditions

Glaucoma; Hydrophthalmos

Condition Hierarchy (Ancestors)

Ocular Hypertension; Eye Diseases; Eye Abnormalities; Glaucoma, Open-Angle; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Infant, Newborn, Diseases

Study Officials

• Ahmed S Elwehidy, DM

  Mansoura faculty of medicine

  STUDY CHAIR

Central Study Contacts

Amr M Abdelkader, MD, FRCS

CONTACT

01004314242; dramrabdelkader@gmail.com

Ahmed s Elwehidy, MD

CONTACT

1009922107; aselwehidy@yahoo.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assisstant professor of ophthalmology

Model Details: Kahook dual blade ab-interno Trabeculotomy versus ab externo viscotrabeculotomy in treatment of primary congenital glaucoma.

Study Record Dates

• First Submitted: October 30, 2021
• First Posted: November 10, 2021
• Study Start: November 1, 2021
• Primary Completion: November 1, 2023
• Study Completion: November 1, 2024
• Last Updated: November 10, 2021

Record last verified: 2021-10

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF

Locations

EG (1)