Viscotrabeculotomy in Pediatric Glaucoma Following Cataract Surgery

NCT05011747 | Unknown

• 1 other identifier: Viscotrabeculotomy in GFCS
• Study Type: interventional
• Target: 20
• Locations: 0 countries
• Sites: N/A

Brief Summary

Long term Surgical Outcomes of Viscotrabeculotomy in Pediatric Glaucoma Following Cataract Surgery. Purpose: This study aims to compare outcomes of single-site rigid probe viscotrabeculotomy (VT) to two-site VT in pediatric secondary glaucoma following cataract surgery. Methods: This is a comparative study was performed on patients aged ≤ 12 years and required surgery for glaucoma following congenital cataract surgery (GFCS) with or without intraocular lens (IOL) implantation. Eyes in which the trabeculotomy involves \<180° of Schlemm's canal ,eyes that have synechial angle closure over ≥ 90° and eyes that have previous procedures other than lensectomy or IOL implantation are excluded from the study. Eyes are then randomized to undergo single-site VT or two-site VT using a random table. The two-site VT by the rigid probe trabeculotome is performed through a superonasal and an inferotemporal triangular scleral flap. Intraocular pressure (IOP), anti-glaucoma medications, complications and success rates at dates of follow up are all reported. Success is defined as IOP between 6-20 mmHg or 35% IOP reduction with or without topical anti-glaucoma medications and without visually-devastating complications or additional glaucoma surgery.

Conditions

Glaucoma Congenital

Keywords

Pediatric glaucoma,; Trabeculotomy; Congenital cataract surgery

Outcome Measures

Primary Outcomes (1)

• the success rate in lowering IOP

  Success is defined as IOP between 6-20 mmHg or 35% IOP reduction with or without topical anti-glaucoma medications and without visually-devastating complications or additional glaucoma surgery. IOP was evaluted during each Follow up visit using applanation tonometry.

  3 years

Secondary Outcomes (6)

• Intraocular pressure (IOP) control values

  3 years

• antiglaucoma medications.

  3 years

• postoperative complications

  3 years

• horizontal corneal diameter.

  3 years

• axial length.

  3 yeras

Study Arms (2)

single-site VT group

ACTIVE COMPARATOR

Viscotrabeculotomy is performed through a superonasal triangular scleral flap.

Procedure: single-site rigid probe viscotrabeculotomy (VT)

two-site VT group

ACTIVE COMPARATOR

Viscotrabeculotomy is performed through a superonasal and an inferotemporal triangular scleral flap.

Procedure: two-site rigid probe viscotrabeculotomy (VT)

Interventions

single-site rigid probe viscotrabeculotomy (VT) PROCEDURE

single-site VT by the rigid probe trabeculotome is performed through a superonasal triangular scleral flap.

single-site VT group

two-site rigid probe viscotrabeculotomy (VT) PROCEDURE

Two-site VT by the rigid probe trabeculotome is performed through a superonasal and an inferotemporal triangular scleral flap.

two-site VT group

Eligibility Criteria

• Age: 2 Months - 12 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Patients aged ≤ 12 years and required surgery for glaucoma following congenital cataract surgery (GFCS) with or without intraocular lens (IOL) implantation.

You may not qualify if:

• Eyes in which the trabeculotomy involves \<180° of Schlemm's canal.
• Eyes that have synechial angle closure over ≥ 90°.
• Eyes that have previous procedures other than lensectomy or IOL implantation.

Sponsors & Collaborators

• Mansoura University: lead

MeSH Terms

Conditions

Hydrophthalmos

Condition Hierarchy (Ancestors)

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

Central Study Contacts

Amr Mohammed Elsayed A Mohammed, MD, FRCS

CONTACT

01004314242; dramrabdelkader@gmail.com

Ahmed S Elwehidy, MD

CONTACT

01009922107; aselwehidy@yahoo.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate professor of ophthalmology

Study Record Dates

• First Submitted: August 6, 2021
• First Posted: August 18, 2021
• Study Start: September 1, 2021
• Primary Completion: September 1, 2024
• Study Completion: December 1, 2024
• Last Updated: August 18, 2021

Record last verified: 2021-08

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: 3 years
• Access Criteria: IPD will be provided as a supplementary digital content with publication