Visco-Circumferential-Suture-Trabeculotomy Versus Rigid Probe Viscotrabeculotomy in Primary Open Angle Glaucoma

NCT05666440 | Unknown DMC

• 1 other identifier: VCSTvVTinPOAG
• Study Type: interventional
• Target: 166
• Locations: 0 countries
• Sites: N/A

Brief Summary

Visco-Circumferential-Suture-Trabeculotomy versus Rigid probe Viscotrabeculotomy in Primary Open Angle Glaucoma.

Conditions

Primary Open Angle Glaucoma

Outcome Measures

Primary Outcomes (3)

• The primary outcome measure was the IOP

  Success was defned as \[15\] an IOP ≤ 18 mmHg (criteria 1), an IOP ≤ 16 mmHg (criteria 2), IOP ≤ 14 mmHg (criteria 3) and ≤ 12 mmHg (criteria 4) and/or IOP reduction by ≥ 30% of baseline IOP (last IOP measurement immediately before surgery) without IOP lowering medications (complete success) (qualifed success was defned as IOP controlled according to the same criteria with/without IOP lowering medications), without the need for further surgery for IOP reduction and without any vision threatening complications or hypotony (IOP ≤ 5 mmHg).

  2 years

• BCVA

  2 years

• number of IOP lowering medications.

  2 years

Study Arms (2)

Visco-Circumferential-Suture-Trabeculotomy

ACTIVE COMPARATOR

Visco-Circumferential-Suture-Trabeculotomy in Primary Open Angle Glaucoma.

Procedure: Visco-Circumferential-Suture-Trabeculotomy in Primary Open Angle Glaucoma.

Rigid probe Viscotrabeculotomy

ACTIVE COMPARATOR

Rigid probe Viscotrabeculotomy in Primary Open Angle Glaucoma.

Procedure: Rigid probe Viscotrabeculotomy in Primary Open Angle Glaucoma.

Interventions

Visco-Circumferential-Suture-Trabeculotomy in Primary Open Angle Glaucoma. PROCEDURE

A superior limbal-based conjunctival flap and a paracentesis. A superficial rectangular scleral flap 4×4 mm was fashioned and dissected forward toward the limbus. A deep sceral flap (2×2 mm) was then created toward the limbus underneath the superficial flap exposing the scleral spur and deroofing SC. Viscoelastic (Healon GV, Pfizer, NY) was injected (using a standard 30 G viscocanalostomy cannula) into the ostia of SC Then, the 5/0 polypropylene suture tip was cauterized into a blunt tip (to ensure atraumatic probing of SC). The tip was inserted into the left ostium of SC using a microsurgical forceps and advanced through the whole circumference of the canal. When the tip presented to the right ostium the AC was filled with a viscoelastic through the paracentesis and traction was applied to approximate both ends of the 5/0 polypropylene suture, thus creating a visco-360-degree trabeculotomy.

Visco-Circumferential-Suture-Trabeculotomy

Rigid probe Viscotrabeculotomy in Primary Open Angle Glaucoma. PROCEDURE

A fornixbased conjunctival incision followed by creation of a partial thickness (about 50% thickness) triangular (4×4×4 mm) scleral fap, followed by localization of Schlemm's canal by radial incisions straddling the limbus. High viscosity sodium hyaluronate (Healon GV, Pfzer) was then slowly injected into both ends of Schlemm's canal. Trabeculotomy was completed using the standard Harm's trabeculotome (Geuder Instruments), the scleral fap was then secured tightly with interrupted 10/0 Nylon sutures and conjunctival closure ensued.

Rigid probe Viscotrabeculotomy

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \- The diagnosis of OAG was based on the optic nerve head appearance typical to glaucoma (increased optic disc cupping, thinning of the neuro-retinal rim, focal notching, splinter haemorrhage), corresponding visual feld loss typical to glaucoma coupled with an elevated IOP above the statistical normal of 21 mmHg and a gonioscopically open angle in the absence of any known cause for glaucoma. IOP-lowering medications were initiated for all patients and only those patients in whom control of the disease failed (as evidenced by progressive optic nerve damage and/or visual feld deterioration) and the decision for surgical intervention to lower the IOP was taken were enrolled in the study. Adult patients (above 18 years of age) fulflling these criteria were enrolled

You may not qualify if:

• Other types of glaucomas and co-morbidities

Sponsors & Collaborators

• Mansoura University: lead

MeSH Terms

Conditions

Glaucoma, Open-Angle

Condition Hierarchy (Ancestors)

Glaucoma; Ocular Hypertension; Eye Diseases

Central Study Contacts

Amr M Abdelkader, MD, FRCS

CONTACT

1004314242; dramrabdelkader@gmail.com

Ahmed s Elwehidy, MD

CONTACT

1009922107; aselwehidy@yahoo.com

Study Design

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

Model Details: Double armed International study

Study Record Dates

• First Submitted: December 17, 2022
• First Posted: December 27, 2022
• Study Start: January 1, 2023
• Primary Completion: March 1, 2023
• Study Completion: April 1, 2023
• Last Updated: December 27, 2022

Record last verified: 2022-12

Data Sharing

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